DSMB SOW.pdf

Statement of Work, dated October 12, 2021 1

ATTACHMENT 1: STATEMENT OF WORK

NIAID/DIVISION OF AIDS (DAIDS) DATA AND SAFETY

MONITORING BOARD (DSMB) MEETING SUPPORT

1. INTRODUCTION AND BACKGROUND:

The mission of the Division of Acquired Immunodeficiency Syndrome (DAIDS), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) is to ensure an end to the human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS) epidemic by supporting research that can lead to the development of therapies, vaccines, and prevention strategies.

NIH policy requiring independent data and safety monitoring boards (DSMB) for all multicenter Phase III trials has existed since 1979; the most recent restatement was issued in 1998 (NIH Policy for Data and Safety Monitoring, NIH Guide Notice 98-084). In light of the related responsibility for monitoring assigned to local Institutional Review Boards (IRB) by federal regulation (45 CFR 46), NIH added a requirement in 1999 that local IRBs be notified of the outcome of all DSMB reviews, even when no major change has been recommended, to document that data and safety monitoring is occurring as expected (Guidance on Reporting Adverse Events to Institutional Review Boards for NIH-Supported Multicenter Clinical Trials, NIH Guide Notice 99-107).

These NIH policies do not address implementation matters, leaving those to individual Institutes and Centers; various approaches are in use. As a result, the NIAID has issued its own policy on basic principles for DSMB operations. DAIDS monitors safety and efficacy of multicenter randomized clinical trials primarily through standing DSMBs. DAIDS considers standing boards to be both more effective and easier to manage than boards established separately for each new trial.

2. SCOPE:

This contract will provide logistical and administrative support for activities associated with the convening of multiple DAIDS DSMB meetings in both domestic and international locations.

3. TECHNICAL REQUIREMENTS:

Independently, and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, materials, equipment, and facilities, not otherwise provided by the Government, as needed to perform the Statement of Work, below.

Specifically, the Contractor shall perform the following tasks:

A. DOMESTIC & INTERNATIONAL DSMB MEETINGS

1) Assist with the following as needed:

a. Coordinate DSMB activities (logistical planning of meetings)

b. Secure venue and lodging arrangements for DSMB meetings

c. Secure travel and ground transportation arrangements for DSMB members and

Ad Hoc experts, if required.

d. The Government shall pay for visa processing, if required by a member.

e. Complete travel documents (Expense Reports)

2) Venue Search and Selection

a. If a government facility is not available for the DSMB meeting in the DC metropolitan area, the Contractor shall begin seeking lodging and/or venue

Statement of Work, dated October 12, 2021 2 quotes from vendors at least six (6) months prior to the meeting.

b. Quotes shall be based on the specific needs of the DSMB meeting, and may include consideration of the following:

i. Availability of sleeping accommodations for DSMB members and ad hoc medical/scientific experts.

ii. Availability of two meeting rooms for each DSMB meeting that accommodate the meeting room specifications and are not within hearing range of each other, as required

iii. Availability for close proximity of onsite food, beverage, and catering

iv. Availability of onsite technical support for:

• LCD projector with screen

• Laptop computer

• Microphones and other audio visual (A/V) equipment as needed

• Conference phone and outside line

• Podium with microphone, as needed

• Registration desk with outside telephone line and electricity

• Internet connection-High-speed or wireless access in registration area and sleeping rooms

• Onsite business center with copying privileges

• Other requirements as needed

c. At least six (6) months prior to the DSMB meeting, or as directed by the COR, the Contractor shall forward to the COR for review and approval at least three vendor quotes from hotels, which meet government requirements (e.g., the HHS Policy on Promoting Efficient Spending: Use of Appropriated Funds for Conferences and meeting Space, Food, Promotional Items, and Printing and Publications).

3) Final Travel Details and Ground Transportation Arrangements

a. At least two weeks prior to a DSMB meeting, the Contractor shall provide final travel details to the COR for review and approval.

b. Arrange ground transportation for meeting participants, as needed.

c. All airfare that is not economy class requires prior approval by the COR.

