documents.json

[
    {
      "Doc_ID_Type": "DIS-PLAN-RES", "Document_Name": "Research Plan/Proposal", "Phase": "Discovery", "Sub_Phase_Discipline": "Target ID / Hit ID / Lead Opt",
      "Purpose_Key_Content": "Outlines objectives, rationale, methods, resources, and timelines for a specific research project or program.",
      "Key_Metadata": "Project ID, Target ID, Therapeutic Area, PI Name, Budget Code",
      "Input_Documents_Data_Sources": "Literature Review, Previous Internal Data, Strategic Goals",
      "Output_Informs_Documents": "Project Initiation, Resource Allocation, Specific Experiments",
      "Authoring_Department(s)": "Research Scientist, PI, Therapeutic Area Lead", "Review_Approval_Dept(s)": "Research Mgmt, Finance (budget)",
      "Complexity_Authoring": "Medium", "Regulatory_Significance": "Internal Strategy/Governance"
    },
    {
      "Doc_ID_Type": "DIS-NOTE-ELN", "Document_Name": "Electronic Lab Notebook (ELN) Entry", "Phase": "Discovery, Preclinical", "Sub_Phase_Discipline": "All Research/Lab Disciplines",
      "Purpose_Key_Content": "Contemporaneous record of experimental procedures, observations, raw data, and initial analysis.",
      "Key_Metadata": "Experiment ID, Date, Scientist Name, Project ID, Compound/Batch ID",
      "Input_Documents_Data_Sources": "Protocols, SOPs, Previous ELN Entries, Reagent Info",
      "Output_Informs_Documents": "Raw Data Source for Reports, Patent Support, Troubleshooting",
      "Authoring_Department(s)": "Bench Scientist, Researcher", "Review_Approval_Dept(s)": "Peer Reviewer, Lab Head (as needed)",
      "Complexity_Authoring": "Low-Medium", "Regulatory_Significance": "Internal Quality, Patent Support, GLP (if applicable)"
    },
    {
      "Doc_ID_Type": "DIS-REP-LIT", "Document_Name": "Literature Review Report", "Phase": "Discovery, Preclinical, Clinical", "Sub_Phase_Discipline": "All Disciplines",
      "Purpose_Key_Content": "Systematic summary and analysis of published scientific literature on a specific topic (e.g., target, pathway, indication, competitor).",
      "Key_Metadata": "Topic/Keywords, Date Range Searched, Databases Used",
      "Input_Documents_Data_Sources": "Search Strategy, Scientific Databases",
      "Output_Informs_Documents": "Research Plans, Target Validation, Protocol Design, IB Sections",
      "Authoring_Department(s)": "Scientist, Medical Writer, Information Specialist", "Review_Approval_Dept(s)": "Therapeutic Area Lead, Discipline Lead",
      "Complexity_Authoring": "Medium", "Regulatory_Significance": "Internal Strategy, Regulatory Submissions (background)"
    },
    {
      "Doc_ID_Type": "DIS-REP-TVAL", "Document_Name": "Target Validation Report", "Phase": "Discovery", "Sub_Phase_Discipline": "Target ID/Validation",
      "Purpose_Key_Content": "Summarizes evidence validating a biological target for drug intervention. Includes genetic, pathway, literature, and experimental data.",
      "Key_Metadata": "Target ID, Pathway Info, Key Assays Used, Validation Tier",
      "Input_Documents_Data_Sources": "Literature Reviews, Internal Experimental Data (e.g., siRNA/CRISPR results), Bioinformatics Analysis Reports",
      "Output_Informs_Documents": "Go/No-Go Decision for Target, Assay Development Plans, Research Proposals",
      "Authoring_Department(s)": "Biology, Bioinformatics, Research Lead", "Review_Approval_Dept(s)": "Research Mgmt, Therapeutic Area Head",
      "Complexity_Authoring": "Medium", "Regulatory_Significance": "Internal R&D Strategy"
    },
    {
      "Doc_ID_Type": "DIS-REP-BIOINF", "Document_Name": "Bioinformatics Analysis Report", "Phase": "Discovery, Preclinical, Clinical", "Sub_Phase_Discipline": "Bioinformatics / Computational Biology",
      "Purpose_Key_Content": "Documents the methods, results, and interpretation of computational analyses (e.g., genomic, proteomic, pathway analysis).",
      "Key_Metadata": "Analysis Type, Data Source (e.g., GEO ID), Software/Versions Used, Key Findings",
      "Input_Documents_Data_Sources": "Raw Sequence Data, Microarray Data, Public Databases, ELN Data",
      "Output_Informs_Documents": "Target Validation, Biomarker ID, Experimental Design, Publications",
      "Authoring_Department(s)": "Bioinformatician, Computational Biologist", "Review_Approval_Dept(s)": "Biology Lead, Statistician (if complex)",
      "Complexity_Authoring": "Medium-High", "Regulatory_Significance": "Internal R&D, Potential Biomarker Qualification"
    },
    {
      "Doc_ID_Type": "DIS-PROT-ASSAY", "Document_Name": "Assay Development Protocol", "Phase": "Discovery", "Sub_Phase_Discipline": "Hit ID / Lead Opt",
      "Purpose_Key_Content": "Details the plan to develop and validate a specific biological or biochemical assay for screening or characterization.",
      "Key_Metadata": "Assay Type, Target ID, Detection Method, Key Reagents, Platform",
      "Input_Documents_Data_Sources": "Target Validation Report, Literature on similar assays",
      "Output_Informs_Documents": "Assay Development Report, Assay Validation Report",
      "Authoring_Department(s)": "Assay Development Scientist, Biology", "Review_Approval_Dept(s)": "Research Lead",
      "Complexity_Authoring": "Medium", "Regulatory_Significance": "Internal R&D Quality"
    },
    {
      "Doc_ID_Type": "DIS-REP-ASSAYDEV", "Document_Name": "Assay Development Report", "Phase": "Discovery", "Sub_Phase_Discipline": "Hit ID / Lead Opt",
      "Purpose_Key_Content": "Documents the process and results of developing a new assay, including optimization experiments.",
      "Key_Metadata": "Assay ID, Optimization Parameters, Final Conditions, Reagent Sources",
      "Input_Documents_Data_Sources": "Assay Development Protocol, ELN Entries",
      "Output_Informs_Documents": "Assay Validation Protocol/Report, Assay SOP",
      "Authoring_Department(s)": "Assay Development Scientist, Biology", "Review_Approval_Dept(s)": "Research Lead",
      "Complexity_Authoring": "Medium", "Regulatory_Significance": "Internal R&D Quality"
    },
    {
      "Doc_ID_Type": "DIS-PROT-ASSAYVAL", "Document_Name": "Assay Validation Protocol", "Phase": "Discovery", "Sub_Phase_Discipline": "Hit ID / Lead Opt",
      "Purpose_Key_Content": "Defines the plan and acceptance criteria for validating the performance characteristics of an assay.",
      "Key_Metadata": "Assay ID, Validation Parameters (e.g., Accuracy, Precision, Specificity, Robustness), Acceptance Criteria",
      "Input_Documents_Data_Sources": "Assay Development Report",
      "Output_Informs_Documents": "Assay Validation Report",
      "Authoring_Department(s)": "Assay Development Scientist, QA (if needed)", "Review_Approval_Dept(s)": "Research Lead, QA (if needed)",
      "Complexity_Authoring": "Medium", "Regulatory_Significance": "Internal R&D Quality / HTS Readiness"
    },
    {
      "Doc_ID_Type": "DIS-REP-ASSAYVAL", "Document_Name": "Assay Validation Report", "Phase": "Discovery", "Sub_Phase_Discipline": "Hit ID / Lead Opt",
      "Purpose_Key_Content": "Documents the performance characteristics (e.g., Z', S/B, reproducibility, specificity) of a developed assay against pre-defined criteria.",
      "Key_Metadata": "Assay ID, Validation Parameters Results, Pass/Fail Status, SOP Link",
      "Input_Documents_Data_Sources": "Assay Validation Protocol, Raw Validation Data (ELN)",
      "Output_Informs_Documents": "Screening Campaigns (HTS), Compound Profiling, Assay SOP",
      "Authoring_Department(s)": "Assay Development Scientist, Biology", "Review_Approval_Dept(s)": "Research Lead, QA (if applicable)",
      "Complexity_Authoring": "Medium", "Regulatory_Significance": "Internal R&D Quality / HTS"
    },
    {
      "Doc_ID_Type": "DIS-SOP-ASSAY", "Document_Name": "Assay Standard Operating Procedure (SOP)", "Phase": "Discovery, Preclinical", "Sub_Phase_Discipline": "Assay Development / Screening",
      "Purpose_Key_Content": "Detailed step-by-step instructions for performing a validated assay consistently.",
      "Key_Metadata": "SOP Number, Version, Effective Date, Assay ID",
      "Input_Documents_Data_Sources": "Assay Validation Report",
      "Output_Informs_Documents": "Assay Execution, Training Records",
      "Authoring_Department(s)": "Assay Development Scientist, Technical Writer", "Review_Approval_Dept(s)": "QA, Research Lead",
      "Complexity_Authoring": "Medium", "Regulatory_Significance": "Internal Quality / GLP (if applicable)"
    },
    {
      "Doc_ID_Type": "DIS-REP-HTS", "Document_Name": "High-Throughput Screening (HTS) Report", "Phase": "Discovery", "Sub_Phase_Discipline": "Hit ID",
      "Purpose_Key_Content": "Summarizes results of a large-scale screening campaign to identify initial 'hits'. Includes campaign summary, hit list, QC metrics.",
      "Key_Metadata": "Campaign ID, Library Screened, Target ID, Hit Criteria, Plate IDs, % Inhibition/Activity Cutoff",
      "Input_Documents_Data_Sources": "Validated Assay Report/SOP, Compound Library Info, Raw Screening Data (LIMS)",
      "Output_Informs_Documents": "Hit Confirmation Plans, Hit-to-Lead Team Initiation, Compound Triage Reports",
      "Authoring_Department(s)": "HTS Group, Automation, Informatics", "Review_Approval_Dept(s)": "Research Lead, Chemistry Lead",
      "Complexity_Authoring": "Medium", "Regulatory_Significance": "Internal R&D Strategy"
    },
    {
      "Doc_ID_Type": "DIS-REP-HITCONF", "Document_Name": "Hit Confirmation/Triage Report", "Phase": "Discovery", "Sub_Phase_Discipline": "Hit ID / Hit-to-Lead",
      "Purpose_Key_Content": "Documents follow-up experiments to confirm activity and selectivity of initial HTS hits, often including dose-response curves.",
      "Key_Metadata": "Hit IDs, Confirmation Assay Results (IC50/EC50), Selectivity Data",
      "Input_Documents_Data_Sources": "HTS Report, Compound Structures, Follow-up Assay Data (ELN)",
      "Output_Informs_Documents": "Selection of Hits for Hit-to-Lead Chemistry",
      "Authoring_Department(s)": "Biology, HTS Group, Medicinal Chemistry", "Review_Approval_Dept(s)": "Research Lead",
      "Complexity_Authoring": "Medium", "Regulatory_Significance": "Internal R&D Strategy"
    },
    {
      "Doc_ID_Type": "DIS-REP-SAR", "Document_Name": "Structure-Activity Relationship (SAR) Report", "Phase": "Discovery", "Sub_Phase_Discipline": "Hit-to-Lead / Lead Opt",
      "Purpose_Key_Content": "Summarizes the relationship between chemical structure modifications and biological activity/properties for a series of compounds.",
      "Key_Metadata": "Chemotype/Series ID, Key Structures, Biological Data (Potency, Selectivity), Physicochemical Properties (Solubility, Permeability)",
      "Input_Documents_Data_Sources": "Compound Synthesis Records (ELN), Biological Assay Data, ADME Screening Data",
      "Output_Informs_Documents": "Lead Candidate Selection Strategy, Next Synthesis Targets, Patent Drafts",
      "Authoring_Department(s)": "Medicinal Chemistry, Biology, DMPK", "Review_Approval_Dept(s)": "Research Lead, Chemistry Lead",
      "Complexity_Authoring": "Medium-High", "Regulatory_Significance": "Internal R&D Strategy, Patent Filings"
    },
    {
      "Doc_ID_Type": "DIS-REP-LO", "Document_Name": "Lead Optimization Report", "Phase": "Discovery", "Sub_Phase_Discipline": "Lead Optimization",
      "Purpose_Key_Content": "Comprehensive report detailing the optimization of a chemical series towards a preclinical candidate profile (potency, selectivity, PK, safety).",
