PCORI Project Status Terms
Research projects funded by PCORI go through several stages from approval to completion. PCORI indicates where a project is along that continuum by noting its status on the web page that provides details about the project. PCORI uses various terms to describe the different stages in a project’s lifecycle, which are defined in the two tables below. The first table refers to research projects that require recruitment of participants. The second table refers to research projects that do not require recruitment of participants, such as some methodology and infrastructure projects. Some terms are based on those used by ClinicalTrials.gov, while others differ, given the wide range of project types PCORI supports and the unique steps we follow to meet the requirements in our authorizing law. PCORI updates project statuses at least quarterly.
PROJECTS THAT REQUIRE RECRUITMENT OF PARTICIPANTS
| Term | Definition |
|---|---|
| Awarded; Contract pending | The project has been approved by PCORI’s Board of Governors and is undergoing a PCORI business and programmatic review, or the final research contract is being executed. |
| Awarded; Contract not executed | This project was approved by PCORI’s Board of Governors. Following PCORI business and programmatic review, a determination was made not to execute a contract. |
| Completed; PCORI Public and Professional Abstracts Posted | All award activities have been completed, and the PCORI public and professional abstracts, which summarize the research and its results, have been posted on PCORI’s website. |
| Completed; PCORI Public and Professional Abstracts Posted, and Final Research Report Posted | The final research report is a detailed report of all work completed as part of the PCORI-funded contract. This project has completed PCORI’s peer review process and acceptance criteria. The project’s final research report has been prepared and posted on PCORI’s website. |
| In progress; Not yet recruiting | The contract has been executed, but the project has not started recruiting participants. |
| In progress; Recruiting | The project is recruiting participants. The research team may also have begun examining participants or administering an intervention. |
| In progress; Enrollment complete | No additional participants are being recruited or enrolled. The project is ongoing. Data analysis may be under way. |
| In progress; Data collected | The final participant was examined or received an intervention for the purposes of final collection of data for the primary outcome. This period is identified by the primary completion date, as specified by ClinicalTrials.gov.[1] |
| In PCORI Peer-Review Process | The project has been completed in accordance with its protocol, and participants are no longer being examined or receiving an intervention. Data collection for all outcomes has been completed. The draft final research report is undergoing PCORI peer review. |
| PCORI Peer-Review Process Complete | This project’s final research report has completed PCORI’s peer review process and acceptance criteria. The project’s public and professional abstracts, which summarize the research and its results, are forthcoming and will be posted on PCORI’s website. |
| Terminated | The project has been stopped earlier than indicated in its protocol, and participants are no longer being recruited, enrolled, examined, or treated in the trial. Note that in cases where a project has been terminated early, the investigators are not required to submit a draft final research report but are required to submit results tables to ClinicalTrials.gov (if applicable). |
PROJECTS THAT DO NOT REQUIRE RECRUITMENT OF PARTICIPANTS*
| Term | Definition |
|---|---|
| Awarded; Contract pending | The project has been approved by PCORI’s Board of Governors and is undergoing a PCORI business and programmatic review, or the final research contract is being executed. |
| Awarded; Contract not executed | This project was approved by PCORI’s Board of Governors. Following PCORI business and programmatic review, a determination was made not to execute a contract. |
| Completed; PCORI Public and Professional Abstracts Posted | All award activities have been completed, and the PCORI public and professional abstracts, which summarize the research and its results, have been posted on PCORI’s website. |
| Completed; PCORI Public and Professional Abstracts Posted, and Final Research Report Posted | The final research report is a detailed report of all work completed as part of the PCORI-funded contract. This project has completed PCORI’s peer review process and acceptance criteria. The project’s final research report has been prepared and posted on PCORI’s website. |
| In progress; Recruitment not applicable | This project is under way. |
| In PCORI Peer-Review Process | The project has been completed in accordance with its protocol, and data collection for all outcomes has been completed. The draft final research report is undergoing PCORI peer review. |
|
PCORI Peer-Review Process Complete |
This project’s final research report has completed PCORI’s peer review process and acceptance criteria. The project’s public and professional abstracts, which summarize the research and its results, are forthcoming and will be posted on PCORI’s website. |
| PCORnet: Phase I completed | PCORnet Phase I projects that are complete and did not continue to Phase II. |
| PCORnet: Phase I completed; Phase II in progress | PCORnet Phase I projects that are complete and continued to Phase II. |
| Terminated | The project has been stopped earlier than indicated in its protocol. |
*For example, some methodology and infrastructure projects
[1] The Primary Completion Date (PCD) is the term currently used on ClinicalTrials.gov for "completion date" defined in Section 801 of the Food and Drug Administration Amendments Act of 2007. For studies that are not clinical trials or observational studies registered on ClinicalTrials.gov, the awardee institution and PCORI shall agree on a PCD as a milestone that precedes the agreed-upon date to submit a draft final research report.
Posted: June 15, 2016; Updated: March 29, 2019
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