Attachment 1 - SOW.pdf

Version 11-30-2016-1 FAR Part 11—Describing Agency Needs

STATEMENT OF WORK (SOW) – SERVICES

GENERAL INFORMATION

Title of Project:

Financial and Clinical Monitoring Activities Support for NIMH Studies

Statement of Need and Purpose:

To acquire comprehensive services in reviewing for-cause clinical site study monitoring, continued review of research practices and audit reports as well as financial audit reports for studies funded by the National Institute of Mental Health (NIMH).

Background Information and Objective:

As part of its oversight responsibilities, the National Institute of Mental Health (NIMH) is seeking support in reviewing and summarizing results from financial and clinical research site monitoring activities and preparing NIMH responses to reports from clinical research sites.

Period of Performance:

The period of performance for this requirement is one 12-month base period with four 12-month option periods.

SCOPE OF WORK

General Requirements:

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

• Review and summarize individual audit reports as well as cumulative results of an Institutional financial audit of NIMH funded studies.

• Review and summarize individual clinical research study audit reports and evaluate grantee-proposed corrective and preventive action plans for adequacy of their response to findings.

• Summarize cumulative findings of the clinical research study audit reports and identify systemic concerns.

• Draft NIMH’s response to clinical and financial research site reports.

• Travel to the research site, as warranted by audit findings to conduct an additional review of study-specific data.

Please note that the Contractor is expected to be available to meet with the Government COR and/or his or her designees for scheduled, as well as short-notice meetings for urgent situations.

Specific Requirements:

I. Review and summarize individual audit reports, as well as cumulative results of an Institutional financial audit of NIMH funded studies.

The contractor will review the comprehensive retrospective financial audit reports of NIMH funded grants from 2016 to present, as well as, quarterly audit reports beginning October 1, 2022 through September 30, 2023 to ensure compliance with:

• Federal Cost Principles outlined in 2 CFR Part 200 Subpart E

• NIH Grants Policy Statement ensuring allowability and allocability

• NIH/NIMH policies and procedures as applicable

The contractor shall provide a summary for each audit finding reports - both the comprehensive retrospective audit (January 2016-October 2022) and the quarterly audit reports beginning October 1, 2022 through September 30, 2023 - for all NIMH funded studies and any final report provided by the grantee organization. The contractor may be tasked to provide further review and responses as directed by the NIMH Chief Grants Management Official.

A. Financial Audit Review Personnel

The Contractor shall provide.personnel with appropriate training and expertise to carry out the audit report review and financial evaluation functions.

The Contractor shall provide a cadre of financial auditors with the appropriate training, experience, and capabilities to review detailed financial reports of expenditures related to NIH grant awards.

Specifically, auditors must have:

A current Certified Public Accountant license and specialize in government grant accounting.

Current knowledge of Federal Grant Award Regulations (2 CFR 200

UNIFORM ADMINISTRATIVE REQUIREMENTS, COST PRINCIPLES,

AND AUDIT REQUIREMENTS FOR FEDERAL AWARDS; and

Current knowledge of NIH grant policies.

II. Review and summarize individual clinical research study audit reports and evaluate grantee-proposed corrective and preventive action plans for adequacy of their response to findings.

The contractor will review audit reports of NIMH-funded grants and ensure compliance with: (1) NIH/NIMH policies and procedures; (2) Federal Regulations for the Protection of Human Subjects (45 CFR 46); (3) protocol-specific requirements; (4) applicable FDA regulations (5) the ICH E6-GCP Guidelines. The contractor will summarize the individual audit reports for each study and identify all safety signals/concerns, including clinical and potential non-compliance concerns, as well as any concerns relevant to the integrity of study data. The contractor will evaluate the adequacy of the grantee-proposed corrective and preventive action plans (CAPA) relative to the audit report findings. The contractor may be tasked to provide further review as directed by the NIMH Office of Clinical Research (OCR).

