CSS 75N95025Q00022.pdf

TEMPLATE

STREAMLINED SOLICITATION FOR COMMERCIAL ITEMS

COMPETITIVE

COMBINED SYNOPSIS / SOLICITATION

Title: Clinical Site and Study Monitoring for NIMH Funded Research in Global Settings

(i) This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued.

(ii) The solicitation number is 75N95025Q00022 and the solicitation is issued as a request for quotation (RFQ)

This acquisition is for a commercial item or service and is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13—Simplified Acquisition Procedures;

FAR Subpart 13.5— Simplified Procedures for Certain Commercial Items; and FAR Part 12—Acquisition of Commercial Items, and is expected to exceed the simplified acquisition threshold.

(iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) Number 2024-07, with effective date 09/30/2024.

(iv) The associated NAICS code 541990 - All Other Professional, Scientific, and Technical Services and the small business size standard is $19.5 Million. This requirement has no set-aside restrictions.

(v) This requirement is for the National Institute of Mental Health (NIMH) program titled Clinical Site and Study Monitoring for NIMH Funded Research in Global Settings.

See Attachment 1 – Statement of Work for complete details and specifications.

(vi) The Government anticipates award of a single award Indefinite Delivery/Indefinite

Quantity (IDIQ) type contract with an ordering period of 11/25/2024 through 11/24/2029 (5-years) and a maximum ordering ceiling of $2,000,000. The Government anticipates issuing firm-fixed price (FFP) task orders during the ordering period on an as needed basis. The first task order is anticipated to be a firm-fixed price task order for the kick off meeting with a period of performance of 11/25/2024 through 12/15/2024.

(vii) The provision at FAR 52.252-1, Solicitation Provisions Incorporated by Reference (Feb

1998), applies to this acquisition.

See Attachment 2 – Additional Terms and Conditions for a list of provisions and clauses that apply to this acquisition and are hereby incorporated by reference:

The clause at FAR 52.252-2, Clauses Incorporated by Reference (Feb 1998), applies to this acquisition. This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at these addresses:

https://www.acquisition.gov/browse/index/far https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

(End of clause)

The following provisions and clauses apply to this acquisition and are attached in full text. Offerors MUST complete the provisions at 52.204-24 and 52.204-26 and submit completed copies as separate documents with their proposal.

• FAR 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Nov 2021)

• FAR 52.204-26 Covered Telecommunications Equipment or Services- Representation (Oct 2020)

• FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders- Commercial Products and Commercial Services (May 2024)

The following is also attached:

• NIH Invoice and Payment Instructions with IPP (Rev. Mar 2023)

(vii) The Government will evaluate quotations or offers in accordance with FAR 13.106-2 and award a purchase order from this solicitation to the responsible offeror whose quote conforming to the solicitation will be most advantageous to the Government, on the basis of best value, technical factors and price considered. Technical factors together shall be considered more important than price and all technical evaluation factors are detailed below. The following factors shall be used to evaluate quotes:

https://www.acquisition.gov/browse/index/far https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

Factor 1: Technical Approach

The Contractor’s proposal shall address each area of the statement of work requirements in sufficient detail to demonstrate a clear understanding of the statement of work and compliance with requirements. The proposed technical approach shall be evaluated for the appropriateness and effectiveness of the overall approach as well as the methods, procedures, and resources proposed for performing the tasks described in this solicitation.

Factor 2: Key Personnel

The Contractor’s proposal shall provide a management plan detailing the proposed management approach as well as a draft training plan and quality control plan. The management plan shall cover key personnel that are able to provide the following:

document experience, educational background and training, and availability of the proposed staff and their designated responsibility on the project. This includes the education, experience, managerial competence and time commitment of the proposed manager and the experience, technical competence, and time commitment of other staff; staff expertise in technical and administrative support (including travel logistics), financial management, reporting and deliverables, and proper invoicing. In addition the plan will include plans for adequate communication with the Government, contractor staff management and training, and quality control. The management approach shall be evaluated for level of conformance to the key personnel qualifications identified in this statement of work, as well as the appropriateness and effectiveness of communication/problem resolution, and staff management and training to ensure quality performance of required efforts. Offeror proposals must contain resumes/CVs for key personnel proposed.

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 psychosocial interventions, and/or services/implementation research projects relevant to areas including mental health, HIV/AIDS, behavioral/biomedical studies of prevention and treatment and implementation science in international settings.

