Search by property

This page provides a simple browsing interface for finding entities described by a property and a named value. Other available search interfaces include the page property search, and the ask query builder.

List of results

• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 12  + (Withdrawal The sponsor may withdraw the application at any time until the reporting date. In such a case, the application may only be withdrawn with …)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.4 - Amendment  + ([...] Any change should be in the form of a protocol amendment, appended to the original protocol and signed by the investigator and the sponsor. Ame…)
• Reference:GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020 Appendix I  + ([...] 6. For trials that are on-going in the UK, should serious breaches that occur at non-UK sites be reported? If a serious breach is identified at …)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 9  + ([...] 9. Responsibilities of the sponsor [...] 9.3 Outsourcing of duties and functions The sponsor may transfer any or all of the duties and functions…)
• Reference:ICH ICH E19 Guideline 2022 6  + ([...] Adverse Event of Special Interest: An event (serious or non-serious) of scientific and medical concern specific to the sponsor’s product or prog…)
• Reference:ICH ICH E9 Guideline 1998 2.3.1  + ([...] Breaking the blind (for a single subject) should be considered only when knowledge of the treatment assignment is deemed essential by the subjec…)
• Reference:USA NIH - SCORE Manual: Appendix Source Documents Requirements Rev 01 16-Aug-2025 Page 3 - CRF  + ([...] Case Report Forms Used as Source Documents Case report forms (CRFs) may be used as source documents if data will be initially recorded on the f…)
• Reference:ICH ICH E2A Guideline 1994 III A. 1.  + ([...] Causality assessment is required for clinical investigation cases. All cases judged by either the reporting health care professional or the spon…)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.3 (b) - CRO  + ([...] Contract research organization means a person that assumes, as an independent contractor with the sponsor, one or more of the obligations of a s…)
• Reference:ICH ICH E6 Guideline - Annex 2 R3 Annex 2 Annex 2 Introduction  + ([...] Data may be broadly classified into two types, and a trial may make use of both types of data (i.e., data generated specifically for the trial (…)
• Reference:USA FDA Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection Jan-2009 Introduction ; III. B. ; IV.  + ([...] For clinical investigations of drug and biological products conducted under an investigational new drug (IND) application, information about adv…)
• Reference:USA FDA Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection Jan-2009 Introduction ; III. B. ; Evaluation  + ([...] For clinical investigations of drug and biological products conducted under an investigational new drug (IND) application, information about adv…)
• Reference:FRA AEC DOC010 V.04 01-Jun-2018 -  + ([...] I – DEMANDE D’AUTORISATION D’ESSAI CLINIQUE DE MEDICAMENT AUPRES DE L’ANSM Préambule [...] Préalablement à la mise en place en France d’un essai…)
• Reference:USA FDA Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection Jan-2009 III A. ; IV.  + ([...] III. REPORTING AEs TO IRBs IN CLINICAL TRIALS OF DRUG AND BIOLOGICAL PRODUCTS CONDUCTED UNDER IND REGULATIONS A. How to Determine If an AE is an…)
• Reference:WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 Page 22  + ([...] In general, all individuals, including healthy volunteers, who participate as research subjects should be viewed as intrinsically vulnerable. W…)
• Reference:FRA Bonnes pratiques - CONTRÔLE QUALITÉ À DISTANCE DES ESSAIS CLINIQUES (CNIL) 16-May-2024 -  + ([...] La surveillance à distance d’une étude peut donc être mise en place, après avoir été autorisée par la CNIL. Dans cette hypothèse, il est nécessa…)
• Reference:WHO WHO - Guidance for best practices for clinical trials 2024 1.1 - NIS  + ([...] Non-interventional studies are observational in nature (hence sometimes known as observational studies), in which health outcomes are typically …)
• Reference:USA NIH - SCORE Manual: Appendix Source Documents Requirements Rev 01 16-Aug-2025 Page 3 - Note  + ([...] Note: Using CRFs as source documents (direct and real-time entry) is different than using printed copies of electronic or paper CRFs as source d…)
• Reference:EU EMA/298712/2022 - Complex clinical trials – Questions and answers 23-May-2022 -  + ([...] Question 1: Important considerations for the planning and conduct of complex clinical trials [...] Question 2: Which additional considerations a…)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.3 (b) - Sponsor  + ([...] Sponsor means a person who takes responsibility for and initiates a clinical investigation. The sponsor may be an individual or pharmaceutical c…)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.3 (b) - Sponsor-Investigator  + ([...] Sponsor-Investigator means an individual who both initiates and conducts an investigation, and under whose immediate direction the investigation…)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.4 - immediate hazard  + ([...] The investigator should not make any changes in the study without the agreement of the sponsor, except when necessary to eliminate an apparent i…)
• Reference:EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017 2.  + ([...] The risk to subject safety in a clinical trial mainly stems from two sources: the IMP and the trial procedures. For example, if a clinical trial…)
• Reference:EU GVP: Module VIII EMA/813938/2011 Rev. 3 (2017) -  + ([...] VIII.B.3. Study protocol [...] VIII.B.3.1. Format and content of the study protocol [...]…)
• Reference:WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 Page 94  + ([...] What is meant by “data quality”? What is meant by “data integrity”? How are the terms related, and how are data quality and integrity achieved w…)

• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 10.7 (e)  + ([...] e) provide the subject with [...]…)

• 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…)