Hugging Face's logo

Spaces:
DivyaS1
/
GSKRAGDemoReplic
Sleeping

App Files Community
davidfearne commited on
Commit
2df8f2e
·
verified ·
1 Parent(s): fa02206

Upload GSKGlossary.md

Browse files
Files changed (1) hide show
  1. assets/GSKGlossary.md +101 -0
assets/GSKGlossary.md ADDED
@@ -0,0 +1,101 @@
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1
+ ## Glossary
2
+ | Nr | Abbreviation | Full Term | Synonym | Definition | Context |
3
+ |-----|--------------|----------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
4
+ | 1 | +/- VE | Positive/Negative | N/A | N/A | - |
5
+ | 2 | Active Substance | N/A | Active Ingredient, Active pharmaceutical Ingredient (API) | Any component that provides pharmacological activity or other direct effects | Used in pharmacology and drug formulation. Example: "The active substance in this medication is ibuprofen." |
6
+ | 3 | AE | Adverse Event | N/A | Any untoward medical occurrence in a patient administered a pharmaceutical product | Used in clinical trials and pharmacovigilance to monitor drug safety. Example: "The patient reported an AE after taking the medication." |
7
+ | 4 | AESI | Adverse Events of Special Interest | N/A | Specific adverse events that are of particular concern for a drug or class of drugs | Monitored closely in clinical trials and post-marketing surveillance. Example: "AESIs for this vaccine include severe allergic reactions." |
8
+ | 5 | Applicant | N/A | N/A | The person or entity that submits an application for a regulatory activity | Involved in the regulatory submission process. Example: "The applicant must provide comprehensive data to the EMA." |
9
+ | 6 | aPV | Additional Pharmacovigilance | N/A | Extra measures taken to monitor the safety of a drug | Used to enhance drug safety monitoring. Example: "aPV activities include additional safety studies." |
10
+ | 7 | EPAR | European Public Assessment Report | N/A | Set of published documents that describe the evaluation of a drug authorized | Used in regulatory affairs to provide detailed information on the evaluation of medicinal products by the EMA. Example: "The EPAR for this new drug highlights its efficacy and safety profile." |
11
+ | 8 | ASCII | N/A | American Standard Code for Information Interchange | Used in data encoding and communication protocols. Example: Ensuring data integrity in electronic health records. |
12
+ | 9 | BEST | Biologics Effectiveness and Safety | N/A | A program to evaluate the effectiveness and safety of biologic products | Used in the context of biologic drug development and monitoring. Example: "The BEST program provides valuable data on biologic therapies." |
13
+ | 10 | Biopharmaceuticals | Biologics | N/A | A pharmaceutical product derived from biological sources and especially the ones produced by biotechnology | Used in drug development and therapeutic treatments. Example: Monoclonal antibodies for cancer therapy. |
14
+ | 11 | BP | Blood Pressure | N/A | The pressure of circulating blood on the walls of blood vessels | A critical parameter in clinical studies and patient monitoring. Example: "The drug's effect on BP was measured." |
15
+ | 12 | BRP | Expert Panels | N/A | Blue Ribbon Panels (BRPs) provide a forum for MedDRA experts from industry and regulatory authorities to discuss and make recommendations to the MedDRA Management Committee on challenging MedDRA issues on behalf of the user community | Used in regulatory discussions and decision-making. Example: Reviewing new drug safety data. |
16
+ | 13 | CAERS | Adverse Event Reporting System | CFSAN | US Center for Food Safety and Applied Nutrition (CFSAN) Adverse Event Reporting System | Used in monitoring and reporting adverse events. Example: Reporting side effects of dietary supplements. |
17
+ | 14 | Cases | Clinical Studies | N/A | Individual instances of adverse events or other reportable conditions in pharmacovigilance and clinical trials | Used in epidemiology and clinical research. Example: "The number of COVID-19 cases in the study was recorded." |
18
+ | 15 | CDC | Centers for Disease Control and Prevention | N/A | A national public health institute in the United States | Involved in disease prevention and control. Example: "The CDC provides guidelines for vaccine administration." |
19
+ | 16 | Change Request | Modification Request | N/A | A MedDRA Change Request (CR) allows a MedDRA subscriber to recommend changes, corrections or improvements to MedDRA and to Standardised MedDRA Queries (SMQs) | Used in maintaining and updating medical terminology databases. Example: Adding new medical terms to MedDRA. |
20
