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• 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…)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - pharmaceutical product  + (pharmaceutical product Any substance or combination of substances which has a therapeutic, prophylactic or diagnostic use, or is intended to modify ph…)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - principal investigator  + (principal investigator The investigator serving as coordinator for certain kinds of clinical trials, e.g. multicentre trials.…)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - protocol  + (protocol A document which states the background, rationale and objectives of the trial and describes its design, methodology and organization, includ…)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.42 - randomization  + (randomization […]…)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - raw data  + (raw data All records or certified copies of original observations, clinical findings or other activities in a clinical trial necessary for the reconst…)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.42 - recruitment  + (recruitment […]…)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - serious adverse event  + (serious adverse event An event that is associated with death, admission to hospital, prolongation of a hospital stay, persistent or significant disabi…)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.46  + (serious health threat […]…)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.47  + (source data […]…)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.48  + (source document […]…)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - sponsor  + (sponsor An individual, a company, an institution or an organization which takes responsibility for the initiation, management and/or financing of a cl…)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.51  + (unanticipated serious adverse device effect USADE […]…)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.52  + (use error […]…)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - validation  + (validation Action of proving, in accordance with the principles of Good Clinical Practice, that any procedure, process, equipment (including the softw…)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - verification (validation) of data  + (verification (validation) of data The procedures carried out to ensure that the data contained in the final report match original observations. These …)
• Reference:N.A. (STROBE)statement: guidelines for reporting observational studies Apr-2008 -  + (von Elm E, Altman DG, Egger M, Pocock SJ, Gøtzsche PC, Vandenbroucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies i…)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.55  + (vulnerable subject [..]…)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - witness  + (witness A person who will not be influenced in any way by those who are involved in the clinical trial, who is present and may provide assistance if r…)
• Reference:DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022 § 10  + (§ 10 Bewertungsverfahren nach Artikel 44 der Verordnung (EU) Nr. 536/2014 Die zuständige Ethik-Kommission übermittelt ihre Bewertung nach § 40c Absat…)
• Reference:DEU MBO - Berufsordnung der Ärzt:innen 11-Jun-2021 § 10 Absatz 3  + (§ 10 Dokumentationspflicht (3) Ärztliche Aufzeichnungen sind für die Dauer von zehn Jahren nach Abschluss der Behandlung aufzubewahren, soweit nicht …)
• Reference:DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022 § 11  + (§ 11 Korrekturmaßnahmen Die zuständige Bundesoberbehörde informiert die zuständige Ethik-Kommission über beabsichtigte Korrekturmaßnahmen nach § 42 A…)
• Reference:USA 21 CFR Part 11 09-Apr-2025 § 11.200  + (§ 11.200 Electronic signature components and controls (a) Electronic signatures that are not based upon biometrics shall: (1) Employ at least two d…)