Feasibility reports apply to those Clinical Trials with drugs, observational studies with drugs or studies with health products only in centers of the Catalan Institute of Health that have been previously evaluated by a reference CEIm.
It is mandatory that the researchers of each primary care center that are included in the study notify their participation to the Research Support Unit (USR) of their territory. To consult the contact of the USRs, enter the following link: Territorial Support Units (USR) – IDIAP Jordi Gol
REMINDER: all those studies in which the participation of the primary care center is only the referral of patients to specialized care, will not have to request the feasibility report from the CERm of the IDIAP Jordi Gol.
Documents to be provided as part of the protocol
CEIm approval of reference.
Investigator’s manual or technical sheet of the drug/health product under investigation.
Patient information sheet and Informed Consent from our centers.
AEMPS authorization (if applicable).
AIPD (if applicable).
List of centers and researchers from our centers.
Suitability of the facilities of our centers.
Insurance policy.
Economic report.
Payment of fees or exemption from payment.
Mandatory sections within the protocol
Procedures and materials used for subject recruitment (if applicable)