+ | 17 | CHMP | Committee for Medicinal Products for Human Use | N/A | Committee responsible for preparing the EMA's opinions on questions concerning human medicines | Involved in the assessment and approval process of new medicines in the EU. Example: "The CHMP has recommended the approval of the new vaccine." |
21
+ | 18 | CIOMS | International Medical Organizations | N/A | Council for International Organizations of Medical Sciences | Used in global health policy and guidelines. Example: Developing ethical guidelines for clinical trials. |
22
+ | 19 | Complex Change Request | Major Modification | N/A | Changes to MedDRA levels above PT (i.e., HLT, HLGT and SOC) | Used in significant updates to medical terminology. Example: Reclassifying disease categories in MedDRA. |
23
+ | 20 | Control | Controlled Population | N/A | A group in a clinical trial that receives a placebo or standard treatment for comparison | Used to assess the efficacy of a new treatment. Example: "The control group received a placebo." |
24
+ | 21 | COSTART | Adverse Reaction Terms | N/A | Coding Symbols for a Thesaurus of Adverse Reaction Terms | Used in coding and reporting adverse drug reactions. Example: Standardizing adverse event terminology in clinical trials. |
25
+ | 22 | CRO | Clinical Research Organization | N/A | Contract Research Organisation | Used in outsourcing clinical trial management. Example: Conducting multi-center clinical trials. |
26
+ | 23 | CTCAE | Adverse Event Criteria | N/A | US Common Terminology Criteria for Adverse Events | Used in assessing and grading adverse events in clinical trials. Example: Reporting severity of chemotherapy side effects. |
27
+ | 24 | CTD | Common Technical Document | N/A | Common Technical Document | Used in regulatory submissions for drug approval. Example: Submitting clinical trial data to regulatory agencies. |
28
+ | 25 | DIA | Drug Information Association | N/A | N/A | Used in professional development and networking in the pharmaceutical industry. Example: Attending DIA conferences for industry updates. |
29
+ | 26 | Dose | N/A | N/A | The amount of a drug administered to a patient | Critical in determining the efficacy and safety of a drug. Example: "The recommended dose is 50 mg daily." |
30
+ | 27 | EEA | European Economic Area | N/A | N/A | Used in regulatory and trade contexts within Europe. Example: Compliance with EEA pharmaceutical regulations. |
31
+ | 28 | EHR | Electronic Health Record(s) | Electronic Medical Record (EMR), Personal Health Record (PHR) | A systematized collection of patient and population information, electronically stored health in a digital format. These records can be shared across different health care settings and include data such as demographics, medical history, medications, lab results, and more | EHRs are used in healthcare settings to improve the quality and efficiency of patient care. They provide a comprehensive view of a patient's medical history, facilitate better coordination among healthcare providers, and support clinical decision-making. EHRs are also used for billing, reporting, and research purposes |
32
+ | 29 | EFPIA | European Pharma Association | N/A | European Federation of Pharmaceutical Industries and Associations, is one of the ICH Parties and also a member of the ICH MedDRA Management Committee | Used in representing pharmaceutical industry interests in Europe. Example: Advocacy for pharmaceutical innovation policies. |
33
+ | 30 | EMA | European Medicines Agency | N/A | Agency responsible for the scientific evaluation, supervision, and safety monitoring of medicines in the EU | Central to the approval and monitoring of medicines in Europe. Example: "The EMA has issued new guidelines for clinical trials." |
34
+ | 31 | EMA | European Medicines Agency | N/A | N/A | Used in drug regulation and approval within the EU. Example: EMA approval of new vaccines. |
35
+ | 32 | EMEA | European Medicines Agency | N/A | Europe, Middle East, and Africa | Refers to the geographical region covered by the EMA. Example: "The EMEA region has specific regulatory requirements." |
36
+ | 33 | EU | European Union | N/A | N/A | Used in regulatory and policy contexts within Europe. Example: EU regulations on drug safety. |
37
+ | 34 | EudraVigilance/EVWEB | Drug Safety Database | N/A | Web-based system developed by EMA to collect and store ICSRs for all drugs with adverse events occurring in Europe | Used in pharmacovigilance and drug safety monitoring. Example: Reporting adverse drug reactions in Europe. |
38
