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Annex 3: WHO good manufacturing practices: main principles for pharmaceutical products
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15. Documentation
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15.6 Where documents require the … +
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EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 Annex 5 A5.2 +
Annex 5 Additional consideration to specific systems
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A5.2 Interactive response technology system
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A5.2.1.2 Stratified randomisation
Where t… +
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Annual list of suspected serious adverse reactions and safety report
35.—(1) As soon as practicable after the end of the reporting year, a sponsor sha… +
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Annual reporting by the sponsor to the Agency
1. Regarding investigational medicinal products other than placebo, the sponsor shall submit annually… +
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USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 Appendix 1 +
Appendix 1: Expedited Reporting Requirements for NCI IND/IDE Agents
Phase 0 Studies: Expedited Reporting Requirements for Adverse Events that Occur o… +
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Appendix A. INVESTIGATOR’S BROCHURE… +
Appendix B. CLINICAL TRIAL PROTOCOL AND PROTOCOL AMENDMENT(S)
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B.8 Assessment of Efficacy
B.8.1 Specification of the efficacy parameters, where a… +
Appendix B. CLINICAL TRIAL PROTOCOL AND PROTOCOL AMENDMENT(S)
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B.12.3 Description of the process for the handling of non-compliance with the prot… +
Appendix B. CLINICAL TRIAL PROTOCOL AND PROTOCOL AMENDMENT(S)
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B.14 Data Handling and Record Keeping
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B.14.3 A statement that records shoul… +
Appendix B. CLINICAL TRIAL PROTOCOL AND PROTOCOL AMENDMENT(S)
Clinical trials should be described in a clear, concise and operationally feasible proto… +
Appendix B. CLINICAL TRIAL PROTOCOL AND PROTOCOL AMENDMENT(S)
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B.2.5 A statement that the trial will be conducted in compliance with the protocol… +
Appendix C. ESSENTIAL RECORDS FOR THE CONDUCT OF A CLINICAL TRIAL
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C.2 Management of Essential Records
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C.2.4 The sponsor and investigator/i… +
Appendix C. ESSENTIAL RECORDS FOR THE CONDUCT OF A CLINICAL TRIAL
C.1 Introduction
C.1.1 Many records are generated before and during the conduct of … +
Appendix C. ESSENTIAL RECORDS FOR THE CONDUCT OF A CLINICAL TRIAL
C.1 Introduction
C.1.1 Many records are generated before and during the conduct of … +
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EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021 Appendix I +
Appendix I – Examples of serious breaches… +
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GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020 Appendix II +
Appendix II Examples of Serious Breaches Notified to MHRA (this is not an exhaustive list)… +
Application for UKMA(UK) relating to generic medicinal products
51B.—(1) An applicant for a UKMA(UK) for a generic medicinal product may, by way of de… +
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Application for clinical investigations
1. The sponsor of a clinical investigation shall submit an application to the Member State(s) in which the … +
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Application for ethics committee opinion
14.—(1) An application for an ethics committee opinion in relation to a clinical trial shall be made by the c… +
GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 15 (1) - (6) +
Application for ethics committee opinion
15.—(1) Subject to paragraphs (3) and (4), an ethics committee shall within the specified period following re… +
