Attachment #5

RURAL Expansion Cohort

Reporting Requirements and Deliverables

June 1, 2027 – August 31, 2031

Item # Description Delivery

Schedule Deliver To

Task Area A

6/1/27 to 8/31/31

(51 months)

B

(51 months)

C

6/1/31 to

(3 months)

Annual Progress Report Annually on May

31 COR, CO X X

Annual Staffing Report Annually on May

31 COR, CO X X

Financial Invoices Monthly CO X X X

Status report of Data and Materials Distribution Agreements Every 6 months

COR,

Executive Committee

X

Annual Quality Assurance and Control Report May 31 CO X

Annual Utilization Report May 31 CO X

Observational Study Monitoring Board (OSMB) Report

2 weeks prior to meeting

COR, CO,

ExSec, OSMB members X

508 Annual Report May 31 CO X

Agenda for Steering Committee and Executive Committee meetings

2 weeks prior to in-person meetings and 3 working days prior to conference calls

COR,

Committee Members, Internal Study Website

X

Minutes of all committee meetings Within 2 weeks of meeting

COR,

Committee Members, Internal Study Website

X

Maintain and update study website accessible by the public Continuous Public X

Maintain and update study website accessible internally by study investigators, review committees, and others as necessary

Continuous Users of internal site X

A copy of all communications to participants, e.g. newsletters Continuous COR X X

Submission of peer-reviewed manuscripts that arise from contract funding to PubMed Central

Immediately upon acceptance for publication

PubMed Central X

Updated report on scientific productivity, including the status of publications and presentations derived from RURAL Study data

At least twice a year for the

Steering Committee and

OSMB

Included with meeting reports

X

Lay summaries of all RURAL published manuscripts

At least once a year

Included in periodic participant newsletters

Item # Description Delivery

Schedule Deliver To

(51 months)

(51 months)

(3 months)

Summary table on the status of stored specimens

At least twice a year for the

Steering Committee and

OSMB

Included with meeting reports

X

Record of participants’ informed consent forms

As directed by

COR

As directed by

COR X

Updates to protocols and manual of operations for clinical events

As changes occur COR X

Update to Participants’ Residential Address with geocoding Annually COR X

Annual follow-up, and ancillary study data and documentation in a datafile

At least annually COR, Investigators X

Ancillary study proposals approved but requiring review by OSMB

Within 3 days of Steering

Committee approval of the proposal

COR, OSMB

Executive Secretary

X

Approval letters for ancillary studies Within 1 week of approval

Ancillary study investigator with copy to

COR

X

Phenotype/genotype/pedigree data set for each approved genetic request

2 weeks after DMDA is fully executed Requestor X

DNA, RNA, and/or other genetic material for each approved genetic request

4 weeks after DMDA is fully executed Requestor X

Phenotype data set for each approved request

4 weeks after DMDA is fully executed Requestor X

Biospecimens for each approved application for use of biospecimens

4 weeks after DMDA is fully executed Requestor X

Update NHLBI Data Repository Data Sets, (including geocoded/place- based data, annual follow- up, exam, events, imaging, and ancillary study data)

In compliance with NIH/NHLBI policies

Submit to BioData

Catalyst and as directed by

X X

Updated dbGaP data sets (including genetic, phenotypic, and family structure data) from both contracts and ancillary studies

In compliance with the NIH

Genomic Data Sharing Policy

Submit to dbGaP/BDC and as directed by the

COR

X

Report Adverse Events and Unanticipated Problems

In compliance with NHLBI policy

NHLBI Project Office, OSMB, and/or IRB per policy

X

Plan for transition between contractors

6 months prior to intended transition

COR, CO X X X

Web-based exam data collection system updates At exam start COR, Study

Investigators X

Final Exam Protocol 4 weeks before the start of the exam

COR, Steering Committee, OSMB

Item # Description Delivery

Schedule Deliver To

(51 months)

(51 months)

(3 months)

Final Exam Manual of Operations 4 weeks before the start of the exam

COR, Steering Committee, investigators

X

Spanish translation of all exam materials (if appropriate)

4 weeks before the start of the exam Investigators X

Progress of the recruitment of participants for the Exam

Bi-monthly to COR and Executive

Committee;

Annually to the

OSMB

COR, Steering Committee, OSMB

X

Site Visit reports Within 10 days of each site visit

NHLBI Project Office X X

Quality Assurance / Quality Control Reports

Monthly during exam

COR, QA/QC

Committee X

Interim exam dataset for internal analyses and quality checks

Within 3 months After completion of each county

COR,

Investigators X

SAS formatted data files and associated documentation of Exam, AFU, and events data

6 months after completion of the exam

COR X

Clinically actionable results from contract supported testing per protocol Continuously Participants X

Report of the outcomes from genetics reporting activities (if funded) Annually

COR,

Executive Committee

X

Information security deliverables in accordance with Section H

In accordance with Section H CO X X X

Final Progress Report Due at the end of each Task Order COR, CO X X X

Final Utilization Report Due at the end of each Task Order CO X X X

Final Financial Report Due at the end of each Task Order CO X X X

Transfer of all biological materials and specimens collected and maintained as required in this contract

By mutual agreement of the

COR and Contractor

The NHLBI repository as directed by

Transfer all data (including final data sets, drives, scans, images, documentation, minutes, reports) collected and maintained as required by tasks in this contract

By mutual agreement of the

COR and Contractor

As directed by

COR X

**Provide all deliverables electronically unless otherwise specified.