+ | 35 | EVWEB | EudraVigilance Web | N/A | N/A | Used in accessing the EudraVigilance database| 36 | Expert Panel | Advisory Committee | N/A | The MedDRA Expert Panel was established by the MSSO to provide feedback to the MSSO on difficult change requests and other problematic maintenance issues | Used in providing expert advice on medical terminology. Example: Reviewing complex change requests in MedDRA. |
39
+ | 37 | FAERS | Adverse Event Reporting System | N/A | US FDA Adverse Event Reporting System; formerly known as "AERS" | Used in monitoring and reporting adverse drug events. Example: Reporting side effects of new medications. |
40
+ | 38 | FDA, United States | Food and Drug Administration | N/A | US Food and Drug Administration, is one of the ICH Parties and also a member of the ICH MedDRA Management Committee | Used in drug regulation and approval in the US. Example: FDA approval of new drugs. |
41
+ | 39 | GVP | Pharmacovigilance Practices | N/A | Good Pharmacovigilance Practices | Used in ensuring drug safety and efficacy. Example: Implementing GVP guidelines in clinical trials. |
42
+ | 40 | HARTS | Adverse Reaction Terminology | N/A | Hoechst Adverse Reaction Terminology System | Used in coding and reporting adverse drug reactions. Example: Standardizing adverse event terminology in clinical trials. |
43
+ | 41 | Health Canada, Canada | Canadian Health Department | N/A | Canadian Federal department for health, is one of the ICH Observers and also a member of the ICH MedDRA Management Committee | Used in drug regulation and approval in Canada. Example: Health Canada approval of new medications. |
44
+ | 42 | HLGT | High Level Group Term | N/A | High Level Group Term level of MedDRA | Used in medical terminology classification. Example: Grouping related medical terms in MedDRA. |
45
+ | 43 | HLT | High Level Term | N/A | High Level Term level of MedDRA | Used in medical terminology classification. Example: Grouping related medical terms in MedDRA. |
46
+ | 44 | ICD | Disease Classification | N/A | International Classification of Diseases | Used in coding and reporting diseases. Example: ICD codes for billing and insurance purposes. |
47
+ | 45 | ICD-CM | Clinical Modification | N/A | International Classification of Diseases - (Clinical Modification) | Used in coding and reporting diseases in clinical settings. Example: ICD-CM codes for hospital records. |
48
+ | 46 | ICH | Harmonisation Council | N/A | International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use is a joint initiative involving both regulators and research-based industry focusing on the technical requirements for medicinal products containing new drugs | Used in developing global pharmaceutical guidelines. Example: ICH guidelines for clinical trial conduct. |
49
+ | 47 | ICH Assembly | Governing Body | N/A | Is the body that governs the ICH, determines the policies and procedures for ICH, selects topics for harmonisation and monitors the progress of harmonisation initiatives. Each of the six Parties has two seats on the ICH Assembly. Each of the Observers nominates non-voting participants to attend the ICH Assembly Meetings, IFPMA also participates as a non-voting observer. | Used in overseeing ICH activities and initiatives. Example: Setting priorities for pharmaceutical harmonisation. |
50
+ | 48 | ICH Secretariat | Administrative Office | N/A | Secretariat located in Geneva, Switzerland responsible for day-to-day management of ICH Assembly, Working Groups and MedDRA Management Committee activities as well as Global Cooperation with non ICH countries activities | Used in managing ICH operations and communications. Example: Coordinating ICH meetings and documentation. |
51
+ | 49 | ICSR | Safety Report | N/A | Individual Case Safety Report | Used in reporting individual adverse drug reactions. Example: Submitting ICSRs to regulatory authorities. |
52
+ | 50 | IFPMA | International Federation of Pharma Manufacturers Association | N/A | International Federation of Pharmaceutical Manufacturers and Associations. | Used in representing pharmaceutical manufacturers globally. Example: Advocacy for global pharmaceutical policies. |
53
+ | 51 | IMDRF | International Medical Device Regulators Forum | N/A | International Medical Device Regulators Forum | Used in harmonising medical device regulations. Example: Developing global standards for medical devices. |
54
+ | 52 | IMI | Medicines Initiative | N/A | Innovative Medicines Initiative | Used in promoting pharmaceutical innovation and research. Example: Funding collaborative research projects. |
55
+ | 53 | ISO | International Standards Organization | N/A | ISO 9001:2008 is an internationally recognised quality management system standard developed by the International Organization for Standardization (ISO) | Used in ensuring quality management in pharmaceutical manufacturing. Example: Implementing ISO standards in production processes. |