III. Summarize cumulative key findings of the clinical research study audit reports and identify systemic concerns.

The contractor will summarize, in a cumulative manner, key findings identified in the audit reports and identify any systemic concerns of the overall clinical research performance, validity, and/or safety.

IV. Depending on audit findings, travel to the site to conduct additional review of study-specific data.

The contractor will travel to the site to conduct additional review of study specific findings if this is indicated based on audit findings.

A. Clinical Audit Report Review and Personnel

The Contractor shall provide clinical and technical personnel with appropriate training, expertise, and experience to carry out the audit report review and CAPA evaluation functions.

The Contractor shall provide a cadre of clinical research auditors with the training, experience, and capabilities to perform review of for-cause audit reports for NIMH supported clinical trials and clinical sites. Auditors shall not be considered key personnel but are must to have certain skills and abilities.

Specifically, auditors are must to have:

• Training and at least 5 years of experience in monitoring clinical trials and studies for mental health and psychiatric disorders.

• Training and at least 5 years of experience in monitoring clinical trials and studies conducted in the United States.

• Exceptional skills in professional scientific writing.

• Current knowledge of NIH policies, Federal Regulations for the Protection of

Human Subjects, FDA regulations, and Good Clinical Practice (GCP).

• Expertise in Research Pharmacy operations; and

• Access to a physician with Psychiatric clinical expertise (as needed for review of clinical patient management).

Summary Reports of the review of clinical audits and CAPAs shall be prepared using a report template prepared by the contractor and approved by the COR and NIMH OCR. The reports must detail a summary of key concerns identified in the audit report and adequacy of the proposed corrective recommendations and corresponding corrective and preventive action plans. Reports shall be delivered to the COR, the NIMH OCR, and other appropriate NIMH staff no later than ten

(10) business days following receipt of each audit report. Findings of questionable data, possibility of intentional misrepresentation of data, and/or disregard for regulatory safeguards and critical findings (e.g., potential unanticipated problems involving risk to subjects or others, serious or continuing regulatory non-compliance) shall be reported to the COR, the NIMH OCR and other appropriate NIMH staff members within five business days of receiving the relevant audit report.

V. Facilities, Equipment, and Other Resource Requirements

The Contractor shall provide all facilities, equipment, and other resources necessary to carry out the requirements detailed in this Statement of Work. This includes the following:

A. Equipment or other resources to conduct clinical audit report review.

B. Equipment or other resources to conduct financial audit report review.

C. Information technology systems for secure electronic file transfer and teleconference capacities.

VI. Personnel Training and Oversight

The Contractor shall ensure that all personnel working under this requirement are appropriately trained with the skills and abilities relevant to this requirement. Toward this end, the Contractor shall provide a Training Plan for audit reviewers and other contractor personnel for Government review and approval. A draft training plan shall be submitted with the Contractor’s proposal for inclusion in technical evaluation.

Please note that HHS policy requires Contractors and Subcontractors to receive security training commensurate with their responsibilities for performing work under the terms and conditions of their contractual agreements. The Contractor will be responsible for assuring that each Contractor/Subcontractor employee has completed the NIH Computer Security Awareness Training prior to performing any contract work, and thereafter completing the NIH-specified fiscal year refresher course during the period of performance of the contract. The successful offeror shall maintain a listing of all individuals who have completed this training and shall submit this listing to the COR each year.

Additionally, Contractor employees and Subcontractors shall be required to receive ethics training. The Contractor will be responsible for assuring that each Contractor/Subcontractor has completed ethics training prior to performing any contract work. The successful offeror shall maintain a listing of all individuals who have completed this training and shall submit this listing to the COR.

VII. Contract Management The Contractor shall provide sufficient project management support to ensure adequate management and coordination of all monitoring activities. This effort shall include responsibility for technical and administrative support (including travel arrangements when approved by the COR), financial management, reporting and deliverables, and proper invoicing. The Contractor shall ensure that all contractor personnel safeguard intellectual property, the confidentiality of human subjects and other data, and other information provided by third parties or by the Government, as well as data generated through this contract.