      "Key_Metadata": "Lead Series ID, Key Compounds Data (incl. In Vivo Efficacy, PK/PD, Prelim Safety), Rationale for Candidate Selection",
      "Input_Documents_Data_Sources": "SAR Reports, In Vitro ADME/DMPK Reports, In Vivo PK Reports, Early Safety/Tox Screens, In Vivo Efficacy Reports",
      "Output_Informs_Documents": "Preclinical Candidate Nomination Form/Report, Patent Filings",
      "Authoring_Department(s)": "Medicinal Chemistry, Biology, DMPK, Early Safety", "Review_Approval_Dept(s)": "Research Mgmt, Patent Attorney, Preclinical Dev Team",
      "Complexity_Authoring": "High", "Regulatory_Significance": "Internal R&D Governance"
    },
    {
      "Doc_ID_Type": "DIS-REP-CANDSEL", "Document_Name": "Candidate Selection Report/Nomination Form", "Phase": "Discovery", "Sub_Phase_Discipline": "Lead Optimization",
      "Purpose_Key_Content": "Formal document justifying the selection of a specific compound as a preclinical development candidate based on accumulated data.",
      "Key_Metadata": "Candidate Compound ID, Backup Candidate(s), Target Profile Scorecard, Key Data Summary (Efficacy, PK, Safety, CMC tractability), Dev Plan Outline",
      "Input_Documents_Data_Sources": "Lead Optimization Report, Key Study Reports (In Vivo Efficacy, PK, Tox), CMC Assessment",
      "Output_Informs_Documents": "Preclinical Development Plan Initiation, Formal Handover to Development Teams",
      "Authoring_Department(s)": "Research Leadership, Project Team Lead", "Review_Approval_Dept(s)": "Senior R&D Management, Development Leadership",
      "Complexity_Authoring": "High", "Regulatory_Significance": "Internal R&D Governance Milestone"
    },
    {
      "Doc_ID_Type": "PAT-DRAFT", "Document_Name": "Patent Draft", "Phase": "Discovery, Preclinical", "Sub_Phase_Discipline": "Legal / IP",
      "Purpose_Key_Content": "Draft application describing novel inventions (e.g., new chemical entities, formulations, methods of use) for filing with patent offices.",
      "Key_Metadata": "Invention Title, Inventors, Claims, Specification, Drawings",
      "Input_Documents_Data_Sources": "ELN Entries, SAR Reports, Candidate Selection Data, Prior Art Search",
      "Output_Informs_Documents": "Patent Filing with Patent Office (e.g., USPTO, EPO)",
      "Authoring_Department(s)": "Patent Attorney/Agent, Inventors (Scientists)", "Review_Approval_Dept(s)": "Internal IP Committee, Senior Management",
      "Complexity_Authoring": "High", "Regulatory_Significance": "Intellectual Property Protection"
    },
    {
      "Doc_ID_Type": "PAT-FILED", "Document_Name": "Filed Patent Application", "Phase": "Discovery, Preclinical, Clinical", "Sub_Phase_Discipline": "Legal / IP",
      "Purpose_Key_Content": "The patent application as filed with a national or regional patent office.",
      "Key_Metadata": "Application Number, Filing Date, Title, Inventors",
      "Input_Documents_Data_Sources": "Patent Draft",
      "Output_Informs_Documents": "Patent Prosecution (Office Actions, Responses), Freedom-to-Operate Assessments",
      "Authoring_Department(s)": "Patent Attorney/Agent", "Review_Approval_Dept(s)": "N/A (External Filing)",
      "Complexity_Authoring": "N/A (Legal Process)", "Regulatory_Significance": "Intellectual Property Asset"
    },
    {
      "Doc_ID_Type": "PRE-PLAN-DEV", "Document_Name": "Preclinical Development Plan", "Phase": "Preclinical", "Sub_Phase_Discipline": "Project Management / Cross-functional",
      "Purpose_Key_Content": "High-level plan outlining the required non-clinical studies (Pharmacology, DMPK, Safety/Tox, CMC) to support clinical trials (IND/CTA).",
      "Key_Metadata": "Candidate Compound ID, Target Indication, Target Clinical Phase Entry, Timelines, Resources",
      "Input_Documents_Data_Sources": "Candidate Selection Report, Regulatory Strategy Outline",
      "Output_Informs_Documents": "Study Protocol Development, Budgeting, Resource Allocation",
      "Authoring_Department(s)": "Project Manager, Preclinical Lead (Tox, PK, Pharm), CMC Lead", "Review_Approval_Dept(s)": "Senior R&D Management",
      "Complexity_Authoring": "High", "Regulatory_Significance": "Internal Strategy/Governance"
    },
    {
      "Doc_ID_Type": "PRE-PROT-PHARM", "Document_Name": "Preclinical Pharmacology Study Protocol", "Phase": "Preclinical", "Sub_Phase_Discipline": "Pharmacology",
      "Purpose_Key_Content": "Defines objectives, methods, animal models, and procedures for an in vivo efficacy or mechanism of action (MOA) study.",
      "Key_Metadata": "Study ID, Compound ID, Animal Model, Dosing Regimen, Endpoints",
      "Input_Documents_Data_Sources": "Candidate Selection Data, Literature, Preclinical Dev Plan",
      "Output_Informs_Documents": "Pharmacology Study Conduct, Raw Data, Pharmacology Study Report",
      "Authoring_Department(s)": "Pharmacology Scientist", "Review_Approval_Dept(s)": "IACUC/Ethics Committee, Research Lead",
      "Complexity_Authoring": "Medium-High", "Regulatory_Significance": "Internal R&D, IND/CTA Enabling (Efficacy Rationale)"
    },
    {
      "Doc_ID_Type": "PRE-REP-PHARM", "Document_Name": "Preclinical Pharmacology Study Report", "Phase": "Preclinical", "Sub_Phase_Discipline": "Pharmacology",
      "Purpose_Key_Content": "Presents results, analysis, and interpretation of an in vivo efficacy or MOA study.",
      "Key_Metadata": "Study ID, Key Findings (Efficacy, PD markers), Statistical Analysis",
      "Input_Documents_Data_Sources": "Pharmacology Study Protocol, Raw Study Data (ELN, LIMS)",
      "Output_Informs_Documents": "Candidate Advancement Decisions, IB, IND/CTA (Module 2.6, 4)",
      "Authoring_Department(s)": "Pharmacology Scientist, Statistician", "Review_Approval_Dept(s)": "Research/Preclinical Lead",
      "Complexity_Authoring": "Medium-High", "Regulatory_Significance": "Internal R&D, Submission Supporting (IND/CTA)"
    },
    {
      "Doc_ID_Type": "PRE-PROT-PK", "Document_Name": "Preclinical Pharmacokinetics (PK) / ADME Study Protocol", "Phase": "Preclinical", "Sub_Phase_Discipline": "DMPK (Drug Metabolism & Pharmacokinetics)",
      "Purpose_Key_Content": "Defines objectives and methods for assessing absorption, distribution, metabolism, excretion, and PK parameters in non-clinical species.",
      "Key_Metadata": "Study ID, Species, Route of Administration, Dose Levels, Sampling Schedule, Bioanalytical Method ID",
      "Input_Documents_Data_Sources": "Candidate Information, Preclinical Dev Plan",
      "Output_Informs_Documents": "PK/ADME Study Conduct, Raw Data (Concentrations), PK/ADME Study Report",
      "Authoring_Department(s)": "DMPK Scientist", "Review_Approval_Dept(s)": "IACUC/Ethics Committee (if in vivo), Preclinical Lead",
      "Complexity_Authoring": "Medium-High", "Regulatory_Significance": "GLP (often for definitive studies), IND/CTA Enabling"
    },
    {
      "Doc_ID_Type": "PRE-REP-PK", "Document_Name": "Preclinical Pharmacokinetics (PK) / ADME Study Report", "Phase": "Preclinical", "Sub_Phase_Discipline": "DMPK",
      "Purpose_Key_Content": "Presents results (e.g., concentration-time profiles, PK parameters like AUC, Cmax, T1/2), analysis, and interpretation of PK/ADME studies.",
      "Key_Metadata": "Study ID, Key PK Parameters, Metabolite ID results (if applicable), Bioanalytical Report Ref.",
      "Input_Documents_Data_Sources": "PK/ADME Study Protocol, Raw Concentration Data, Bioanalytical Report",
      "Output_Informs_Documents": "Human Dose Prediction, IB, IND/CTA (Module 2.6, 4), Toxicology Dose Selection",
      "Authoring_Department(s)": "DMPK Scientist, Bioanalytical Scientist, Statistician (for modeling)", "Review_Approval_Dept(s)": "Preclinical Lead, QA (if GLP)",
      "Complexity_Authoring": "High", "Regulatory_Significance": "GLP (often), Submission Critical (IND/CTA, NDA/BLA)"
    },
    {
      "Doc_ID_Type": "PRE-PROT-TOX", "Document_Name": "Preclinical Toxicology Study Protocol", "Phase": "Preclinical", "Sub_Phase_Discipline": "Toxicology (Safety Assessment)",
      "Purpose_Key_Content": "Defines the objectives, design, methodology, and procedures for a specific non-clinical safety study (e.g., single-dose, repeat-dose, genotox, safety pharm).",
      "Key_Metadata": "Study ID, Species, Strain, Dose Levels, Duration, Test Article ID, GLP Status, Endpoints (Clinical Obs, Clin Path, Histopath)",
      "Input_Documents_Data_Sources": "Candidate Selection Report, Preclinical Dev Plan, Formulation Report, PK Data (for dose selection)",
      "Output_Informs_Documents": "Toxicology Study Conduct, Raw Data Collection, Toxicology Study Report",
      "Authoring_Department(s)": "Toxicologist, Study Director", "Review_Approval_Dept(s)": "IACUC/Ethics Committee, QA (GLP), Preclinical Lead",
      "Complexity_Authoring": "High", "Regulatory_Significance": "GLP, IND/CTA Enabling"
    },
    {
      "Doc_ID_Type": "PRE-REP-TOX", "Document_Name": "Preclinical Toxicology Study Report", "Phase": "Preclinical", "Sub_Phase_Discipline": "Toxicology (Safety Assessment)",
      "Purpose_Key_Content": "Presents the results, analysis, and interpretation of a non-clinical safety study. Includes findings, NOAEL, clinical signs, pathology.",
      "Key_Metadata": "Study ID, GLP Compliance Statement, Key Findings (incl. NOAEL), Test Article ID, Pathology Report Ref.",
      "Input_Documents_Data_Sources": "Toxicology Study Protocol, Raw Study Data (incl. Pathology, Clinical Pathology), Statistical Analysis Report (if applicable), Bioanalytical Report (if applicable)",
      "Output_Informs_Documents": "Investigator's Brochure (IB), IND/CTA Application (CTD Module 2.4, 2.6, 4), Risk Assessment, Clinical Protocol Hazard Section",
      "Authoring_Department(s)": "Toxicologist, Pathologist, Statistician, Study Director", "Review_Approval_Dept(s)": "QA (GLP), Preclinical Lead, Regulatory Affairs",
      "Complexity_Authoring": "High", "Regulatory_Significance": "GLP, Submission Critical (IND/CTA, NDA/BLA)"
    },
    {
      "Doc_ID_Type": "PRE-PROT-BIOA", "Document_Name": "Bioanalytical Method Validation Protocol", "Phase": "Preclinical, Clinical", "Sub_Phase_Discipline": "Bioanalysis / DMPK / CMC",
      "Purpose_Key_Content": "Plan outlining procedures and acceptance criteria for validating an analytical method to quantify drug/metabolite in biological matrices (e.g., plasma, urine) or drug substance/product.",
      "Key_Metadata": "Method ID, Analyte, Matrix, Validation Parameters (Accuracy, Precision, Selectivity, Stability, LLOQ), Instrument Type",
      "Input_Documents_Data_Sources": "Assay Development Info, Regulatory Guidances (FDA/EMA)",
      "Output_Informs_Documents": "Bioanalytical Method Validation Report, Method SOP",
      "Authoring_Department(s)": "Bioanalytical Scientist, Analytical Chemist", "Review_Approval_Dept(s)": "QA, Method Development Lead",
      "Complexity_Authoring": "Medium-High", "Regulatory_Significance": "GLP/GCP/GMP Compliance, Submission Supporting"
    },
    {
      "Doc_ID_Type": "PRE-REP-BIOA", "Document_Name": "Bioanalytical Method Validation Report", "Phase": "Preclinical, Clinical", "Sub_Phase_Discipline": "Bioanalysis / DMPK / CMC",
      "Purpose_Key_Content": "Documents the successful validation of a bioanalytical method according to the protocol and regulatory guidelines.",
      "Key_Metadata": "Method ID, Validation Summary (Pass/Fail for each parameter), SOP Reference",
      "Input_Documents_Data_Sources": "Bioanalytical Method Validation Protocol, Raw Validation Data",