56
+ | 54 | J-ART | Japanese Adverse Reaction Terminology | N/A | N/A | Used in coding and reporting adverse drug reactions in Japan. Example: Standardizing adverse event terminology in Japanese clinical trials. |
57
+ | 55 | JMB | Japanese Management Board | N/A | N/A | Used in overseeing MedDRA activities in Japan. Example: Managing MedDRA updates and translations. |
58
+ | 56 | JMO | Japanese Maintenance Organization | N/A | Japanese Maintenance Organization, is a partner of the MSSO and is responsible for maintaining and distributing MedDRA in Japan | Used in maintaining MedDRA in Japan. Example: Distributing MedDRA updates to Japanese users. |
59
+ | 57 | JPMA | Japan Pharma Association | N/A | Japan Pharmaceutical Manufacturers Association, is one of the ICH Parties and also a member of the ICH MedDRA Management Committee | Used in representing pharmaceutical manufacturers in Japan. Example: Advocacy for pharmaceutical policies in Japan. |
60
+ | 58 | LLT | Lowest Level Term | N/A | Lowest Level Term level of MedDRA | Used in medical terminology classification. Example: Detailed coding of medical terms in MedDRA. |
61
+ | 59 | MAH | Marketing Authorization Holder | N/A | The company or entity that holds the authorization to market a drug | Responsible for the drug's compliance with regulatory requirements. Example: "The MAH must report any safety concerns to the EMA." |
62
+ | 60 | MAA | Marketing Authorization Application | New Drug Application (NDA) (US) | An application submitted by pharmaceutical companies to regulatory authorities seeking approval to market and distribute a new pharmaceutical product or a variation of an existing product. The application includes detailed scientific, technical, and regulatory information to ensure the product is safe, effective, and of high quality. | MAAs are used in the pharmaceutical industry to obtain permission to bring new medicinal products to market. They are submitted to regulatory bodies such as the European Medicines Agency (EMA) or the UK Medicines and Healthcare products Regulatory Agency (MHRA). The process involves rigorous review to ensure compliance with safety, efficacy, and quality standards. |
63
+ | 61 | MedDRA | Medical Dictionary | N/A | Medical Dictionary for Regulatory Activities; developed under the auspices of ICH and maintained by MSSO, and providing an international medical dictionary applicable to all phases of biopharmaceutical and medical product development | Used in coding and reporting medical information. Example: Standardizing medical terminology in regulatory submissions. |
64
+ | 62 | MedDRA Code | Term Code | N/A | In contrast to the typical use of the word "code" in the regulatory milieu, within MedDRA, the code refers to the eight-digit number assigned to each term and is not to be confused with the text string of the term itself. Each term in MedDRA has a unique non-expressive 8-digit code. | Used in identifying medical terms in MedDRA. Example: Using MedDRA codes for accurate data entry in clinical trials. |
65
+ | 63 | MedDRA Management Committee | MedDRA MC | N/A | Is appointed by the ICH Assembly to oversee the activities of the "Maintenance and Support Services Organisation" (MSSO) for MedDRA, and ensure that the MSSO is meeting the various needs of MedDRA users. The Management Committee is composed of one representative from each of the six ICH Parties and one representative from MHRA and Health Canada. The ICH MedDRA Secretariat supports the MedDRA Management Committee and acts as a non-voting observer on the committee. | Used in overseeing MedDRA activities and ensuring its proper maintenance. Example: Reviewing updates and changes to MedDRA terminology. |
66
+ | 64 | MedDRA/J | Japanese MedDRA | N/A | Japanese translation of MedDRA | Used in coding and reporting medical information in Japan. Example: Using MedDRA/J for regulatory submissions in Japan. || 65 | MHLW, Japan | Japan Ministry of Health | N/A | Japan Ministry of Health, Labour and Welfare, is one of the ICH Parties and also a member of the ICH MedDRA Management Committee | Used in drug regulation and public health in Japan. Example: MHLW approval of new pharmaceuticals. |
67
+ | 66 | MHRA, UK | UK Medicines Agency | N/A | UK Medicines and Healthcare Products Regulatory Agency, is a member of the ICH MedDRA Management Committee | Used in drug regulation and safety monitoring in the UK. Example: MHRA's role in approving new medications. |
68
+ | 67 | MSSO | MedDRA Maintenance Organization | N/A | Maintenance and Support Services Organization, the repository, maintainer, and distributor of MedDRA | Used in maintaining and distributing MedDRA. Example: MSSO's role in updating MedDRA terms. |
69
+ | 68 | Multiaxiality | Multi-Classification | N/A | Terms in MedDRA may belong to more than one SOC; this property, called multiaxiality, allows for flexibility in the output and analysis of MedDRA coded data | Used in flexible data analysis and reporting. Example: Analyzing adverse event data across multiple SOCs. |
70
+ | 69 | NEC | Not Elsewhere Classified | N/A | Not elsewhere classified is a standard abbreviation used to denote groupings of miscellaneous terms that do not readily fit into other hierarchical classifications within a particular SOC. The NEC designation is used only with HLTs and HLGTs for grouping purposes | Used in grouping miscellaneous medical terms. Example: Classifying rare adverse events under NEC. |
71
+ | 70 | NOS | Not Otherwise Specified | N/A | Not otherwise specified terms are only found on the LLT level and are meant to represent concepts for which no further specific information is available (e.g., during coding of adverse events) | Used in coding non-specific medical terms. Example: Coding an adverse event as NOS when details are lacking. |
72
+ | 71 | Participants | Subjects | N/A | Individuals who take part in a clinical trial | Used in clinical research to refer to study volunteers. Example: "The trial has 100 participants." |
73
+ | 72 | PDF | Portable Document Format | N/A | N/A | Used in sharing and storing documents. Example: Submitting regulatory documents in PDF format. |
74
+ | 73 | Pharmacogenetic | Genetic Pharmacology | N/A | The study of the interrelation of hereditary constitution and response to drugs | Used in personalized medicine and drug development. Example: Studying genetic factors affecting drug metabolism. |
75
+ | 74 | Pharmacovigilance | Drug Safety Monitoring | N/A | The pharmacological science relating to detection, assessment, understanding and prevention of adverse effects, particularly the long and short term side effects of medicines | Used in monitoring and ensuring drug safety. Example: Conducting pharmacovigilance studies to detect adverse drug reactions. |
76
+ | 75 | Phase | N/A | N/A | A stage in the clinical trial process | Used to describe the different stages of clinical trials (Phase I, II, III, IV). Example: "The drug is currently in Phase II trials." |
77
+ | 76 | PhRMA | Pharma Association | N/A | Pharmaceutical Research and Manufacturers of America, is one of the ICH Parties and also a member of the ICH MedDRA Management Committee | Used in representing pharmaceutical manufacturers in the US. Example: Advocacy for pharmaceutical research and development. |
78
+ | 77 | PIP | Paediatric Investigation Plan | N/A | A development plan aimed at ensuring that the necessary data are obtained through studies in children to support the authorization of a medicine for children | Used in the context of drug development and regulatory submissions. Example: "The PIP must be submitted to the EMA for approval before starting pediatric trials." |
79
+ | 78 | PMDA, Japan | Japan Drug Agency | N/A | Japan Pharmaceuticals and Medical Devices Agency | Used in drug and medical device regulation in Japan. Example: PMDA's role in approving new medical devices. |
80
+ | 79 | Population | - | N/A | The group of individuals participating in a clinical study | Used in clinical research to define the study sample. Example: "The study population includes adults aged 18-65." |
81
+ | 80 | PRAC | Pharmacovigilance Risk Assessment Committee | N/A | Committee responsible for assessing and monitoring the safety of human medicines | Focuses on the safety of medicines and risk management. Example: "The PRAC is reviewing the safety data for this medication." |
82
+ | 81 | PT | Preferred Term | N/A | N/A | Used in coding and reporting medical terms in MedDRA. Example: Using PTs for standardized adverse event reporting. |
83
+ | 82 | PTC | Points to Consider | N/A | MedDRA Points to Consider documents provide best practice approaches for the use of MedDRA | Used in guiding the use of MedDRA. Example: Following PTC guidelines for accurate coding. |
84
+ | 83 | QMS | Quality Management System | N/A | N/A | Used in ensuring quality in pharmaceutical manufacturing and processes. Example: Implementing a QMS to comply with regulatory standards. |
85
+ | 84 | Rapporteur | Lead Representative | N/A | A representative of one of the six ICH parties designated by the Steering Committee when a new topic is formally adopted. The Rapporteur is responsible for leading a working group (EWG/IWG) and ensuring that the group keeps an up-to-date action plan and timetable, with clear deliverables and deadlines | Used in leading ICH working groups. Example: A Rapporteur coordinating the development of new guidelines. |