This position requires expert communication skills and organizational abilities including the ability to 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.

Factor 3: Past Performance

The Contractor shall provide at least two (2) past performance references with knowledge of the contractor’s relevant skills and experience related to the requirements outlined in this Statement of Work.

References shall include the following information:

a) Name of Organization

b) Description of Contractor’s Responsibilities as they related to this SOW

c) Contract Period of Performance

d) Contact Name and Title

e) Telephone Number

f) E-mail address

Past Performance shall be evaluated for relevance to the current requirement, length of experience, and customer satisfaction in reference to the following:

1) Contractor’s experience in the successful monitoring of clinical research studies.

2) Contractor’s experience in the monitoring of clinical trials and research studies for mental health, HIV/AIDS, prevention and treatment and implementation science in international settings.

3) Evidence of expertise with regulatory approval processes associated with clinical research as well as human subjects’ protection regulations and good clinical practice guidelines.

Technical proposals will be evaluated using an adjectival rating in accordance with the following scale:

High Confidence- The Government has high confidence that the Offeror understands the requirement, proposes a sound approach, and will be successful in performing the contract with little or no Government intervention.

Some Confidence - The Government has some confidence that the Offeror understands the requirement, proposes a sound approach, and will be successful in performing the contract with some Government intervention.

Low Confidence - The Government has low confidence that the Offeror understands the requirement, proposes a sound approach, or will be successful in performing the contract even with Government intervention.

A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer’s specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

(ix) The Offerors to include a completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications-Commercial Items (May 2024), with its offer.

If the offeror has completed FAR clause 52.212-3 at www.sam.gov, then the offeror does http://www.sam.gov/ not need to provide a completed copy with its offer.

(x) The clause at FAR 52.212-4, Contract Terms and Conditions- Commercial Products and Commercial Services (NOV 2023), applies to this acquisition. Addendum to this FAR clause applies to this acquisition and is attached.

(xi) Additional contract requirements or terms and conditions are applicable to this acquisition. Technical & Business Volume combined shall be no longer than 10 pages, excluding key personnel resume(s)/curriculum vitae. Offerors shall provide the FFP estimates in its offer for the site visits for evaluation of anticipated task orders issued on an as needed basis during the IDIQ contract. The minimum and maximum number of site visits per contract year of the IDIQ’s 5- year ordering period for estimate purposes shall be provided in accordance with the SOW (Attachment 1).

SOW (page 4): The Contractor should anticipate conducting one to two monitoring visits to a given study site in each 12-month contract period in locations determined by staff in CGMHR and DAR each 12-month contract period. Specialized clinical site monitoring visits will be completed on an as-needed basis when indicated. The general location of sites will be in Asia, South America, Central America, Pacific Islands, Eastern Europe, and Africa.

SOW (page 5): The Contractor should anticipate conducting one (1) to two (2) routine

(i.e. SIV, IMV, COV) site monitoring visits to a given study site in each twelve-month contract period (approximately a minimum of four (4) to a maximum of twelve (12) routine site monitoring visits overall in each twelve-month contract period).

See attachment 2 for the other additional T&Cs.

(xii) The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement.

(xii) Responses to this solicitation must include clear and convincing evidence of the offeror’s capability of fulfilling the requirement as it relates to the technical evaluation criteria. The price proposal must include the labor categories, an estimate of the number of hours required for each labor category, fully loaded fixed hourly rate or each labor category, breakdown and rationale for other direct costs or materials, and the total amount.

The Unique Entity ID from SAM.gov, the Taxpayer Identification Number (TIN), and the certification of business size must be included in the response. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.

All questions must be received by 9:00 A.M. Eastern Time, on 11/06/2024, and reference Solicitation Number 75N95025Q00022. Questions may be submitted electronically to Cassandra Conley, Contract Specialist, at cassandra.conley@nih.gov.

All offers must be received by 9:00 A.M. Eastern Time, on 11/14/2024, and reference Solicitation Number 75N95025Q00022. Responses must be submitted electronically to Cassandra Conley, Contract Specialist, at cassandra.conley@nih.gov.

