These clinical studies only require a positive opinion from the EC, recognised by the Act of 07/05/2004. Approval of the FAMHP is not necessary. The file needs to be submitted directly to the EC.
The following types of studies should be submitted according to this pathway:
➔ PMCF-research without extra burdensome or invasive procedures ( Act on experiments on human beings - the EC has 28 days to deliver an opinion)
➔ other clinical study with CE-marked tool that is used for the intended purpose (BRD clinical study - the EC has 45 days to deliver an opinion)
Compile the file
The following are mandatory for a valid application:
- Cover letter of the investigator
- Protocol (+ summary)
- Method of recruitment - Recruitment material
- Information and consent form, patient documents
- Suitability/competence of the principal investigator/promoter by means of CV
- GDPR questionnaire
- Proof of “no fault” insurance
- CE certificate
- Instructions of the manufacturer
- Brochure for investigators (IB)
If relevant for your study, the following components are also submitted:
- Suitability of the facilities/agreement involved supporting services
- Info of local ECs + proof of simultaneous submission to the local ECs
- Contracts/ financial agreements.
E.g. Clinical Trial Agreement, Material/Data Transfer agreement, Confidentiality agreement, contract access KWS, etc.