Attachment 1 - NIDCD DSMB Support Service SOW.pdf

Attachment 1

Statement of Work (SOW)

Clinical Trials Section

National Institute on Deafness and Other Communication

Disorders

TABLE OF CONTENTS

1.0 Introduction 3

1.1 Background 3

1.2 Scope 3

1.3 Objectives 3

2.0 Requirements 4

2.1 Tasks 4

2.2 Deliverables 5

2.3 Schedule 5

2.4 Assumptions 5

3.0 Government Furnished Property 6

4.0 Security Requirements 6

1.0 INTRODUCTION/OVERVIEW

A service contract is necessary to facilitate the National Institutes on Deafness and Other Communication Disorders (NIDCD) Data and Safety Monitoring Board (DSMB) activities.

1.1 BACKGROUND

Research supported by the NIDCD includes clinical trials that require additional oversight and monitoring to ensure safety of participants and the validity of data, per the NIH Policy for Data and Safety Monitoring.1 The NIDCD utilizes the NIDCD DSMB for selected high risk clinical trials.2

The NIDCD DSMB serves as an independent advisory body to both the study investigators and the NIDCD. The DSMB makes recommendations to NIDCD concerning the continuation, modification, or termination of the study.

In order to preserve the independent aspect of the DSMB, a DSMB support service entity that is not part of the NIDCD is necessary to control open and closed access to certain data and to manage restricted confidential documents.

1.2 SCOPE

The contractor will support the NIDCD Clinical Trials Section (CTS) by providing administrative, technical, and logistics support for the NIDCD DSMB activities. There is one NIDCD DSMB with ten members, including one Chair. One DSMB meeting per Option Year is expected.

1.3 OBJECTIVES

1 https://grants.nih.gov/grants/guide/notice-files/not98-084.html 2 https://www.nidcd.nih.gov/research/clinical-studies/nidcd-guidelines-data-and-safety-monitoring-clinical-trials

The contractor will facilitate the NIDCD DSMB meetings, write DSMB observations and recommendations, and manage the NIDCD DSMB meeting related communications.

The administrative service will maintain the integrity of the independent advisory board by managing confidential information. The technical writing service will contribute to NIDCD management of high-risk clinical trial. The logistics service will result in efficient CTS resource management.

2.0 REQUIREMENTS

2.1 TASKS

The contractor shall:

A. Review the existing DSMB meeting timeline template, prepare a participant tracker for each DSMB meeting, and monitor DSMB meeting related tasks.

B. Provide administrative, technical, and logistics support for all NIDCD DSMB activities.

C. Maintain a secure centralized electronic portal for filing and sharing of

DSMB meeting materials among NIDCD staff, study teams, and DSMB members. The portal will control selected users’ access to closed meeting (unblinded) documents and must allow the users to download, review, and print out documents. Provide the users with the options for the original and PDF form of documents and separate specific documents.

D. Collect DSMB members’ Conflict of Interest (COI) certification forms for each meeting. Verify research collaborations and co-publications in last three (3) years based on the members’ responses. Report findings to

NIDCD.

E. Serve as the DSMB Coordinator for the NIDCD DSMB. Duties include:

• ensuring communications and requests related to the NIDCD DSMB are appropriately addressed

• polling DSMB members’ availability

• scheduling one meeting annually

• notifying potential attendees of each DSMB meeting

• providing logistics support

• providing study teams with instructions in preparation of the

DSMB meeting and clarifying expectations during the open and closed sessions

• facilitating Teams meetings

• moderating the meetings

• drafting and distributing meeting agendas

• distributing meeting materials

• organizing and filing materials related to the NIDCD DSMB, including ad hoc requests

• running administrative portions of the meetings

F. Ensure the study teams’ meeting materials are submitted according to the timeline. Duties include:

• providing the study teams instructions as well as templates for meeting materials e.g., for open reports, closed reports, and presentations

• requesting the study team to prepare and submit meeting material packages and presentations

• reviewing the meeting material packages to ensure specific items were submitted

G. Write, edit, and obtain approval for the DSMB summary reports and the DSMB recommendations.

H. Manage and distribute honorariums to the non-Federal DSMB members who attend DSMB meetings.

I. Request and file study teams’ written responses to DSMB recommendations.

2.2 DELIVERABLES

The contractor must deliver COI forms completed by the DSMB members, DSMB meeting agendas, meeting preparation instructions to the research teams, one virtual DSMB meeting per Option Year, DSMB meeting reports which include observations and recommendations, honorarium payments to non-Federal DSMB members, and study teams’ written responses to DSMB recommendations.

2.3 SCHEDULE

Period of performance: September 2, 2026 – September 1, 2027

Each DSMB meeting schedule will depend on the members’ availability. One (1) regular virtual meeting will occur each Option Year.

The contract will be performed at the contractor’s work site and through virtual meetings.

2.4 ASSUMPTIONS

Assume one (1) established virtual DSMB meeting each Option Year.

Assume each DSMB meeting reviews one (1) or two (2) clinical trials.

Assume each established virtual DSMB meeting does not exceed six (6) hours in length.

Assume among ten (10) members, seven (7) non-Federal DSMB members receive an honorarium of $200 per person per meeting day.

Assume each meeting will be hosted using Teams.

Assume the contractor will maintain the current DSMB SharePoint site and tracking tool for filing and sharing of DSMB information.

Assume monthly check-in meetings will not be required throughout the year.

Assume up to one (1) additional ad hoc review is included and could include:

(a) One (1) DSMB review via email. The contractor will distribute documents, collect comments, and collate into one report submitted to NIDCD. The review via email does not require honorarium.; or

(b) One (1) virtual review meeting up to two (2) hours and up to four (4) DSMB members. The contractor will pay up to four (4) honoraria, draft a recommendation report, and submit to NIDCD. No study team attends.

Assume not every DSMB member must attend each meeting. The quorum is three (3) voting members.

Assume the NIDCD COI Officer will prepare COI forms with study specific information for each DSMB meeting and send them to the contractor.

3.0 GOVERNMENT FURNISHED PROPERTY

N/A

4.0 SECURITY REQUIREMENTS

N/A