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STANDARD OPERATING PROCEDURE Research Administration SOP No: R-Reg-001 SOP Title: Overview of Study Start-Up
7. Ensure that the Regulatory Binder meets all requirements as defined by E6 ICH GCP Chapter 8 (see SOP titled Regulatory Binder). Additionally, please file the Lab approval letter, the Lab Director’s CV and license, CAP, CLIA, and department Note to File documenting that lab personnel are not included on the DOA logs. Please, also file the department Note to File regarding study personnel to be included in Box 6 of the 1572 as applicable.
8. Build a CRC manual with all SOURCE documents and supportive materials and information to carry-out the study.
9. Review the start-up checklist with the team lead and ensure that they are included in Velos and eIRB as “other study personnel”. Please, be prepared to review the regulatory and CRC binders prior to holding a PACT meeting with your study team.
10. Upon obtaining and documenting all milestones on the Milestone Report, work with the sponsor to complete the site initiation visit (SIV) (see SOP titled Sponsor Communications).
11. Upon PSA approval and sponsor activation, update the study status in Velos setting to “Active and Enrolling”(see SOP Study Registration) and contact Research.Finance@Childrens.com and cc your financial analyst to build your study accounting record and activate your study in EPIC (observe alpha split by your PI’s last name).
6. RELEVANT POLICIES AND FORMS
SOA Start-Up Process Flow_Department of Pediatrics (Appendix 1) SOA Stat-Up Process Flow_Department of Non-Pediatrics (Appendix 2) Study Start-Up Checklist: SOA Rule Applied
T: Research/CRC 2019 Resources/ CRC Checklist Study Start-Up Checklist: SOA Rule No Applicable
T: Research/CRC 2019 Resources/ CRC Checklist Laboratory Questionnaire
T: Research/CRC 2019 Resources/ Laboratory Laboratory DOA NTF and Essential Documents
T: Research/CRC 2019 Resources/ Laboratory 1572 Note to File
T: Research/CRC 2019 Resources/