This includes when VCU PI is the prime awardee and when participating as a site via another institution.
Step 1: PI communicates with Pediatric Research Office (PRO) team to execute confidentiality agreement (CDA) with sponsor and to inquire if PRO clinical research coordinator (CRC) bandwidth exists (if needed). PRO assigns initial CRC to assist with process as needed.
Step 2: Sponsor conducts feasibility visit or call which typically requires completion of a questionnaire.
Step 3: If Sponsor accepts VCU as site; PI receives regulatory package that may include budget. NOTE: PI must commit a minimum of 1% effort to the study. If the budget does not cover this cost, it is the PI's responsibility to secure institutional funds to meet this cost share in advance of submission or in advance of acceptance to move forward.
Step 4: PI submits Protocol Review and Oversight Committee (PROC) feasibility questionnaire with optional input or assistance from CRC. An advance meeting with CRC is highly recommended.
Step 5: Go or no-go decision is received from PROC. (PROC approval does not constitute study approval.)
Step 6: PRO conducts initial review of sponsor docs, sends to VCU School of Medicine Clinical Trials Office (SOMCT) to create time grids and verify study calendar (standard of care vs. research billing).
Step 7: SOMCT sends time grids. CRC will complete time grid and calendar with input from PI.
Step 8: SOMCT sends draft workbook. PI and PRO team conduct initial budget review, including meeting with SOMCT if necessary to answer questions and discuss budget negotiation.
Step 9: SOMCT works with PRO to construct proposed budget to be submitted to sponsor.
Step 10: SOMCT submits budget to sponsor and negotiates if necessary.
Step 11: SOMCT seeks explicit approval from PRO, CRC and PI for any changes to budget.
Step 12: Once both parties agree to proceed, PRO will obtain an index so that IRB protocol can be submitted for review and approval. Costs are now incurred.
Step 13: PI/CRC submit protocol to IRB.
Step 14: IRB protocol is approved (typically with interim revisions).
Step 15: SOMCT submits to OnCore which triggers ancillaries to activate invoice for setup fees. Ancillary costs are now incurred.
Step 16: Research team (PI, Co-Is, CRCs) complete trainings as required by sponsor.
Step 17: Site initiation visit is held.
Step 18: Project begins! Screening, enrollment, etc.
