Regulation and Ethical Committee approval

France

Observational studies require the advice of the CCTIRS and then the authorization of the CNIL for the treatment of personal health data.
Persons included in the study must be personally informed through a written document of the objectives of the study and on the treatment of data, as well as on their right to object, of access and of rectification, no written consent is required.
Evaluation of the project by the CCTIRS takes one month, followed by 2 months for evaluation by CNIL.
Protocol can be in English but resume must be in French.

Addresses & websites

CCTIRS = Comité Consultatif sur le Traitement de l’Information en matière de Recherche dans le Domaine de la Santé
Ministère de l’Enseignement supérieur et de la Recherche
A l’attention de Monsieur Jean-Louis Serre
Direction de la Recherche et de l’Innovation
1, rue Descartes, 75231 PARIS Cedex 05
Instruction on the dossier on the site:
http://www.enseignementsup-recherche.gouv.fr/cid20537/cctirs.html

CNIL online Submission
8 rue Vivienne 75083 Paris cedex 02
T. 01 53 73 22 22 - F. 01 53 73 22 00
www.cnil.fr

Other information

Table 1:

Country	EC submission	HA submission/ notification	Comments
France	CCTIRS (1-2 months)	NO	CNIL (2 months: after CCTIRS approval)
Germany	CEC & LEC	Notification	National coordinator The following might not be required Notification to: KBV =Federal Panel Doctors association GKV = Central Federal Association of the statutory Health Insurance Funds PKV = Association of private Health Insurances
Italy	CEC & LEC (45+30 days)	AIFA notification	Internal hospital approval might be required
Netherlands	YES (~2 months)	NO	CGR Foundation Board of directors to sign contracts after EC approval
Spain	YES (~ 60 days)	First submission for classification then CEC & LEC
UK	YES	NO	Proportionate Review can be quick (14 days) + R&D submissions
Belgium	YES (60 days)	NO	Coordinating investigator

CEC = Country Ethical Committee
LEC = Local Ethical Committee

Table 2:

Country	Essential Documents
General	Protocol (in English in most countries); synopsis and ICF in local language; CRF
France	Expanded protocol synopsis
Germany	Statement for data protection, financial disclosure form (might not be required if it relates to investigator fees), list of sites (can be updated), National coordinator, signature page, add. EC forms, draft contract and budget (might not be required if it relates to investigator fees)
Italy	List of sites, contract (might not be required if it relates to investigator fees), observational Study Declaration, National Coordinator
Spain	Protocol fully translated, site Budget (might not be required if it relates to investigator fees), MoH classification letter, submission until 5th day of the month
UK	Protocol, GP letter, Insurance certificate, DP
Netherlands	Protocol in English, synopsis in local language, ICF, CRF, DP