Att_04 - Reporting Requirements.pdf

Attachment 04 – Reporting Requirements

Reporting Requirements

TECHNICAL PROGRESS REPORTS

In addition to those reports required by the other terms of this solicitation, the preparation and submission of regularly recurring Technical Progress Reports will be required in any contract resulting from this solicitation. These reports shall provide descriptive information about the activities undertaken during the reporting period and will require information about planned activities for future reporting periods, as well as anticipated problems.

All reports required herein shall be submitted in an electronic format. All electronic reports submitted shall be compliant with Section 508 of the Rehabilitation Act of 1973. Additional information about testing documents for Section 508 compliance, including specific checklists, by application, can be found at:

http://www.hhs.gov/web/508/index.html under "Helpful Resources."

1. Quarterly Progress Reports This report shall document and summarize all work results for activities conducted by the NHGRI Biorepository during the reporting period. This report shall be in sufficient detail to explain comprehensively the results achieved. The initial reporting period consists of the first full three months of performance plus any fractional part of the initial month. Thereafter, the reporting period shall consist of three full calendar months. A quarterly progress report is not required for the periods in which the final technical report is due. This report shall include the following:

• Protocol Monitoring

• Data Management Support Services;

• Regulatory Support for IND and IDE Submissions;

• Data Safety and Monitoring Board (DSMB) Support; and

• Statistical Expertise.

2. Final Technical Report

This report shall consist of the work performed and results obtained for the entire contract period of performance and shall provide a cumulative representation of the information required in the quarterly progress reports. This report shall be in sufficient detail to describe comprehensively the results achieved. A draft of the final report shall be submitted to the COR and Contracting Officer for review at least 30 days prior to the expiration date of the contract. The final report is due on or before the expiration date of the contract.

DELIVERABLES

Deliverables are included within the Statement of Work.