PCORI INTERIM PROGRESS REPORT

Use continuation pages as needed. Limit 15 pages, not including the Certification page.

DATE (mm/dd/yyyy):

PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE):

TITLE OF PROJECT:

PROJECT REPORTING PERIOD: (mm/dd/yyyy) to (mm/dd/yyyy)

Principal Investigator Contact Information Updates

Note any updates to the Principal Investigator’s Contact Information.

PI First Name:

PI Last Name:

PI Institution:

PI Address Line 1:

PI Address Line 2:

PI City:

PI State:

PI Zip/Postal Code:

PI Telephone Number:

PI Email Address:

Primary Patient and OtherStakeholder Partner Contact Information

Complete the contact information below, if applicable.

Primary Partner First Name:

Primary Partner Last Name:

Primary Partner Email Address:

Primary Partner Telephone Number:

MILESTONES UPDATE

Complete all fields. In the Accomplishments and Challengessection below you will be asked

to discuss project progress and milestones in greater detail.

Milestone Label
(e.g., A, B-1, etc.) / Milestone Name / Description / Projected Completion Date (mm/dd/yyyy) / Status
(Click to select)
[choose one]Completed as proposed in contractNot yet initiatedIn progress, as proposed in contractDelayedDropped/terminated
[choose one]Completed as proposed in contractNot yet initiatedIn progress, as proposed in contractDelayedDropped/terminated
[choose one]Completed as proposed in contractNot yet initiatedIn progress, as proposed in contractDelayedDropped/terminated
[choose one]Completed as proposed in contractNot yet initiatedIn progress, as proposed in contractDelayedDropped/terminated
[choose one]Completed as proposed in contractNot yet initiatedIn progress, as proposed in contractDelayedDropped/terminated
[choose one]Completed as proposed in contractNot yet initiatedIn progress, as proposed in contractDelayedDropped/terminated
[choose one]Completed as proposed in contractNot yet initiatedIn progress, as proposed in contractDelayedDropped/terminated
[choose one]Completed as proposed in contractNot yet initiatedIn progress, as proposed in contractDelayedDropped/terminated
[choose one]Completed as proposed in contractNot yet initiatedIn progress, as proposed in contractDelayedDropped/terminated
[choose one]Completed as proposed in contractNot yet initiatedIn progress, as proposed in contractDelayedDropped/terminated
[choose one]Completed as proposed in contractNot yet initiatedIn progress, as proposed in contractDelayedDropped/terminated
[choose one]Completed as proposed in contractNot yet initiatedIn progress, as proposed in contractDelayedDropped/terminated
[choose one]Completed as proposed in contractNot yet initiatedIn progress, as proposed in contractDelayedDropped/terminated
[choose one]Completed as proposed in contractNot yet initiatedIn progress, as proposed in contractDelayedDropped/terminated
[choose one]Completed as proposed in contractNot yet initiatedIn progress, as proposed in contractDelayedDropped/terminated
[choose one]Completed as proposed in contractNot yet initiatedIn progress, as proposed in contractDelayedDropped/terminated
[choose one]Completed as proposed in contractNot yet initiatedIn progress, as proposed in contractDelayedDropped/terminated
[choose one]Completed as proposed in contractNot yet initiatedIn progress, as proposed in contractDelayedDropped/terminated
[choose one]Completed as proposed in contractNot yet initiatedIn progress, as proposed in contractDelayedDropped/terminated
[choose one]Completed as proposed in contractNot yet initiatedIn progress, as proposed in contractDelayedDropped/terminated
[choose one]Completed as proposed in contractNot yet initiatedIn progress, as proposed in contractDelayedDropped/terminated
[choose one]Completed as proposed in contractNot yet initiatedIn progress, as proposed in contractDelayedDropped/terminated
[choose one]Completed as proposed in contractNot yet initiatedIn progress, as proposed in contractDelayedDropped/terminated
[choose one]Completed as proposed in contractNot yet initiatedIn progress, as proposed in contractDelayedDropped/terminated
[choose one]Completed as proposed in contractNot yet initiatedIn progress, as proposed in contractDelayedDropped/terminated
[choose one]Completed as proposed in contractNot yet initiatedIn progress, as proposed in contractDelayedDropped/terminated
[choose one]Completed as proposed in contractNot yet initiatedIn progress, as proposed in contractDelayedDropped/terminated
[choose one]Completed as proposed in contractNot yet initiatedIn progress, as proposed in contractDelayedDropped/terminated
[choose one]Completed as proposed in contractNot yet initiatedIn progress, as proposed in contractDelayedDropped/terminated
[choose one]Completed as proposed in contractNot yet initiatedIn progress, as proposed in contractDelayedDropped/terminated
[choose one]Completed as proposed in contractNot yet initiatedIn progress, as proposed in contractDelayedDropped/terminated
[choose one]Completed as proposed in contractNot yet initiatedIn progress, as proposed in contractDelayedDropped/terminated
[choose one]Completed as proposed in contractNot yet initiatedIn progress, as proposed in contractDelayedDropped/terminated
[choose one]Completed as proposed in contractNot yet initiatedIn progress, as proposed in contractDelayedDropped/terminated
[choose one]Completed as proposed in contractNot yet initiatedIn progress, as proposed in contractDelayedDropped/terminated
[choose one]Completed as proposed in contractNot yet initiatedIn progress, as proposed in contractDelayedDropped/terminated
[choose one]Completed as proposed in contractNot yet initiatedIn progress, as proposed in contractDelayedDropped/terminated
[choose one]Completed as proposed in contractNot yet initiatedIn progress, as proposed in contractDelayedDropped/terminated
[choose one]Completed as proposed in contractNot yet initiatedIn progress, as proposed in contractDelayedDropped/terminated

Note: If your project includes recruitment of participants and recruitment milestones that were not included in the Milestones Update table, pleasecomplete the following.

