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Study Closeout — Roles & Responsibilities

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Spectrum support for Clinical Research is divided into four stages, the last of which is Close Out and Publish Study.
This stage includes regulatory and compliance information and required citation information when publishing your study.

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Roles and Responsibilities

RMG provides information about roles and responsibilities for Study Closeout as summarized below. Please visit the RMG website for more information.

PI and/or Study Coordinator

  • Verifies that all Case Report forms have been submitted and that all study requirements have been met, including any final reports.
  • Ensures that all allocable costs have been charged to the study.
  • Approves final accounting and verifies that funds to remain with Stanford have been appropriately earned.
  • Submits final report to IRB.
  • Identifies possible ClinicalTrials.gov results posting requirements and posts results.
  • Identifies possible FDA Sponsor-Investigator requirements such as IND withdrawal or IDE final report.
  • Submits reports as needed to sponsor.
  • Stores study records appropriately.

Department

  • Ensures that all allocable costs have been charged to the study.
  • Reviews study receipts with Coordinator to ensure that all funds due Stanford have been received, and that all funds received have been earned.

RMG

  • Determines appropriateness of funds to remain with Stanford.
  • As needed, assists Department and PI with closeout process, including resolution of overdrafts.

OSR Accounting

  • Reviews PI effort. Closes study account.
  • Transfers balances to income accounts.
  • Works with dept to resolve overdrafts.