Page 148 - eBook Version 8 Book 1 of 2 JUL 2022
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STANDARD OPERATING PROCEDURE
Research Administration Electronic Regulatory Binder Structure:
CCS_Research (\\childrens.med\depts\RESEARCH\SHARE) PI Last Name_Velos#_eIRB number
Research Administration SOP No: R-Reg-100 SOP Title: Regulatory Binder
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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