Close Out Study

Roles and Responsibilities

The UCLA Clinical and Translational Research Centers (CTRCs) provide information about roles and responsibilities for Study Closeout as summarized below.

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.
• Submits reports as needed to sponsor.
• Stores study records appropriately.

PI's Department

• Ensures that all allocable costs have been charged to the study (your local CTRC can assist with answering questions as needed).
• Reviews study receipts with Coordinator to ensure that all funds due to the CTRC have been received, and that all funds received have been earned.
• Reviews PI effort. Closes study account.
• Transfers balances to income accounts.
• Works with departmental accounting office to resolve any overdrafts.

CTRC

• Determines appropriateness of funds to remain with the CTRC.
• Moves study to a "closed" state in the CTRC system.

As a scientific/medical expert, you are likely to be called upon to speak to the media about advances in your field. Each UCLA CTSI institution’s medical school has a staff of media relations professionals who work with reporters, editors and producers nationwide. These media representatives operate in a world apart from academic medicine and understand how to assist with the following:

• screen media calls
• help decide when an interview is appropriate and get answers to such key questions as the reporter’s deadline, the time needed for the interview and the kinds of questions the reporter is likely to ask
• offer insights on individual reporters who we may have worked with in the past

For stories involving broadcast media, media representative can assist with:

• organizing shoots*, including selecting locations and handling of the logistics to ensure a smooth process
  *For shoots that take place in clinical settings and that include patients: media representatives will want to insure that HIPAA consents are signed and that there is minimal disruption to patient care activities.

RESOURCES

UCLA

• For detailed advice on dealing with the media, view the Resources for Faculty & Staff on the UCLA Health Sciences Media Relations website. CTSI media contact: Kim Irwin, 310-794-2262, Senior Public Relations Officer for UCLA Health Sciences.

KEY POINTS

• Contact media representatives as soon an article is accepted for publication, so that we can maximize media exposure for your research.
• Notify media representatives of honors and important speaking engagements so that we can share this information internally and externally
• REQUIRED: Cite the UCLA CTSI grant as a supporting institute for your research in press releases and other media outreach.

font-weight: bold;">REQUIRED

All publications resulting from the utilization of any UCLA CTSI resource or service must be compliant with the NIH Public Access Policy. The policy requires scientists to submit final peer-reviewed journal manuscripts that arise from NIH funds to PubMed Central upon acceptance for publication. Papers must be accessible to the public on PubMed Central no later than 12 months after publication.

The following is excerpted from the National Institutes of Health Public Access website:
"The NIH Public Access Policy ensures that the public has access to the published results of NIH funded research. It requires scientists to submit final peer-reviewed journal manuscripts that arise from NIH funds to the digital archive PubMed Central upon acceptance for publication. To help advance science and improve human health, the Policy requires that these papers are accessible to the public on PubMed Central no later than 12 months after publication."

The policy covers any manuscript that meets the following conditions:

• It was peer-reviewed
• It was accepted for publication in a journal on or after April 7, 2000
• It arose from:
  • any direct funding from an NIH grant or cooperative agreement active in FY 2008 or beyond, or
  • any direct funding from an NIH contract signed on or after April 7, 2008, or
  • any direct funding from the NIH Intramural Program

The PMCID is unique reference number that is assigned to each article that is accepted into PubMed Central.

For step-by-step instructions about how to bring your publication into compliance, please go to the NIH site, which covers these topics:

• Applicability of NIH Public Access Policy
• Copyright
• Submitting a paper to PubMed Central (PMC)
• Including PMCID in citations

Click here to see an informational webinar that addresses How the NIH Policy Mandate Affects Researchers.

REQUIRED

The National Institute of Health (NIH) requires researchers to acknowledge federal funding in peer-reviewed publications and presentations.

The UCLA CTSI is part of the Clinical and Translational Science Award (CTSA) program, funded by the National Center for Advancing Translational Sciences (Grant Number UL1 TR000124) at the National Institutes of Health (NIH). All publications resulting from the use of CTSI resources must comply with the NIH Public Access Policy and NIH Funding Acknowledgment requirements.

UCLA CTSI resources or services that qualify as "NIH-funded" include:

• Biostatistics, study design, or bioethics consultations
• Clinical and Translational Research Center facilities or resources
• CTSI funding/awards
• CTSI consults, advice (beyond a brief consult) or training
• CTSI letters of support

New NIH publicity requirements: As of April 2012, all grantee institutions are required to acknowledge federal funding in every journal article, news release, news story, or other story for public dissemination that features NIH-supported research. Including this information will help the NIH populate the Research Portfolio Online Reporting Tool Expenditures and Results (RePORTER) tool found at report.nih.gov with compelling descriptions of the research they support, and to communicate the value of taxpayer-funded research to the media, advocates and policymakers.

If you have a pending NIH-funded study about to be published, please notify the relevant NIH NCATS communication office of the release or story before publication.

More information:

• NIH Grants Policy Statement

CITATION LANGUAGE

Any publications or projects completed using UCLA CTSI resources must cite the UCLA CTSI grant and comply with NIH Public Access Policy and be submitted to PubMed Central to receive a PMCID assignment.

Required Grant Citation Language

• K scholars
  • This research was supported by NIH/National Center for Advancing Translational Science (NCATS) UCLA CTSI Grant Number KL2TR001882.
• TL1 trainees
  • This research was supported by NIH/National Center for Advancing Translational Science (NCATS) UCLA CTSI Grant Number TL1TR001883.
• All other CTSI-supported researchers
  • The research described was supported by NIH/National Center for Advancing Translational Science (NCATS) UCLA CTSI Grant Number UL1TR001881.

Note: If the research was supported by more than one grant, please reference all relevant grant numbers.

CITATION LANGUAGE

Each publication, press release, or other document that cites the results from NIH grant-supported research must be submitted to PubMed Central, and the PMCID number must be reported.

The PMCID is a unique reference number assigned to each article accepted into PubMed Central.

For more information about this requirement, see the NIH website regarding public access.

Check Your NIH Compliance Status (My NCBI)

Investigators can use My NCBI to check the compliance status of their publications and to initiate the compliance process.

• Sign in to My NCBI using the "NIH Login" button.
• Use your eRA Commons credentials on the subsequent sign-in page.
• Once signed in, go to the My Bibliography section.

Instructions on how to use My NCBI to manage compliance can be found in the NCBI Help Manual under the heading, Managing Compliance to NIH Public Access Policy.

A My NCBI account can be created with accounts you already have, such as eRA Commons or Google. Go here for instructions.