ATTACHMENT_5_Base_IDIQ_List_of_Possible_Deliverables.pdf
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- Solicitation number
- 75N94025R00008
About this file
This document is Attachment 5 to RFP 75N94025R00008, which outlines the List of Possible Deliverables for Task Orders issued under a base Indefinite Delivery/Indefinite Quantity (IDIQ) contract. The deliverables encompass technical reports, recurring reports, final reports, and IT and administrative reports related to clinical research organization (CRO) study and data management services. Technical reports include literature reviews, FDA Pre-IND meeting packages, draft protocols, regulatory plans, medication plans, manuals of operations, standard operating procedures, monitoring plans, analytical plans, meeting agendas, and data management plans, with due dates typically specified in individual task orders and ranging from 1 week to 6 months following the contract start date. Recurring deliverables include monitoring reports (due within 2 weeks of clinical site visits), protocol updates (within 1 week of finalization), FDA IND reports (annually), quarterly study progress and financial reports (by the 5th of the following month), annual progress and financial reports, and meeting minutes (within 2 days). All deliverables must be submitted electronically to the Contracting Officer's Representative, Contracting Officer, and Information Systems Security Officer, with specific recipients identified after contract award.
Final reports include a comprehensive Final Clinical Study Report due 2 months after data analysis, a complete data set in SAS format with statistical code and algorithms, and various IT and administrative reports. IT security deliverables are mandated, including roster of employees requiring suitability investigations, NIH IT security awareness training certificates, contractor employee non-disclosure agreements, Information Technology System Security Plan documentation (due 90 days after contract start), IT Security Authorization Documentation including privacy impact assessments and contingency plans (due 120 days after start), and annual assessments thereafter. Additional IT-related deliverables include vulnerability scanning reports (90 days after start), Section 508 Annual Reports (within 30 days of task order anniversary), reporting of new and departed employees (within 5 business days), and financial conflict of interest reporting. All electronic deliverables must comply with Revised Section 508 Standards of the Rehabilitation Act of 1973, with specific guidance and VPAT templates required for accessibility compliance. The Service Contract Annual Report is due October 31st of each task order year and must be submitted electronically to SAM.gov.
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ATTACHMENT 5 – RFP 75N94025R00008
List of Possible Task Order Deliverables – IDIQ Contract
2.20.2026 Attachment 5
List of Possible Deliverables for Task Orders Issued Under the Base IDIQ Contract
The reporting requirements and deliverables for this IDIQ contract include, but are not limited to, the following:
a. Technical Reports Delivery and Distribution Schedule
Reports & Deliverable Due Date Electronic Copy to:
One Time Reports
Literature Review / Findings To be specified in Task Order
(Typically, 2 weeks from date of COR request)
To be specified in Task Order
FDA Pre-IND Meeting Package for Potential New Study
To be specified in Task Order
(Typically, 1 week before submission)
To be specified in Task Order
Draft Protocol for Potential New Study
To be specified in Task Order
(Typically, 2 weeks before FDA submission)
To be specified in Task Order
Regulatory Plan To be specified in Task Order
(Typically, end of Month 1 of CRO Study and Data Management Task Order)
To be specified in Task Order
Medication Plan To be specified in Task Order
(Typically, end of Month 3 of CRO Study and Data Management Task Order)