      "Output_Informs_Documents": "Sample Analysis (PK/Tox/Clinical studies), Method SOP, Regulatory Submissions (CTD Modules 2, 4, 5)",
      "Authoring_Department(s)": "Bioanalytical Scientist, Analytical Chemist", "Review_Approval_Dept(s)": "QA, Method Development Lead",
      "Complexity_Authoring": "Medium-High", "Regulatory_Significance": "GLP/GCP/GMP Compliance, Submission Critical"
    },
    {
      "Doc_ID_Type": "PRE-REP-CMC-PROCDEV", "Document_Name": "CMC Process Development Report (API/DS)", "Phase": "Preclinical, Clinical", "Sub_Phase_Discipline": "CMC (Chemistry, Manufacturing, Controls)",
      "Purpose_Key_Content": "Describes the development of the manufacturing process for the drug substance (API). Route selection, optimization, impurity control, KPPs.",
      "Key_Metadata": "API Name, Process Stage (e.g., Route Scouting, Optimization), Key Process Parameters (KPPs), Critical Quality Attributes (CQAs), Impurity Profile",
      "Input_Documents_Data_Sources": "Lead Optimization Reports, Early Formulation Data, Analytical Methods",
      "Output_Informs_Documents": "API Specifications, Manufacturing Batch Records (Dev), Tech Transfer Documents, CTD Module 3",
      "Authoring_Department(s)": "Process Chemistry, Chemical Engineering", "Review_Approval_Dept(s)": "Analytical Development, QA, CMC Lead",
      "Complexity_Authoring": "High", "Regulatory_Significance": "GMP (later stages), Submission Critical (IND/CTA, NDA/BLA)"
    },
    {
      "Doc_ID_Type": "PRE-REP-CMC-FORMDEV", "Document_Name": "CMC Formulation Development Report (DP)", "Phase": "Preclinical, Clinical", "Sub_Phase_Discipline": "CMC (Formulation Development)",
      "Purpose_Key_Content": "Documents the development and selection of the drug product formulation (e.g., tablet, capsule, injectable), including excipient compatibility, process development.",
      "Key_Metadata": "Product Name, Formulation Composition, Dosage Form, Manufacturing Process Outline, Stability Assessment",
      "Input_Documents_Data_Sources": "API Characterization Data, Preclinical PK/Tox Needs (e.g., vehicle), Target Product Profile (TPP)",
      "Output_Informs_Documents": "Drug Product Specification, Manufacturing Batch Records (Dev), Stability Protocols, CTD Module 3",
      "Authoring_Department(s)": "Formulation Scientist, Process Engineer", "Review_Approval_Dept(s)": "Analytical Development, QA, CMC Lead, Clinical Supply Lead",
      "Complexity_Authoring": "High", "Regulatory_Significance": "GMP (later stages), Submission Critical (IND/CTA, NDA/BLA)"
    },
    {
      "Doc_ID_Type": "PRE-SPEC-API", "Document_Name": "Drug Substance (API) Specification", "Phase": "Preclinical, Clinical, Post-Approval", "Sub_Phase_Discipline": "CMC / QA",
      "Purpose_Key_Content": "Defines the list of tests, analytical procedures, and acceptance criteria required for release of the API. Based on ICH Q6A.",
      "Key_Metadata": "API Name, Specification Number, Version, Effective Date, Tests (e.g., Appearance, ID, Assay, Impurities, Residual Solvents), Methods, Acceptance Criteria",
      "Input_Documents_Data_Sources": "API Process Development Reports, Analytical Method Validation Reports, Stability Data, Reference Standard Cert.",
      "Output_Informs_Documents": "API Batch Release Testing, Certificate of Analysis (CoA), Stability Program, CTD Module 3",
      "Authoring_Department(s)": "Analytical Development, CMC Lead", "Review_Approval_Dept(s)": "QA, Regulatory Affairs",
      "Complexity_Authoring": "High", "Regulatory_Significance": "GMP, Submission Critical"
    },
    {
      "Doc_ID_Type": "PRE-SPEC-DP", "Document_Name": "Drug Product Specification", "Phase": "Preclinical, Clinical, Post-Approval", "Sub_Phase_Discipline": "CMC / QA",
      "Purpose_Key_Content": "Defines the list of tests, analytical procedures, and acceptance criteria required for release of the Drug Product. Based on ICH Q6A/B.",
      "Key_Metadata": "Product Name, Dosage Form, Strength, Specification Number, Version, Effective Date, Tests (e.g., Appearance, ID, Assay, Content Uniformity, Dissolution, Impurities), Methods, Acceptance Criteria",
      "Input_Documents_Data_Sources": "DP Formulation/Process Development Reports, Analytical Method Validation Reports, Stability Data, API Spec, Reference Standard Cert.",
      "Output_Informs_Documents": "DP Batch Release Testing, Certificate of Analysis (CoA), Stability Program, CTD Module 3",
      "Authoring_Department(s)": "Analytical Development, Formulation Dev, CMC Lead", "Review_Approval_Dept(s)": "QA, Regulatory Affairs",
      "Complexity_Authoring": "High", "Regulatory_Significance": "GMP, Submission Critical"
    },
    {
      "Doc_ID_Type": "PRE-PROT-CMC-STAB", "Document_Name": "CMC Stability Protocol", "Phase": "Preclinical, Clinical, Post-Approval", "Sub_Phase_Discipline": "CMC / QA",
      "Purpose_Key_Content": "Plan outlining the stability studies to be performed on API or DP, including batches, storage conditions (ICH), testing schedule, and tests to be performed.",
      "Key_Metadata": "API/Product Name, Protocol Number, Batches Included, Storage Conditions, Pull Schedule, Specification Ref.",
      "Input_Documents_Data_Sources": "API/DP Specifications, Formulation Report, Regulatory Guidances (ICH Q1)",
      "Output_Informs_Documents": "Stability Study Execution, Stability Report",
      "Authoring_Department(s)": "Stability Coordinator, Analytical Dev / Formulation Dev", "Review_Approval_Dept(s)": "QA, CMC Lead",
      "Complexity_Authoring": "Medium", "Regulatory_Significance": "GMP, Submission Critical"
    },
    {
      "Doc_ID_Type": "PRE-REP-CMC-STAB", "Document_Name": "CMC Stability Report", "Phase": "Preclinical, Clinical, Post-Approval", "Sub_Phase_Discipline": "CMC",
      "Purpose_Key_Content": "Summarizes stability data for API or DP under defined storage conditions. Supports shelf-life/retest date determination. Includes data tables, trends, justification for shelf life.",
      "Key_Metadata": "API/Product Name, Batch Numbers, Storage Conditions, Stability Timepoints, Specification Link, Proposed Shelf Life/Retest Date",
      "Input_Documents_Data_Sources": "Stability Protocols, Raw Stability Data (Analytical Results), Specifications",
      "Output_Informs_Documents": "Shelf-Life Assignment, Regulatory Submissions (IND/CTD M3, NDA/MAA), Product Labeling, Certificate of Analysis",
      "Authoring_Department(s)": "Analytical Development, Stability Coordinator, Statistician (trending)", "Review_Approval_Dept(s)": "QA, CMC Lead, Regulatory Affairs",
      "Complexity_Authoring": "High", "Regulatory_Significance": "GMP, Submission Critical"
    },
    {
      "Doc_ID_Type": "PRE-RECORD-BATCH-DEV", "Document_Name": "Development Batch Record", "Phase": "Preclinical, Clinical", "Sub_Phase_Discipline": "CMC (Manufacturing)",
      "Purpose_Key_Content": "Record documenting the manufacturing steps performed for a specific development or non-GMP batch of API or DP.",
      "Key_Metadata": "Product Name, Batch Number, Date, Process Steps, In-Process Controls (IPCs), Raw Material Lots, Operator Signatures",
      "Input_Documents_Data_Sources": "Process Development Report, Master Batch Record (if available)",
      "Output_Informs_Documents": "CMC Development Reports, Tech Transfer, Characterization of Batch",
      "Authoring_Department(s)": "Process Chemist/Engineer, Formulation Scientist, Manufacturing Operator", "Review_Approval_Dept(s)": "CMC Lead",
      "Complexity_Authoring": "Medium", "Regulatory_Significance": "Non-GMP (but good practice)"
    },
    {
      "Doc_ID_Type": "PRE-RECORD-BATCH-GMP", "Document_Name": "GMP Master Batch Record (MBR)", "Phase": "Clinical, Post-Approval", "Sub_Phase_Discipline": "CMC (Manufacturing) / QA",
      "Purpose_Key_Content": "Approved template instruction set for manufacturing a specific API or DP under GMP conditions.",
      "Key_Metadata": "Product Name, MBR Number, Version, Effective Date, Detailed Process Steps, IPCs, Material Specs",
      "Input_Documents_Data_Sources": "Process Development/Validation Reports, Specifications",
      "Output_Informs_Documents": "GMP Batch Production Record (Executed)",
      "Authoring_Department(s)": "Process Development, Manufacturing Science/Tech Transfer", "Review_Approval_Dept(s)": "Manufacturing, QA",
      "Complexity_Authoring": "High", "Regulatory_Significance": "GMP Critical"
    },
    {
      "Doc_ID_Type": "PRE-RECORD-BATCH-GMP-EXE", "Document_Name": "Executed GMP Batch Production Record (BPR)", "Phase": "Clinical, Post-Approval", "Sub_Phase_Discipline": "CMC (Manufacturing) / QA",
      "Purpose_Key_Content": "Completed record documenting the actual manufacturing steps, materials used, conditions, and results for a specific GMP batch. Includes deviations, investigations.",
      "Key_Metadata": "Product Name, Batch Number, MBR Ref, Start/End Dates, Actual Results, Operator/Verifier Signatures, Deviation Refs",
      "Input_Documents_Data_Sources": "GMP Master Batch Record (MBR), Raw Material CoAs, Logbooks",
      "Output_Informs_Documents": "Batch Release Decision by QA, Certificate of Analysis (CoA), Regulatory Submissions (supportive data), Annual Product Review (APR/PQR)",
      "Authoring_Department(s)": "Manufacturing Operators/Supervisors", "Review_Approval_Dept(s)": "Manufacturing Lead, QA Review/Approval",
      "Complexity_Authoring": "High", "Regulatory_Significance": "GMP Critical, Batch Release Prerequisite"
    },
    {
      "Doc_ID_Type": "PRE-CoA", "Document_Name": "Certificate of Analysis (CoA)", "Phase": "Preclinical, Clinical, Post-Approval", "Sub_Phase_Discipline": "QA / QC",
      "Purpose_Key_Content": "Document certifying that a specific batch of API, DP, or critical material meets its pre-defined specifications.",
      "Key_Metadata": "Product/Material Name, Batch/Lot Number, Date of Manufacture, Expiry/Retest Date, Specification Ref, Test Results, QC/QA Approval Signature",
      "Input_Documents_Data_Sources": "Executed Batch Record (for DP/API), QC Testing Results (LIMS)",
      "Output_Informs_Documents": "Batch Release, Clinical Supply Shipment, Use in Further Manufacturing/Studies",
      "Authoring_Department(s)": "QC Analyst/Manager", "Review_Approval_Dept(s)": "QA Manager/Director",
      "Complexity_Authoring": "Medium", "Regulatory_Significance": "GMP/GLP/GCP Critical, Required for Release/Use"
    },
    {
      "Doc_ID_Type": "PRE-REP-TECHTRAN", "Document_Name": "Technology Transfer Report", "Phase": "Preclinical, Clinical, Post-Approval", "Sub_Phase_Discipline": "CMC (Manufacturing Science / Tech Transfer)",
      "Purpose_Key_Content": "Documents the transfer of manufacturing process knowledge and analytical methods from a sending unit (e.g., R&D) to a receiving unit (e.g., GMP plant, CMO).",
      "Key_Metadata": "Product Name, Process/Method Transferred, Sending/Receiving Sites, Key Transfer Activities, Success Criteria, Gap Analysis",
      "Input_Documents_Data_Sources": "Process Development Reports, Analytical Method Validation Reports, MBR Drafts, Specifications",
      "Output_Informs_Documents": "GMP Manufacturing at Receiving Site, Process Validation Activities",
      "Authoring_Department(s)": "Tech Transfer Lead, Sending/Receiving Unit SMEs (Mfg, QC, Eng)", "Review_Approval_Dept(s)": "QA, Site Heads",
      "Complexity_Authoring": "High", "Regulatory_Significance": "GMP, Critical for successful manufacturing scale-up/transfer"
    },
    {
