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• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 5.14  + (5.14 Termination of trial If the sponsor elects or is required to terminate the clinical trial prematurely, then the investigator(s), ethics committee…)
• Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 5.2  + (5.2 Pre-Treatment AEs A pre-treatment adverse event is an adverse event that occurs after a participant has signed an informed consent, but before int…)
• Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 5.3.1  + (5.3.1 Persistent AE A persistent AE (e.g., chronic) is one that extends continuously, without resolution between treatment cycles/courses. Instructio…)
• Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 5.3.2  + (5.3.2 Recurrent AEs A recurrent AE is one that occurs and resolves during a cycle/course of therapy and then reoccurs in a later cycle/course. Instru…)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 5.6  + (5.6 Investigational product The sponsor is responsible for supplying the investigational pharmaceutical product(s) and, if applicable, comparator prod…)
• Reference:ICH ICH E8 Guideline R1 (2021) 5.6  + (5.6 Statistical Analysis […] For double-blind studies, the statistical analysis should be finalised before treatment assignments are revealed. Therefo…)
• Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 5.6.6.1  + (5.6.6.1 Pregnancy • Although not an AE in and of itself, pregnancy as well as its outcome must be documented via CTEP-AERS. CTEP agrees to soliciting…)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 5.8.2  + (5.8.2 Process of obtaining informed consent The principal investigator or his/her authorized designee shall comply with […]…)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 5.8.3  + (5.8.3 Special circumstances for informed consent 5.8.3.1 General The provisions given in 5.8.3.2 to 5.8.3.4 are subject to national regulations. 5.8…)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 5.8.4 - 5.8.6  + (5.8.4 Information to be provided to the subject [...] 5.8.5 Informed consent signature [...] 5.8.6 New information […]…)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 6.1  + (6 Clinical investigation planning 6.1 General […]…)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 70 Paragraph 6 – 7  + (6. During the period when the application is being assessed, the Member State may request additional information from the sponsor. The expiry of the…)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 66 Paragraph 6 – 7  + (6. During the period when the application is being assessed the Member State may request additional information from the sponsor. The expiry of the …)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 77 Paragraph 6 – 7  + (6. The Commission shall issue guidelines regarding the content and structure of the summary of the performance study report. In addition, the Commi…)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 77 Paragraph 6 – 7  + (6. The Commission shall issue guidelines regarding the content and structure of the summary of the clinical investigation report. In addition, the …)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 63 Paragraph 6 – 7  + (6. The subject shall be informed that a clinical investigation report and a summary presented in terms understandable to the intended user will be m…)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 59 Paragraph 6 – 7  + (6. The subject shall be informed that a report of the performance study and a summary presented in terms understandable to the intended user will be…)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 29 Paragraph 6-8  + (6. The subject shall be informed that the summary of the results of the clinical trial and a summary presented in terms understandable to a layperso…)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 6  + (6. RESPONSIBILITIES OF THE MONITOR […] 6.2 Assessment of the trial site […] 6.3 Staff education and compliance The monitor should ensure that all staf…)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 ANNEX XV Chapter III, 6  + (6. The Sponsor shall provide evidence that the investigation is being conducted in line with good clinical practice, for instance through internal or …)
• Reference:ICH ICH E8 Guideline R1 (2021) 6.1.4  + (6.1.4 Access to Interim Data Inappropriate access to data during the conduct of the study may compromise study integrity (Sections 5.5 and 5.6 and ICH…)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 6.2  + (6.2 Assessment of the trial site The monitor should assess the trial site prior to the clinical trial to ensure that the facilities (including laborat…)
• Reference:ICH ICH E8 Guideline R1 (2021) 6.2.2  + (6.2.2 Withdrawal Criteria Clear criteria for stopping treatment or study procedures for a study participant while remaining in the study are necessary…)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 6.3  + (6.3 Justification for the design of the clinical investigation [...] The clinical investigation shall be designed to evaluate […]…)
• Reference:EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021 6.4  + (6.4. Principal Investigator The principal investigator should have a process in place to ensure that: • the site staff or service providers delegated…)

• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 6.9  + (6.9 Agreement(s) […]…)

• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 7.6  + (7 .6 Additional members of the investigation site team […]…)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 58 Paragraph 7 – 8  + (7. The investigator shall be a person exercising a profession which is recognised in the Member State concerned, as qualifying for the role of inves…)
• Reference:GBR MEDDEV 2.7/3 revision 3 May-2015 7.1  + (7. REPORTING TIMELINES 7.1 Report by sponsor to NCAs. The sponsor must report to the NCAs where the clinical investigation has commenced: - for all re…)
• Reference:GBR MEDDEV 2.7/3 revision 3 May-2015 7.2  + (7. REPORTING TIMELINES [...] 7.2 Report by the investigator to the sponsor The sponsor shall implement and maintain a system to ensure that the report…)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 7.1 - Committee  + (7.1 Handling of and recording adverse events […] Consideration should be given to establishing a special committee to monitor adverse events (see also…)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 7.1 - Investigator  + (7.1 Handling of and recording adverse events In accordance with Sections 4.1 and 4.3 of these guidelines, the investigator must ensure the safety of t…)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 7.1 - Sponsor  + (7.1 Handling of and recording adverse events […] The occurrence of adverse events must be monitored carefully and recorded in detail during the course…)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 7.11  + (7.11 Auditing [...] An audit can be used [...]…)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 7.2 - Investigator  + (7.2 Reporting […] The investigator The investigator has to report serious adverse events to the sponsor immediately and to the drug regulatory authori…)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 7.2 - Sponsor  + (7.2 Reporting […] The sponsor During the trial, the sponsor is responsible for reporting and trial-related adverse events or reactions associated with…)
• Reference:ICH ICH E6 Guideline R3 (2025) II 7.4  + (7.4 Trial processes should be operationally feasible and avoid unnecessary complexity, procedures and data collection. Trial processes should support …)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 7.4.3-001  + (7.4.3 Device deficiencies […]…)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 7.4.3-002  + (7.4.3 Device deficiencies […]…)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 7.5.1  + (7.5.1 Amendments […]…)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 7.5.3  + (7.5.3 Source documents […]…)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 7.8  + (7.8.1 Traceability of documents and data [….]…)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 7.9  + (7.9 Investigational device accountability […]…)
• 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…)