Fax responses will not be accepted.

http://www.sam.gov/ mailto:cassandra.conley@nih.gov mailto:cassandra.conley@nih.gov

STATEMENT OF WORK

SERVICES

GENERAL INFORMATION

Title of Project:

Clinical Site and Study Monitoring for NIMH Funded Research in Global Settings

Statement of Need and Purpose:

The purpose of this procurement is to acquire comprehensive clinical site and study monitoring services for research in global settings that target the goals of the National Institute of Mental Health, with particular emphasis on projects addressing the priorities of the Center for Global Mental Health Research (CGMHR) and the Division of AIDS Research (DAR).

Background Information and Objective:

The National Institute of Mental Health (NIMH) Division of AIDS Research (DAR) supports research to reduce the incidence of HIV/AIDS worldwide and to decrease the burden of living with HIV/AIDS. The Center for Global Mental Health Research (CGMHR) coordinates the NIMH’s efforts to reduce mental health disparities beyond the United States. As part of the NIMH’s Global Mental Health Research Strategy, the Center sponsors research that increases the body of evidence necessary to inform decisions concerning the adoption and scaling up of evidence-based interventions beyond the United States, particularly in low and middle income countries (LMICs).

Period of Performance:

The Government anticipates award of a single award Indefinite Delivery/Indefinite Quantity (IDIQ) type contract with an ordering period of 11/25/2024 through 11/24/2029 (5-years). Firm-fixed price task orders shall be issued on an as needed basis.

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 and Site Training Materials to conduct clinical site monitoring visits.

• The contractor shall conduct clinical site monitoring visits at sites determined by staff in CGMHR and DAR. The general location of sites will be in Asia, South America, Central America, Pacific Islands, Eastern Europe, and Africa.

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:

1. Development of Clinical Site Monitoring Standard Operating Procedures for

Implementation and Site Training Materials

The Contractor shall develop Standard Operating Procedures (SOPs) governing all aspects of the conduct of both routine and specialized clinical site monitoring visits to the

COR within fourteen (14) calendar days of the contract effective date.

Separate SOPs shall be provided for each of the following events and activities:

• Site Initiation Visits

The purpose of the Site Initiation Visit (SIV) is to ensure a study team is ready to initiate the enrollment of participants into the study, including possession of required regulatory approvals (e.g., IRB, DSMB, FDA) and receipt of appropriate training on study specific procedures and Good Clinical Practice (GCP). The SIV includes, but is not limited to a review of planned study procedures, the IRB approved protocol and consent documents, manual of operations, regulatory binder, and source document and CRF templates. It is anticipated that the level of effort for site initiation visits shall be the same at each site.

• Interim Site Visits

Interim Site Visits (ISVs) monitor compliance with federal and country-specific regulatory requirements, Good Clinical Practice, International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines, protocol-specific requirements, and NIMH policies and procedures. Each ISV 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, protocol deviations, primary outcome data, and electronic case report forms. The visit will also include an assessment of site operations, IP accountability (if applicable), and follow-up on previous monitoring visit action items.

Some of the regulatory requirements and policies and procedures which will be applicable may be found at the following locations:

https://grants.nih.gov/policy/humansubjects.htm https://www.nimh.nih.gov/funding/clinical-research/nimh-policy-governing-the-monitoring-of-clinical-trials https://www.nimh.nih.gov/funding/clinical-research/nimh-reportable-events-policy https://www.nimh.nih.gov/funding/clinical-research/policy-governing-independent-safety-monitors-and-independent-data-and-safety-monitoring-boards

• Site Close-out Visits Once enrollment has completed, a Close-out Visit (COV) will be conducted to ensure the protocol was followed, all adverse events and deviations were reported per protocol, and that source data were entered appropriately into the study database. The COV includes, but is not limited to, reviewing action items from the previous monitoring visit, verifying that all SAEs and protocol deviations were reported per protocol, reviewing informed consent forms, ensuring subjects were randomized to the correct intervention, performing IP accountability (if applicable), and discussing record retention requirements.

https://grants.nih.gov/policy/humansubjects.htm https://www.nimh.nih.gov/funding/clinical-research/nimh-policy-governing-the-monitoring-of-clinical-trials https://www.nimh.nih.gov/funding/clinical-research/nimh-policy-governing-the-monitoring-of-clinical-trials https://www.nimh.nih.gov/funding/clinical-research/nimh-reportable-events-policy https://www.nimh.nih.gov/funding/clinical-research/policy-governing-independent-safety-monitors-and-independent-data-and-safety-monitoring-boards https://www.nimh.nih.gov/funding/clinical-research/policy-governing-independent-safety-monitors-and-independent-data-and-safety-monitoring-boards

• Specialized Clinical Site Monitoring Visits Specialized clinical site monitoring visits shall be conducted that may include remedial and for-cause visits. These visits will focus on specific aspects of clinical trial conduct and clinical site operations. Specific data and other information will be collected, and assessed as directed by NIMH staff and the

COR.

