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PCORI INTERIM PROGRESS REPORT - RESEARCH AWARDS

PROGRESS REPORT DETAILS

Progress Report Name:

Status:

Late Status Indicator:

Submission Date:

Contract #:

Project Title:

Period Covered by this Report: to

Iteration of Progress Report:

PRINCIPAL INVESTIGATOR AND INSTITUTION UPDATED CONTACT INFORMATION

PI Name:

PI Email:

PI Office Phone:

AO Name:

AO Email:

AO Office Phone:

Institution Legal Name:

Address (street, city, state, zipcode):

Telephone:

MILESTONE UPDATE SAMPLE BELOW. Automatically populated from Salesforce project record.

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MILESTONES UPDATE

Milestone - Deliverable ID

Milestone - Deliverable Name

Description Due Date Completed Date

Milestone - Deliverable Status

Reason For Delay

Other Reason For Delay

Supplemental Funding

A Contract Effective Date

- / 1/2016 12 / 1/2016 12 Completed

Formal Final Study

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If any milestones will not be completed, list the reasons why and the implications for your project.

RECRUITMENT, ENROLLMENT AND RETENTION UPDATE

Trials and Observational Studies

Instructions: Effective June 1' 2017, PCORI awardees are requested to submit monthly enrollment updates directly to

their Program Officer (PO) and Program Associate (PA).

Record the total cumulative number of participants enrolled in the trial to date:

Site Information:

Number of sites, clinics and/or practices from which you will recruit study participants

If you recruited study participants from sources that are not site specific (e.g., websites,

newspapers), please provide the number and names of those sources

Total number of sites, clinics, and/or practices that have enrolled at least 1 participant

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Racial/Ethnic and Gender Enrollment Table

If more detailed information is available regarding racial/ethnic subgroups for the participants in your study, please

upload a table with this information in the Additional Documents section.

Please describe the following:

1. Describe your systematic effort to identify potentially eligible individuals to enroll in your project (i.e., how are

you finding potentially eligible individuals for your project?).

a. Describe any significant changes from your approved research plan.

2. Describe your systematic effort to screen individuals who appear eligible. Refer to Methodology Standard, PC-2,

and describe how this standard is being met (i.e., of the individuals identified, how are you approaching and/or

testing them to determine potential eligibility?).

a. Report reasons for ineligibility and the number of individuals for each reason.

3. Describe your systematic effort to document information about eligible individuals who decline to enroll in the

project.

a. Report reasons for declining and the number of individuals for each reason.

4. Describe your systematic effort to reduce attrition of participants enrolled in your project (as applicable).

5. Report the time points at which participants are lost to follow-up (e.g., mid-way through the intervention, after

the intervention, specific follow-up time points) and the number of participants for each time point.

Qualitative Research Methods (e.g., focus groups, interviews, surveys)

1. For qualitative research methods (e.g., focus groups, interviews or other), provide an update on: a. Data collection

(progress and challenges), b. Progress with your analysis and description of the analysis methods, c. Plans for

reporting qualitative analyses.

Other 0 0 0

Missing Race 0

Ethnicity

Hispanic(Latino/Latina) 0 0 0

Non-Hispanic 0 0 0

Missing Ethnicity 0

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ACCOMPLISHMENTS AND CHALLENGES

Discuss and document study progress and all significant events for the current reporting period. In particular, please

discuss:

1. Any significant change from the funded application, including changes in the study protocol, engagement plan,

end points, sample size, etc. Include reasons for these changes. Please note that you should discuss changes with

PCORI program staff prior to implementation and some change require prior approval from PCORI (see your

executed funding contract for changes that require PCORI prior approval and notice thirty (30) days in advance of

the proposed change).

2. Progress and accomplishments achieved during the current 6-month reporting period, with reference to planned

project activities, milestones, and planning for dissemination. (Please include the specific milestone label as

relevant.)

3. Challenges with project progress including anticipated upcoming challenges (e.g., delays in IRB approval, delays in

recruitment of sites, participant retention issues). How have you overcome these challenges? What is your

continued plan for overcoming these challenges? (Please include the specific milestone label as relevant.)

