Attachment 1 -Statement of Work_Amendment 01.pdf

Amended on 8/1/2022

June 28, 2022

STATEMENT OF WORK (SOW) – SERVICES

GENERAL INFORMATION

Title of Project:

Clinical Research and Study Monitoring Support for NIMH Studies

Statement of Need and Purpose:

To acquire comprehensive clinical site and study monitoring services for studies funded by the National institute of Mental Health (NIMH).

Background Information and Objective:

The NIMH Office of Clinical Research (OCR) provides institute-wide coordination and oversight for NIMH-funded clinical research studies including strategic guidance and recommendations to NIMH leadership about clinical research initiatives. An important component of the oversight activities involve on-site monitoring of NIMH funded clinical research.

Period of Performance:

The period of performance for this requirement is one 12-month base year with four two (2) 12-month option years.

SCOPE OF WORK

General Requirements:

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

• Development of Clinical Site Monitoring Standard Operating Procedures for Implementation to conduct specialized (e.g., for cause) clinical site monitoring visits.

• The contractor shall conduct specialized clinical site monitoring visits at sites determined by the NIMH OCR. The general location of sites identified in this statement of work are final.

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. Development of Clinical Site Monitoring Standard Operating Procedures for Implementation

The Contractor shall develop Standard Operating Procedures (SOPs) governing all aspects of the conduct of specialized (e.g., for cause) clinical site monitoring visits to the COR within fourteen (14) calendar days of the contract effective date. The SOP will be reviewed by the COR and the NIMH OCR and additional changes may be recommended prior to implementation.

The SOP shall include the following components:

• A description of each aspect of clinical research conduct and clinical site operations to be reviewed

• Sources of data and other information for monitoring each aspect of clinical research conduct and clinical site operations. The contractor shall work in collaboration with NIMH to determine this information.

• The types of clinical site personnel and key study personnel required to participate in site visits. Personnel will include study staff within NIMH funded studies. Staff may be federal employees or non-federal personnel.

• Detailed operational instructions addressing the site visit process.

• Scheduling processes and procedures for preparing clinical site staff for monitoring visits.

o These processes and procedures shall include questions and other materials to be provided to site staff in advance of site visits, as well as data, documents, and other information to be gathered and made available by clinical sites.

• The average length of the site visit and the number of contract monitors required. The contractor shall provide data to support the length of site visits based on the study design and sources of data to be reviewed. (The length of a site visit and the number of contract monitors required will be decided in collaboration with the NIMH OCR and COR.)

Additionally, the Contractor shall keep abreast of all changes in Federal requirements governing human subjects’ research, GCP and ICH guidelines, and NIMH policies and procedures. The Contractor shall update SOPs, as necessary, within thirty (30) calendar days of the effective date of all such changes; and submit updated SOPs for COR and the NIMH OCR for review and approval. Updated SOPs shall be implemented by the Contractor only after receipt of written COR approval.

II. Specialized Clinical Site Monitoring Visits

Specialized Site Visits to NIMH-funded grants clinical sites monitor and ensure compliance with: (1) 21 CFR 312—GCP; (2) 45 CFR 46—“Human Subjects Protection;” (3) the ICH E6- GCP Guidelines; (4) protocol-specific requirements; (5) policies and guidance set forth by the U.S. Department of Health and Human Services Office of Human Research Protections and (6) NIMH policies and procedures. Each site visit will be tailored to the study protocol/procedures, and will include (but not be limited to): a review of the study regulatory binder, informed consent forms, subject eligibility, safety reporting, ensuring subjects were correctly randomized, protocol violations/deviations, primary outcome data, and electronic case report forms. The visit will also include an assessment of site operations, IP accountability (if applicable), and other items as directed by the NIMH OCR.

A. Clinical Site Monitoring Personnel

The Contractor shall provide clinical and technical personnel with appropriate training, expertise and experience to carry out the site monitoring functions of the this requirement.

The Contractor shall provide and maintain a cadre of site monitors with the training, experience, and capabilities to perform clinical site and study monitoring functions for NIMH supported clinical trials and clinical sites. Site monitors shall not be considered key personnel but are expected to have certain skills and abilities.

Specifically, site monitors are expected to have:

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

• Training and significant experience in monitoring clinical trials and studies conducted in the United States and Canada sites

• Current knowledge of FDA regulations, Good Clinical Practice (GCP), and human subjects regulations.

B. Specialized Clinical Site Monitoring Visits

The Contractor shall perform specialized clinical site monitoring visits to be assigned by the NIMH OCR. Specialized clinical site monitoring visits may include remedial and for-cause visits. Scheduling of “for cause” site visits will be determined by the NIMH OCR on a case-by-case basis depending on the nature and potential risk characteristics associated with such visits. These visits will focus on specific aspects of clinical trial conduct and clinical site operations. The Contractor will collaborate with the NIMH OCR in determining which specialized forms and templates will be used (and/or developed) that specify the data and other information to be collected, assessed, and reported for specialized clinical site visits. The COR, in collaboration with the NIMH OCR, will oversee this process and will approve all forms and templates prior to implementation.