4) DSMB Member Reimbursement

a. Non-government DSMB members shall be reimbursed for lodging, meals and incidental travel expenses in accordance with the Federal Travel Regulation (FTR) no later than thirty (30) calendar days after the meeting.

b. Non-government DSMB members should receive an honorarium payment as directed by the COR per meeting day. Honorarium shall be paid no later than thirty (30) calendar days after the meeting. DSMB members who are employees of the United States Government shall not receive an honorarium for service on the DSMB.

5) DSMB Documents

a. Prior to each meeting, upon request of the COR, the Contractor shall submit the Logistics Factsheet along with the final version of the Travel Spreadsheet no later than thirty (30) calendar days after each meeting, the Contractor shall complete member travel reimbursements and honorariums and submit the Trip Report to the COR. Documents for travelers will be provided to travelers before they travel, so no documents will be made in-country for international travel.

6) Site Visits

Statement of Work, dated October 12, 2021 3

a. During a scheduled international DSMB meeting, the Contractor may be requested to make travel arrangements (e.g., flight and ground transportation) for DSMB members and ad hoc scientific/medical experts to attend a clinical study site visit.

b. At least two weeks prior to a DSMB meeting/clinical study site visit, the Contractor shall provide final travel details to the COR for review and approval.

B. DSMB TELECONFERENCE (SCHEDULED AND AD HOC)

DSMB Member Reimbursement Non-government DSMB members shall receive an honorarium payment as directed by the COR per meeting day. Honorarium shall be paid no later than thirty (30) calendar days after the meeting. DSMB members who are employees of the United States Government shall not receive an honorarium for service on the DSMB.

C. OTHER REPORTS AND DELIVERABLES

1) Travel Spreadsheet

The Contractor shall maintain and submit a travel spreadsheet for each meeting and provide to the COR, as requested. Details may include such items as:

• Traveler’s Name

• Airline and Flight Number

• Arrival Date

• Departure Date

• Number of Nights in the Hotel

• Confirmation Number

• Hotel Name

• Reimbursement Date of Issuance

• Honoraria Date of Issuance

2) Logistics Factsheet

The Contractor shall submit a logistics factsheet to the COR for review and approval upon selection of the meeting venue. The logistics factsheet may include items such as:

• Meeting Location

• Security Requirements

• Tentative Agenda

• Immigration Information

• Travel Arrangements

• Personal Travel

• Hotel Information

• Honorarium

• Meals

• Expense Reimbursement

• Ground Transportation

• Climate

• Parking

• Important Deadlines

• Contract Information

D. MEETINGS and TELECONFERENCES

Statement of Work, dated October 12, 2021 4

1) Meetings The Contractor shall be available to attend face to face meetings with the COR at least once a quarter or as needed to review the overall progress of venue and travel arrangements for meeting planning.

2) Teleconferences

The Contractor shall be available for bi-weekly teleconferences or as needed with the COR to review the overall progress of the contract.

E. OPTIONS

In addition to the above functions and services to be provided for the Base period, the Government may exercise, at its discretion, Options as follows: 1) Options to extend the term of the contract; and 2) Options to accommodate significant increases in work. These Options are defined as follows:

1) Options 1 through 4 to Extend the Term of the Contract: The Government may exercise options to extend the period of performance of the contract beyond the base period (Year 1), annually, for a total contract period of up to 5 years. Assume that the scope and types of activities outlined herein (i.e., for year 1 of the contract would be continued for each succeeding annual contract period for a total period of performance of 5 years. The Contractor shall provide 0.75 FTE for the Base Period and each Term Option Periods 1-4.

2) Options 5 through 9 to Increase Services: The Government may exercise options for increased level of effort that may result from unanticipated increases in demand for logistical and administrative support for the activities associated with convening DAIDS DSMB meetings.

Should the Government elect to exercise an option for increased level of effort, the Contractor shall provide an additional 0.50 FTE for each option exercised. The period of performance of an Option for Increased Services will not exceed the term of the base year or Option year in which the Option is exercised.

[END OF STATEMENT OF WORK]