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• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.3.3  + (4.3.3 Security (a) The security of the trial data and records should be managed throughout the data life cycle. (b) The responsible party should ens…)
• Reference:ICH ICH E8 Guideline R1 (2021) 4.3.3.1  + (4.3.3.1 Investigations in pregnant women Investigation of drugs that may be used in pregnancy is important. Where pregnant women volunteer to be enrol…)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.3.4  + (4.3.4 Validation (a) The responsible party is responsible for the validation status of the system throughout its life cycle. The approach to validatio…)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 4.3.8  + (4.3.8 User Management (a) Access controls are integral to computerised systems used in clinical trials to limit system access to authorised users and…)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.4 - Introduction  + (4.4 Compliance with the protocol The investigator must agree and sign the protocol ( or another legally acceptable document mentioning the agreement w…)
• Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.4  + (4.4. Source data The term source data refers to the original reported observation in a source document. Source documents could be e.g. hospital record…)
• Reference:EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017 4.4  + (4.4. Trial management Monitoring Monitoring activities should focus on preventing or mitigating important and likely sources of error in the conduct, …)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.5  + (4.5 Information for subjects and informed consent […] Information should be given in both oral and written form in a language understandable to the su…)
• Reference:ICH ICH E9 Guideline 1998 4.5  + (4.5 Interim Analysis and Early Stopping An interim analysis is any analysis intended to compare treatment arms with respect to efficacy or safety at a…)
• Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.5 ALCOA  + (4.5. ALCOA++ principles A number of attributes are considered of universal importance to data. These include that the data are: Attributable Data sho…)
• Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.5 CCEAT  + (4.5. ALCOA++ principles [...] Complete To reconstruct and fully understand an event, data should be a complete representation of the observation made.…)
• Reference:EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017 4.5  + (4.5. Trial documentation Content of the Trial Master File (TMF) […] Examples of how risk-adaptation could affect the TMF include the following: - comb…)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.6  + (4.6 The investigational product The investigator must be thoroughly familiar with the properties, effects and safety of the investigational pharmaceut…)
• Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.6  + (4.6. Criticality and risks For systems deployed by the investigator/institution specifically for the purposes of clinical trials, the investigator sh…)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.7  + (4.7 Site of the trial, facilities and staff Clinical trials must be carried out under conditions which ensure adequate safety for the subjects. The s…)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.8 - 4.9  + (4.8 Notification of the trial or submission to the drug regulatory authority As governed by national regulations, the investigator, sponsor, or invest…)
• Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.8  + (4.8. Electronic signatures Whenever ICH E6 requires a document to be signed and an electronic signature is used for that purpose, the electronic signa…)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 58 Paragraph 5-001  + (5. A performance study as referred to in paragraph 1 may be conducted only where all of the following conditions are met: (a) the performance study…)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 58 Paragraph 5-002  + (5. A performance study as referred to in paragraph 1 may be conducted only where all of the following conditions are met: (a) the performance study…)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 80 Paragraph 5 – 6  + (5. In the case of PMCF investigations referred to in Article 74(1), the provisions on vigilance laid down in Articles 87 to 90 and in the acts adopt…)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 76 Paragraph 5 – 6  + (5. In the case of PMPF studies referred to in Article 70(1), the provisions on vigilance laid down in Articles 82 to 85 and in the implementing acts…)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 77 Paragraph 5  + (5. Irrespective of the outcome of the clinical investigation, within one year of the end of the clinical investigation or within three months of the…)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 5.7  + (5. 7 Vulnerable populations […]…)
• Reference:FRA SURV VIG DOC118 V01 REC-Avis aux promoteurs -Partie V 16-May-2025 5.  + (5. AUTRES OBLIGATIONS DE NOTIFICATION DE DONNEES DE SECURITE POUR LES PROMOTEURS CONDUISANT DES ESSAIS CHEZ LES VOLONTAIRES SAINS EN FRANCE 5.1. Disp…)
• Reference:ICH ICH E8 Guideline R1 (2021) 5.  + (5. DESIGN ELEMENTS AND DATA SOURCES FOR CLINICAL STUDIES […] Master protocol studies allow for the investigation of multiple drugs or multiple conditi…)

• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 5  + (5. RESPONSIBILITIES OF THE SPONSOR…)

• Reference:EU INS/GCP/46309/2012 - Classification and analysis of the GCP inspection findings of GCP inspections conducted at the request of the CHMP 2012 5  + (5. Results 5.1. Overview of GCP inspections requested by the CHMP and carried out between 2000-2012 Between 2000-2012, a total of 398 site inspectio…)
• Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 3 Absatz 5 – 6  + (5. „Hauptprüfer“ den verantwortlichen Leiter einer Gruppe von Prüfern, die in einer Prüfstelle eine klinische Prüfung oder Leistungsstudie durchführen…)
• Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 5.1  + (5.1 Pre-existing Conditions (formerly referred to as Baseline AEs) A pre-existing medical condition identified on baseline assessment is not considere…)
• Reference:EU EMA/INS/GCP/856758/ 2018 Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic) 06-Dec-2018 5.1 - 5.2-001  + (5.1. Certified copies A certified copy is a paper or electronic copy of the original document that has been verified (e.g. by a dated signature) or ha…)
• Reference:EU EMA/INS/GCP/856758/ 2018 Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic) 06-Dec-2018 5.1 - 5.2-002  + (5.1. Certified copies A certified copy is a paper or electronic copy of the original document that has been verified (e.g. by a dated signature) or ha…)
• Reference:EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021 5.1  + (5.1. What needs to be reported? Any breach of: • The Regulation (EU) No 536/2014. or • The clinical trial protocol version applicable at the time of …)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 5.12  + (5.12 Study reports The sponsor is responsible for ensuring the preparation and appropriate approval(s) of a comprehensive final clinical study report …)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 5.13  + (5.13 Handling of adverse events The sponsor should provide special forms for reporting any adverse event that occur during the clinical trial. The spo…)
• 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…)