Here is a list documents that need to be kept at the study site. 
1. Signed FDA form 1572
2. CVs of all investigators
3. Signed approved protocol
4. Informed CONSENTS / all amended informed consents
5. Investigator’s Brochure
6. IRB approval
7. IRB membership
8. Assurance number
9. Drug accountability
10. IND SAFETY reports
11. Annual/interim reports
12. All information given to the subjects
13. CRF s on each subject (signed, dated)
14. AE reports
15. All source documents not kept in Medical record
16. Meeting minutes/correspondence
17. Signature log/equipment logs
18. Laboratory documentation a. Certification
Abnormal range table with dates
19. Specimen handling
a. Instructions/labels/shipping
20. Staff education records
21. Financial agreements
a. Sponsor 
b. Subject
22. study agreement grant
23. Letter of indemnification
24. Advertisements
25. End of study REPORT

Here is a list documents that need to be kept at the study site. 
1. Signed FDA form 1572
2. CVs of all investigators
3. Signed approved protocol
4. Informed consents / all amended informed consents
5. Investigator’s Brochure
6. IRB approval
7. IRB membership
8. Assurance number
9. Drug accountability
10. IND safety reports
11. Annual/interim reports
12. All information given to the subjects
13. CRF s on each subject (signed, dated)
14. AE reports
15. All source documents not kept in Medical record
16. Meeting minutes/correspondence
17. Signature log/equipment logs
18. Laboratory documentation a. Certification
Abnormal range table with dates
19. Specimen handling
a. Instructions/labels/shipping
20. Staff education records
21. Financial agreements
a. Sponsor 
b. Subject
22. study agreement grant
23. Letter of indemnification
24. Advertisements
25. End of study report