Description
The objective of this guideline is to facilitate the compilation of a single core clinical study report acceptable to all regulatory authorities of the ICH regions. The regulatory authority-specific additions will consist of modules to be considered as appendices, available upon request according to regional regulatory requirements.
Key Topics
Terms and concepts identified from this document
Scope & Applicability
Product Classes
3Synonymous with drugs, medicines, medicinal products, vaccines, and biological products.; Product intended to benefit population groups once authorized; The product being tested in the clinical trial.; The product being studied in the clinical trial.; monitoring extent based on the nature of the investigational product; Management, storage, and accountability of the product being tested.; management should be arranged and conducted in accordance with applicable regulatory requirements; The produ
RTRT and CTD sections apply to drug products
Regulated under section 351(i) of the PHS Act; Virus, therapeutic serum, toxin, vaccine, or protein applicable to prevention or treatment; Alternative regulation category for products meeting device definition
Stakeholders
10Responsible for submission and communication oversight; Safeguard the rights, safety and well-being of trial participants; Reviewing trial conduct and records
The regulatory authority representative who verifies the results.
Bodies that accept clinical trial data and grant marketing authorizations.
Entity submitting development data and knowledge; Entity performing the work process for change
Safety oversight body for interpreting adverse events; Safety oversight body for study design
Governs top dose in clinical studies
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
Entity responsible for submitting applications under section 524B
Responsible for reviewing case report forms
DMC member knowledgeable about statistical methods and sequential analysis
Regulatory Context
Regulatory Activities
3Submission for product approval
data which should be presented in a registration application
For a historically controlled trial, it is important to explain how the particular control was selected.
Document Types
9CSR supported by ADaM datasets; Contains analysis results and animal listings
Contains details of the statistical analysis performed on each primary efficacy variable.
Process by which a subject voluntarily confirms his or her willingness to participate in a particular trial; Integral feature of the ethical conduct of a trial
Regulatory authorities may require all individual data in archival case report tabulations.
A document describing changes made to the original clinical trial protocol.
Defines the standard of veterinary practice and limits for anesthetic regimens
collect on the case report form (CRF) the Investigator's clinical interpretation
Documentation of quality audits performed; Audit certificates, if available, should be provided in the same appendix.; Audit certificates should be included in the appendix if available.
Document used to obtain and record participant consent; Document used to obtain and document participant consent.; Documents confirming participants' informed consent was appropriately obtained.; written, signed and dated form documenting the process of informed consent
Attributes
10statistically justified calculation required in the plan
Constructed using statistical methods to estimate effects.
Statistical parameter for genes of interest
Test product, dose, and mode of administration, including batch number.
Product characteristic evaluated alongside name similarity.
Seriousness of the effects of a hazard
Determination of the relationship between a product and an adverse event
Factor to consider in risk assessment (one-time, constant, or intermittent).
Trial design should provide strong control of Type I error
Patient characteristics such as age, sex, and race.
Technical Details
Substances
3Pharmaceutical form of an active ingredient or placebo being tested; Product being tested in the clinical trial; Pharmaceutical form of an active ingredient being tested in a trial
Comparison between the test drug and the active control.; Comparator drug used in the study; Used as a comparator in the efficacy analysis.
Accountability procedures for the investigational product including placebo; used as a reference in a clinical trial
Testing Methods
10Analysis of test data and rationale for sample sizes
Statistical considerations in clinical trials
The validity of the assumptions for an experiment can be examined using analysis of variance (AOV).
Example of a statistical test requiring specific documentation.
Functional assessment in the study design
Clinical assessment of the patient
Monitoring required when concomitant use is unavoidable.
Informative analysis for reporting adverse event rates
Supportive information for covariate adjustment.
Analysis of covariance used to test differences in slopes and intercepts; Analysis of covariance used in stability data analysis
Processes
8Manufacturing and handling should maintain blinding
Studies analyzed by analysis of variance techniques.
A study design requiring specific documentation of sequences and washouts.
Evaluation of safety-related laboratory tests
Assumes all patients who received at least one dose are included
Process of assigning trial participants to treatment or control groups using an element of chance; Process of assigning participants to treatment groups.; Process of assigning participants to groups using chance to reduce bias.
Basic principles of the guideline can be applied to these trials
required before baseline assessments for prior hormonal therapy
Clinical Concepts
10Criteria for participant enrollment in the trial.; Characteristics that every potential participant must satisfy to qualify for trial enrollment.
The main variables subject to statistical analysis.
Analysis from which certain patients and observations may be excluded.
Baseline assessment
Patient data listings include protocol deviations.
Includes fever, tachycardia, bradycardia, hypertension, hypotension, and respiratory rate
Safety data that should generally be collected under all circumstances
Events not seen at baseline and events that worsened even if present at baseline
The main outcome measure in a clinical trial
Medications taken by patients during the study that may affect response.; Other drugs taken by the patient during the study
Standards & References
External Standards
6References should be given in accordance with the 1979 Vancouver Declaration.
Toxicity grading scales
World Health Organization recommendations for mAb cocktails
Format for reporting outcomes in adverse event listings
Federal Register publication citation for the guideline
Ethical principles that are the origin of GCP standards.; Ethical principles for medical research involving human subjects
Specifications
5Subject inclusion criteria for selection and withdrawal.
Reference criteria for laboratory analysis
The primary measurements and endpoints used to determine efficacy should be clearly specified.
Marker used as a substitute for a direct measure of clinical benefit
Subject exclusion criteria for selection and withdrawal.
ICH References (3)
document remedial actions in the clinical trial report; Structure and Content of Clinical Study Reports standards.
Defines serious adverse events for clinical study reports
Further guidance on the design and analysis of studies exploring dose-response.
Related MFDS Guidelines
Korean regulatory guidelines covering similar topics
See Also (8)
- DSCSA Implementation: Product Tracing Requirements — Compliance Policy
- E6(R3) Good Clinical Practice: Annex 2
- Consumer Antiseptic Rub Final Rule Questions and Answers Guidance for Industry: Guidance for Industry
- Best Practices for Communication Between IND Sponsors and FDA During Drug Development
- Botanical Drug Development: Guidance for Industry
- Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry
- Reformulating Drug Products That Contain Carbomers Manufactured With Benzene
- ANDA Submissions -- Refuse-to-Receive Standards Rev.2