4. A summary of any reports submitted to the sponsor, a DSMB, an IRB, the FDA, or other regulatory or oversight

body about unanticipated problems involving risks to subjects or others relating to the research project (e.g.,

adverse events, deviation from approved protocol that places subjects at increased risk of harm, data breach,

procedural or medication error) that were reported during the reporting period.

5. A summary of any significant decisions, findings, recommendations, actions and directions of a DSMB, an IRB, the

FDA or any other regulatory or oversight body relating to the research project during the reporting period.

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METHODOLOGY STANDARDS

Please report how your project meets PCORI's Methodology Standards that apply to your ongoing research (enter N/A if

appropriate). The following Standards should be addressed at the appropriate study phases (see table below):

Methodology Standards to address Report how these Methodology Standards are

being met

Standards for Formulating Research Questions

Standards Associated with Patient Centeredness

Standards for Data Integrity & Rigorous Analyses

Standards for Preventing and Handling Missing Data

Standards of Heterogeneity of Treatment Effects

Other Standards (as applicable to your project and required by your

Program Officer)

ENGAGEMENT REPORT

1. Engagement may not occur during all reporting periods or may not occur as planned. Did you engage with

patients and/or other stakeholders in any way during the current reporting period?

1a. Why did engagement not occur during this reporting

period? N/A

2. Describe progress on your engagement plan during the current reporting period. Refer to Methodology Standard

PC-1 and describe how this standard is being met.

3. Which communities were engaged with this PCORI project during the reporting period?

4. How did you engage with patients and/or other stakeholders in this research project during the reporting period?

4a. Are any of the patient and/or stakeholder partners serving as Co-Investigators? Co-Investigators typically

devote a specified percentage of time to the project and share responsibility for the project with Principal

Investigator(s).

5. In which phases of the project were patients and/or other stakeholders engaged during the reporting period?

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6. Which choice(s) reflects the ways in which patients and/or other stakeholders were engaged during the reporting

period?

7. Rate how much influence patients and/or other stakeholders had during the reporting period. By influence, we

mean affecting or contributing to decisions or processes related to the project.

8. For the current reporting period, describe engagement activities (what patients and/or other stakeholders

actually did) and any impact this had on the project (e.g., how engagement activities informed decisions or led to

project modifications).

Include specific examples

9. Rate how much influence patients and/or other stakeholders had during the reporting period. By influence, we

mean affecting or contributing to decisions or processes related to the project.

10. Describe challenges with patient and/or other stakeholder engagement during the reporting period. How have

you overcome these challenges? What is your continued plan for addressing these challenges?

FINANCIAL STATUS UPDATE

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.

PUBLICATIONS UPDATE

REMINDER: 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.

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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 (MS-1511-33406)".

"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."

ADDITIONAL DOCUMENTS

1. Copies of drafts of instruments, data dictionaries, educational materials, manuals, or other project deliverables, if not

already delivered

2. Abstracts from presentations made to professional groups or associations

3. Manuscripts submitted or in press

4. Summaries of preliminary data

5. Minutes or summaries from patient and/or stakeholder meetings 6. Bibliographies

7. Summaries from Data and Safety Monitoring Board/Committee (DSMB) meetings

8. Final study protocol

9. Other communications efforts

10. Copies of reports from any consultants or advisors, where applicable

11. Other documents or materials, as appropriate

12. Websites, blogs, or other Internet-based links

13. Public affairs or popular press coverage of the study online, on television, radio, etc.

14. New and continuing IRB approvals

CERTIFICATION After the Submit button is clicked, an approval process will begin within the Approval History section below. This report

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

Principal Investigator:

By clicking Approve within this report’s Approval process, I, as a Principal Investigator, certify that I have reviewed and

approved this progress report (and any associated attachments, if applicable), and the information provided is correct.

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Administrative Official:

By clicking Approve within this report’s Approval process, I, as an Administrative Official, certify that I have reviewed

and approved this progress report (and any associated attachments, if applicable), and the information provided is

correct.

Notes and Attachments

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Approval History

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