      "Doc_ID_Type": "IB", "Document_Name": "Investigator's Brochure", "Phase": "Preclinical, Clinical (All Phases)", "Sub_Phase_Discipline": "Clinical Development / Regulatory Affairs",
      "Purpose_Key_Content": "Compilation of non-clinical and clinical data relevant to the study of the investigational product in humans. Provided to investigators. Updated periodically.",
      "Key_Metadata": "Product Name, Version Number, Effective Date, Edition Number",
      "Input_Documents_Data_Sources": "All relevant Preclinical Reports (Tox, Pharm, ADME, CMC), Prior Clinical Study Reports (if any), Safety Updates (e.g., SUSARs, DSURs), Literature",
      "Output_Informs_Documents": "Clinical Study Conduct (Investigator Reference), EC/IRB Submissions, Regulatory Submissions (IND/CTA updates), Basis for ICF Risk Section",
      "Authoring_Department(s)": "Medical Writer, Preclinical Lead, Clinical Lead, CMC Lead, Safety Physician", "Review_Approval_Dept(s)": "Regulatory Affairs, QA, Senior Management",
      "Complexity_Authoring": "High", "Regulatory_Significance": "GCP, Submission Critical (IND/CTA)"
    },
    {
      "Doc_ID_Type": "REG-PLAN-STRAT", "Document_Name": "Regulatory Strategy Plan", "Phase": "Discovery, Preclinical, Clinical", "Sub_Phase_Discipline": "Regulatory Affairs",
      "Purpose_Key_Content": "High-level document outlining the planned regulatory pathway(s) for product development and approval in target regions (e.g., US, EU, Japan). Includes HTA interactions, special designations.",
      "Key_Metadata": "Product Name, Target Indication(s), Target Regions, Key Regulatory Milestones (e.g., Pre-IND, IND, EOP2, Pre-NDA), Planned Designations (Orphan, BTD)",
      "Input_Documents_Data_Sources": "Target Product Profile (TPP), Preclinical Dev Plan, Clinical Dev Plan (CDP), Competitor Intelligence",
      "Output_Informs_Documents": "IND/CTA Planning, Meeting Requests, Agency Interactions, Clinical Protocol Design",
      "Authoring_Department(s)": "Regulatory Affairs Lead", "Review_Approval_Dept(s)": "Senior R&D Management, Commercial Lead",
      "Complexity_Authoring": "High", "Regulatory_Significance": "Internal Strategy/Governance"
    },
    {
      "Doc_ID_Type": "REG-MEET-REQ", "Document_Name": "Regulatory Agency Meeting Request (e.g., Type B/C, Scientific Advice)", "Phase": "Preclinical, Clinical", "Sub_Phase_Discipline": "Regulatory Affairs",
      "Purpose_Key_Content": "Formal request submitted to a health authority (e.g., FDA, EMA) to obtain guidance on specific development questions.",
      "Key_Metadata": "Product Name, Meeting Type, Proposed Dates, List of Questions, Attendee List",
      "Input_Documents_Data_Sources": "Regulatory Strategy, Specific Development Questions/Data",
      "Output_Informs_Documents": "Meeting Briefing Book, Agency Meeting Granted/Denied",
      "Authoring_Department(s)": "Regulatory Affairs Lead", "Review_Approval_Dept(s)": "Cross-functional Team (Clin, Nonclin, CMC, Stats)",
      "Complexity_Authoring": "Medium", "Regulatory_Significance": "Regulatory Interaction"
    },
    {
      "Doc_ID_Type": "REG-MEET-BRIEF", "Document_Name": "Regulatory Agency Meeting Briefing Book/Package", "Phase": "Preclinical, Clinical", "Sub_Phase_Discipline": "Regulatory Affairs / Cross-functional",
      "Purpose_Key_Content": "Comprehensive package of information provided to the agency in advance of a scheduled meeting. Includes background, data summaries, specific questions.",
      "Key_Metadata": "Product Name, Meeting Date, Application Number (if any), Detailed Background, Data Summaries (Nonclinical, CMC, Clinical), Specific Questions for Agency",
      "Input_Documents_Data_Sources": "Meeting Request, Key Study Reports/Summaries, Proposed Development Plans (e.g., Phase 3 design)",
      "Output_Informs_Documents": "Agency Meeting Conduct, Agency Meeting Minutes",
      "Authoring_Department(s)": "Regulatory Affairs Lead, Medical Writer, SMEs (Clin, Nonclin, CMC, Stats)", "Review_Approval_Dept(s)": "Senior R&D Management",
      "Complexity_Authoring": "High", "Regulatory_Significance": "Regulatory Interaction Critical"
    },
    {
      "Doc_ID_Type": "REG-MEET-MIN", "Document_Name": "Regulatory Agency Meeting Minutes (Sponsor & Agency Versions)", "Phase": "Preclinical, Clinical", "Sub_Phase_Discipline": "Regulatory Affairs",
      "Purpose_Key_Content": "Official record of discussions, agreements, and advice received during a meeting with a health authority.",
      "Key_Metadata": "Product Name, Meeting Date, Application Number (if any), Attendees, Key Discussion Points, Agreements, Action Items",
      "Input_Documents_Data_Sources": "Agency Meeting Conduct, Briefing Book",
      "Output_Informs_Documents": "Updates to Regulatory Strategy, Clinical Protocol Amendments, IND/CTA Amendments, Development Plan Adjustments",
      "Authoring_Department(s)": "Regulatory Affairs Lead (+/- Agency)", "Review_Approval_Dept(s)": "Internal Team Review, Senior Management",
      "Complexity_Authoring": "High", "Regulatory_Significance": "Regulatory Interaction Record, Future Submission Reference"
    },
    {
      "Doc_ID_Type": "REG-SUB-IND", "Document_Name": "Investigational New Drug (IND) Application (US)", "Phase": "Preclinical (End), Clinical Phase 1", "Sub_Phase_Discipline": "Regulatory Affairs / Cross-functional",
      "Purpose_Key_Content": "Submission to FDA to request authorization to administer an investigational drug to humans. Includes preclinical data, CMC info, clinical protocol. (eCTD Format: Modules 1-5 Preclinical/CMC/Protocol Focus)",
      "Key_Metadata": "Product Name, IND Number (assigned by FDA), Submission Type (Original, Amendment), Sequence Number",
      "Input_Documents_Data_Sources": "IB, Preclinical Reports (Tox, PK, Pharm), CMC Reports (Mfg, Specs, Stability), Phase 1 Protocol, FDA Forms (1571, 1572)",
      "Output_Informs_Documents": "Authorization to start Clinical Trials in US, IND Maintenance (Amendments, Annual Reports)",
      "Authoring_Department(s)": "Regulatory Affairs Lead, SMEs (Nonclin, CMC, Clin Ops, Medical)", "Review_Approval_Dept(s)": "Senior Management, QA",
      "Complexity_Authoring": "High", "Regulatory_Significance": "Submission Critical (FDA)"
    },
    {
      "Doc_ID_Type": "REG-SUB-CTA", "Document_Name": "Clinical Trial Application (CTA) (EU/Other Regions)", "Phase": "Preclinical (End), Clinical Phase 1", "Sub_Phase_Discipline": "Regulatory Affairs / Cross-functional",
      "Purpose_Key_Content": "Submission to National Competent Authorities (NCAs) and Ethics Committees (ECs) in Europe (via CTIS) or other regions to request authorization for a clinical trial. Content varies but similar basis to IND.",
      "Key_Metadata": "Product Name, EudraCT/CTIS Number, Submission Type, Countries",
      "Input_Documents_Data_Sources": "IB, Preclinical Data Summary, CMC Data Summary (IMPD), Clinical Protocol, ICF, Local Forms",
      "Output_Informs_Documents": "Authorization to start Clinical Trials in specific countries, CTA Maintenance (Amendments)",
      "Authoring_Department(s)": "Regulatory Affairs Lead, SMEs (Nonclin, CMC, Clin Ops, Medical), Local Affiliates", "Review_Approval_Dept(s)": "Senior Management, QA",
      "Complexity_Authoring": "High", "Regulatory_Significance": "Submission Critical (NCA/EC)"
    },
    {
      "Doc_ID_Type": "REG-SUB-IMPD", "Document_Name": "Investigational Medicinal Product Dossier (IMPD)", "Phase": "Preclinical (End), Clinical", "Sub_Phase_Discipline": "CMC / Regulatory Affairs",
      "Purpose_Key_Content": "Document providing detailed CMC information for the investigational product, required for CTAs in Europe and other regions. Can be full or simplified.",
      "Key_Metadata": "Product Name, Version, Sections (Quality/CMC data)",
      "Input_Documents_Data_Sources": "CMC Development Reports, Specifications, Stability Reports, Batch Records Info",
      "Output_Informs_Documents": "CTA Submission (Part of), Updates via Amendments",
      "Authoring_Department(s)": "CMC SMEs, Regulatory CMC Writer", "Review_Approval_Dept(s)": "QA, Regulatory Affairs",
      "Complexity_Authoring": "High", "Regulatory_Significance": "Submission Critical (CTA)"
    },
    {
      "Doc_ID_Type": "CLI-PLAN-CDP", "Document_Name": "Clinical Development Plan (CDP)", "Phase": "Clinical (All Phases)", "Sub_Phase_Discipline": "Clinical Development / Medical Affairs",
      "Purpose_Key_Content": "Overall strategy document outlining the sequence of clinical trials (Phase 1-3) and related activities needed to demonstrate safety and efficacy for regulatory approval in target indication(s).",
      "Key_Metadata": "Product Name, Target Indication(s), Target Product Profile (TPP), Planned Studies (Phase 1, 2, 3), Timelines, High-level Budget/Resources",
      "Input_Documents_Data_Sources": "Target Product Profile, Preclinical Data Summary, Regulatory Strategy",
      "Output_Informs_Documents": "Clinical Study Protocol Development, Resource Planning, Budgeting",
      "Authoring_Department(s)": "Clinical Lead, Medical Director, Statistician, Regulatory Affairs, Clin Ops Lead", "Review_Approval_Dept(s)": "Senior R&D Management, Commercial Lead",
      "Complexity_Authoring": "High", "Regulatory_Significance": "Internal Strategy/Governance"
    },
    {
      "Doc_ID_Type": "CLI-PLAN-TPP", "Document_Name": "Target Product Profile (TPP)", "Phase": "Discovery (late), Preclinical, Clinical", "Sub_Phase_Discipline": "Clinical Development / Commercial / Medical Affairs",
      "Purpose_Key_Content": "Document outlining the desired characteristics of the drug product upon approval. Includes target indication, efficacy, safety, dosing, formulation attributes. Guides development decisions.",
      "Key_Metadata": "Product Concept Name, Target Indication, Key Efficacy/Safety Attributes (Minimal vs Ideal), Dosing/Administration, Competitive Context",
      "Input_Documents_Data_Sources": "Market Research, Medical Need Assessment, Early Scientific Data, Regulatory Landscape",
      "Output_Informs_Documents": "Clinical Development Plan, Clinical Protocol Design (Endpoints), CMC Formulation Goals",
      "Authoring_Department(s)": "Commercial Lead, Medical Affairs Lead, Clinical Lead, Regulatory Lead", "Review_Approval_Dept(s)": "Senior Management",
      "Complexity_Authoring": "High", "Regulatory_Significance": "Internal Strategy/Governance"
    },
    {
      "Doc_ID_Type": "CLI-PROT-P1", "Document_Name": "Clinical Study Protocol (Phase 1)", "Phase": "Clinical Phase 1", "Sub_Phase_Discipline": "Clinical Operations / Medical",
      "Purpose_Key_Content": "Details the plan for a Phase 1 trial (e.g., SAD/MAD, PK, Food Effect, BA/BE). Objectives, design, patient population/healthy volunteers, procedures, endpoints, basic stats.",
      "Key_Metadata": "Protocol ID, Version, Study Title, Phase, Indication (if specific), Planned Enrollment, Schema",
      "Input_Documents_Data_Sources": "IB, Preclinical Data Summary, Statistical Input, Regulatory Feedback/IND/CTA",
      "Output_Informs_Documents": "IRB/EC Submission, CTA/IND Submission, ICF Development, CRF Design, SAP Outline, Clinical Study Conduct",
      "Authoring_Department(s)": "Medical Monitor/Clinical Scientist, Statistician, Clin Ops Lead", "Review_Approval_Dept(s)": "Legal, Regulatory Affairs, Safety, Senior Management",
      "Complexity_Authoring": "High", "Regulatory_Significance": "GCP, Submission Critical"
    },
    {