Contract management shall also oversee quality assurance and control.

LEVEL OF EFFORT:

Supervisory Program Manager 500 hours per period of performance.

Clinical study audit report reviewers 2600 hours per period of performance.

Psychiatrist reviewer 300 hours per period of performance Financial audit report reviewers 1200 hours per period of performance.

GOVERNMENT RESPONSIBILITIES;

Government Furnished Property (GFP):

No Government furnished property shall be provided.

Government Furnished Information (GFI):

Government Furnished Information, including study data, shall be provided for the purposes of executing this requirement. Consultant(s) shall guarantee strict confidentiality of the information/data that it is provided by the NIH or by any other participant on the project to which the contractor is assigned.

DELIVERY OR DELIVERABLES

The Contractor shall provide the following deliverables and reports:

1. Provide report(s) of individual findings and recommendations No later than 10 business days after the receipt of each clinical study audit report and no more than 30 business days for quarterly financial audit report, the contractor must provide a concise summary detailing key findings, the adequacy of the recommendations to address the findings, and associated plan to address deficiencies identified as areas of improvement. Findings of questionable data, possibility of intentional misrepresentation of data, and/or disregard for regulatory safeguards and critical findings (e.g., potential unanticipated problems involving risk to subjects or others, serious or continuing regulatory non-compliance) shall be reported to the COR, the NIMH OCR and other appropriate NIMH staff members within five business days of receiving the relevant audit report.

2. Provide report(s) of summarized findings and recommendations On a bi-weekly basis and after receipt of the final audit report, the Contractor must provide an ongoing comprehensive summary detailing key findings of the cumulative audit reports and identify any systemic concerns related to the financial and clinical research oversight at a specified Grantee Institution.

REPORTING REQUIREMENTS

Ad-Hoc Meetings and Reports At the request of the COR, the Contractor shall arrange teleconferences and/or meetings with the COR, other COR-designated NIMH Staff as necessary to discuss contractual matters, and other relevant Contractor Staff to discuss specific audit review assignments and work products. For each such meeting/teleconference, the Contractor shall be responsible for preparing and distributing the agenda and other materials, including site visit reports and recommendations for improvements or corrective actions at least three

(3) calendar days in advance of the teleconference or in-person meeting. The Contractor shall also prepare and distribute meeting minutes that include written summaries of the major decisions and action items resulting from these meetings and teleconferences and submit to the COR and other COR-designated NIMH staff within seven (7) calendar days of meeting/teleconference completion.

OTHER CONSIDERATIONS

Travel:

Depending on audit findings, travel to the site may be necessary to conduct an additional review of study-specific data and/or financial data. The Government will exercise an option for travel, as approved in advance by the Contracting Officer’s Representative. Visits to clinical sites will take place in the United States.

Key Personnel:

The Contractor shall propose one (1) Supervisory Program Manager as key personnel for this contract. The proposed Key Personnel will become subject to the provisions of Health and Human Services Acquisition Regulation (HHSAR) Clause HHSAR 352.237-75 Key Personnel as follows:

The key personnel specified in this contract are considered to be essential to work performance.

At least 30 days prior to the contractor voluntarily diverting any of the specified individuals to other programs or contracts the Contractor shall notify the Contracting Officer and shall submit a justification for the diversion or replacement and a request to replace the individual. The request must identify the proposed replacement and provide an explanation of how the replacement's skills, experience, and credentials meet or exceed the requirements of the contract. If the employee of the contractor is terminated for cause or separates from the contractor voluntarily with less than thirty day notice, the Contractor shall provide the maximum notice practicable under the circumstances. The Contractor shall not divert, replace, or announce any such change to key personnel without the written consent of the Contracting Officer. The contract will be modified to add or delete key personnel as necessary to reflect the agreement of the parties.

