Attachment_3_-_Revised_Statement_of_Work.pdf

STATEMENT OF WORK

I. General Description of the Required Objectives and Desired Results

The proposed acquisition will support continued follow-up of Women's Health Initiative (WHI) -

Clinical Coordinating Center subjects to expand knowledge about the determinants of cardiovascular disease in older women, and support a core scientific resource for the research community, including mentoring young investigators. The objectives are to:

• Expand knowledge about the determinants of cardiovascular disease in older women (and conversely determinants of successful aging with absence of cardiovascular disease);

• Expand the study as a scientific resource for the research community;

• Mentor young investigators;

• Facilitate a new generation of large simple prevention trials.

The current structure consisting of a Clinical Coordinating Center, four Regional Centers, and committee/scientific interest groups shall be maintained.

Regional Center Functions: (Does not apply to this requirement but described here for informational purposes): Participant follow-up and events adjudication.

The functions of the Regional Centers are:

• Continue outcomes documentation and adjudication in the Medical Records Cohort. Though the number of women followed decreases over time, numbers of outcomes remain high because of increased rates. These outcomes in aging women are critical to realizing the primary objective of the current renewal, i.e. the study of cardiovascular disease (CVD) related to aging. These and other adjudicated outcomes will continue to support any clinical trials funded during the current period, as well as any future trials, and in addition they anchor Center for Medicare and Medicaid Services (CMS) and self-reported outcomes;

• Continue collecting self-reported outcomes in the Self Report Cohort. Self-reported outcomes are necessary to inform planning and conduct (including further documentation/adjudication of outcomes as needed) of ancillary studies and clinical trials;

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• Continue collecting data on activities of daily living and quality of life which are intrinsic to study goals;

• Maintain optimal retention through mail contact and phone calls as needed to follow up on outcomes;

• Continue mentoring young investigators though the Regional Centers;

• Continue recruiting non-WHI investigators to collaborate or to analyze the data themselves;

in the majority of cases WHI data are now being analyzed by the investigators themselves.

Data Collection Activities:

1. Retain study participants over the life of the contract.

2. Document clinical outcomes in hormone trial participants for the life of the contract.

Collect participant self-reported outcomes and selected exposure data (non-responders to annual central mailings only). Investigate self-reports by collecting supporting medical records, forward case packets for central adjudication, and record outcomes into the WHI database as directed in the manual of operating procedures

3. Document clinical outcomes in African American and Hispanic participants for the life of the contract. Procedures will parallel those for the hormone trial participants, as in 2.

Above.

4. Obtain self-reported clinical outcomes and selected exposure data in the remaining cohort

(non-responders to annual central mailings only.) Current return of these central mailings is 93% annually.

5. Document cancer and other clinical outcomes in the remaining former Dietary

Modification (DM) trial and Observational Study (OS) participants. Procedures will parallel those for the hormone trial participants, as in 2. Above.

Management Activities:

6. Submit a management plan for coordinating data collection activities in the region.

Include division of labor among prime contract, subcontract employees, and consultants.

Discuss plans to overcome known barriers to data collection.

7. Submit required technical and financial reports at specified intervals; respond to Contract

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Office and Project Office inquiries regarding contract management

8. Maintain Institutional Review Board (IRB) approvals. Collaborate with IRB officials at the Clinical Coordinating Center to establish an agreement allowing the Fred Hutchinson

Cancer Research Center (FHCRC) to function as lead IRB for the study.

9. Carry out data quality assurance activities, maintain data integrity.

10. Maintain a high level of cooperation and coordination with WHI Investigators, Clinical

Coordinating Center, and the NHLBI Project and Contract Offices.

If the Government chooses to exercise each Option period, the Contractor shall perform study activities in accordance with the protocol and manual of operating procedures.

Specific performance for this requirement is:

Coordinating Center Core Functions: These functions relate to maintaining and updating the data and biologic specimens as well, as the continuing follow-up of outcomes in ~85,000 participants.

The Core functions of the Coordinating Centers are:

• Coordinate data collection for this large and complex study; maintain investigator, public, and study participant websites and documentation/data resources;

• Make data and biologic specimens available to the research community;

• Provide data and analytic support for paper proposals approved by the Publications and

Presentations Committee;

• Provide data and basic support for proposed ancillary studies and consortium studies;

• Deposit curated data into BioLINCC and dbGAP at the required intervals;

• Update study files with clinical outcome, laboratory, and ancillary study data;

• Provide support for administrative functions such as committee meetings and conference calls;

• Provide annual study updates to Steering Committee, NHLBI, and Observational Studies

Monitoring Board (OSMB).