To be specified in Task Order
Draft Protocol To be specified in Task Order
(Typically, end of Month 4 of CRO Study and Data Management Task Order)
To be specified in Task Order
2.20.2026 Attachment 5
Manual of Operations – Draft To be specified in Task Order
(Typically, beginning of Month 5 of CRO Study and Data Management Task Order)
To be specified in Task Order
Manual of Operations – Final To be specified in Task Order
(Typically, end of Month 5 of CRO Study and Data Management Task Order)
To be specified in Task Order
Final MOP, Protocol, Protocol Manual, source documents and CRFs
To be specified in Task Order
(Typically, end of Month 6 of CRO Study and Data Management Task Order)
To be specified in Task Order
Standard Operating Procedures To be specified in Task Order
(Typically, end of Month 6 of CRO Study and Data Management Task Order)
To be specified in Task Order
Monitoring Plan To be specified in Task Order
(Typically, end of Month 6 of CRO Study and Data Management Task Order)
To be specified in Task Order
Analytical Plan To be specified in Task Order
(Typically, end of Month 6 of CRO Study and Data Management Task Order)
To be specified in Task Order
Kick-off Meeting Agenda To be specified in Task Order
(Typically, 2 months prior to K/O Meeting with NIAAA clinical site contractors)
2.20.2026 Attachment 5
Kick-off Meeting Slides To be specified in Task Order
(Typically, 1 month prior to K/O Meeting with NIAAA clinical site contractors)
To be specified in Task Order
Close-out Meeting Agenda and Slides
To be specified in Task Order
(Typically, 2 weeks prior to C/O meeting)
To be specified in Task Order
Data Management Plan To be specified in Task Order
(Typically, end of Month 6 of CRO Study and Data Management Task Order)
To be specified in Task Order
FDA IND Application or Waiver To be specified in Task Order
(Typically, 2 days after finalization of IND package)
To be specified in Task Order
Data Dictionary To be specified in Task Order
(Typically, 30 days after 1st subject is recruited by NIAAA clinical site contractors)
To be specified in Task Order
Electronic Content Management System tested and operational
To be specified in Task Order
(Typically, 30 days prior to Kick-off meeting with NIAAA clinical site contractors)
Reoccurring Deliverables
Monitoring Reports To be specified in Task Order
(Typically, within 2 weeks after clinical site visit)
2.20.2026 Attachment 5
Updates to the protocol, CRFs, MOP, or any other study related documents
To be specified in Task Order
(Typically, within 1 week of finalization)
To be specified in Task Order
FDA IND report To be specified in Task Order
(Typically, annually)
To be specified in Task Order
Quarterly Study Progress Report To be specified in Task Order
(Typically, by the 5th of the month following the completed 3-month quarterly period)
To be specified in Task Order
Quarterly Financial Report To be specified in Task Order
(Typically, by the 5th of the month following the completed 3-month quarterly period)
To be specified in Task Order
Annual Progress and Financial Report To be specified in Task Order
(Typically, last day of each annual performance period. No Quarterly Report is due when an Annual Report is due.)
To be specified in Task Order
Meeting/Teleconference Minutes To be specified in Task Order
(Typically, within 2 days after call or meeting)
Final Reports
2.20.2026 Attachment 5
Final Clinical Study Report
The Contractor shall submit a final report describing the activities and accomplishments of the Contractor in the performance of this contract.
The final report shall be typed double space or space and a half and shall include all illustrations, tables, drawings, charts, data sheets, and other pertinent material as is necessary and sufficient to comprehensively explain the results achieved under the Task Order.
To be specified in Task Order
(Typically, 2 months after analysis of data.
No Quarterly or Annual Report due).
