Contact Points
Primary Contract Specialist
Secondary Contracting Officer
Manhattan Beach, California
90266-3423
The purpose of this procurement is to acquire comprehensive services in psychiatric clinical consultation for review of: safety in National institute of Mental Health (NIMH) grant applications, clinical site study monitoring reports, research protocols, and other documents relevant to clinical research data and safety monitoring and the protection of participants in research studies funded by the National institute of Mental Health (NIMH).
As part of its oversight responsibilities, the Office of Clinical Research (OCR) in the National Institute of Mental Health (NIMH) is seeking support in psychiatric clinical consultation for the review of safety in studies funded by the NIMH. This includes reviewing NIMH grant applications, clinical site study monitoring reports, research protocols, and other documents relevant to clinical research data and safety monitoring and the protection of participants in research.
- Provide psychiatric consultation on clinical questions that arise during NIMH staff oversight activities.
- Review NIMH grant applications to evaluate plans to ensure research participant safety and provide recommendations on their adequacy to NIMH staff.
- Review reportable event reports (e.g., reports of serious adverse events or unanticipated problems), research protocols, consent forms and other relevant documents, and provide recommendations to NIMH staff on the adequacy of safety plans and the steps taken to protect participants in NIMH funded research studies.
- Provide clinical review and consultation on clinical data contained in data and safety monitoring reports of NIMH funded studies.
- Review clinical research study audit reports and, when indicated, evaluate the adequacy of study team responses to findings.
Interested parties may identify in writing their interest and capability in response to this requirement. Responses to this notice shall contain sufficient information to establish the interested parties’ bona-fide capabilities for fulfilling the requirement and include: unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.
All responses must be received by closing date and must reference the announcement. Responses may be submitted electronically to the attention of the contract specialist. Fax responses will not be accepted.
All responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency.