Description
Since the ICH E3 guidance was made final, experiences implementing the guidance in the ICH regions have given rise to requests for clarification. This question and answer (Q&A) document is intended to facilitate implementing the ICH E3 guidance by clarifying key issues.
Key Topics
Terms and concepts identified from this document
Scope & Applicability
Product Classes
2Product category requiring specific CSR data
A type of ATMP involving recombinant nucleic acids or viral vectors.
Stakeholders
4Way questions are framed is critical to collecting unbiased patient input
Clear understanding for ethics committees and regulators.
Responsible for qualifications, training, and trial conduct; Individual responsible for trial conduct and data governance at a site.; May delegate tasks but retains overall responsibility; Person responsible for the conduct of the clinical trial at a trial site; Responsible for trial conduct and participant safety; Responsible for trial conduct, data integrity, and investigational product management.; Individual responsible for trial conduct at a site and informing the institution.; maintaining
responsible for justifying omission of studies
Regulatory Context
Regulatory Activities
1Submission for product approval
Document Types
10Example flowchart showing the disposition of patients in a clinical study.
STF used in eCTD v3.2.2 to reference datasets
eCTD specifications for regulatory submissions
provided by the sponsor when required by regulatory requirements
collect on the case report form (CRF) the Investigator's clinical interpretation
Defines the standard of veterinary practice and limits for anesthetic regimens
Repositories held by the sponsor for essential records
Brief summary format for exploratory genomic data.
Format for submitting development information; Module 3 of the CTD for detailed descriptions of analytical procedures; ICH guideline M4Q(R1) for the registration of pharmaceuticals.
CSR supported by ADaM datasets; Contains analysis results and animal listings
Attributes
3Causality assessment of adverse events
Adherence to study drug regimen
ICH E3 suggests presentation of this information in the efficacy evaluation
Technical Details
Testing Methods
2Analysis of test data and rationale for sample sizes
Verification of analytical procedures
Processes
1studies for which ICH E3 was not originally designed but can be adapted
Clinical Concepts
9Patients receiving double-blinded medication in the study regimen.
Unsatisfactory response regarding efficacy as a reason for withdrawal.
Deviation affecting data reliability or subject safety
Departure from study design or procedures
Adverse events resulting in death, hospitalization, or significant disability.
Reactions or events observed in patients; Information described in an ICSR; Information associated with the use of biopharmaceuticals; Clinical information corrected during an amendment; Section D describes the singular subject who experienced one or several adverse events/reactions.; Reactions or events observed in patients or foetuses; The onset of a reaction/event following drug administration.; Reporting of reactions to suspect drugs; Reaction or event reported by the primary source; Reactio
basic principles can be applied to these trials
basic principles can be applied to these trials
ICH E3 was developed for submission of these studies
Standards & References
Specifications
1studies with health economic or quality of life outcomes
ICH References (4)
Referenced for safety data collection and adverse event reporting plans.
Evaluation of benefit/risk across regions or important subpopulations
Organization of the Common Technical Document; Organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use
document remedial actions in the clinical trial report; Structure and Content of Clinical Study Reports standards.
Related MFDS Guidelines
Korean regulatory guidelines covering similar topics
See Also (8)
- E11A Pediatric Extrapolation
- M15 General Principles for Model-Informed Drug Development
- Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product
- Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances
- Rare Diseases: Considerations for the Development of Drugs and Biological Products
- Q3C Impurities: Residual Solvents_2011
- Providing Regulatory Submissions in Electronic Format --Content of the Risk Evaluation and Mitigation Strategies Document Using Structured Product Labeling: Guidance for Industry
- Q4B Annex 5: Disintegration Test General Chapter