Attachment 5: Report Reqs and Deliverables

Attachment #5

RURAL Expansion Cohort
Reporting Requirements and Deliverables
June 1, 2027 – August 31, 2031

Item
#

Description

Annual Progress Report
Annual Staffing Report

Delivery
Schedule

Annually on May
Annually on May

Task Area Task Area
Task Area
A
B
C
Deliver To

6/1/27 to
8/31/31
(51
months)

6/1/27 to
8/31/31
(51
months)

COR, CO

X

X

COR, CO

X

X
X

Financial Invoices

Monthly

CO

X

Status report of Data and Materials
Distribution Agreements

Every 6 months

X

Annual Quality Assurance and
Control Report

COR,
Executive
Committee

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

COR,
Committee
Members,
Internal Study
Website

X

2 weeks prior to

in-person
Agenda for Steering Committee
meetings and 3
and Executive Committee meetings
working days
prior to
conference calls

COR,
Committee
Within 2 weeks of
Minutes of all committee meetings
Members,
meeting
Internal Study
Website
Maintain and update study website
Continuous
Public
accessible by the public
Maintain and update study website
accessible internally by study
Users of
Continuous
investigators, review committees,
internal site
and others as necessary
A copy of all communications to
Continuous
COR
participants, e.g. newsletters
Submission of peer-reviewed
Immediately
PubMed
manuscripts that arise from
upon acceptance
Central
contract funding to PubMed Central for publication
At least twice a
Updated report on scientific
year for the
Included with
productivity, including the status of
Steering
meeting
publications and presentations
Committee and
reports
derived from RURAL Study data

OSMB

Included in
Lay summaries of all RURAL
At least once a
periodic
published manuscripts
year
participant
newsletters

X

X
X
X
X

X

X

6/1/31 to
8/31/31
(3 months)

X

Attachment #5

Item
#

Description

Summary table on the status of
stored specimens

Delivery
Schedule

At least twice a
year for the
Steering
Committee and

OSMB

As directed by
COR
As changes
occur

Task Area Task Area
Task Area
A
B
C
Deliver To

Included with
meeting
reports

Record of participants’ informed
As directed by
consent forms
COR
Updates to protocols and manual of
COR
operations for clinical events