Requirements for CRO/Clinical trial center establishment in Bangladesh
1. Company profile of the CRO/Clinical trial center
2. Organogram with name of key personnel
3. CV of Researchers & members
4. Job description
5. GCP training records of the personnel involved in Clinical trial
6. Clinical trial center should have bio-analytical lab, if not then
a. they must have a contract with bio-analytical/analytical lab having biological sample analytical facility
b. Biological sample storage & carrying facility
c. Analytical lab needs accreditation or, operates under GCP compliance (Training record)
7. Appoint a Chief investigator or, contract
8. Whether the CRO got Institutional Review Board (IRB)/Independent Ethics Committee (IEC)
9. Storage facility of IP, temperature sensitive product storage facility
10. SOP for Handling of IP (i.e., investigational product)
11. Archive facility (Controlled access, pest controlled and fireproof)
12. Does the CRO has the hospital facility/in-house subject area/pool of subject
14. Whether they have emergency handling facility such as, intensive care facility in the hospital/has contract with any nearby hospital’s intensive care unit
15. Emergency trolly & ambulance facility
16. Quality management System and SOPs for each activity/practice
17. Contractual/sub-contractual agreement with third parties (Hospitals, clinics, university, analytical lab etc.)
18. Subject recruitment process, handling, compensation and confidentiality
19. Ethical clearance
20. Does the CRO/CT Center have own IRB/IEC?
21. Does the CRO/CT Center have DSMB?
22. Main products’ name, the CRO will include in the studies (Drug group)
23. Estimated cost categories, by molecule
24. Estimated time to perform study
25. Bio-statistical software
* This is basically a checklist adopted by DGDA on 26-10-2017 (Form no. NRA-CTO-003/F01-01)
