Study Review & Approval Process
Clinical Research Services Program Study Approval Process
- All required study submission materials must be received by the IIMS Clinical Research Services (CRS) Program as specified below before final approval to conduct the study can be given.
- Initial evaluation of resources and cost can be achieved by submission of a draft or final Protocol and a completed Schedule of Visit Assessments, along with lab and pharmacy manuals, if necessary. In order to plan resources and budgets, these materials can be submitted at the study planning and budgeting stage of grant or protocol development and/or prior to final IRB approval.
Purpose & Mechanism of Cost Leveraging
The CTSA grant to the IIMS allows for the CRS Program to work on a cost-recovery basis with special rates available for federally-funded studies. For pilot studies funded by the IIMS, additional cost-discounts may be applied as specified by the IIMS.
With submission of the Protocol and Schedule of Visit Assessments, study protocols will be evaluated for resource requirements and costs to determine the extent to which CRS Program resources are available to support the study. Study-related costs will be estimated by program staff and cost-discounting will be applied, and estimates are then provided to the Clinical Trials Office (CTO) for budget negotiations with the sponsor.
For budgeting purposes, services are estimated on a worst-case scenario basis to ensure that sufficient funds are available to conduct the study under all circumstances. Once the sponsor has approved the budget and the study has commenced, charges are based on actual time and services provided, which, on average, typically come in below estimates. If the account is a UT Health – San Antonio account, the account will be charged monthly by electronic interdepartmental transfer (IDT) utilizing iLab, the CRS’s invoicing system. If the account is located outside of the UT-Health Science Center, then an invoice will be issued to the Investigator at their host institution. All revenue will be deposited into the CRS Program Cost Recovery Account and will be reinvested in program resources to enable further extension of support to other clinical studies.
Approval Request, Submission Materials
A single copy of the following materials must be submitted to gain approval to conduct clinical study procedures:
- The CRU study data collection form
- An IRB-approved Grant or Study Protocol (if one exists beyond the IRB Forms)
- Schedule of Assessments Template (note, this is typically included in the protocol and/or provided to the CRU by the Clinical Trials Office, so it is not required in all cases)
- A completed IRB-Form C and IRB-stamped Consent Form
- A copy of the IRB Approval Letter prior to the start of visits
- Study teams should submit all required study materials through the VA’s IRBNet system, including the Evaluation of STVHCS Resources for Clinical Research: BRU form.
- The BCRU study data collection form
- The Visit Schedule of Assessments should be provided to illustrate the schedule of which procedures/assessments will be conducted at the BCRU, as well as identify which procedures will be performed by BCRU staff or whether the PI’s study team will conduct those assessments themselves. The Visit Schedule of Assessments requires:
- the investigator to estimate the length of time of each study visit at the BCRU;
- If any food provision or dietary consult is required for your study, this information must be indicated on the Schedule Timeline;
- If study procedure schedules or timelines differ for two different study groups (i.e., patients and controls), then a separate Visit Schedule of Assessments must be submitted for each population group.