Welcome to Doc_Map_Agent
A comprehensive R&D document authoring accelerator
- 04/05/2025 - Assessment completed for Client XYZ Pharma
- 04/02/2025 - Document blueprint updated: Clinical Study Report
- 03/28/2025 - New process flow created: IND Submission
Document Catalog
Filters
Phase
Document Type
Results (125 documents)
Clinical Study Protocol
Defines the objectives, design, methodology, and statistical considerations for a clinical trial.
Investigator's Brochure
Compilation of clinical and non-clinical data on the investigational product relevant to study in human subjects.
New Drug Application
Formal submission to FDA requesting approval to market a new drug in the United States.
Target ID Report
Documents identifying and validating biological targets for potential therapeutic intervention.
Clinical Study Protocol
Phase: Clinical
Owner: Clinical Operations
Purpose: Defines the objectives, design, methodology, and statistical considerations for a clinical trial.
Format: PDF, DOCX
Typical Length: 50-100 pages
Update Frequency: As needed
Retention: Life of product + 5 years
Security Classification: Confidential
- Protocol Synopsis Development
- Full Protocol Drafting
- Internal Review
- Medical/Scientific Review
- Statistical Review
- Regulatory Review
- Final Approval
- Distribution
Document Dependency Mapping
Critical Dependencies:
- Investigational Product Profile → Clinical Study Protocol
- Clinical Study Protocol → Informed Consent Form
- Clinical Study Protocol → Case Report Form
Impact Analysis:
Changes to Clinical Study Protocol will impact 4 downstream documents and potentially delay study start by 2-4 weeks.
Recommendations:
- Prioritize Protocol finalization to unblock dependent docs
- Consider parallel development of Statistical Analysis Plan
- Establish version control process for Protocol amendments
Process Visualization
Selected Process: Clinical Trial Execution
Duration: Typically 1-5 years
Key Milestones:
- First Patient First Visit
- Last Patient First Visit
- Last Patient Last Visit
- Database Lock
Critical Documents:
Process Simulation & Bottleneck Analysis
Simulation Settings
Resource Allocation:
Timeline Constraints:
Estimated Timeline: 187 days (04/15/2025 - 10/19/2025)
Status: 4 days behind target end date
Identified Bottlenecks:
- Protocol Review (15 days) - Regulatory resources constrained
- CRF Development (21 days) - Data Management resources needed
- Statistical Analysis (18 days) - Statistics team overallocated
Recommendations:
- Increase Regulatory resources from 2 to 3 (saves 5 days)
- Start CRF development in parallel with Protocol finalization
- Consider outsourcing part of statistical analysis
Document Ecosystem Assessment
Assessment Type
Scope:
Gap Analysis
Identify missing or outdated documents in the client's ecosystem.
Compliance Check
Verify regulatory compliance of document ecosystem.
Maturity Model
Assess process maturity and identify improvement areas.
Document Blueprint: Clinical Study Protocol
Blueprint Actions
- Protocol Title Page
- Synopsis
- Table of Contents
- List of Abbreviations
- Protocol Introduction
- Study Objectives
- Study Design
- Subject Selection
- Study Treatments
- Study Procedures
- Adverse Events
- Statistical Methods
- Data Management
- Ethics and Regulations
- References
- Appendices
Purpose: Describes the overall design of the study, including study type, randomization, blinding, and duration.
Content Guidelines:
- Clearly state study design type (e.g., parallel, crossover)
- Describe randomization and blinding procedures
- Define study periods and visit schedule
- Include study schematic diagram
- Specify duration of subject participation