      "Doc_ID_Type": "CLI-PROT-P2", "Document_Name": "Clinical Study Protocol (Phase 2)", "Phase": "Clinical Phase 2", "Sub_Phase_Discipline": "Clinical Operations / Medical",
      "Purpose_Key_Content": "Details the plan for a Phase 2 trial (e.g., Dose-finding, Proof-of-Concept). Objectives (often efficacy focus), design (e.g., randomized, controlled), patient population, endpoints (primary/secondary), procedures, detailed stats section.",
      "Key_Metadata": "Protocol ID, Version, Study Title, Phase, Indication, Planned Enrollment, Randomization Scheme, Blinding",
      "Input_Documents_Data_Sources": "IB, Phase 1 Data Report(s), Preclinical Efficacy Rationale, TPP, Statistical Input, Regulatory Feedback (e.g., EOP1)",
      "Output_Informs_Documents": "IRB/EC Submission, CTA/IND Submission/Amendment, ICF Development, CRF Design, SAP, Clinical Study Conduct",
      "Authoring_Department(s)": "Medical Monitor/Clinical Scientist, Statistician, Clin Ops Lead", "Review_Approval_Dept(s)": "Legal, Regulatory Affairs, Safety, Senior Management",
      "Complexity_Authoring": "High", "Regulatory_Significance": "GCP, Submission Critical"
    },
    {
      "Doc_ID_Type": "CLI-PROT-P3", "Document_Name": "Clinical Study Protocol (Phase 3)", "Phase": "Clinical Phase 3", "Sub_Phase_Discipline": "Clinical Operations / Medical",
      "Purpose_Key_Content": "Details the plan for a Phase 3 pivotal trial (Confirmatory efficacy & safety). Large scale, often randomized, controlled, multi-center. Objectives, rigorous design, specific patient population, primary/key secondary endpoints, detailed statistical analysis plan summary.",
      "Key_Metadata": "Protocol ID, Version, Study Title, Phase, Indication, Planned Enrollment, Statistical Power Calculation, Blinding, DMC Charter Ref",
      "Input_Documents_Data_Sources": "IB, Phase 2 Data Report(s), TPP, Statistical Input, Regulatory Feedback (e.g., EOP2 Agreement, SPA)",
      "Output_Informs_Documents": "IRB/EC Submission, CTA/IND Submission/Amendment, ICF Development, CRF Design, SAP, Clinical Study Conduct",
      "Authoring_Department(s)": "Medical Monitor/Clinical Scientist, Statistician, Clin Ops Lead", "Review_Approval_Dept(s)": "Legal, Regulatory Affairs, Safety, Senior Management",
      "Complexity_Authoring": "High", "Regulatory_Significance": "GCP, Submission Critical (NDA/BLA/MAA Basis)"
    },
    {
      "Doc_ID_Type": "ICF", "Document_Name": "Informed Consent Form", "Phase": "Clinical (All Phases)", "Sub_Phase_Discipline": "Clinical Operations / Legal / Ethics",
      "Purpose_Key_Content": "Document for potential trial participants outlining study purpose, procedures, risks, benefits, confidentiality, voluntariness, rights. Must be approved by EC/IRB.",
      "Key_Metadata": "Protocol ID, Version, Site/Country Specific variations, Language, EC/IRB Approval Stamp/Date",
      "Input_Documents_Data_Sources": "Clinical Study Protocol, IB (Safety Section), Local Regulatory/EC Templates & Requirements",
      "Output_Informs_Documents": "Participant Enrollment Process, IRB/EC Approval Documentation",
      "Authoring_Department(s)": "Clinical Operations, Medical Writer, Legal", "Review_Approval_Dept(s)": "IRB/EC, Sponsor Ethics Review (if applicable)",
      "Complexity_Authoring": "Medium", "Regulatory_Significance": "GCP, Regulatory/Ethics Approval Critical"
    },
    {
      "Doc_ID_Type": "CRF", "Document_Name": "Case Report Form (Paper or eCRF Specification)", "Phase": "Clinical (All Phases)", "Sub_Phase_Discipline": "Data Management / Clinical Operations",
      "Purpose_Key_Content": "Tool used to collect data from each participant in a clinical trial as required by the protocol. Paper form or specifications for electronic version (eCRF).",
      "Key_Metadata": "Protocol ID, CRF Version, Module/Visit Structure, Variable Definitions, Data Entry Fields, Edit Checks (for eCRF)",
      "Input_Documents_Data_Sources": "Clinical Study Protocol, Schedule of Assessments",
      "Output_Informs_Documents": "Data Collection at Sites, Database Build (for eCRF), Data Management Plan (DMP), Statistical Analysis (Data Source)",
      "Authoring_Department(s)": "Data Manager, Clinical Scientist (content input), CRF Designer/Programmer (eCRF)", "Review_Approval_Dept(s)": "Clinical Lead, Statistician, Clin Ops",
      "Complexity_Authoring": "Medium-High", "Regulatory_Significance": "GCP, Data Integrity Critical"
    },
    {
      "Doc_ID_Type": "CLI-PLAN-DMP", "Document_Name": "Data Management Plan (DMP)", "Phase": "Clinical (All Phases)", "Sub_Phase_Discipline": "Data Management",
      "Purpose_Key_Content": "Describes all data management activities for a clinical trial: database design, data collection methods, edit checks, query process, data coding (MedDRA, WHODrug), SAE reconciliation, database lock procedures.",
      "Key_Metadata": "Protocol ID, DMP Version, Database Platform, Coding Dictionaries/Versions, Data Review Plan, Lock Procedures",
      "Input_Documents_Data_Sources": "Clinical Study Protocol, CRF Specifications, SAP (variable list)",
      "Output_Informs_Documents": "Database Build/UAT, Data Cleaning Activities, Database Lock Readiness",
      "Authoring_Department(s)": "Lead Data Manager", "Review_Approval_Dept(s)": "Clinical Lead, Statistician, Clin Ops, Safety/PV",
      "Complexity_Authoring": "High", "Regulatory_Significance": "GCP, Data Integrity Critical"
    },
    {
      "Doc_ID_Type": "CLI-PLAN-SAP", "Document_Name": "Statistical Analysis Plan (SAP)", "Phase": "Clinical (All Phases)", "Sub_Phase_Discipline": "Biostatistics",
      "Purpose_Key_Content": "Detailed plan outlining how the clinical trial data will be analyzed. Defines analysis populations (ITT, PP), endpoints derivation, statistical methods, sensitivity analyses, handling of missing data, table/listing/figure (TLF) shells.",
      "Key_Metadata": "Protocol ID, SAP Version, Analysis Timepoints (e.g., Interim, Final), Statistical Software",
      "Input_Documents_Data_Sources": "Clinical Study Protocol, CRF (variable definitions), DMP (data structure)",
      "Output_Informs_Documents": "Statistical Programming (SAS/R code), TLF Generation, Clinical Study Report (CSR), Data Monitoring Committee (DMC) Analysis",
      "Authoring_Department(s)": "Biostatistician", "Review_Approval_Dept(s)": "Clinical Lead, Medical Monitor, Data Management, Regulatory Affairs (if complex)",
      "Complexity_Authoring": "High", "Regulatory_Significance": "GCP, Submission Critical (CSR Basis), DMC Charter Input"
    },
    {
      "Doc_ID_Type": "CLI-PLAN-SMP", "Document_Name": "Safety Management Plan / Safety Monitoring Plan", "Phase": "Clinical (All Phases)", "Sub_Phase_Discipline": "Pharmacovigilance / Safety / Clinical",
      "Purpose_Key_Content": "Describes how safety data (AEs, SAEs, AESIs) will be collected, managed, reviewed, reported (e.g., SUSARs), and reconciled during a clinical trial.",
      "Key_Metadata": "Protocol ID, SMP Version, Definitions (AE, SAE), Reporting Timelines, Reconciliation Process, AESI List",
      "Input_Documents_Data_Sources": "Clinical Study Protocol, IB, Company SOPs for PV",
      "Output_Informs_Documents": "Safety Data Collection & Processing, SUSAR Reporting, DSUR/Annual Report Input, CSR Safety Section",
      "Authoring_Department(s)": "Safety Physician/Scientist, Clinical Lead", "Review_Approval_Dept(s)": "Regulatory Affairs, QA",
      "Complexity_Authoring": "High", "Regulatory_Significance": "GCP/GVP, Regulatory Compliance Critical"
    },
    {
      "Doc_ID_Type": "CLI-PLAN-MON", "Document_Name": "Clinical Monitoring Plan", "Phase": "Clinical (All Phases)", "Sub_Phase_Discipline": "Clinical Operations",
      "Purpose_Key_Content": "Outlines the strategy, methods, frequency, and intensity of monitoring activities to oversee trial conduct at clinical sites, ensuring GCP compliance and data quality (e.g., SDV, central monitoring).",
      "Key_Metadata": "Protocol ID, Monitoring Plan Version, Monitoring Types (On-site, Remote, Central), SDV % Strategy, Key Risk Indicators (KRIs)",
      "Input_Documents_Data_Sources": "Clinical Study Protocol, Risk Assessment (RBM), Company Monitoring SOPs",
      "Output_Informs_Documents": "Site Monitoring Visits, Monitoring Visit Reports, Issue Escalation",
      "Authoring_Department(s)": "Clinical Research Associate (CRA) Lead / Clinical Trial Manager (CTM)", "Review_Approval_Dept(s)": "Clin Ops Management, QA (GCP Compliance)",
      "Complexity_Authoring": "Medium-High", "Regulatory_Significance": "GCP, Trial Oversight Critical"
    },
    {
      "Doc_ID_Type": "CLI-REP-MONVISIT", "Document_Name": "Monitoring Visit Report", "Phase": "Clinical (All Phases)", "Sub_Phase_Discipline": "Clinical Operations",
      "Purpose_Key_Content": "Report completed by a CRA after a monitoring visit (selection, initiation, interim, close-out) detailing findings, issues, action items, and site compliance.",
      "Key_Metadata": "Protocol ID, Site ID, Visit Date, Visit Type, Summary of Findings, Action Items/Follow-up",
      "Input_Documents_Data_Sources": "Monitoring Plan, Site Data/Documents Reviewed, Previous Reports",
      "Output_Informs_Documents": "Site Management, Issue Resolution/Tracking, TMF Filing, Sponsor Oversight Documentation",
      "Authoring_Department(s)": "Clinical Research Associate (CRA)", "Review_Approval_Dept(s)": "CRA Lead / CTM Review/Approval",
      "Complexity_Authoring": "Medium", "Regulatory_Significance": "GCP, Trial Oversight Documentation"
    },
    {
      "Doc_ID_Type": "CLI-REP-SITEFEAS", "Document_Name": "Site Feasibility / Selection Report", "Phase": "Clinical (All Phases)", "Sub_Phase_Discipline": "Clinical Operations",
      "Purpose_Key_Content": "Report summarizing the assessment and selection of clinical trial sites, based on feasibility questionnaires, site capabilities, investigator experience, patient population access.",
      "Key_Metadata": "Protocol ID, Site ID, Investigator Name, Key Feasibility Metrics, Selection Rationale",
      "Input_Documents_Data_Sources": "Protocol Synopsis, Site Feasibility Questionnaire Results, Site Qualification Visit Reports",
      "Output_Informs_Documents": "Site Initiation, Contract/Budget Negotiation",
      "Authoring_Department(s)": "Clinical Trial Manager (CTM), CRA", "Review_Approval_Dept(s)": "Clin Ops Management",
      "Complexity_Authoring": "Medium", "Regulatory_Significance": "GCP, Trial Execution Planning"
    },
    {
      "Doc_ID_Type": "CLI-CHARTER-DMC", "Document_Name": "Data Monitoring Committee (DMC/DSMB) Charter", "Phase": "Clinical (Phase 2/3, sometimes P1)", "Sub_Phase_Discipline": "Biostatistics / Clinical / Safety",
      "Purpose_Key_Content": "Defines the roles, responsibilities, composition, procedures, data access, and meeting schedule for the independent committee reviewing accumulating trial data for safety and/or efficacy.",
      "Key_Metadata": "Protocol ID, DMC Charter Version, Committee Member List, Meeting Frequency, Stopping Rules/Guidelines",
      "Input_Documents_Data_Sources": "Clinical Study Protocol, SAP (for analysis plan), Safety Monitoring Plan",
      "Output_Informs_Documents": "DMC Meetings, DMC Recommendations, Interim Analysis Conduct",
      "Authoring_Department(s)": "Biostatistician, Clinical Lead, Safety Lead", "Review_Approval_Dept(s)": "Sponsor Senior Management, Legal (Indemnification)",
      "Complexity_Authoring": "High", "Regulatory_Significance": "GCP, Independent Oversight Critical"
    },
    {
