I'd think based on the submission criteria documents below they are going to need more than 3 people and ones with background on the trial design."In short, these are the key documents you will need to submit the initial trial application to the regulatory authority:
- Clinical trial application cover letter
- Clinical trial application form
- Study protocol
- Investigator’s Brochure (IB) and/or Summary of Product Characteristics (SmPC)
- GMP-related documents (manufacturer/importer authorizations, Qualified Person Declaration)
- Investigational Medicinal Product Dossier (IMPD)
- Drug labels
- Evaluation fees"
I'd think based on the submission criteria documents below they...
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