During specialized clinical site monitoring visits the Contractor shall review and document the following aspects of clinical research conduct and clinical site operations:

i. The accuracy and completeness of reportable data on Case Report Forms (CRFs)

ii. Adherence to inclusion and exclusion criteria

iii. Reporting of protocol violations

iv. Accuracy and completeness of the reporting of protocol exemptions

v. Documentation and reporting of Serious Adverse Events (SAEs)

vi. Documentation of informed consent and adherence to informed consent procedures

vii. Documentation of findings, including verification of endpoints

viii. Maintenance of appropriate source documentation

ix. Adherence to federal, GCP and ICH guidelines, and NIMH policies and procedures

x. Adequacy of operations, performance, and management related to protocol-specific requirements

xi. Regulatory review to assess the adequacy of procedures for ensuring compliance with regulatory requirements

xii. Adherence to other protocol specific requirements

For all specialized clinical site monitoring visits, the contractor will provide clinical sites involved with a description of the site-specific activities/protocols to be reviewed, data and other information to be collected/assessed, and instructions on the clinical site personnel and materials to be made available. This information shall be provided to the clinical sites no less than fourteen (14) calendar days prior to the scheduled site visit.

Reports of clinical site monitoring visits shall be prepared using site visit report templates determined (and/or developed) in collaboration with the NIMH OCR and approved by the COR and NIMH OCR. The reports must detail any adverse findings or compliance violations as well as corrective recommendations. Reports shall be delivered to the COR, the NIMH OCR and other appropriate NIMH staff members, no later than ten (10) business days following completion of each site visit. Findings of suspicious data, possibility of intentional misrepresentation of data, and/or disregard for regulatory safeguards and critical findings (e.g., any fraudulent findings, prefilling of CRFs, invalid signatures, and unreported Serious Adverse Events) shall be reported to the COR, the NIMH OCR and other appropriate NIMH staff members within 24 hours of site visit completion by telephone and email.

III. 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 site and study monitoring activities, and to provide ready access to monitoring staff and services for clinical sites in the United States and Canada.

B. Information technology systems and state-of-the-art field equipment, including laptops, blackberries, and smartphones for the conduct of specialized clinical site visits and monitoring activities conducted at clinical sites in the United States and Canada.

IV. 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 site monitors 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 the Non-Employee Ethics Orientation:

Interacting with Government Employees provided by the United States Office of Government Ethics 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.

V. Contract Management

The Contractor shall provide sufficient project management support to ensure adequate management and coordination of all site 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 250 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. Attend onsite and/or remote monitoring visit (as determined by the NIMH OCR and COR) in collaboration with NIMH staff (as applicable) Conducting specialized site visits in collaboration with NIMH staff (if applicable) and prepare site visit related activities and provide guidance during the visit. The assigned site monitor(s) must provide adequate time to prepare for the site visit and meeting(s) with NIMH staff.

2. Provide Site Visit Report(s) of findings and recommendations No later than 10 business days after site visit, contractor must provide comprehensive reports detailing site visit findings and provide recommendations to address findings and a comprehensive plan to address deficiencies identified as areas of improvement.

REPORTING REQUIREMENTS

1. Monthly Progress Reports

The Contractor shall prepare a contract progress report for the Government each month.

The report shall include the status of ongoing and future clinical site monitoring assignments; issues related to contract staffing and turnover, workload, and scheduling;

project management procedures and assessment of the efficiency and quality of the clinical site monitoring activities conducted.

The Contractor shall be responsible for submitting the report to the NIMH COR and Contracting Officer at least five (5) calendar days before the end of the month.

2. Annual Progress Reports

The Contractor shall prepare an annual contract progress report for the Government. The annual progress report shall include a summary of all clinical site monitoring visits completed and associated findings within the past year; problems and obstacles encountered and approaches to overcoming identified problems and obstacles; recommendations for modifications in project timelines, procedures and approaches; contract resources; and future plans. The report shall include additional materials and data pertinent to the review of contract progress, performance, efficiency and resource utilization.

The Contractor shall be responsible for submitting the annual report to the NIMH COR and Contracting Officer at least thirty (30) calendar days before the end of the period of performance.

3. Final Report

The Contractor shall prepare a final contract report for the Government. The final report shall include a summary of all clinical site monitoring visits completed and associated findings over the course of the contract. The report shall include additional materials and data pertinent to the review of contract progress, performance, efficiency and resource utilization.

The Contractor shall be responsible for submitting the final report to the NIMH COR and Contracting Officer at least thirty (30) calendar days before the end of the final period of performance.

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, e.g., NIMH OCR, the Contracting Officer as necessary to discuss contractual matters, and other relevant Contractor Staff to discuss specific clinical site monitoring assignments, including recently completed and upcoming clinical site monitoring visits. The contractor can expect up to three to four teleconferences per clinical site monitoring visit. 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:

The Government will authorize expenses for travel and lodging for site visits, as approved in advance by the Contracting Officer’s Representative. All travel expenses must be in accordance with the Federal Travel Regulations. The amount of lodging will be determined based on the length of the site visit. The Government anticipates up to three travelers per trip. Travel time may not be billed to the Government per the Federal Travel Regulation. Site visits will take place in the United States and Canada.

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.

B. 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 clinical site monitoring activities carried out by the site monitors, including tracking site visit assignments, assigning monitors, developing and maintaining site visit schedules, resolving scheduling conflicts, ensuring completion of appropriate pre-site visit activities and correspondence, and assisting in the assessment of the performance of site monitors and the quality of site monitoring 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 monitoring contracts and monitoring of clinical trials and research studies for mental health and psychiatric disorders.

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:

Section 508 is applicable to this contract.

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 https://irtsectraining.nih.gov/NDA.aspx https://irtsectraining.nih.gov/NDA.aspx 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.