Target / Projected Completion Date
(mm/dd/yyyy) / Actual Completion Date
(mm/dd/yyyy) / Status
(Click to select)
Start of recruitment / [choose one]Completed as proposed in contractNot yet initiatedIn progress, as proposed in contractDelayedDropped/terminated
25% of recruitment / [choose one]Completed as proposed in contractNot yet initiatedIn progress, as proposed in contractDelayedDropped/terminated
50% of recruitment / [choose one]Completed as proposed in contractNot yet initiatedIn progress, as proposed in contractDelayedDropped/terminated
75% of recruitment / [choose one]Completed as proposed in contractNot yet initiatedIn progress, as proposed in contractDelayedDropped/terminated
Completion of recruitment / [choose one]Completed as proposed in contractNot yet initiatedIn progress, as proposed in contractDelayedDropped/terminated

ACCOMPLISHMENTS AND CHALLENGES
Use continuation pages as needed. Limit3 pages.

Discuss study progress, including any impact or outcomes, considering:

  • Any significant change from the funded proposal, including changes in the study protocol, engagement plan, endpoints, sample size, etc. Include reasons for these changes. Please note that you should discuss changes with PCORI program staff prior to implementation; this report should document changes during the reporting period.
  • Progress made, with reference to planned activities and milestones.
  • Challenges faced and plans to address them (e.g., delays in IRB approval, completion of engagement focus groups, retention issues).

PROGRESS STATEMENT FOR PUBLIC USE

Limit 250 words.

Describe notable progress to date, preliminary results, or engagement/stakeholder experiences using nontechnical language that is ready for public use. (Note: This information may be publicly disseminated by PCORI.)

FINANCIAL STATUSUPDATE
Limit 2pages.

Describe any significant deviations in costs and budget, how those deviations affected the study progress (e.g., staffing and cost estimates), and any anticipated need for budget modifications. Significant deviations are considered any adjustment that exceeds 25% of a budget category.

KEY PERSONNEL EFFORT UPDATE
Use continuation pages as needed. Limit 1 page.

Note any changes in key personnel (not already reported) that were 25% or more of level of effort approved in the contract, along with their role, change in percentage effort, if applicable, andan explanation for changes. If you have more than five changes to report, please include additional information under “Explanation of Changes.”

Name (First, Last) / Title / Contracted Percentage Effort / Actual Percentage Effort
% / %
% / %
% / %
% / %
% / %

Explanation ofChanges:

Note any proposed changes to key personnel in the next 6 months, if applicable, and provide an explanation for changes, below. Note that changes in excess of 25% of contracted level of effort require approval from PCORI. Add rows as necessary.If you have more than five proposed changes to report, please include additional information under “Explanation of Changes.”)

Name (First, Last) / Title / Contracted Percentage Effort / Actual Percentage Effort
% / %
% / %
% / %
% / %
% / %

Explanation of changes:

ENGAGEMENT UPDATE
Use continuation pages as needed. Limit 3 pages.

Describe in detail the patient/stakeholder engagement activities listed under Milestones Update, above.

Please provide details on any accomplishments or challenges related to your engagement plan listed under Accomplishments and Challenges section, above.

There may be additional consequences or benefits engaging patients and other stakeholders in your research. We would like to learn as much as possible about the impact of including an engagement plan in your research. Please describe any additional consequences or results of your engagement plan on the research project, the patients engaged in the research project, or on any of the investigators. (Examples include: the patient engagement partner is now recognized as a leader in your community; or has been invited to give talks; or has become involved in other engagement activities.)

ADDITIONALDOCUMENTS

All attachments should be combined with this document and submitted to PCORI as one PDF.

Additionally, please complete the “Other Publications” section below, if necessary.

Any documents that you feel are relevant and noteworthy can be shared, such as:

  • Copies of drafts of instruments, data dictionaries, educational materials, manuals, or other project deliverables, if not already delivered
  • Abstracts from presentations made to professional groups or associations
  • Summaries of preliminary data
  • Bibliographies
  • Other communications efforts
  • Copies of reports from any consultants or advisors, where applicable
  • Other documents or materials, as appropriate

REMINDER: Accepted presentations and full-length peer-reviewed publications related to PCORI-funded research should be reported to PCORI within 30 days of acceptance and prior to the publication date, via the Notification of Public Acceptance template. Notification of Peer Review Rejectionshould be submitted annually. Both templates can are available atPCORI’s Awardee Resources. Please refer to the appropriate funding cycle based on the date the project wasproposed and funded.

List invited talks or non-peer-reviewed publications (e.g., op-ed pieces or commentaries) below.

Publication/Presentation Title / Publication Type
(e.g., invited talk, non-peer-reviewed publication, etc.) / Publication/Presentation Date
(mm/dd/yyyy) / Comments

CERTIFICATION

This document must be certified by the Principal Investigator and the designated Administrative Official (AO).

Principal Investigator:

I certify that I, as the Principal Investigator, have reviewed and approved this document (and any associated attachments, if applicable).

PI First Name:

PI Last Name:
Date:

Administrative Official:

I certify that I, as the designated Administrative Official, have reviewed and approved this document (and any associated attachments, if applicable).

AO First Name:

AO Last Name:
Date:

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PCORI Interim Progress Report