This document informs the awardee about the schedule for preparing and peer reviewing the draft final research report.
Steps for completion of peer-review requirements.
- Start early! Begin work on the draft final research report early, using the instructions posted on the PCORI website. You can write much of the draft final research report, especially a description of your study methods and your study’s adherence to the PCORI Methodology Standards, before you finish analyzing your study data. Remember that the report should be written with a general scientific audience in mind. Do not use field-specific jargon without defining it, and do not write as if you are addressing PCORI directly.
- Two to three months before the draft final research report due date:
PCORI’s Peer ReviewContractor, the PCORI Editorial Office, will notify you by email that it is time to submit a structured abstract describing your study and listing key personnel and their affiliations. The email from the editorial office will contain a copy of your original abstract and key personnel for the project. The email will also contain a link for you to directly access your record in Editorial Manager®, where you can update the abstract with results and conclusions, update your list of study authors, and identify keywords for the study. You will also be asked to nominate up to four individuals whom you think are well qualified to serve as subject-matter expert peer reviewers of your draft final research report but would not have a conflict of interest with the report or study team. The associate editor assigned to your project will use all of this information to recruit peer reviewers for your report.
- At least one month before the draft final research report due date:
If you registered at ClinicalTrials.gov, submit the four required results tables to the website using directions available at ClinicalTrials.gov. Notify your PCORI program officer when you have submitted your results to ClinicalTrials.gov, as this is a contract milestone.
- Reconciling the four results tables: The ClinicalTrials.gov staff may ask you to modify the tables. Once ClinicalTrials.gov has accepted your tables, make sure that the results match the results shown in the tables in your draft final research report. The format of the tables in the draft final research report should be suitable for journal publication; do not simply copy and paste the tables from the ClinicalTrials.gov website.
- On or before the draft final research report due date: Submit your draft final research report to Editorial Manager®, our peer-review software system, using these submission instructions. The first step will be a technical check of the report to make sure that it includes all required components for the submission.
- An experienced editor conducts a pre-peer review of the draft final research report for clarity and completeness. The pre-peer review editor will determine whether the report is sufficiently clear for peer reviewers to evaluate the science, and whether the report adequately conforms to the Instructions for the Draft Final Research Report. If edits are necessary, the editor will send you a letter describing the edits, along with a copy of your report with marginal comments. You have two weeks to make changes in response to comments from prereview and to resubmit into Editorial Manager®. Most reports are approved for peer review after one revision in this phase.
- Once the peer-review office considers your report ready for peer review, it will be sent to external peer reviewers to assess scientific integrity as well as relevance and usefulness. You will receive an email confirmation that your report has entered peer review.
- Once external peer reviewers have submitted their comments: The associate editor will send you a letter synthesizing the main points from reviewers as well as a copy of the reviewers’ comments. This should occur about 60 days after the report enters peer review. You will have 45 working days to respond to the peer-review comments.
- After you have revised the draft final research report and prepared your response to peer-review comments: Resubmit the revised report and response letter to Editorial Manager®. The associate editor will notify you if additional revisions are required, or if, as in rare instances, the draft report will need to be sent back to external reviewers. Most reports complete this part of peer review after one or two revisions.
- After external peer review, the draft final research report gets a final review from PCORI: The PCORI Director of Peer Review and Scientific Publications will read the report to be sure it is ready for PCORI’s acceptance. You may be asked to complete additional edits of the report at this stage to improve clarity. You will be notified by the Peer Review Office when PCORI has accepted the report.
- The PCORI Translation Center then uses the final research report to prepare project summary materials for web posting. They will use the report and your responses to reviewers’ comments to finish creating two 500-word abstracts, one for medical professionals and the other for the public, called a lay summary. You will have an opportunity to suggest edits to these abstracts; PCORI will then post them to pcori.org. PCORI must post these abstracts within 90 days of PCORI’s acceptance of the final research report. PCORI will also post a summary of the peer-review process and the required ancillary information, including conflict of interest disclosures from you and your institution.
- Soon after a journal publishes your main results article: In accordance with its authorizing legislation, PCORI will post your final research report and study protocol to pcori.org. The PCORI Peer Review Office and your program officer will work with you to determine the best time to post. PCORI must post the final research report on pcori.org no later than 12 months after the date of its final acceptance by PCORI.
Posted: November 22, 2016; Updated: December 20, 2018