All SOPs 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 be responsible for providing this information.

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

• Detailed operational instructions addressing the site visit process.

• Clear delineation of the the proposed process for scheduling site visits with ongoing communication of these plans with the NIMH Program Officer (PO) and COR 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.

Additionally, the Contractor shall keep abreast of all changes in Federal and country-specific 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 review and approval. Updated SOPs shall be implemented by the Contractor only after receipt of written COR approval.

2. Clinical Site Monitoring Visits

The Contractor shall conduct both routine and specialized monitoring visits to NIMH sponsored CGMHR and DAR grants clinical sites to ensure compliance with: (1) 21 CFR 312—GCP; (2) 45 CFR 46—“Human

3. Subjects Protection;” (3) the ICH E6-GCP Guidelines; (4) country-specific requirements governing human subjects research; (5) protocol-specific requirements; (6) policies and guidance set forth by the U.S. Department of Health and Human Services Office of Human Research Protections and (7) NIMH policies and procedures.

The Contractor should anticipate conducting one to two monitoring visits to a given study site in each 12-month contract period in locations determined by staff in CGMHR and DAR each 12-month contract period. Specialized clinical site monitoring visits will be completed on an as-needed basis when indicated. The general location of sites will be in Asia, South America, Central America, Pacific Islands, Eastern Europe, and Africa.

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 the full scope of NIMH -supported clinical trials and clinical sites detailed in this statement of work. 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 studies of psychosocial interventions for mental health and psychiatric disorders.

• Training and experience in monitoring implementation research studies including but not limited to provider-level, clinic-level, and system-level factors affecting the delivery of mental health care.

• Training and experience in behavioral and biomedical clinical studies targeting HIV prevention, treatment, and long term management.

• Training and significant experience in monitoring clinical trials conducted at foreign sites in resource-limited countries, in a variety of community- and hospital-based settings, and across a broad range of diverse patient populations and cultures.

• Knowledge of country-specific health care systems, clinical research regulations, local customs and business practices relevant to the sites indicated in this statement of work.

• Fluency in speaking and reading English and proficiency speaking and reading in the language of countries where clinical studies and trials will be conducted and where clinical records are not maintained in English, including local languages and regional dialects.

The contractor should plan to recruit, hire and train site monitors (to be able to service the locations described above) within a reasonable timeframe prior to a site visit.

The Contractor shall ensure that in-country site monitors shall be used whenever possible and appropriate. This shall assist in ensuring relevant country-specific knowledge and language proficiencies and to reduce costs.

B. Clinical Site Monitoring Visits

The Contractor shall perform routine clinical site monitoring visits as scheduled by the NIMH. These visits include site initiation visits, interim monitoring visits and closeout visits (as described above). The schedule shall be based on study progress at each site.

The Contractor should anticipate conducting one (1) to two (2) routine (i.e. SIV, IMV, COV) site monitoring visits to a given study site in each twelve-month contract period (approximately a minimum of four (4) to a maximum of twelve

(12) routine site monitoring visits overall in each twelve-month contract period).

Assignments for routine clinical site monitoring visits will be provided to the Contractor no less than six (6) weeks in advance of each contract period quarter.

During routine 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 Adverse Events (AEs) and 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 and country-specific regulatory requirements, 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 routine 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 twenty-one (21) calendar days prior to the scheduled site visit.

Reports of routine clinical site monitoring visits shall be prepared using site visit report templates developed by the Contractor and approved by the COR.

Reports shall be delivered to the COR and other appropriate NIMH staff members no later than fourteen (14) calendar days following completion of each site visit. Findings 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 and other appropriate NIMH staff members within 24 hours of site visit completion by telephone and email.

C. Specialized Clinical Site Monitoring Visits

The Contractor shall perform a variety of specialized clinical site monitoring visits, to be assigned by the COR on an as-needed basis when indicated and requested by CGMHR and DAR staff. These visits will focus on specific aspects of clinical trial conduct and clinical site operations. Specialized clinical site monitoring visits may include remedial and for-cause visits.

