Activity # 13: Study Closure
|Download Supplemental Checklist||Download Chapter on Informed Consent||Download Chapter 13||Download the entire Guidebook||Back to Process Maps|
Activity # 13: Study Closure
13.1 Financial Analyst Closes Bulk & DaFIS Accounts
At the end of a study, regulatory and financial documentation has to be completed. Closure notices must be sent to finance to close the Bulk Account and DaFIS (Kuali) account.
13.2 IRB Notified about Permanent Study Closure
Complete the “FORM: Continuing Review Progress Report (HRP-212),” attach all requested supplements, have the formed signed by the individuals listed in the form, and provide the requested number of copies to the IRB Administration. Maintain electronic copies of all information submitted to the IRB in case revisions are required. Reference the Investigators Manual (HRP-103) for further information http://research.ucdavis.edu/c/cs/hrp/documents/HRP103INVESTIGATORMANUAL.docx
13.3 IDS Notified and Study Drug Disposed
Once all study drugs and devices have been accounted for, the coordinator must work with IDS staff to close the study at the pharmacy. The IDS can be reached at:
2315 Stockton Blvd, Rm DT 0762, Sacramento, CA 95817
Phone: (916) 703-4093
Pager: (916) 762-3929
13.4 Health System Contracts Notified
Once the project is terminated by the sponsor or the contract end date expires, Clinical Trials Contracts will note the termination or expiration of the agreement and close the file. Closing the agreement file does not close the project account, and this closeout process must be done through Extramural Accounting. Clinical Trials Contracts must retain the agreement for the period of time designated in the agreement or if not so designated the period legally required The PI and department must retain the project records for the period of time designated in the agreement.
13.5 Documents Archived
For drugs, according to 21 CRF 312.62(c), an investigator shall retain records required to be maintained under the part for a period of 2 years following the date a marketing application is approved for the drug for the indication for which it is being investigated; or, if no application is to be filed or if the applications is not approved for such indication, until 2 years after the investigation is discontinued and FDA is notified.
For devices, according to 21 CRF 812.140(d), an investigator or sponsor shall maintain the records required by this subpart during the investigation and for a period of 2 years after the latter of the following two dates: The date on which the investigation is terminated or completed, or the date that the records are no longer required for purposes of supporting a premarket approval application or a notice of completion of a product development protocol.
Study Sponsors may have additional document retaining provisions stipulated in the Contract.
13.6 Publications and PMCID.
The National Institutes of Health (NIH) requires researchers to acknowledge federal funding in peer-reviewed publications by citing any NIH grants that supported the research process described in the publication. In addition, the NIH Public Access Policy requires that all investigators “funded by the NIH,” be it through direct funding or through use of resources of an NIH-funded center (such as the UC Davis Clinical and Translational Science Center) submit an electronic version of their final, peer-reviewed manuscripts to PubMed Central (PMC) upon acceptance of publication. This policy ensures that the public has access to the published results of NIH-funded research. Failure to submit the manuscript to PMC within NIH-imposed deadlines may result in a delay of processing the grant awards of the researchers or centers whose grants were cited in the manuscript.
Useful resources about complying with the NIH Public Access Policy:
Details of the NIH Public Access Policy: http://publicaccess.nih.gov/
Directions and tutorials for submitting a manuscript to PMC through the NIH Manuscript Submission system: http://www.nihms.nih.gov/help/
Information about citing the CTSC in a publication: http://www.ucdmc.ucdavis.edu/ctsc/