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STATEMENT CONCERNING DEVICES FOR SPECIAL PURPOSES
1.For custom-made devices or for devices intended for clinical investigations the manufacturer or hi… +
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STATISTICAL PRINCIPLES FOR CLINICAL TRIALS E9
ADDENDUM ON ESTIMANDS AND SENSITIVITY ANALYSIS IN CLINICAL TRIALS TO THE GUIDELINE ON STATISTICAL PRIN… +
STRUCTURE AND CONTENT OF CLINICAL STUDY REPORTS… +
STUDIES IN SUPPORT OF SPECIAL POPULATIONS: GERIATRICS… +
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Scientific Requirements and Research Protocols
[...]
22. The design and performance of all medical research involving human participants must be clear… +
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Serious Adverse Event (SAE):
Any unfavourable medical occurrence that is considered serious at any dose if it:
• Results in death,
• Is life-threaten… +
Serious Adverse Event or Adverse Drug Reaction
During clinical investigations, adverse events may occur which, if suspected to be medicinal product-re… +
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Serious adverse event or serious suspected adverse reaction. An adverse event or suspected adverse reaction is considered “serious” if, in the view of… +
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Service Provider
A person or organisation (commercial, academic or other) providing a service used by either the sponsor or the investigator to fulfil… +
Signature
A unique mark, symbol or entry executed, adopted or authorised by an individual, in accordance with applicable regulatory requirements and/o… +
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Soumission CPP à réaliser via la plateforme centralisée avec tirage au sort du CPP
https://siriph.sante.gouv.fr/si-riph-2g/#/login… +
Soumission à l'ANSM:
E-Mail: EC.DM-COS@ansm-sante.fr… +
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Source Records
Original documents or data (which includes relevant metadata) or certified copies of the original documents or data, irrespective of … +
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Specific considerations for vulnerable populations
1. Where the subjects are minors, specific consideration shall be given to the assessment of the… +
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Sponsor
An individual, company, institution or organisation that takes responsibility for the initiation, management and arrangement of the financing … +
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GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 3 (6) - (11) +
Sponsor of a clinical trial
3.— (6) After the clinical trial has been authorised by the licensing authority in accordance with regulation 18, 19 or 20… +
GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 3 (1) - (5) +
Sponsor of a clinical trial
3.—(1) In these Regulations, subject to the following paragraphs, “sponsor” means, in relation to a clinical trial, the pe… +
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Sponsor-Investigator
An individual who both initiates and conducts, alone or with others, a clinical trial, and under whose immediate direction the i… +
Study Population
The population to be studied should be chosen to support the study objectives and is defined through the inclusion and exclusion crit… +
Sub-Investigator
Any individual member of the clinical trial team designated and under the oversight of the investigator to perform significant trial-… +
