Page 348 - eBook Version 8 Book 1 of 2 JUL 2022

STANDARD OPERATING PROCEDURE
6. ConsentandHIPPAForms
➢ Current approved version
➢ Previous versions
7. CV’s and Licensures (Reference in central CRER file)
8. Lab Accreditation (Reference in central CRER file)
9. Delegation and Training Log
➢ DOA
➢ Staffing Plan
➢ Training
➢ Contacts
Research Administration SOP No: R-Rec-003 SOP Title: Secured Shared Drive
10.Study Materials – Create additional sub-folders as needed, remove if not applicable ➢ Information Sheets
➢ Manuals
➢ Patient Diaries
➢ CRF’s
➢ Note to File
➢ Lab and Pathology
➢ Pharmacy
➢ Deviation Logs
➢ Quality Reviews
➢ CAPA (Corrective and Preventive Action Plan) ➢ Financial Documents
o CTS (Coordinator Time Sheet) o ClinCard
o SOA/W
o Time Tracker
o RBR checklist
11.Sponsor Correspondence ➢ Amendments
➢ Consent Revisions
➢ Monitoring
➢ Newsletters
➢ Safety
➢ Study Close-out ➢ Study Start-up
12.Site Correspondence
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