What is Clinical Trial Sponsor’s responsibilities?

According to GCP guidelines, the sponsor is generally responsible the following:

1. Select Investigators
2. Monitor progress of clinical trial
3. Ensure trial is conducted in accordance with protocol
4. Monitor safety
5. Drug disposition and reconciliation
6. Maintain required records and reports
7. Transfer of obligations to a CRO

The clinical trial sponsor also has the following additional responsibilities:

1. Inform Investigators of information important to study conduct, e.g., provide Investigator’s Brochure/report of prior investigations, investigational plan, updates during study as new information becomes available, in particular, safety/adverse effects
2. Obtain required information from Investigator
3. Signed Form FDA 1572 and/or Investigator Agreement
4. Curriculum vitae
5. Financial disclosure information
6. Clinical Protocol
7. Shipment of investigational product only to Investigators participating in the investigation
8. Submission of Protocol Amendments describing any “change in a Phase I protocol that significantly affects the safety of subjects or any change in a Phase 2 or 3 Protocol that significantly affects the safety of subjects, the scope of the investigation, or the scientific quality of the study”
9. Annual Report to FDA on progress of the IND or IDE
10. Permitting FDA access to records during inspection.