Stanford

Close Out Study

RR-High-04

The last stage for Clinical Research is Close Out and Publish Study.
This includes regulatory and compliance information and required citation information when publishing your study.


What should I do at the end of my study?

1.  Assign Tasks for Study Completion
1.  Get Advice on Media Outreach (before publication)
2.  Publish Your Study – REQUIREMENTS!

For detailed information, open the color-coded items below this key.

GUIDANCE — Items to consider

The clinical research process for clinical and translational research projects, from study idea and design through close-out and publication, requires consideration and often consultation with appropriate experts regarding:

Getting Started

  • Do I need help with my study design?
  • What is a Case Report Form and how do I create one?
  • Can I do my study at Stanford?
  • What resources are available to support my project?

Regulatory Requirements

  • What are FDA requirements?
  • Do I need IRB approval?
  • Do I need an IND or IDE for my research project?
  • What does it mean to be a Sponsor-Investigator?
  • What documents are essential for my research?

Budget and Billing Matters

  • What is RMG and who is my RPM?
  • What is Medicare Pre-authorization?
  • How do I get started with my budget?
  • Who do I contact for billing issues?
  • What is the workbook?

Staffing Needs

  • Do I need a coordinator?
  • What does a coordinator do?
  • How much will a coordinator cost?

Grant and Contract Processes

  • When do I need a contract?
  • What is the Office of Sponsored Research (OSR) and who is my contract officer?
  • How do I finance my study?
  • Do I need a contract if I am getting equipment on loan?
  • Who do I contact about my grant?

Study Closeout — Roles & Responsibilities

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.

Clinical Trials.gov Results Posting

Results submission is required for Applicable Clinical Trials [ACTs] that were required to register under FDAAA 801 and that study drugs, biologics, or devices that are approved, licensed, or cleared by FDA.

Document Management & Storage


Get Advice on Media Outreach (before publication)

As a scientific/medical expert, you are likely to be called upon to speak to the media about advances in your field. The medical school’s Office of Communication and Public Affairs has a staff of media relations professionals who work daily with reporters, editors and producers nationwide. We understand the needs of media representatives, who operate in a world apart from academic medicine.

  • We can help screen media calls.
  • We can 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.
  • We can also offer insights on individual reporters who we may have worked with in the past.

For stories involving broadcast media:

  • We can be involved from day one in organizing the shoot, including selecting locations and handling all of the logistics to ensure that things go smoothly.
  • It is particularly important for us to be involved in shoots that take place in clinical settings and that include patients, as we will want to insure that HIPAA consents are signed and that there is minimal disruption to patient care activities.

RESOURCES

KEY POINTS

  • Contact us as soon an article is accepted for publication, so that we can maximize media exposure for your research.
  • Notify our office of honors and important speaking engagements so that we can share this information internally and externally.
Contacts

You can reach the Office of Communication and Public Affairs at the numbers below or page our office anytime day or night at at (650) 723-8222, pager ID 25314.

Susan Ipaktchian  email
Director of Print & Web Communications
Phone: (650) 725-5375

Michelle Brandt  email
Associate Director, Media Relations and Digital Communications
Phone: (650) 723-0272

Paul Costello  email
Chief Communications Officer
Phone: (650) 725-5370

Comply with NIH Public Access Policy

REQUIREMENT!

All publications resulting from the utilization of any Spectrum resource or service must be compliant with the NIH Public Access Policy.

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


Next Steps

Acknowledge Grant Support — Wording for Manuscripts

Submit Manuscript to PubMed Central & Report PMCID

REQUIREMENT!

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.

Next Steps