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Specific examples of populations that have typically been excluded from clinical trials (either explicitly or by implicit exclusion) include pregn… +
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To ensure no confusion or misunderstanding of the difference between the terms "serious" and "severe," which are not synonymous, the following not… +
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GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020 D When should the notification be made +
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When should the notification be made?
• Within 7 days of the Sponsor becoming aware of the breach. If the notification function has been delegated… +
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§ 312.6 Labeling of an investigational new drug.
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§ 312.7 Promotion of investigational drugs.
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§ 312.8 Charging for investigational drugs un… +
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 - +
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“Clinical Investigation of Medical Devices for Human Subjects—Good Clinical Practice,” ISO 14155:2011, which FDA recognized in 2012 as a consensus… +
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GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 2 relevant ethics committee +
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“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… +
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adverse device effect
ADE
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adverse event
AE
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adverse event
Any untoward medical occurrence in a clinical trial subject administered a pharmaceutical product; it does not necessarily have a causal… +
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… +
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… +
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blinding
masking
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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… +
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clinical investigation
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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… +
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - clinical trial Phases +
clinical trial
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Clinical trials are generally classified into Phases I to IV. It is not possible to draw distinct lines between the phases, and d… +
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comparator
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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.… +
contract
A document, dated and signed by the investigator, institution and sponsor, that sets out any agreements on financial matters and delegation/d… +
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… +