86
+ | 85 | Regulatory intelligence | N/A | N/A | New or updated regulations, standards or guidances, which could impact the acquisition or maintenance of regulatory licenses for a company | Used in staying informed about regulatory changes. Example: Monitoring regulatory intelligence to ensure compliance. || 86 | RMP | Risk Management Plan | N/A | A detailed description of the risk management system for a medicinal product | Used to ensure that the benefits of a drug outweigh its risks. Example: "The RMP outlines the strategies to monitor and mitigate risks." |
87
+ | 87 | RNA | Ribonucleic Acid | N/A | A molecule essential for various biological roles, including coding, decoding, regulation, and expression of genes | Used in the context of genetic research and vaccine development. Example: "mRNA vaccines use RNA to instruct cells to produce a protein that triggers an immune response." |
88
+ | 88 | RWE | Real World Evidence | N/A | Clinical evidence regarding the usage and potential benefits or risks of a medical product derived from the analysis of Real World Data. It is the outcome of analyzing RWD to generate meaningful insights that can inform regulatory decisions. | Patient-based non-interventional pre- or postauthorization studies performed to support the marketing authorization application (primary and/or secondary use of data) or Product-related literature review |
89
+ | 89 | RWD | Real World Data | N/A | Data relating to patient health status and the delivery of healthcare routinely collected from a variety of sources. These sources include | Different sources of RWD include: Electronic Health Records (EHRs), Claims and Billing Data, Product and Disease Registries, Patient-Generated Data, Pharmacy Data, Social Media and Online Health Communities, Clinical Practice Data, Public Health Databases |
90
+ | 90 | SAE | Serious Adverse Event | Serious Adverse Reaction (SAR) | An adverse event that results in death, is life-threatening, requires hospitalization, or causes significant disability | Critical in assessing the safety profile of a drug. Example: "The clinical trial was paused due to an SAE." |
91
+ | 91 | Simple Change | Minor Modification | N/A | Changes to the PT and LLT levels of MedDRA | Used in making minor updates to MedDRA terminology. Example: Adding a new PT to MedDRA. |
92
+ | 92 | SMQ | Standardised Query | N/A | Standardised MedDRA Query is a grouping of MedDRA terms, ordinarily at the Preferred Term (PT) level that relate to a defined medical condition or area of interest | Used in querying MedDRA for specific medical conditions. Example: Using an SMQ to identify cases of liver toxicity. |
93
+ | 93 | SNOMED CT | Clinical Terminology | N/A | Systematized Nomenclature of Medicine -- Clinical Terms | Used in coding and reporting clinical information. Example: Using SNOMED CT for electronic health records. |
94
+ | 94 | SOC | System Organ Class | N/A | System Organ Class level of MedDRA | Used in classifying medical terms in MedDRA. Example: Grouping related terms under a single SOC. |
95
+ | 95 | Studies | Research | N/A | Systematic investigations to establish facts or principles | Used in the context of scientific research. Example: "The studies show promising results." |
96
+ | 96 | Table | N/A | N/A | N/A | N/A |
97
+ | 97 | Trial | Clinical Trial | N/A | A research study to evaluate the safety and efficacy of a medical intervention | Essential in the drug development process. Example: "The clinical trial is in Phase III." |
98
+ | 98 | VAERS | Vaccine Adverse Event Reporting System | N/A | US Vaccine Adverse Event Reporting System | Used in monitoring and reporting vaccine-related adverse events. Example: Submitting reports to VAERS for vaccine safety monitoring. |
99
+ | 99 | WEB-RADR | Adverse Drug Reaction Reporting | N/A | Web Recognising Adverse Drug Reactions | Used in reporting adverse drug reactions online. Example: Using WEB-RADR for mobile reporting of adverse events. |
100
+ | 100 | WHO | World Health Organization | N/A | World Health Organization and one of the ICH Observers | Used in global health policy and guidelines. Example: WHO's role in setting international health standards. |
101
+ | 101 | WHO-ART | WHO Adverse Reaction Terminology | N/A | World Health Organization Adverse Reaction Terminology | Used in coding and reporting adverse drug reactions. Example: Using WHO-ART for international adverse event reporting. |