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• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 58  + (Additional requirements for certain performance studies 1. Any performance study: (a) in which surgically invasive sample-taking is done only for …)
• Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Adverse Drug Reaction (ADR)  + (Adverse Drug Reaction (ADR): • in the pre-approval clinical experience with a new investigational product or its new usages (particularly as the ther…)
• Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Adverse Event (AE)  + (Adverse Event (AE): Any unfavourable medical occurrence in a trial participant administered the investigational product. The adverse event does not …)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 ANNEX III Section 2.1  + (Adverse Events and Causality 2. Medication errors, pregnancies and uses outside what is foreseen in the protocol, including misuse and abuse of the p…)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex F  + (Adverse event categorization…)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.32 - Adverse event  + (Adverse event means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.…)
• Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Agreement  + (Agreement A document or set of documents describing the details of any arrangements on delegation or transfer, distribution and/or sharing of activit…)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 24  + (Amendments by the sponsor 24.—(1) A sponsor may make an amendment to a clinical trial authorisation, other than a substantial amendment, at any time. …)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 22-23  + (Amendments to clinical trial authorisation 22. Subject to regulation 30, an amendment to a clinical trial authorisation may be made— (a)by the lic…)
• Reference:EU Eudralex - volume 4 GMP Guidelines Annex 11 Jan-2011 14  + (Annex 11: Computerised Systems 14. Electronic Signature Electronic records may be signed electronically. Electronic signatures are expected to: a. ha…)
• Reference:EU GUIDANCE ON THE MANAGEMENT OF CLINICAL TRIALS DURING THE COVID-19 (CORONAVIRUS) PANDEMIC v5 10-Feb-2022 Annex 1  + (Annex 1: Protection of trial participants’ rights during remote source data verification […] - A documented risk assessment should be performed […] - …)
• Reference:WHO WHO - EXPERT COMMITTEE ON SPECIFICATIONS FOR PHARMACEUTICAL PREPARATIONS Forty-fifth report -  + (Annex 3: WHO good manufacturing practices: main principles for pharmaceutical products [...] 15. Documentation [...] 15.6 Where documents require the …)
• Reference: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 [...] A5.2 Interactive response technology system [...] A5.2.1.2 Stratified randomisation Where t…)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 35  + (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…)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 43  + (Annual reporting by the sponsor to the Agency 1. Regarding investigational medicinal products other than placebo, the sponsor shall submit annually…)
• Reference: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…)
• Reference:ICH ICH E6 Guideline R3 (2025) Appendix A  + (Appendix A. INVESTIGATOR’S BROCHURE…)
• Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 8  + (Appendix B. CLINICAL TRIAL PROTOCOL AND PROTOCOL AMENDMENT(S) [...] B.8 Assessment of Efficacy B.8.1 Specification of the efficacy parameters, where a…)
• Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 12.3  + (Appendix B. CLINICAL TRIAL PROTOCOL AND PROTOCOL AMENDMENT(S) [...] B.12.3 Description of the process for the handling of non-compliance with the prot…)
• Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 14.3  + (Appendix B. CLINICAL TRIAL PROTOCOL AND PROTOCOL AMENDMENT(S) [...] B.14 Data Handling and Record Keeping [...] B.14.3 A statement that records shoul…)
• Reference:ICH ICH E6 Guideline R3 (2025) Appendix B  + (Appendix B. CLINICAL TRIAL PROTOCOL AND PROTOCOL AMENDMENT(S) Clinical trials should be described in a clear, concise and operationally feasible proto…)
• Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 2.5  + (Appendix B. CLINICAL TRIAL PROTOCOL AND PROTOCOL AMENDMENT(S) [...] B.2.5 A statement that the trial will be conducted in compliance with the protocol…)
• Reference:ICH ICH E6 Guideline R3 (2025) Appendix C 2  + (Appendix C. ESSENTIAL RECORDS FOR THE CONDUCT OF A CLINICAL TRIAL [...] C.2 Management of Essential Records [...] C.2.4 The sponsor and investigator/i…)
• Reference:ICH ICH E6 Guideline R3 (2025) Appendix C-001  + (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 …)
• Reference:ICH ICH E6 Guideline R3 (2025) Appendix C-002  + (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 …)

• Reference: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…)

• Reference: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)…)