Specialized clinical site visits may be conducted either in tandem with other clinical site monitoring visits or as separate independent visits, as approved by the COR. The Contractor shall conduct specialized clinical site visits in accordance with the timelines specified in the monitoring assignments provided by the COR. Scheduling of “for cause” site visits will be determined by the COR on a case-by-case basis depending on the nature and potential risk characteristics associated with such visits. The Contractor will develop specialized forms and templates specifying the data and other information to be collected, assessed, and reported for specialized clinical site visits. The COR will oversee the development process and will approve all forms and templates prior to implementation.

For all specialized site visits, the contractor shall 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 twenty-one (21) calendar days prior to the scheduled site visit.

The Contractor shall prepare summaries of the results of specialized visits and submit these to the COR and any other identified NIMH staff member(s) within five (5) calendar days of visit completion. Critical findings (e.g. any fraudulent findings, prefilling of CRFs, invalid signatures, and unreported SAEs) shall be reported to the COR and appropriate NIMH staff member within 24 hours of visit completion by telephone and email. Completed reports of specialized site visits shall be sent to the COR and NIMH staff member within fourteen (14) calendar days of site visit completion.

4. 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. Regional or local field offices, equipment, or other resources to conduct clinical site and study monitoring activities outside of the U.S., as identified in this statement of work, and to provide ready access to monitoring staff and services for foreign clinical sites.

B. Information technology systems and state-of-the-art field equipment, including laptops, blackberries, and smartphones with international connectivity for the conduct of routine and specialized clinical site visits and monitoring activities conducted at and foreign clinical sites.

5. 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 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.

6. 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:

A. Provide report(s) of findings

Reports for routine clinical site monitoring visits shall be delivered to the COR and other appropriate NIMH staff members no later than fourteen (14) calendar days following completion of each site visit. Reports of specialized site visits shall be sent to the COR and NIMH staff member within fourteen (14) calendar days of site visit completion.

REPORTING REQUIREMENTS

A. Contract Kick-Off Meeting

Within two (2) weeks of the effective date of the contract, the Contractor shall participate in a Contract Kick-Off Meeting with the COR, Contracting Officer, other NIMH Staff designated by the COR. The Supervisory Program Manager and other relevant Contractor staff shall be in attendance. The meeting shall be held by teleconference. The purpose of the Contract Initiation Meeting shall be to orient the Contractor to NIMH contract procedures, discuss NIMH policies and procedures, review the status of site monitors on staff and recruitment efforts to hire monitors within specified timelines, and review current and upcoming clinical site monitoring assignments.

B. Progress Review Meetings and Reports

The Contractor shall plan and conduct contract progress review meetings or teleconferences for the Government each month or as directed by Government. These meetings shall review the status of ongoing and future clinical site monitoring assignments;

issues related to contract staffing and turnover, workload, and scheduling; significant findings resulting from clinical site monitoring visits conducted over the preceding month and the status of their resolution; project management procedures and assessment of the efficiency and quality of the clinical site monitoring activities conducted.

Progress Review Meetings/Teleconferences shall include the COR, other COR-designated NIMH staff, e.g., POs, the Contracting Officer as necessary to discuss contractual matters, as well as the Contractor’s Supervisory Program Manager and other relevant Contractor Staff. The meeting/teleconference schedule will be established by the COR post-award.

The Contractor shall be responsible for preparing and distributing agendas and other meeting/teleconference materials at least three (3) calendar days in advance of the teleconference/meeting. The contractor shall also be responsible for preparing and distributing to participants written meeting minutes that include written summaries of all action items and decisions resulting from these meetings/teleconferences within seven (7) calendar days of meeting/teleconference completion.

C. Annual Progress Review Meeting and Report

The Contractor shall plan and conduct annual progress review meetings. The meeting may be held by teleconference. The purpose of the meetings will be for NIMH staff to review and discuss issues identified at sites and recommendations to address them (e.g., data quality issues, issues around reporting of Serious Adverse Events, etc.); project progress; 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.

Annual meetings shall be attended by the COR, and all relevant Contractor personnel, including the Supervisory Program Manger financial personnel, and other relevant personnel. In planning and conducting the annual progress review meetings, the contractor shall be responsible for:

A) Developing and submitting the agenda for COR review and approval at least thirty (30) days before each meeting.

B) Developing additional materials and data pertinent to the review of contract progress, performance, efficiency and resource utilization.

C) Distributing agendas and additional materials to meeting participants at least seven (7) days in advance of the meeting dates.

