Page 346 - eBook Version 8 Book 1 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: R-Rec-003 SOP Title: Secured Shared Drive
Research Administration Electronic Regulatory Binder Structure:
CCS_Research (\\childrens.med\depts\RESEARCH\SHARE) PI Last Name_Velos#_eIRB number
1. Internal Reviews
2. IRB
3. Essential Documents
4. Protocol
5. Investigational Brochure
6. Consent and HIPPA Forms
7. CV’s and Licensures (Reference in central CRER file) 8. Lab Accreditation ((Reference in central CRER file) 9. Delegation and Training Log
10. Study Materials
11. Sponsor Correspondence
12. Site Correspondence
13. Screening and Enrollment Log
DSMB (if applicable)
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