Before a study starts, it is necessary to get all mandatory approvals. The required documents may vary from Country to Country and from an Ethics Committee (EC) to another. Application for a Clinical Research to EC before a study starts, it is necessary to get all mandatory approvals. The required documents may vary from Country to Country and from an Ethics Committee (EC) to another.
A master version of the following should be drafted and used as a customable template:
Informed Consent Form
Letter to General Practitioner
Protocol
Patient card (if required)
synopsis (in local language)
Other documents usually needed for the submission are:
Investigators Brochure (IB) of the Medical Device
Instructions For Use (IFU) of the IP
CE Mark of the IP
Curriculum Vitae (CV) of the Principal Investigator (PI)
Financial Agreement (draft)
Insurance Policy and Certificate
Paper CRF
List of participating centers
A Study Start Up (SSU) specialist or equivalent is in charge of preparing the dossiers.
Application for a Clinical Research to EC
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Glossary
