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• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 7-10  + (7.—(1) Subject to paragraph (3), the Authority may, by a notice in writing, recognise a committee as an ethics committee for the purposes of these Reg…)
• Reference:EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020 8-001  + (8 Reporting timelines 8.1 Report by sponsor to NCAs. The sponsor must report to all NCAs where the clinical investigation is authorised to start: • Fo…)
• Reference:EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020 8-002  + (8 Reporting timelines 8.1 Report by sponsor to NCAs. The sponsor must report to all NCAs where the clinical investigation is authorised to start: • Fo…)
• Reference:EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020 8.2-001  + (8 Reporting timelines [...] 8.2 Report by the investigator to the sponsor The sponsor shall implement and maintain a system to ensure that the reporti…)
• Reference:EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020 8.2-002  + (8 Reporting timelines [...] 8.2 Report by the investigator to the sponsor The sponsor shall implement and maintain a system to ensure that the reporti…)
• Reference:GBR MEDDEV 2.7/3 revision 3 May-2015 8  + (8. CAUSALITY ASSESSMENT The relationship between the use of the medical device (including the medical - surgical procedure) and the occurrence of each…)
• Reference:ICH ICH E11 Guideline R1 (2017) 8  + (8. GLOSSARY Parental (legal guardian) consent/permission: Expression of understanding and agreement by fully informed parent(s) or legal guardian to …)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 8 - Electronic data handling  + (8. RECORD KEEPING AND HANDLING OF DATA […] In the event of electronic data handling, confidentiality of the database must be secured by safety procedu…)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 8  + (8. RECORD KEEPING AND HANDLING OF DATA […] All steps involved in data management should be documented in order to allow step-by-step retrospective ass…)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 8 - Introduction  + (8. RECORD KEEPING AND HANDLING OF DATA [...] A basic aspect of the integrity of data is the safeguarding of “blinding” with regard to treatment assign…)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 8.2  + (8.2 Suspension or premature termination of the clinical investigation 8.2.1 Procedure for suspension or premature termination [...] 8.2.2 Procedure fo…)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 8.3  + (8.3 Archiving of data As required by national regulations, the investigator must arrange for the retention of the subject identification codes for a s…)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 8.3  + (8.3 Routine close-out […]…)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 9.1  + (9.1 Experimental design The scientific integrity of a clinical trial and the credibility of the data produced depend primarily on the design of the tr…)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 9.2  + (9.2 Randomization and blinding In case of a randomized clinical trial, the randomization procedure must be documented. Where a sealed code for each in…)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 9.2.2  + (9.2.2 Preparation of documents and materials [...] e) provide insurance covering […]…)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 9.2.4  + (9.2.4 Monitoring 9.2.4.1 General Monitoring shall [...] 9.2.4.2 Qualifications of the monitor Monitors shall be [...] 9.2.4.3 Assessment of the inv…)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 9.2.5  + (9.2.5 Safety evaluation and reporting The sponsor is responsible for […]…)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 9.3  + (9.3 Statistical analysis The type(s) of statistical analyses to be used must be specified in the protocol, and any other subsequent deviations from th…)
• Reference:EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017 4.1  + (A risk based quality management system for clinical trials should include the following steps: - critical process and data identification - risk ident…)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex A A.17  + (A.17 Publication policy […]…)
• Reference:ICH ICH E6 Guideline R3 (2025) Appendix A 3.4  + (A.3 Contents of the Investigator’s Brochure [...] A.3.4 Physical, Chemical and Pharmaceutical Properties and Formulation A description should be prov…)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex A A.5  + (A.5 Objectives and hypotheses of the clinical investigation [...] The objectives of the clinical investigation shall […]…)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex A A.6.3-001  + (A.6.3 Subjects a) Inclusion […]…)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex A A.6.3-002  + (A.6.3 Subjects a) Inclusion criteria[…]…)

• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex A A.7  + (A.7 Statistical design and analysis…)

• Reference:WHO WHO - Guidance for best practices for clinical trials 2024 Annex 2 2.5  + (A2.2.5 Protecting research participants Researchers should allocate adequate time and resources for measures and materials to obtain properly informed…)
• Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 Annex A A5.3  + (A5.3 Electronic informed consent Ethics committees will review all material related to the informed consent process. Before the implementation of an e…)
• Reference:EU Regulation (EU) No 520/2012 - performance of pharmacovigilance activities 20-Jun-12 Annex III 1.  + (ANNEX III Protocols, abstracts and final study reports for post-authorisation safety studies 1. Format of the study protocol [...]…)
• Reference:EU Regulation (EU) No 520/2012 - performance of pharmacovigilance activities 20-Jun-12 Annex III 2. ; 3.  + (ANNEX III Protocols, abstracts and final study reports for post-authorisation safety studies [...] 2. Format of the abstract of the final study rep…)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 3 Part 1 1.  + (APPLICATION FOR ETHICS COMMITTEE OPINION 1. An application document including the following information or, in each case, an explanation of why that …)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 34  + (Additional national measures Member States may maintain additional measures regarding persons performing mandatory military service, persons deprived…)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 58 Paragraph 5 (j)  + (Additional requirements for certain performance studies (j) the medical care provided to the subjects is the responsibility of an appropriately quali…)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 58 Paragraph 1 – 3  + (Additional requirements for certain performance studies 1. Any performance study: (a) in which surgically invasive sample-taking is done only for …)
• 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…)