France

DCT Feasibility Assessment France The below version control table serves to document all updates made to the guidebook. The purpose is to ensure the information is always accurate and up-to-date. Disclaimers ...

This guidebook provides an overview of the current and proposed regulatory landscape applicable in France in relation to Decentralized Clinical Trials (“DCT”). It supplements the regulations applicable to the EU and EEA described in the European Me...

2.1 Name of Regulatory Authority The National Agency for the Safety of Medicines and Health Products/ Agence nationale de sécurité du médicament et des produits de santé (“ANSM”) 2.2 Name of Ethics Committee Comités de Protection de...

3.1 Provide a list of documents needed to be submitted for EC/IRB review and approval including the number of copies and/or translations as relevant.   The EU Regulation 536/2014 specifies that the documents to be evaluated are divided in...

4.1 Provide a list of documents needed to be submitted for RA/CA review and approval including the number of copies and/or translations as relevant.  The EU Regulation 536/2014 specifies that the documents to be evaluated are divided into ...

5.1 Does local regulation require PI/CI to be approved/registered by any health authority (e.g., RA/EC)?   No . Local Regulations do not require a PI/CI to be approved by a Health Authority, though they must meet the criteria (as indicate...

6.1 Provide a list of documents needed for export permit relevant to biological specimen shipment. Authorization must be sought from the French Ministry of Research to import and export human organs, cell tissues, and their derivatives which ar...

7.1  Do the country regulations allow Decentralized Clinical Trials (DCT) elements (e.g., eConsent, ePRO administration, remote investigator site, etc.)? Yes . 7.2  Is there any specific regulation/ guidance on the use of DCT eleme...

8.1 What data privacy and/or technology regulations need to be complied with to run a trial in the countries of interest?   The following data privacy regulations apply in France: Regulation (EU) 2016/679 - General Data Protection Regulati...

9.1 Clinical trial subject recruitment: Are digital advertisements (including social media streams such as TikTok) allowed and, if so, what regulations govern them ?   Yes . Unless the protocol already contains this information, the pro...

10.1 Clinical Trial with Investigational Medicinal Product Prior to commencing a clinical trial, a sponsor must submit a clinical trial authorization application file via CTIS . The EU's Clinical Trial Regulation (EU) 536/2014 came into force...

Europe Union (EU) EU Clinical Trial Regulation (EU CTR) 536/2014 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02014R0536-20220131   EMA- Questions and Answers Document Regulation (EU) 536/2014 https://health.ec.europa....

None.