NOTE: During the first ninety (90) days of the contract performance period no key personnel substitutions by the contractor will be made unless such substitutions are necessitated by an individual’s sudden illness, death or termination of employment.

A. Supervisory Program Manager Role Description:

The Supervisory Program Manager shall be the primary point of contact for all contract tasks, projects, reports, and invoices. This individual is responsible for the overall quality and performance of all contractor and for any subcontractor work performed under this contract. This individual is also responsible for overall customer relationship management and problem resolution.

The Supervisory Program Manager will oversee all audit activities carried out by the site clinical, psychiatric, and financial auditors including tracking assignments, assigning reviewers, developing and maintaining schedules, resolving scheduling conflicts, ensuring completion of appropriate activities and correspondence, and assisting in the assessment of the performance and the quality of activities carried out.

Supervisory Program Manger Mandatory Qualifications:

The Supervisory Program Manager must have a master’s degree in a relevant scientific discipline and extensive experience (approximately 10 or more years) in overseeing clinical research monitoring, auditing, and/or oversight. Preferably experience specific to the monitoring of clinical trials and research studies for mental health and psychiatric disorders. This position requires expert communication skills and organizational abilities including the ability to track the audit trail for the multiple reports received, reviewed, and finalized. This project with have multiple streams of information considering both the clinical research study audit and the financial audit reports and the Supervisory Program Manager is required to track the progress of all reports.

Information System Security Plan:

1. An information system security plan applies to this requirement because Contractor personnel is expected to have routine access to sensitive government data or information, whether in an NIH-controlled information system or hard copy.

2. The Contractor shall complete and submit a signed and witnessed "Commitment to Protect

Non-Public Information-Contractor-Employee Non-Disclosure Agreement" form for each Contractor and subcontractor employee who may have access to non-public Department information under this contract.

3. The Contractor shall maintain compliance with NIH requirements for training and certification in the ethical conduct of research, participant information protection, and the security of NIH computers and communications.

Data Rights:

The National Institute of Mental Health shall have unlimited rights to and ownership of all data and deliverables provided under this contract including reports, analyses, recommendations, briefings, work plans, created SOPs and all other deliverables. This SOW includes the deliverables provided under this contract and any optional task deliverables exercised by the contracting officer. In addition, it includes any additional deliverables required by contract change.

The definition of “unlimited rights” is contained in Federal Acquisition Regulation (FAR) 27.401, “Definitions.” FAR clause 52.227-14, “Rights in Data-General,” is hereby incorporated by reference and shall be made a part of any resulting contract/order.

Section 508—Electronic and Information Technology Standards:

The contractor is NOT required to develop, procure, maintain, or use Electronic and Information Technology (EIT) in the performance of the SOW.

Publications and Publicity:

The NIMH does not expect any publications to arise from work completed under this contract.

Confidentiality of Information:

This requirement is subject to the HHSAR Clause 352.224-71 Confidential Information (December 18, 2015) and the Contractor shall abide by the Privacy Act of 1974 (5 U.S.C. § 552a). The Contractor will not disclose, publish, divulge, release, or make known, in any manner or to any extent, to any individual other than the authorized government employees the content of any sensitive information provided under this contract. For this requirement, the Government may provide to the Contractor information or data of a nature that is proprietary information or data pertaining to this project. This requirement is expected to generate information or data which is confidential. The Contractor shall handle all sensitive information or data in a secure manner and consult with the authorized government employee prior to any release, disclosure, dissemination, or publication.

Work on this project will require the Contractor to access privacy information. Personnel shall adhere to the Privacy Act, Title 5 of the U.S. Code, Section 552a, and applicable agency rules and regulations. The Contractor shall be responsible for properly protecting all information used, gathered, or developed as a result of work under this task. The Contractor shall also protect all unclassified Government data, etc., by treating information as sensitive business, confidential information, controlling and limiting access to the information, and ensuring the records and software solution are secured.

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