Att. 05 Reporting Requirements_Deliverables.pdf

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Attached to
Study Coordinating Center for Lung Health Cohort
Solicitation number
RFP-75N92026R00008
Issued by

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This document is Attachment 5 to a federal contract, specifying comprehensive reporting requirements and deliverables for what appears to be a multi-year observational study program.

The contractor must deliver 20 distinct reporting and deliverable items on specified schedules to designated recipients. Monthly deliverables include 12 meeting minutes (to COR) and financial invoices (to CO). Annual submissions comprise environmental geocodes reports, CT quality assessment reports, annual meeting reports, quality control plans, biorepository inventory updates, and third-party agreement summaries, all to the COR. Twice-yearly semi-annual progress reports go to both COR and CO. Specialized reports include an IRB approval document (delivered once per qualified site to COR and CO), LHC Observational Study Monitoring Board reports (2 weeks prior to meetings), 508 annual compliance reports (to CO), and weekly recruitment reports (to COR and Executive Committee). Manuscript deliverables require submission of at least four manuscripts annually and immediate submission of all final peer-reviewed publications arising from contract funding to PubMed Central. The contractor must maintain continuous updates to study websites with internal pages for investigators. All data and images must be submitted as directed by the COR and CO to the NHLBI data repository. Final contract closeout deliverables include a draft final progress report (30 calendar days before expiration), final progress report (on expiration), and final financial report (on expiration), with the final two items going to both COR and CO. Most deliverables support both Task Area 1.0 and Task Area 2.0.

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Reporting Requirements and Deliverables ATTACHMENT 5 April 30, 2026 Page 1 of 2

Reporting Requirements and Deliverables

Item # Description Quantity Delivery Schedule Deliver to Task Area 1.0

Task Area 2.0

(1) Meeting Minutes 12 Once a month COR X X

(2) Environmental (Geocodes) Report 1 Once a year COR X

(3) CT Quality Assessment Report 1 Once a year COR X

(4) Approved IRB 1 Once per qualified site COR, CO X

(5) Annual Meeting Reports 1 Once a year COR X

(6) LHC Observational Study Monitoring Board (OSMB) Reports

1 2 weeks prior to the meeting

COR, CO, and OSMB members

X

(7) Quality Control Plan/Reports 1 Once a year COR X

(8) Update of biorepository inventory 1 Once a year COR X X

(9) Third Party Agreement (TPAs) summary report

1 Once a year COR X

(10) Semi-Annual Progress Report 1 Twice a year COR CO X

(11) 508 Annual Report 1 Once a year CO X

(12) Financial Invoices 1 Every month CO X X

(13) Manuscripts At least 4 Once a year As part of Progress

X

(14) Submission of final peer- reviewed journal manuscripts that arise from contract funding to the digital archive PubMed Central

1 per publication

Immediately upon acceptance for publication

PubMed Central X

(15) Up-to-date study websites including internal website pages for study investigators and others as necessary

1 Continuous Public X

Reporting Requirements and Deliverables ATTACHMENT 5 April 30, 2026 Page 2 of 2

(16) Weekly recruitment reports 1 Weekly COR, Executive Committee

X

(17) All data and images N/A As directed by the COR and

CO

NHLBI data repository or as directed by COR

X

(18) Draft Final Progress Report 1 30 calendar days prior to contract expiration

COR, CO X X

(19) Final Progress Report 1 On contract expiration COR, CO X X

(20) Final Financial Report 1 On contract expiration CO X X

File details come from the government source that posted it. Updated .