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II. Project/Contract Requirements:

A. STUDY COORDINATION ACTIVITIES

1. Maintain a high level of cooperation and coordination with WHI Investigators and the NHLBI Project and Contract Offices;

2. Provide a Manual of Operating Procedures to accomplish the goals of the WHI contract period and, distribute to WHI Regional Centers and Project Office;

3. Provide central adjudication and limited outcomes liaison staff to assist the WHI

Regional Centers in outcomes ascertainment and, monitor Regional Center performance in outcomes ascertainment;

4. Maintain IRB approvals. Collaborate with Institutional Review Board (IRB) officials at the Regional Centers to establish an agreement allowing the Clinical

Coordinating Center to serve as the lead IRB for the study;

5. Coordinate and support investigator effort for active participation in study management, scientific investigations, and writing groups;

6. Coordinate, participate in, and provide any information necessary for study committee conference calls and meetings, including minutes and other correspondence as needed.

B. TRAINING ACTIVITIES

1. Train WHI Regional Center staff as necessary in data collection, entry, and management, and outcomes ascertainment procedures;

C. DATA COLLECTION ACTIVITIES

1. Retain study participants over the life of the contract;

2. Revise current data collection forms as necessary, print and distribute forms;

3. Develop data collection and management procedures;

4. Conduct follow-up mailings of data collection forms for outcomes ascertainment and selected exposures to participants enrolled in the WHI Extension;

5. Search the National Death Index annually to locate matches for WHI participants.

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Obtain death certificates as appropriate;

6. Obtain CMS data on WHI participants at regular intervals; merge with WHI database.

D. DATA MANAGEMENT ACTIVITIES

1. Maintain WHI database including quality assurance and quality control procedures. Maintain confidentiality and security of data. Provide expertise necessary to integrate data from outside the WHI (e.g. CMS) into the WHI database;

2. Maintain and update as needed the WHI web-based data entry and management system, including quality control procedures. All web applications must comply with section 508, see http://www.section508.gov/;

3. Develop/update an information systems security plan in accordance with Table 3 of the Federal Information Security Safeguard Requirements Summary at http://irm.cit.nih.gov/security/table3.htm;

4. Coordinate the purchase and support the installation of any hardware and software needed to acquire and transmit data according to manual of operating procedures;

5. Collect, edit, store, analyze and report on data from the WHI Regional Centers in accordance with the protocol and manual of operating procedures;

6. Prepare NHLBI Data Repository datasets in accordance with the NHLBI Limited

Access Data Clause and the NHLBI Policy for Distribution of Data.

E. BIOMEDICAL ACTIVITIES

1. Maintain the WHI biologic specimen resource in accordance with the protocol and manual of operating procedures;

2. Track inventory of available specimens;

3. Provide specimens to investigators in accordance with study policies/procedures for access to specimens;

4. Oversee analyses of biologic specimens to test specific hypotheses as required by the protocol and manual of operating procedures;

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5. Conduct feasibility and quality assurance studies as needed, maintain pooled reference samples.

F. REPORTING ACTIVITIES

1. Analyze the relative frequencies of outcomes of interest across treatment groups and report the data annually for the Observational Studies Monitoring Board

(OSMB), or as requested by the Project Officer;

2. Prepare and distribute interim Regional Center enrollment reports;

3. Prepare and distribute interim Regional Center performance reports;

4. Prepare and distribute annual study progress reports;

5. Prepare Transition Plan prior to contract expiration.

G. SCIENTIFIC ACTIVITIES

1. Provide scientific and operational expertise to support WHI investigators and non-

WHI scientists in preparing to use the WHI resources, including the WHI database and biologic specimens, including maintenance of www.WHIScience.org;

All web applications must comply with section 508, see http://www.section508.gov/;

2. In collaboration with WHI and other ancillary study investigators, generate hypotheses and design approaches to testing hypotheses that complement WHI study results. Generate paper proposals; participate in manuscript development;

3. Participate in evaluation of proposals for manuscripts and ancillary studies;

4. As required, provide effort and resources for contractually-funded ancillary studies. The Contractor shall initiate this work only after approval from the appropriate study committees and when so directed by the NHLBI Contracting

Officer Representative;

5. Conduct pilot laboratory studies, as needed. The Contractor shall initiate this work only after approval from the appropriate study committees and when so directed by the NHLBI Contracting Officer Representative. Pilot laboratory

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6. Submit plan for coordination of and participate in scientific activities across various disciplines, including but not limited to cardiovascular, cancer, aging, health services research, and genetics. Propose methods of engaging scientific expertise not available among WHI investigators;

Note: most scientific activities are expected to be WHI-wide collaborations.

7. Propose estimated numbers of WHI-approved publications and ancillary studies each year;

8. Contribute to study management through service on study operations and/or advisory committees;

9. Actively engage new investigators inside and outside current centers to propose analyses and ancillary studies, to perform distributed data analyses, and to train new investigators. Propose number of new investigators to be trained each year.

Investigators are encouraged to include junior faculty from underrepresented racial and ethnic groups and individuals with disabilities in their training programs;

10. Provide plans to serve as a platform for any additional randomized controlled clinical trials in cardiovascular and other areas.

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