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• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 2 (1)  + ([...] “chief investigator” means— (a)in relation to a clinical trial conducted at a single trial site, the investigator for that site, or (b)in relati…)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 2 clinical trial  + ([...] “clinical trial” means any investigation in human subjects, other than a non-interventional trial, intended— (a)to discover or verify the clinic…)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 2 non-interventional trial  + ([...] “non-interventional trial” means a study of one or more medicinal products which have a marketing authorization, where the following conditions …)
• Reference:GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020 D Investigator/Institution  + ([...] Investigator/Institution: The investigator/institution (for example, vendor, CRO or investigator site) should also have a process in place to i…)
• Reference:WHO WHO - Guidance for best practices for clinical trials 2024 1.1 - Platform, basket and umbrella trials  + ([...] Platform, basket and umbrella trials all use master protocols (15–18) which allow simultaneous evaluation of multiple interventions within the …)
• Reference:WHO WHO - Guidance for best practices for clinical trials 2024 1.1 - Clinical Research  + ([…] Clinical research is indispensable for resolving public health challenges. Clinical research studies can be thought of as spanning five generic ar…)
• Reference:EU EMA/INS/GCP/143492/2022 - ANNEX I TO PROCEDURE FOR CONDUCTING GCP INSPECTIONS REQUESTED BY THE CHMP: INVESTIGATOR SITE 2022 Page 6  + ([…] Documentation in the source data of the process of obtaining the initial informed consent and subsequent consent to updates, including paediatric …)
• Reference:GBR Making changes to a research study to manage the impact of COVID-19 12-Oct-2021 -  + ([…] Remote monitoring and source data verification must not result in confidential patient information being sent to the sponsor or stored by the spon…)
• Reference:USA FDA Guidance for Industry - Electronic Source Data in Clinical Investigations Sep-2013 II  + ([…] Source data should be attributable, legible, contemporaneous, original, and accurate (ALCOA) and must meet the regulatory requirements for recordk…)
• Reference:WHO WHO - Guidance for best practices for clinical trials 2024 2.1.3  + ([…] Specific examples of populations that have typically been excluded from clinical trials (either explicitly or by implicit exclusion) include pregn…)
• Reference:ICH ICH E2A Guideline 1994 II B. Serious/Severe  + ([…] To ensure no confusion or misunderstanding of the difference between the terms "serious" and "severe," which are not synonymous, the following not…)
• Reference:GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020 D When should the notification be made  + ([…] When should the notification be made? • Within 7 days of the Sponsor becoming aware of the breach. If the notification function has been delegated…)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.6 - §312.8 ; § 312.10  + ([…] § 312.6 Labeling of an investigational new drug. […] § 312.7 Promotion of investigational drugs. […] § 312.8 Charging for investigational drugs un…)
• Reference:USA Acceptance of Clinical Data to Support Medical Device Applications and Submissions Frequently Asked Questions - Guidance for Industry and Food and Drug Administration Staff 21-Feb-2018 -  + ([…] “Clinical Investigation of Medical Devices for Human Subjects—Good Clinical Practice,” ISO 14155:2011, which FDA recognized in 2012 as a consensus…)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 2 relevant ethics committee  + ([…] “relevant ethics committee”, in relation to a clinical trial, means— (a)in a case where an ethics committee has given a favourable opinion in rela…)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.1  + (adverse device effect ADE […]…)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.2  + (adverse event AE […]…)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - adverse event  + (adverse event Any untoward medical occurrence in a clinical trial subject administered a pharmaceutical product; it does not necessarily have a causal…)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - adverse reaction  + (adverse reaction A response to a pharmaceutical product that is noxious and unintended and which occurs at doses normally used or tested in man for pr…)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - audit of a trial  + (audit of a trial A systematic examination, carried out independently of those directly involved in the trial, to determine whether the conduct of a tr…)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.5  + (blinding masking […]…)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - case -report form (CRF)  + (case -report form (CRF) A document that is used to record data on each trial subject during the course of the trial, as defined by the protocol. The d…)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.8  + (clinical investigation […]…)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - clinical trial  + (clinical trial A systematic study on pharmaceutical products in human subjects (including patients and other volunteers) in order to discover or verif…)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - clinical trial Phases  + (clinical trial [...] Clinical trials are generally classified into Phases I to IV. It is not possible to draw distinct lines between the phases, and d…)

• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.12  + (comparator […]…)

• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - comparator product  + (comparator product A pharmaceutical or other product (which may be a placebo) used as a reference in a clinical trial.…)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - contract  + (contract A document, dated and signed by the investigator, institution and sponsor, that sets out any agreements on financial matters and delegation/d…)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - contract research organization (CRO)  + (contract research organization (CRO) A scientific organization (commercial, academic or other) to which a sponsor may transfer some of its tasks and o…)
• Reference:EU GUIDANCE ON THE MANAGEMENT OF CLINICAL TRIALS DURING THE COVID-19 (CORONAVIRUS) PANDEMIC v5 10-Feb-2022 11 d)  + (d) Remote source data verification […] Remote SDV may be considered for trials: - involving COVID-19 treatment or prevention; - investigating serious …)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - escape treatment  + (escape treatment Any supplementary treatment provided to relieve the trial subject of symptoms caused by the investigated disease in the clinical tria…)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - ethics committee  + (ethics committee An independent body (a review board or a committee, institutional, regional or national), constituted of medical professionals and no…)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.24  + (ethics committee EC […]…)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - final report  + (final report A comprehensive description of the trial after its completion including a description of experimental methods (including statistical meth…)
• Reference:AUT BASG - FAQ 11-Feb-2025 Schwarz  + (https://basg.gv.at/gesundheitsberufe/klinische-studien/gute-klinische-praxis-und-gcp-inspektion/faq-dokumentation-gcp Ist es korrekt, dass die Verwe…)
• Reference:DEU Bundestag - Sachstand zur Aufbewahrung von Patientenakten in der ambulanten Praxis Fristen und Form 01-Mar-2021 -  + (https://www.bundestag.de/resource/blob/858466/8c44dd9b4dfc7f144f94db82693c8dba/WD-9-015-21-pdf-data.pdf…)
• Reference:GBR NIHR - National Institute for Health and Care Research 28-Jan-2025 -  + (https://www.ct-toolkit.ac.uk/routemap/r-and-d-submission Clinical trials conducted on the premises of an NHS organisation, with NHS patients or with …)
• Reference:USA Expedited Review: Categories of Research that may be Reviewed Through an Expedited Review Procedure 1998 -  + (https://www.hhs.gov/ohrp/regulations-and-policy/guidance/categories-of-research-expedited-review-procedure-1998/index.html Research Categories Resea…)
• Reference:GBR IRAS - Integrated Research Application System 28-Jan-2025 IRAS  + (https://www.myresearchproject.org.uk/ IRAS: Integrated Research Application System ; provides a single gateway for researchers to apply to the new NI…)
• Reference:GBR IRAS - Integrated Research Application System 28-Jan-2025 Templates  + (https://www.myresearchproject.org.uk/help/hlptemplatesfor.aspx…)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.26  + (independent not involved in the development of the investigational device or the conduct of a clinical investigation (3.8), except for their specifica…)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - informed consent  + (informed consent A subject's voluntary confirmation of willingness to participate in a particular trial, and the documentation thereof. This consent s…)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - inspection  + (inspection An officially-conducted examination (i.e. review of the conduct of the trial, including quality assurance, personnel involved, any delegati…)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.29  + (investigational medical device […]…)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - investigational product (synonym: study product)  + (investigational product (synonym: study product) Any pharmaceutical product (see definition) or placebo being tested or used as a reference in a clini…)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - investigator  + (investigator A person responsible for the trial and for the rights, health and welfare of the subjects in the trial. The investigator should have qual…)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - investigator’s brochure  + (investigator’s brochure A collection of data for the investigator consisting of all the relevant information on the investigational product(s), includ…)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex A - medical device-001  + (medical device […]…)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex A - medical device-002  + (medical device […]…)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - monitor  + (monitor A person appointed by, and responsible to, the sponsor or Contract Research Organization (CRO) for the monitoring and reporting of progress of…)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - patient/subject file  + (patient/subject file A collection of data consisting of all relevant information on the patient or subject (such as hospital file, consultation record…)