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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… +
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Non-interventional studies are observational in nature (hence sometimes known as observational studies), in which health outcomes are typically … +
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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… +
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Question 1: Important considerations for the planning and conduct of complex clinical trials
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Question 2: Which additional considerations a… +
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Sponsor means a person who takes responsibility for and initiates a clinical investigation. The sponsor may be an individual or pharmaceutical c… +
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Sponsor-Investigator means an individual who both initiates and conducts an investigation, and under whose immediate direction the investigation… +
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The investigator should not make any changes in the study without the agreement of the sponsor, except when necessary to eliminate an apparent i… +
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EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017 2. +
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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… +
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VIII.B.3. Study protocol
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VIII.B.3.1. Format and content of the study protocol
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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… +
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e) provide the subject with [...]… +
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“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… +
GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 2 clinical trial +
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“clinical trial” means any investigation in human subjects, other than a non-interventional trial, intended—
(a)to discover or verify the clinic… +
GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 2 non-interventional trial +
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“non-interventional trial” means a study of one or more medicinal products which have a marketing authorization, where the following conditions … +
GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020 D Investigator/Institution +
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Investigator/Institution:
The investigator/institution (for example, vendor, CRO or investigator site) should also have a process in place to i… +
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WHO WHO - Guidance for best practices for clinical trials 2024 1.1 - Platform, basket and umbrella trials +
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Platform, basket and umbrella trials all use master protocols (15–18) which allow simultaneous evaluation of multiple interventions within the … +
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Clinical research is indispensable for resolving public health challenges. Clinical research studies can be thought of as spanning five generic ar… +
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EU EMA/INS/GCP/143492/2022 - ANNEX I TO PROCEDURE FOR CONDUCTING GCP INSPECTIONS REQUESTED BY THE CHMP: INVESTIGATOR SITE 2022 Page 6 +
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Documentation in the source data of the process of obtaining the initial informed consent and subsequent consent to updates, including paediatric … +
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Remote monitoring and source data verification must not result in confidential patient information being sent to the sponsor or stored by the spon… +
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Source data should be attributable, legible, contemporaneous, original, and accurate (ALCOA) and must meet the regulatory requirements for recordk… +
