CHAPTER 12: Study Closure
12.1 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 DaFIS (Kuali) account.
12.2 IRB Permanent Study Closure
Complete the “FORM: Continuing Review Progress Report (HRP-212),” attach all requested
supplements, and have the formed signed by the individuals listed in the form. 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/wp-content/uploads/HRP103-INVESTIGATOR-MANUAL.pdf
12.3 IDS Closure and Study Drug Disposal
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
Email: IDS@ucdmc.ucdavis.edu
12.4 Health System Contracts Closure
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 Principal
Investigator and department must retain the project records for the period of time designated in the
agreement.
http://www.ucdmc.ucdavis.edu/healthsystemcontracts/clinicaltrialscontracts/contactus.html
12.5 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.
Study Sponsors may have additional document retaining provisions stipulated in the Contract.
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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.
12.6 Publications and PMCID
The National Institutes of Health (NIH) requires researchers to acknowledge federal funding in peerreviewed 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, peerreviewed 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/
CHAPTER #12
Information about citing the CTSC in a publication: http://www.ucdmc.ucdavis.edu/ctsc/
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