      "Doc_ID_Type": "CLI-REP-DMC", "Document_Name": "Data Monitoring Committee (DMC/DSMB) Meeting Minutes/Recommendations", "Phase": "Clinical (Phase 2/3, sometimes P1)", "Sub_Phase_Discipline": "Biostatistics / Clinical / Safety",
      "Purpose_Key_Content": "Record of DMC meetings, including data reviewed (often blinded), deliberations, and formal recommendations to the sponsor (e.g., continue, modify, stop trial).",
      "Key_Metadata": "Protocol ID, DMC Meeting Date, Data Cutoff Date, Summary of Data Reviewed, DMC Recommendation",
      "Input_Documents_Data_Sources": "DMC Charter, Interim Analysis Reports (Statistician Output)",
      "Output_Informs_Documents": "Sponsor Decision on Trial Continuation/Modification, Regulatory Reporting (if applicable), CSR Section",
      "Authoring_Department(s)": "DMC Chair (Minutes Draft), Sponsor Statistician/Clin Lead (Facilitation)", "Review_Approval_Dept(s)": "Sponsor Senior Management (Action on Recommendations)",
      "Complexity_Authoring": "High", "Regulatory_Significance": "GCP, Trial Integrity & Participant Safety Critical"
    },
    {
      "Doc_ID_Type": "CLI-REP-INTERIM", "Document_Name": "Interim Analysis Report", "Phase": "Clinical (Phase 2/3 often)", "Sub_Phase_Discipline": "Biostatistics",
      "Purpose_Key_Content": "Report presenting the results of a pre-planned statistical analysis performed on accumulating trial data before formal trial completion. Used for DMC review or internal decisions.",
      "Key_Metadata": "Protocol ID, Analysis Timepoint, Data Cutoff Date, Statistical Methods Used, Key Efficacy/Safety Results",
      "Input_Documents_Data_Sources": "SAP (Interim Section), Cleaned Interim Dataset",
      "Output_Informs_Documents": "DMC Review, Potential Early Stopping Decision, Adaptive Design Modifications",
      "Authoring_Department(s)": "Biostatistician", "Review_Approval_Dept(s)": "Internal Review Team (Stat Lead, Clin Lead)",
      "Complexity_Authoring": "High", "Regulatory_Significance": "GCP, Pre-specified in SAP, Potential Impact on Trial"
    },
    {
      "Doc_ID_Type": "CLI-REP-CSR", "Document_Name": "Clinical Study Report (CSR)", "Phase": "Clinical (All Phases)", "Sub_Phase_Discipline": "Clinical Development / Medical Writing",
      "Purpose_Key_Content": "ICH E3 compliant comprehensive report detailing the conduct, results (efficacy & safety), and interpretation of a completed clinical trial. Includes appendices with protocol, SAP, sample CRF, etc.",
      "Key_Metadata": "Protocol ID, Study Title, ICH E3 Structure Compliance Statement, Phase, Synopsis",
      "Input_Documents_Data_Sources": "CSP, SAP, Final Clinical Database (Locked), Tables/Listings/Figures (TLFs), IB, Safety Reports, DMC Reports, Literature",
      "Output_Informs_Documents": "Regulatory Submissions (CTD Module 5), Publications/Presentations, Future Clinical Development Plans, IB Updates, Safety Labeling Updates",
      "Authoring_Department(s)": "Medical Writer, Clinical Lead, Biostatistician, Safety Physician, Clin Ops Lead, Data Manager", "Review_Approval_Dept(s)": "QA (GCP Compliance), Regulatory Affairs, Senior Management",
      "Complexity_Authoring": "High", "Regulatory_Significance": "GCP, Submission Critical (NDA/BLA/MAA)"
    },
    {
      "Doc_ID_Type": "eTMF-INDEX", "Document_Name": "Electronic Trial Master File (eTMF) Index/Structure", "Phase": "Clinical (All Phases)", "Sub_Phase_Discipline": "Clinical Operations / TMF Management",
      "Purpose_Key_Content": "Defines the standardized structure, naming conventions, and metadata requirements for organizing and filing essential trial documents in the eTMF system (often based on DIA TMF Reference Model).",
      "Key_Metadata": "TMF Structure Version, Section/Artifact List, Naming Conventions, Required Metadata Fields",
      "Input_Documents_Data_Sources": "DIA TMF Reference Model, Company SOPs",
      "Output_Informs_Documents": "TMF Filing/QC Activities, Inspection Readiness",
      "Authoring_Department(s)": "TMF Manager/Specialist, Clin Ops Lead", "Review_Approval_Dept(s)": "QA (GCP Compliance)",
      "Complexity_Authoring": "Medium", "Regulatory_Significance": "GCP, Inspection Readiness Critical"
    },
    {
      "Doc_ID_Type": "REG-SUB-NDA", "Document_Name": "New Drug Application (NDA) / Biologics License Application (BLA) (US)", "Phase": "Regulatory Submission", "Sub_Phase_Discipline": "Regulatory Affairs / Cross-functional",
      "Purpose_Key_Content": "Comprehensive submission to FDA requesting approval to market a new drug or biologic. Includes all nonclinical, CMC, clinical data, labeling. (eCTD Format: Modules 1-5)",
      "Key_Metadata": "Product Name, NDA/BLA Number (assigned), Submission Type (e.g., 505(b)(1)), Sequence Number",
      "Input_Documents_Data_Sources": "All CSRs, Nonclinical Reports, CMC Data Package (M3), Proposed Labeling, Integrated Summaries (ISS/ISE - M5, M2), FDA Forms",
      "Output_Informs_Documents": "FDA Review Cycle (PDUFA clock), Facility Inspections, Labeling Negotiations, Approval/Rejection",
      "Authoring_Department(s)": "Regulatory Affairs Lead, SMEs (All disciplines), Medical Writers", "Review_Approval_Dept(s)": "Senior Management, Legal, Commercial",
      "Complexity_Authoring": "High", "Regulatory_Significance": "Submission Critical (FDA Market Approval)"
    },
    {
      "Doc_ID_Type": "REG-SUB-MAA", "Document_Name": "Marketing Authorisation Application (MAA) (EU)", "Phase": "Regulatory Submission", "Sub_Phase_Discipline": "Regulatory Affairs / Cross-functional",
      "Purpose_Key_Content": "Comprehensive submission to EMA (or national agency via MRP/DCP) requesting approval to market a new medicinal product in Europe. Similar scope to NDA/BLA. (eCTD Format: Modules 1-5)",
      "Key_Metadata": "Product Name, Procedure Type (Centralised, MRP, DCP), Application Number (assigned), Sequence Number",
      "Input_Documents_Data_Sources": "All CSRs, Nonclinical Reports, CMC Data Package (M3), Proposed SmPC/PIL/Labeling, Risk Management Plan (RMP), Pediatric Investigation Plan (PIP) Compliance",
      "Output_Informs_Documents": "EMA/CHMP Review Cycle, Rapporteur/Co-Rapporteur Assessment, Clock Stops, Inspections, Approval/Rejection",
      "Authoring_Department(s)": "Regulatory Affairs Lead, SMEs (All disciplines), Medical Writers, PV Lead (RMP), Pediatric Coordinator (PIP)", "Review_Approval_Dept(s)": "Senior Management, Legal, Commercial",
      "Complexity_Authoring": "High", "Regulatory_Significance": "Submission Critical (EMA/EU Market Approval)"
    },
    {
      "Doc_ID_Type": "REG-CTD-M1", "Document_Name": "CTD Module 1 (Administrative Information)", "Phase": "Regulatory Submission", "Sub_Phase_Discipline": "Regulatory Affairs",
      "Purpose_Key_Content": "Region-specific administrative information (forms, cover letters, certifications, labeling - varies by region US/EU/JP etc.).",
      "Key_Metadata": "Product Name, Application Type/Number, Region Specific Forms (e.g., 356h, EU Application Form), Proposed Labeling/SmPC/PIL",
      "Input_Documents_Data_Sources": "Regulatory Strategy, Submission Plan, Final Proposed Labeling",
      "Output_Informs_Documents": "Regulatory Agency Processing, Review Initiation",
      "Authoring_Department(s)": "Regulatory Affairs Operations/Publisher, RA Lead", "Review_Approval_Dept(s)": "RA Management",
      "Complexity_Authoring": "Medium", "Regulatory_Significance": "Submission Critical (Administrative)"
    },
    {
      "Doc_ID_Type": "REG-CTD-M2", "Document_Name": "CTD Module 2 (Summaries)", "Phase": "Regulatory Submission", "Sub_Phase_Discipline": "Medical Writing / SMEs / Regulatory Affairs",
      "Purpose_Key_Content": "Summaries of Quality (M2.3), Nonclinical (M2.4 Overview, M2.6 Summaries), and Clinical (M2.5 Overview, M2.7 Summaries) data presented in Modules 3, 4, and 5.",
      "Key_Metadata": "Product Name, Application Type/Number, Specific Summary Doc (e.g., 2.7.3 Summary of Clinical Efficacy)",
      "Input_Documents_Data_Sources": "CSRs, Nonclinical Reports, CMC Reports, Integrated Summaries (ISS/ISE)",
      "Output_Informs_Documents": "Key Review Document for Agencies, Basis for Assessment Reports",
      "Authoring_Department(s)": "Medical Writers, SMEs (Clin, Nonclin, CMC, PK, Stats), RA Lead", "Review_Approval_Dept(s)": "Senior SMEs, RA Management",
      "Complexity_Authoring": "High", "Regulatory_Significance": "Submission Critical (Core Agency Review Content)"
    },
    {
      "Doc_ID_Type": "REG-CTD-M3", "Document_Name": "CTD Module 3 (Quality / CMC)", "Phase": "Regulatory Submission", "Sub_Phase_Discipline": "CMC / Regulatory Affairs",
      "Purpose_Key_Content": "Contains all detailed CMC information for Drug Substance and Drug Product (Manufacturing, Characterization, Controls, Stability, Container Closure, etc.).",
      "Key_Metadata": "Product Name, Application Type/Number, Section Reference (e.g., 3.2.P.2 Pharmaceutical Development)",
      "Input_Documents_Data_Sources": "CMC Development Reports, Validation Reports, Batch Records, Stability Reports, Specifications, CoAs",
      "Output_Informs_Documents": "Regulatory Agency Quality Review, Basis for Approval of Mfg/Controls, Inspections",
      "Authoring_Department(s)": "CMC SMEs (Chem, Analyt, Form, Mfg, QA), Regulatory CMC Writer", "Review_Approval_Dept(s)": "QA, CMC Leadership, RA Lead",
      "Complexity_Authoring": "High", "Regulatory_Significance": "GMP, Submission Critical (Quality Approval Basis)"
    },
    {
      "Doc_ID_Type": "REG-CTD-M4", "Document_Name": "CTD Module 4 (Nonclinical Study Reports)", "Phase": "Regulatory Submission", "Sub_Phase_Discipline": "Nonclinical / Regulatory Affairs",
      "Purpose_Key_Content": "Contains all nonclinical study reports (Pharmacology, PK, Toxicology).",
      "Key_Metadata": "Product Name, Application Type/Number, Study Report Identifier",
      "Input_Documents_Data_Sources": "Final GLP/Non-GLP Nonclinical Study Reports",
      "Output_Informs_Documents": "Regulatory Agency Nonclinical Review",
      "Authoring_Department(s)": "Nonclinical SMEs (Tox, PK, Pharm), Medical Writer (if formatting), RA Publisher", "Review_Approval_Dept(s)": "Nonclinical Leadership, RA Lead",
      "Complexity_Authoring": "Medium (compilation), High (content)", "Regulatory_Significance": "GLP (where applicable), Submission Critical (Safety Basis)"
    },
    {
      "Doc_ID_Type": "REG-CTD-M5", "Document_Name": "CTD Module 5 (Clinical Study Reports)", "Phase": "Regulatory Submission", "Sub_Phase_Discipline": "Clinical / Biostatistics / Medical Writing / Regulatory Affairs",
      "Purpose_Key_Content": "Contains all clinical study reports (PK, PD, Efficacy/Safety Phases 1-3), ISS/ISE, literature references.",
      "Key_Metadata": "Product Name, Application Type/Number, CSR Identifier, ISS/ISE Documents",
      "Input_Documents_Data_Sources": "Final CSRs, Statistical Analysis Outputs for ISS/ISE, Literature Reprints",
      "Output_Informs_Documents": "Regulatory Agency Clinical/Statistical Review, Basis for Efficacy/Safety Approval",
      "Authoring_Department(s)": "Medical Writers, Statisticians (ISS/ISE), Clinical Leads, RA Publisher", "Review_Approval_Dept(s)": "Clinical/Stats Leadership, RA Lead",
      "Complexity_Authoring": "High", "Regulatory_Significance": "GCP, Submission Critical (Efficacy/Safety Approval Basis)"
    },
    {
      "Doc_ID_Type": "REG-ISS", "Document_Name": "Integrated Summary of Safety (ISS)", "Phase": "Regulatory Submission", "Sub_Phase_Discipline": "Clinical Safety / Biostatistics / Medical Writing",