To be specified in Task Order
Complete Data Set** All data and data sets acquired and maintained by the Contractor under the CRO Task Order shall be returned to the
NIAAA
To be specified in Task Order
(Typically, 2 months after analysis of data)
To be specified in Task Order
Statistical Code and Algorithms used in data analysis
To be specified in Task Order
(Typically, 2 months after analysis of data)
To be specified in Task Order
IT and Administrative Reports Roster of Employees Requiring Suitability Investigations
• Federal Information Processing Standard Publication
199 (FIPS-
199) Assessment
• Boundary Scope Memo (BSM)
To be specified in Task Order
(Typically, 30 days following the start date of CRO Study and Data Management Task Order)
COR, CO, ISSO
List of Employees Requiring NIH IT Security Awareness Training
To be specified in Task Order
(Typically, 30 days following the start date of CRO Study and Data Management Task Order)
COR, CO, ISSO
2.20.2026 Attachment 5
Contractor- Employee Non- Disclosure Agreements
To be specified in Task Order
(Typically, 30 days following the start date of CRO Study and Data Management Task Order)
COR, CO, ISSO
NIH IT Security Awareness Training (provide certificates of completion)
To be specified in Task Order
(Typically, 30 days following the start date of CRO Study and Data Management Task Order and Annually for each year the Task Order is active – to be completed each year on or before 30 days from notification of availability of annual training module from
ISSO)
COR, CO, ISSO
Information Technology System Security Plan (IT-SSP)
• System Security Plan
• Risk Acceptance Waiver*
• Plan of Action and Milestone (POAM)* *If applicable
To be specified in Task Order
(Typically, 90 days following the start date of CRO Study and Data Management Task Order)
2.20.2026 Attachment 5
IT Security Authorization (IT-
SA)
Documentation:
• Privacy Impact Assessment
(PIA)
• Contingency Plan (CP)
• Configuration Management Plan (CMP)
• Security Assessment Plan (SAP)
• Security Assessment Report (SAR)
• E- Authentication Threshold Analysis (ETA)
• Interconnection Security Agreement (ISA)*
• Memorandum of Understanding
(MOU)*
*If Applicable
To be specified in Task Order
(Typically, 120 days following the start date of CRO Study and Data Management Task Order)
COR, CO, ISSO
Annual Assessment:
Information Technology System Security Plan
(IT-SSP)
• System Security Plan
• Risk Acceptance Waiver*
• Plan of Action and Milestone
To be specified in Task Order
(Typically, annually, after Authority to Operate [ATO] is granted).
2.20.2026 Attachment 5
(POAM)*
*If Applicable
Reporting of New and Departed Employees
To be specified in Task Order
(Typically, within 5 business days of a staffing change)
COR, CO, ISSO
Contractor- Employee Non- Disclosure Agreements
To be specified in Task Order
(Typically, 30 days following the start date of CRO Study and Data Management Task Order)
COR, CO
Vulnerability Scanning Reports To be specified in Task Order
(Typically, 90 days following the start date of CRO Study and Data Management Task Order)
COR, CO, ISSO
Section 508 Annual Report
To be specified in Task Order
(Typically, within 30 days after anniversary date of Task Order)
COR, CO
Reporting of Financial Conflict of Interest (FCOI)
To be specified in Task Order
(Typically, as applicable in
COR, CO
2.20.2026 Attachment 5
accordance with 45 CFR Part 94.5(b))
Service Contract Annual Report
Reference FAR Clause 52.204-15, “Service Contract Reporting Requirements for Indefinite Delivery Contracts” included in full text in the IDIQ base contract, Section L.
To be specified in Task Order
(Typically, October 31st of each Task Order year.
Reporting Period is the previous Government Fiscal Year (October 1 through September 30)
Submit electronically to https://www.SAM.gov
*If applicable
**Data set will be provided in SAS - includes the complete SAS code used to complete all analyses.
All electronic reports and deliverables submitted shall be compliant and in conformance with the Revised Section 508 Standards of the Rehabilitation Act of 1973 (29 U.S.C. 794d).
Additional information about testing all deliverables and reports including guidance and specific checklists, by application, as well as completion of VPATs for Section 508 compliance and conformance, can be found at https://www.hhs.gov/web/section-508/index.html under “Making Files Accessible” for checklists and “Contracting” for required appropriate VPAT templates using the ART tool that are to be completed. Information about the ART tool and the needed VPAT statements is located at https://www.itic.org/policy/accessibility/vpat as Word document or using an online tool at https://www.section508.gov/buy/accessibility-requirements-tool .
Copies of reports shall be sent to the following:
Contracting Officer’s Representative (COR) Email will be provided after award
Contracting Officer (CO) Email will be provided after award
Information Systems Security Officer (ISSO) Email will be provided after award https://www.sam.gov/ https://www.hhs.gov/web/section-508/index.html https://www.itic.org/policy/accessibility/vpat https://www.section508.gov/buy/accessibility-requirements-tool https://www.section508.gov/buy/accessibility-requirements-tool
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