• Reference:GBR The Human Medicines Regulations 2012 01-Jan-2025 Article 51B  + (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…)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 70 Paragraph 1  + (Application for clinical investigations 1. The sponsor of a clinical investigation shall submit an application to the Member State(s) in which the …)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 14  + (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…)
• Reference: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…)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 15 (7) - (10)  + (Application for ethics committee opinion 15.— (7) If— (a)any subject to the clinical trial is to be an adult incapable by reason of physical and ment…)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 66 Paragraph 1  + (Application for performance studies 1. The sponsor of a performance study referred to in Article 58(1) and (2) shall enter and submit an applicatio…)
• Reference:GBR The Medical Devices Regulations 2002 11-Feb-2021 Article 18  + (Approved bodies and the conformity assessment procedures for general medical devices 18.—(1) An approved body which is responsible for carrying out a…)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 58  + (Archiving of the clinical trial master file Unless other Union law requires archiving for a longer period, the sponsor and the investigator shall arc…)
• Reference:EU Directive 2001/83/EC - Community code relating to medicinal products for human use 20-Jun-12 Article 107n  + (Article 107n 1. Before a study is conducted, the marketing authorisation holder shall submit a draft protocol to the Pharmacovigilance Risk Assessm…)
• Reference:EU Regulation (EC) No 726/2004 - authorisation and supervision of medicinal products for human use 28-Jan-22 Article 26  + (Article 26 1. The Agency shall, in collaboration with the Member States and the Commission, set up and maintain a European medicines web-portal [EU…)
• Reference:FRA Code de la Santé Publique - Partie législative - 1ere partie, Livre 1er, Titre II 16-May-2025 L5311-1  + (Article L5311 I.-L'Agence nationale de sécurité du médicament et des produits de santé est un établissement public de l'Etat, placé sous la tutelle du…)
• Reference:FRA Code de la Santé Publique - Partie Réglementaire - 1ere partie, Livre 1er, Titre II 16-May-2025 Article R1121-3-1  + (Article R1121-3-1 I.-Lorsqu'une recherche mentionnée au 1° et au 2° de l'article L. 1121-1 à finalité commerciale est réalisée dans des établissement…)
• Reference:FRA Code de la Santé Publique - Partie Réglementaire - 1ere partie, Livre 1er, Titre II 16-May-2025 Article R1123-20  + (Article R1123-20 I. – La demande d'avis sur un projet de recherche impliquant la personne humaine est déposée par le promoteur sur le système d'infor…)
• Reference:FRA Code de la Santé Publique - Partie Réglementaire - 1ere partie, Livre 1er, Titre II 16-May-2025 Article R1123-20-1  + (Article R1123-20-1 I.-Un système d'information des recherches impliquant la personne humaine permet : 1° Les échanges entre les promoteurs et les co…)
• Reference:FRA Code de la Santé Publique - Partie Réglementaire - 1ere partie, Livre 1er, Titre II 16-May-2025 R1123-46  + (Article R1123-46 Pour l'application de la présente section, on entend par : […] 12° Pour les recherches impliquant la personne humaine, fait nouveau :…)
• Reference:FRA Code de la Santé Publique - Partie Réglementaire - 1ere partie, Livre 1er, Titre II 16-May-2025 R1123-53  + (Article R1123-53 Pour les recherches mentionnées au 1° de l'article L. 1121-1 autres que celles mentionnées aux articles R. 1123-54 à R. 1123-58, le …)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 18 Paragraph 1-3  + (Assessment of a substantial modification of an aspect covered by Part I of the assessment report 1. The reporting Member State shall assess the app…)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 22  + (Assessment of a substantial modification of aspects covered by Parts I and II of the assessment report — Assessment of the aspects covered by Part II …)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 7  + (Assessment report — Aspects covered by Part II 1. Each Member State concerned shall assess, for its own territory, the application with respect to …)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 6  + (Assessment report — Aspects covered by Part I 1. The reporting Member State shall assess the application […] (a) Whether the clinical trial is a l…)
• Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Audit  + (Audit A systematic and independent examination of trial-related activities and records performed by the sponsor, service provider (including contract …)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 19 - 20  + (Authorisation procedure for clinical trials involving medicinal products for gene therapy etc. […] Authorisation procedure for clinical trials involvi…)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 18  + (Authorisation procedure for clinical trials involving general medicinal products 18.—(1) This regulation applies to clinical trials involving medicina…)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 67  + (Authorised investigational and authorised auxiliary medicinal products 1. Authorised investigational medicinal products and authorised auxiliary me…)