      "Purpose_Key_Content": "Integrates safety data across multiple clinical trials to provide an overall assessment of the product's safety profile. (Part of CTD M5 & summarized in M2)",
      "Key_Metadata": "Product Name, Application Number, Data Cutoff Date, Pooling Strategy",
      "Input_Documents_Data_Sources": "Multiple CSRs, Final Clinical Databases, Safety Management Plan",
      "Output_Informs_Documents": "Regulatory Agency Safety Review, Product Labeling (Safety Sections)",
      "Authoring_Department(s)": "Safety Physician, Statistician, Medical Writer", "Review_Approval_Dept(s)": "Clinical Lead, PV Head, RA Lead",
      "Complexity_Authoring": "High", "Regulatory_Significance": "GCP, Submission Critical (Labeling/Approval)"
    },
    {
      "Doc_ID_Type": "REG-ISE", "Document_Name": "Integrated Summary of Efficacy (ISE)", "Phase": "Regulatory Submission", "Sub_Phase_Discipline": "Clinical Development / Biostatistics / Medical Writing",
      "Purpose_Key_Content": "Integrates efficacy data across multiple clinical trials (usually pivotal Phase 3) to provide robust evidence of effectiveness. (Part of CTD M5 & summarized in M2)",
      "Key_Metadata": "Product Name, Application Number, Data Cutoff Date, Pooling Strategy, Key Endpoints Analysis",
      "Input_Documents_Data_Sources": "Multiple CSRs (esp. Pivotal Trials), Final Clinical Databases, SAPs",
      "Output_Informs_Documents": "Regulatory Agency Efficacy Review, Product Labeling (Efficacy Sections, Indication)",
      "Authoring_Department(s)": "Clinical Lead, Statistician, Medical Writer", "Review_Approval_Dept(s)": "Stats Head, RA Lead",
      "Complexity_Authoring": "High", "Regulatory_Significance": "GCP, Submission Critical (Labeling/Approval)"
    },
    {
      "Doc_ID_Type": "REG-LABEL-US", "Document_Name": "Prescribing Information (PI) / US Package Insert", "Phase": "Regulatory Submission, Post-Approval", "Sub_Phase_Discipline": "Regulatory Affairs / Medical / Clinical / Safety / Commercial",
      "Purpose_Key_Content": "FDA-approved labeling document providing information for safe and effective use of the drug. Includes Indications, Dosage, Contraindications, Warnings, AEs, Clinical Studies sections.",
      "Key_Metadata": "Product Name, NDA/BLA Number, Version/Date, Sections (per PLR format)",
      "Input_Documents_Data_Sources": "ISS, ISE, Key CSRs, Final Approved Data",
      "Output_Informs_Documents": "Marketed Product Use, FDA Website, Promotional Material Review",
      "Authoring_Department(s)": "Regulatory Labeling Lead, Medical Writer, SMEs (Clin, Safety, PK), Commercial Input", "Review_Approval_Dept(s)": "Negotiation with FDA, Internal Review Committee",
      "Complexity_Authoring": "High", "Regulatory_Significance": "FDA Approved, Legally Binding Document"
    },
    {
      "Doc_ID_Type": "REG-LABEL-EU", "Document_Name": "Summary of Product Characteristics (SmPC) / Package Leaflet (PIL) / Outer Labeling (EU)", "Phase": "Regulatory Submission, Post-Approval", "Sub_Phase_Discipline": "Regulatory Affairs / Medical / Clinical / Safety / Commercial",
      "Purpose_Key_Content": "EMA/NCA-approved documents. SmPC is for HCPs, PIL is for patients. Provides key info on use, risks, benefits. Structure defined by QRD templates.",
      "Key_Metadata": "Product Name, MA Number, Version/Date, Sections (per QRD template)",
      "Input_Documents_Data_Sources": "ISS, ISE, Key CSRs, RMP, Final Approved Data, Usability Testing (PIL)",
      "Output_Informs_Documents": "Marketed Product Use, EMA/NCA Website, Promotional Material Review",
      "Authoring_Department(s)": "Regulatory Labeling Lead, Medical Writer, SMEs (Clin, Safety, PK), PV (RMP link), Commercial Input", "Review_Approval_Dept(s)": "Negotiation with EMA/NCA (CHMP Opinions), Internal Review Committee",
      "Complexity_Authoring": "High", "Regulatory_Significance": "EMA/NCA Approved, Legally Binding Document"
    },
    {
      "Doc_ID_Type": "REG-RTQ", "Document_Name": "Response to Regulatory Questions (RTQ) / Information Request (IR)", "Phase": "Regulatory Submission Review Phase", "Sub_Phase_Discipline": "Regulatory Affairs + SMEs",
      "Purpose_Key_Content": "Formal response document addressing questions raised by a health authority during review of a submission (e.g., IND, NDA, MAA).",
      "Key_Metadata": "Application Number, Question Reference, Submission Sequence, Date",
      "Input_Documents_Data_Sources": "Regulatory Question Letter/Email, Internal Data/Reports/Re-analysis, SME Input",
      "Output_Informs_Documents": "Regulatory Agency Review of Response, Potential Clock Stop/Restart, Potential for Approval/Rejection/Label Changes",
      "Authoring_Department(s)": "Regulatory Affairs Lead, Relevant SMEs (Clin, Nonclin, CMC, Stats, Safety)", "Review_Approval_Dept(s)": "Senior Management, Legal (if needed)",
      "Complexity_Authoring": "High", "Regulatory_Significance": "Submission Critical (Direct Agency Interaction)"
    },
    {
      "Doc_ID_Type": "REG-AMD", "Document_Name": "Amendment / Variation", "Phase": "Pre/Post-Approval", "Sub_Phase_Discipline": "Regulatory Affairs + SMEs",
      "Purpose_Key_Content": "Submission to update an existing application (e.g., IND Amendment for new protocol; NDA/MAA Variation for CMC change or safety update).",
      "Key_Metadata": "Application Number, Amendment/Variation Type (e.g., Protocol, CMC Change - Type IA/IB/II), Submission Sequence",
      "Input_Documents_Data_Sources": "New Protocol, New CMC Data, New Safety Data (DSUR), Updated IB",
      "Output_Informs_Documents": "Regulatory Agency Review/Approval/Acknowledgement (depending on type), Implementation of Change",
      "Authoring_Department(s)": "Regulatory Affairs Lead, Relevant SMEs", "Review_Approval_Dept(s)": "QA (for CMC changes), Safety Committee (for safety changes)",
      "Complexity_Authoring": "Medium-High", "Regulatory_Significance": "Regulatory Compliance Critical"
    },
    {
      "Doc_ID_Type": "REG-AR", "Document_Name": "IND Annual Report / DSUR (Development Safety Update Report)", "Phase": "Clinical (Annual)", "Sub_Phase_Discipline": "Regulatory Affairs / Safety / Clinical",
      "Purpose_Key_Content": "Periodic report submitted to regulatory agencies summarizing trial progress and cumulative safety information for an investigational product. DSUR is ICH standard.",
      "Key_Metadata": "IND Number / Product Name, Reporting Period, Summary of Clinical Activity, Cumulative Safety Data Analysis",
      "Input_Documents_Data_Sources": "Ongoing CSRs/Interim Data, Global Safety Database, IB",
      "Output_Informs_Documents": "Continued Authorization for IND/CTAs, Agency Safety Review",
      "Authoring_Department(s)": "Regulatory Affairs Lead, Safety Physician/Scientist, Clinical Lead, Medical Writer", "Review_Approval_Dept(s)": "PV Head, Senior Management",
      "Complexity_Authoring": "High", "Regulatory_Significance": "GCP/GVP, Regulatory Requirement"
    },
    {
      "Doc_ID_Type": "REG-PIP", "Document_Name": "Pediatric Investigation Plan (PIP) (EU) / Pediatric Study Plan (PSP) (US)", "Phase": "Clinical (Early Phase 2/End of Phase 2)", "Sub_Phase_Discipline": "Regulatory Affairs / Clinical / Pediatric Experts",
      "Purpose_Key_Content": "Plan submitted to EMA (PIP) or FDA (PSP) outlining how the drug will be studied in pediatric populations. Agreement required for MAA/NDA submission (unless waived/deferred).",
      "Key_Metadata": "Product Name, Indication, Proposed Pediatric Studies (PK, Safety, Efficacy), Timelines, Waiver/Deferral Request (if applicable)",
      "Input_Documents_Data_Sources": "Adult Clinical Data, Preclinical Data, Pediatric Disease Knowledge, Modeling/Simulation Data",
      "Output_Informs_Documents": "Agreement with EMA (PDCO) / FDA, Pediatric Study Conduct, MAA/NDA Filing Prerequisite",
      "Authoring_Department(s)": "Regulatory Affairs Lead, Clinical Lead, Pediatrician/Expert, PK Modeler", "Review_Approval_Dept(s)": "Senior Management",
      "Complexity_Authoring": "High", "Regulatory_Significance": "Regulatory Requirement (EU/US)"
    },
    {
      "Doc_ID_Type": "REG-ODD", "Document_Name": "Orphan Drug Designation Application", "Phase": "Preclinical / Clinical", "Sub_Phase_Discipline": "Regulatory Affairs",
      "Purpose_Key_Content": "Application submitted to FDA or EMA requesting special status for a drug intended to treat a rare disease/condition, providing development incentives.",
      "Key_Metadata": "Product Name, Rare Disease/Condition, Rationale (Prevalence, Medical Need, Scientific Justification)",
      "Input_Documents_Data_Sources": "Preclinical Data (Proof of Concept), Clinical Data (if available), Epidemiology Data, Literature",
      "Output_Informs_Documents": "ODD Granted/Denied, Development Incentives (Market Exclusivity, Fee Waivers)",
      "Authoring_Department(s)": "Regulatory Affairs Lead, Medical/Clinical Lead", "Review_Approval_Dept(s)": "Senior Management",
      "Complexity_Authoring": "Medium-High", "Regulatory_Significance": "Regulatory Strategy/Incentive"
    },
    {
      "Doc_ID_Type": "REG-RMP", "Document_Name": "Risk Management Plan (RMP) (EU/Other Regions)", "Phase": "Regulatory Submission, Post-Approval", "Sub_Phase_Discipline": "Pharmacovigilance / Safety / Regulatory Affairs",
      "Purpose_Key_Content": "Document describing the known/potential risks of a drug, plans for characterizing risks further (pharmacovigilance activities), and measures to minimize risks (Risk Minimization Measures - RMM). Required for MAA.",
      "Key_Metadata": "Product Name, Version, Safety Specification (Risks), PV Plan, RMMs",
      "Input_Documents_Data_Sources": "ISS, CSRs, Preclinical Data, Epidemiological Data",
      "Output_Informs_Documents": "EMA/NCA Review/Approval, Post-Marketing PV Activities, Implementation of RMMs, Periodic Updates (with PSUR)",
      "Authoring_Department(s)": "PV Lead/Safety Physician, Regulatory Affairs, Medical Writer, Clinical Lead", "Review_Approval_Dept(s)": "Senior Management, QA",
      "Complexity_Authoring": "High", "Regulatory_Significance": "GVP, Submission Critical (MAA), Post-Marketing Requirement"
    },
    {
      "Doc_ID_Type": "PMS-PSUR", "Document_Name": "Periodic Safety Update Report (PSUR/PBRER)", "Phase": "Post-Marketing", "Sub_Phase_Discipline": "Pharmacovigilance / Safety",
      "Purpose_Key_Content": "Periodic report summarizing global interval and cumulative safety data for an approved product. Assesses benefit-risk balance. ICH E2C(R2) defines PBRER format.",
      "Key_Metadata": "Product Name, Reporting Period (Interval), Data Lock Point, Reference Safety Info (e.g., Label), Global Sales Data",
      "Input_Documents_Data_Sources": "Global Safety Database, Clinical Study Data (ongoing/completed), Literature, Spontaneous Reports, RMP",
      "Output_Informs_Documents": "Regulatory Agency Review, Signal Detection, Label Updates, RMP Updates, Benefit-Risk Assessment",
      "Authoring_Department(s)": "Pharmacovigilance / Safety Physician, Medical Writer, Epidemiologist (if needed)", "Review_Approval_Dept(s)": "Regulatory Affairs, QA, Qualified Person PV (EU), Senior Management",
      "Complexity_Authoring": "High", "Regulatory_Significance": "GVP, Regulatory Requirement"
    },
    {
      "Doc_ID_Type": "PMS-PV-SIGNAL", "Document_Name": "Signal Detection/Evaluation Report", "Phase": "Post-Marketing", "Sub_Phase_Discipline": "Pharmacovigilance / Safety",
      "Purpose_Key_Content": "Internal report documenting the process of detecting, validating, prioritizing, and assessing potential new safety signals from various data sources.",
      "Key_Metadata": "Potential Signal Topic, Data Sources Reviewed, Assessment Findings, Recommended Actions (e.g., Further analysis, Label change, Study)",
      "Input_Documents_Data_Sources": "Safety Databases, Literature, Clinical Data, Health Authority Websites",
      "Output_Informs_Documents": "Input to PSURs, RMP Updates, Potential Label Changes, Regulatory Notifications (if urgent)",
      "Authoring_Department(s)": "PV Scientist/Physician, Epidemiologist", "Review_Approval_Dept(s)": "PV Management, Safety Committee",
      "Complexity_Authoring": "Medium-High", "Regulatory_Significance": "GVP, Internal Process/Regulatory Expectation"
    },
    {
      "Doc_ID_Type": "PMS-AUDIT-GXP", "Document_Name": "GCP/GLP/GMP Audit Report", "Phase": "All Phases", "Sub_Phase_Discipline": "Quality Assurance (QA)",
      "Purpose_Key_Content": "Report documenting findings from an audit conducted by QA (or external auditor) to assess compliance of a study, site, vendor, or internal process against GxP regulations and SOPs.",
      "Key_Metadata": "Audit Scope, Audit Date, Auditee, Auditors, Findings (Observations classified by severity), Recommendations, CAPA references",
      "Input_Documents_Data_Sources": "Audit Plan, Applicable Regulations/SOPs, Documents/Processes Reviewed",
      "Output_Informs_Documents": "Corrective and Preventive Action (CAPA) Plan, Compliance Improvement, Vendor Qualification Documentation",
      "Authoring_Department(s)": "Lead Auditor", "Review_Approval_Dept(s)": "QA Management, Auditee Management (for response)",
      "Complexity_Authoring": "Medium", "Regulatory_Significance": "GCP/GLP/GMP Compliance Oversight"
    },
    {
      "Doc_ID_Type": "PMS-CAPA", "Document_Name": "Corrective and Preventive Action (CAPA) Plan/Record", "Phase": "All Phases", "Sub_Phase_Discipline": "QA / Operational Depts",
      "Purpose_Key_Content": "Record documenting actions taken to address deviations or audit findings, including root cause analysis, corrective actions, preventive actions, effectiveness checks.",
      "Key_Metadata": "Deviation/Audit Finding Ref, Root Cause Analysis, CAPA Details, Owner, Due Date, Effectiveness Check Results",
      "Input_Documents_Data_Sources": "Deviation Report, Audit Report",
      "Output_Informs_Documents": "Resolution of Non-compliance, Process Improvement, Closure of Audit Finding",
      "Authoring_Department(s)": "Owner of CAPA (Operational Dept)", "Review_Approval_Dept(s)": "QA Approval/Oversight",
      "Complexity_Authoring": "Medium", "Regulatory_Significance": "Quality Management System (QMS) Core Process"
    },
    {
      "Doc_ID_Type": "QMS-SOP", "Document_Name": "Standard Operating Procedure (SOP)", "Phase": "All Phases", "Sub_Phase_Discipline": "QA / Functional Depts",
      "Purpose_Key_Content": "Document providing detailed, written instructions for performing specific routine operations or activities to ensure consistency and compliance.",
      "Key_Metadata": "SOP Title, SOP Number, Version, Effective Date, Author/Owner Dept, Step-by-Step Procedures",
      "Input_Documents_Data_Sources": "Process Knowledge, Regulatory Requirements, Best Practices",
      "Output_Informs_Documents": "Standardized Process Execution, Training Material, Audit Reference",
      "Authoring_Department(s)": "SME from Functional Dept, Technical Writer", "Review_Approval_Dept(s)": "Functional Dept Head, QA Approval",
      "Complexity_Authoring": "Medium", "Regulatory_Significance": "GCP/GLP/GMP & QMS Requirement"
    },
    {
      "Doc_ID_Type": "QMS-TRAINREC", "Document_Name": "Training Record", "Phase": "All Phases", "Sub_Phase_Discipline": "All Personnel / HR / QA",
      "Purpose_Key_Content": "Documentation confirming that personnel have been trained on specific SOPs, regulations, protocols, or job functions.",
      "Key_Metadata": "Employee Name, Training Topic (SOP#, Protocol#), Date Trained, Trainer Signature/Method, Assessment (if applicable)",
      "Input_Documents_Data_Sources": "SOPs, Protocols, Training Materials",
      "Output_Informs_Documents": "Evidence of Qualified Personnel, Inspection Readiness",
      "Authoring_Department(s)": "Employee, Trainer, Supervisor, LMS Admin", "Review_Approval_Dept(s)": "N/A (Record)",
      "Complexity_Authoring": "Low", "Regulatory_Significance": "GCP/GLP/GMP Requirement"
    },
    {
      "Doc_ID_Type": "PM-PLAN", "Document_Name": "Project Management Plan / Integrated Development Plan", "Phase": "All Phases", "Sub_Phase_Discipline": "Project Management",
      "Purpose_Key_Content": "Overarching plan integrating timelines, resources, budget, risks, and milestones across all functional areas for the entire development program.",
      "Key_Metadata": "Product Name, Project Goals, Key Milestones (Gantt Chart), Budget Summary, Resource Allocation, Risk Register, Communication Plan",
      "Input_Documents_Data_Sources": "Functional Plans (Clin Dev, Nonclin, CMC, Reg), TPP",
      "Output_Informs_Documents": "Project Tracking, Budget Management, Resource Allocation, Risk Mitigation, Governance Updates",
      "Authoring_Department(s)": "Project Manager", "Review_Approval_Dept(s)": "Project Team, Senior Management/Governance Committee",
      "Complexity_Authoring": "High", "Regulatory_Significance": "Internal Governance/Operations"
    },
    {
      "Doc_ID_Type": "PM-RISKREG", "Document_Name": "Risk Register", "Phase": "All Phases", "Sub_Phase_Discipline": "Project Management / Cross-functional",
      "Purpose_Key_Content": "Living document identifying potential risks to the project (timeline, budget, technical, regulatory), their likelihood and impact, and planned mitigation/contingency actions.",
      "Key_Metadata": "Risk ID, Risk Description, Category, Likelihood, Impact, Mitigation Plan, Owner, Status",
      "Input_Documents_Data_Sources": "Project Team Input, Functional Plans, Past Experience",
      "Output_Informs_Documents": "Proactive Risk Management, Input to Project Plans, Governance Reporting",
      "Authoring_Department(s)": "Project Manager, Project Team Members", "Review_Approval_Dept(s)": "Project Team Review",
      "Complexity_Authoring": "Medium", "Regulatory_Significance": "Internal Governance/Best Practice"
    },
     {
        "Doc_ID_Type": "CLI-MAN-IMPHANDLE", "Document_Name": "IMP Handling Manual", "Phase": "Clinical (All Phases)", "Sub_Phase_Discipline": "Clinical Supply / Site Staff",
        "Purpose_Key_Content": "Provides instructions for site staff on receiving, storing, dispensing, returning, and accounting for the Investigational Medicinal Product.",
        "Key_Metadata": "Protocol ID, Product Name, Storage Conditions, Dispensing Instructions, Accountability Procedures",
        "Input_Documents_Data_Sources": "CLI-PROT, CMC-LABEL-IMP, PRE-REP-CMC-STAB",
        "Output_Informs_Documents": "Site Training, IMP Handling at Site, CLI-LOG-IMPACC",
        "Authoring_Department(s)": "Clinical Supply Lead, Clinical Operations", "Review_Approval_Dept(s)": "QA",
        "Complexity_Authoring": "Medium", "Regulatory_Significance": "GCP/GMP (Drug Accountability, Storage)"
     },
     {
        "Doc_ID_Type": "CMC-LABEL-IMP", "Document_Name": "IMP Label Specification/Approval", "Phase": "Clinical (All Phases)", "Sub_Phase_Discipline": "CMC / Regulatory Affairs / Clinical Supply",
        "Purpose_Key_Content": "Defines the content and layout of labels applied to the Investigational Medicinal Product, ensuring compliance with regulations (e.g., Annex 13 in EU).",
        "Key_Metadata": "Product Name, Protocol ID, Batch Number Placement, Storage Conditions, Expiry Date Format, Warning Statements, Regulatory Compliance Checklist",
        "Input_Documents_Data_Sources": "CLI-PROT, Regulatory Guidelines (e.g., Annex 13), PRE-SPEC-DP",
        "Output_Informs_Documents": "IMP Packaging and Labeling Operations, Release of IMP for Clinical Use",
        "Authoring_Department(s)": "Clinical Supply/Packaging, Regulatory Affairs", "Review_Approval_Dept(s)": "QA, CMC Lead",
        "Complexity_Authoring": "Medium", "Regulatory_Significance": "GCP/GMP, Regulatory Compliance Critical"
     },
     {
        "Doc_ID_Type": "CLI-LOG-IMPACC", "Document_Name": "IMP Accountability Log", "Phase": "Clinical (All Phases)", "Sub_Phase_Discipline": "Site Staff / Clinical Supply / Monitoring",
        "Purpose_Key_Content": "Log maintained at the clinical site (or centrally) to track receipt, dispensing, return, and destruction of Investigational Medicinal Product for each participant.",
        "Key_Metadata": "Protocol ID, Site ID, Participant ID, Date, Amount Dispensed/Returned, Batch/Lot Number, Pharmacist/Staff Signature",
        "Input_Documents_Data_Sources": "Dispensing Records, Return Records, CLI-MAN-IMPHANDLE",
        "Output_Informs_Documents": "Monitoring Visit Reports (CLI-REP-MONVISIT), Drug Reconciliation, LOG-IMPDESTRUCT",
        "Authoring_Department(s)": "Site Pharmacist/Coordinator", "Review_Approval_Dept(s)": "Monitor (CRA)",
        "Complexity_Authoring": "Low (per entry)", "Regulatory_Significance": "GCP (Essential Document)"
     },
      {
      "Doc_ID_Type": "CLI-FIN-BUDGET", "Document_Name": "Clinical Trial Budget", "Phase": "Clinical (All Phases)", "Sub_Phase_Discipline": "Clinical Operations / Finance",
      "Purpose_Key_Content": "Detailed breakdown of planned costs associated with conducting a clinical trial, including site payments, vendor costs, internal resources, and contingency.",
      "Key_Metadata": "Protocol ID, Budget Version, Cost Categories (e.g., Site Fees, Monitoring, Data Management, IMP), Total Cost Estimate",
      "Input_Documents_Data_Sources": "CLI-PROT, Site Contracts Drafts, Vendor Proposals, PM-PLAN Resource Allocation",
      "Output_Informs_Documents": "Contract Negotiations (CLI-AGREE-CT), Financial Accruals, Project Budget Tracking",
      "Authoring_Department(s)": "Clinical Outsourcing/Contracts, Clinical Trial Manager, Finance", "Review_Approval_Dept(s)": "Clin Ops Management, Finance Management",
      "Complexity_Authoring": "High", "Regulatory_Significance": "Internal Governance / Financial Control"
      },
      {
      "Doc_ID_Type": "VEND-AGREE-CRO", "Document_Name": "CRO Master Service Agreement / Work Order", "Phase": "All Phases (as applicable)", "Sub_Phase_Discipline": "Legal / Outsourcing / Functional Dept",
      "Purpose_Key_Content": "Legal contract outlining the terms, conditions, scope of work, responsibilities, and payment terms between the sponsor and a Contract Research Organization (CRO) or other key vendor.",
      "Key_Metadata": "Vendor Name, Agreement Date, Scope of Work ID, Service Level Agreements (SLAs), Payment Milestones",
      "Input_Documents_Data_Sources": "Vendor Qualification Report (QA-REP-VENDORQUAL), Request for Proposal (RFP) Responses, Budget Approvals",
      "Output_Informs_Documents": "Vendor Performance Management, Invoice Processing, Sponsor Oversight Activities",
      "Authoring_Department(s)": "Sponsor Legal/Contracts Dept, Outsourcing Manager", "Review_Approval_Dept(s)": "Functional Area Head (using vendor), Finance",
      "Complexity_Authoring": "High", "Regulatory_Significance": "GCP/GLP/GMP (Vendor Oversight Documentation)"
      }
  ]