Finishing Your Study

Begin the Closeout Process

• Review PI responsibilities for closeout.
• Make sure to complete the closeout form in iRIS to submit to the IRB.
  • Record Retention
    • Follow the University SOP on Documentation, Documents, and Data Management for regulations on how long records should be stored. This SOP also covers guidelines for VA studies.
  • Financial Closeout Procedures
    • Grants and Contracts offer assistance on Clinical Trial Closeout. The Clinical Trial Closeout Worksheet can be used to assist in final budget calculation.
    • Please review the Administrative Policies Section 574 (Clinical Trial Financial Policy for Sponsored Studies) for information regarding Facilities and Administrative Costs on Clinical Trials and Cost Accounting and Allocation of Expenses.
    • Review the Grant & Contracts Policies and Procedures to find the Sponsored Program Financial Reporting and Closeout Policy.
  • Intellectual Property and Copyright Disclosures
    • Under Development
  • Final Reports to Sponsors
    • Under Development
  • Publication and Peer Review
    • The HSC Writing Center may be able to provide assistance in writing your manuscript
    • Clinicaltrials.gov provides a document to assist in reviewing study results, and explains how clinicaltrials.gov can help review protocols and results to ensure validity, consistency, formatting, and more. Get further guidance here: ClinicalTrials.gov Results Quality Control Review Criteria.pdf
  • Acknowledge Grant Support
    • Under Development
  • Comply with NIH Public Access Policy
    • Ensure that you follow NIH Public Access Policy.
    • All publications with results from NIH-funded research must be submitted to PubMed Central and the PMCID has to be reported through NCBI. View the NIH Website about public access for more information.