Reporting

Accessing Your Awarded Contract in PCORI Online

In order to set up your account in PCORI Online, please refer to the User Access Cheat Sheet. All users should set up their own individual accounts. The PI must also submit a list of authorized users to [email protected] to ensure that appropriate access to the award is granted in PCORI Online. Please download, complete, and return the Authorized User Request Form here.

Study Registration Requirements

PCORI adopted a process for public release of the results of the comparative clinical effectiveness research studies that it funds. This process includes registering and submitting summary results information to ClinicalTrials.gov for relevant clinical trials and observational studies. Patient registries are similarly required to be registered on ClinicalTrials.gov and the Agency for Healthcare Research and Quality's Registry of Patient Registries (RoPR).

Awardees should select and register their project on the appropriate site for the study design (Clinicaltrials.gov, RoPR, or other as approved by PCORI before study start date). The Study Identification Number and the Primary Research Completion Date should be submitted to PCORI, and PCORI should be listed as a collaborator for all studies.

Publications and Presentations

Awardees should record information in PCORI Online regarding publications and presentations (scientific and notable lay media coverage) related to your PCORI-funded research.  As of January 13, 2018, the reporting of any publications and presentations as well as lay media coverage should be submitted through PCORI Online in your project record under the “Publications” tab.  Instructions for doing so are available in the Research Awards User Guide here.

Publications and/or presentations by any member of the research team, including patient and stakeholder partners, should include those:

  1. Scientific manuscripts in preparation to be submitted
  2. Scientific manuscripts that have been submitted to a publication
  3. Scientific manuscripts that have been accepted to a publication
  4. Scientific manuscripts that are in-press
  5. Scientific manuscripts that have been published
  6. Scientific conference abstracts and poster presentations
  7. Lay media coverage

Please attach any submitted or published manuscripts, other publications, conference abstracts, as well as weblinks or news clips for lay media coverage, etc. to the project record as described in the Research Awards User Guide. Ensure that all publications/communication/media pieces contain the following acknowledgement of PCORI funding and required disclaimer:

"Research reported in this [work, publication, article, report, presentation, etc.] was [partially] funded through a Patient-Centered Outcomes Research Institute (PCORI) Award (PCS-1409-24099)".

"The [views, statements, opinions] in this [work, publication, article, report] are solely the responsibility of the authors and do not necessarily represent the views of the Patient-Centered Outcomes Research Institute (PCORI), its Board of Governors or Methodology Committee."

Adherence to the PCORI Methodology Standards

In accordance with PCORI’s authorizing legislation, PCORI’s Methodology Committee has developed a set of standards that represent minimal requirements for the design, conduct, analysis, and reporting of scientifically valid patient-centered outcomes research.

Engagement Plan

Effective engagement of patients and stakeholders in research requires a well-thought-out plan. Therefore, all applications for PCORI research funding must include an Engagement Plan that outlines how stakeholder partners will be involved in all phases of the study.

The Engagement Plan must be included in all PCORI applications to describe how the research team will be responsive to Criterion 6—Patient and stakeholder engagement—under PCORI's Merit Review Criteria for funding. The Engagement Plan is evaluated as part of the research award application in the merit review process to assess the patient centeredness and engagement elements of the proposed research study.

Many aspects of an engagement plan may change or evolve between the submission of the research application and the start of the study. These changes may reflect a refinement in thinking about the study’s needs and could result in changes to the composition of the stakeholders who are involved, the restructuring of advisory boards and governance committees, or the methods for engaging stakeholders and evaluating engagement.

Recognizing that engagement methods may evolve, PCORI awardees submit a more robust engagement design using PCORI's Updated Engagement Plan template within the project’s first six months. Sample updated engagement plans are available for PCORI awardees upon request.

If you would like to learn more, view an accompanying webinar that addresses steps to completing the updated Engagement Plan and how it can be used as a tool for facilitating engagement throughout the study.

Interim and Final Progress Reporting

All PCORI progress reports must be submitted within PCORI Online.

For information regarding what each required report submission may entail, please see the PCORI awardee training session series.

Monthly Recruitment Reporting

PCORI awardees are requested to submit monthly enrollment updates and CONSORT diagrams directly to their Program Officer (PO) and Program Associate (PA). Awardees should discuss reporting needs and format with the PO/PA.

Institutional Review Board (IRB) Reporting

For all PCORI awards involving human subjects as defined by Federal regulations, the Awardee is required to identify an Institutional Review Board (IRB) of record, otherwise known as the prime, lead, or main IRB.  This documentation must be reflected in the IRB section of the project page in PCORI Online.  Note:  IRB documentation should NOT be attached to IRB-related milestones or in the Notes and Attachments section of the award page.

Every award is required to have a current Prime site IRB approval on file in Salesforce, with an initial approval and annual continuing review until either Peer Review and/or activities associated with human subjects has ceased.  For sites that are not the Prime IRB, and are therefore sub-sites, only the initial approval of sub-sites is required to be reflected in Salesforce.

Please refer to the awardee training materials in the PCORI Online: Awardee User Guide and the PCORI Online Research Awards Cheat Sheet. 

Final Results Reporting

As part of our commitment to the patients and other stakeholders who contribute to our research projects, we believe that these participants and partners should be directly informed about the results. We ask that awardee institutions make "every reasonable effort" to ensure that study participants and partners receive the abstract the PCOR Translation Center prepares summarizing a study’s results in an accessible style.

Draft Final Research Report

The Draft Final Research Report (DFRR) is submitted 4-6 months after the conclusion of the research and represents an integrated, cohesive account of the design, conduct, analysis, and results of the project. The DFRR undergoes peer review by PCORI and is subsequently posted to PCORI’s website to ensure public access to the results of the research.

Peer Review of Research Studies

By law, all PCORI-funded primary research must undergo peer review and all results must be made available to the public. To comply with the law, PCORI developed a process for peer-reviewing our primary research and making research findings publicly available in a form and format useful to patients, clinicians, and others.

Posted: April 27, 2018; Updated: August 25, 2020