D) Developing oral presentation materials.

E) Making logistical and travel arrangements for all Contractor participants if needed.

F) Preparing and Submitting Annual Progress Review Meeting Reports, for

COR and Contracting Officer review and approval, within thirty (30) days of meeting completion. The Annual Progress Review Meeting Reports shall discuss issues identified at sites and provide recommendations to address them (e.g., data quality issues, issues around reporting of Serious Adverse Events, etc.); project progress; 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..

D. Ad-Hoc Meetings and Reports

At the request of the COR, the Contractor shall arrange teleconferences and/or meetings with the COR to discuss specific clinical site monitoring assignments, including recently completed and upcoming clinical site monitoring visits. 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.

E. Draft Training Plan

The Contractor shall submit as a supplement to its written technical proposal, a draft Quality Training Plan that describes the Contractor’s training strategy in reference to the following:

• Initial and continuing training activities to be carried out both in-house and through non-contractor organizations

• Frequency of training

• Training methods/approaches (e.g., workshops, videocasts, written materials, etc.)

• Provisions for ensuring that experienced monitors accompany new monitors on initial site visits—both routine and specialized

• Plans for monitoring training effectiveness

• Conformance with Government Information Security Training and Ethics

Training requirements as detailed in this Statement of Work

F. Final Training Plan

A final Training Plan, with updates per COR comments, shall be delivered to the Government no later than three (3) working days after the Contract Kick-Off Meeting.

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 Regulation. The Government anticipates one traveler per trip.

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 Personnelin the contract..

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 overseeing the site monitors, 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.

B. 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 psychosocial interventions, and/or services/implementation research projects relevant to areas including mental health, HIV/AIDS, behavioral/biomedical studies of prevention and treatment and implementation science in international settings.

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

ADDITIONAL TERMS AND CONDITIONS

FEDERAL ACQUISITION REGULATION (FAR) PROVISIONS INCORPORATED BY REFERENCE

52.252-1 Solicitation Provisions Incorporated by Reference (FEB 1998)

This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this address:

https://www.acquisition.gov/ https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/part-352-solicitation-provisions-contract-clauses/index.html

(End of provision)

Table A – Provisions Incorporated by Reference FAR Provision Title Date 52.204-7 System for Award Management OCT 2018 52.204-16 Commercial and Government Entity Code Reporting AUG 2020 52.212-1 Instructions to Offerors—Commercial Products and Commercial Services SEPT 2023

52.212-3 Offeror Representations and Certifications—Commercial Products and

Commercial Services

MAY 2024

HHS ACQUISITION REGULATION (HHSAR) PROVSIONS INCLUDED IN FULL TEXT

352.239-73 Electronic and Information Technology Accessibility Notice (December 18, 2015)

(a) Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998 and the Architectural and Transportation Barriers Compliance Board Electronic and Information (EIT) Accessibility Standards (36 CFR part 1194), require that when Federal agencies develop, procure, maintain, or use electronic and information technology, Federal employees with disabilities have access to and use of information and data that is comparable to the access and use by Federal employees who are not individuals with disabilities, unless an undue burden would be imposed on the agency. Section 508 also requires https://www.acquisition.gov/ https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/part-352-solicitation-provisions-contract-clauses/index.html https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/part-352-solicitation-provisions-contract-clauses/index.html that individuals with disabilities, who are members of the public seeking information or services from a Federal agency, have access to and use of information and data that is comparable to that provided to the public who are not individuals with disabilities, unless an undue burden would be imposed on the agency.

(b) Accordingly, any offeror responding to this solicitation must comply with established HHS EIT accessibility standards. Information about Section 508 is available at https://www.hhs.gov/web/508. The complete text of the Section 508 Final Provisions can be accessed at https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards.

(c) The Section 508 accessibility standards applicable to this solicitation are stated in the clause at 352.239-74, Electronic and Information Technology Accessibility.

In order to facilitate the Government’s determination whether proposed EIT supplies meet applicable Section 508 accessibility standards, offerors must submit an HHS Section 508 Product Assessment Template, in accordance with its completion instructions. The purpose of the template is to assist HHS acquisition and program officials in determining whether proposed EIT supplies conform to applicable Section 508 accessibility standards. The template allows offerors or developers to self-evaluate their supplies and document—in detail—whether they conform to a specific Section 508 accessibility standard, and any underway remediation efforts addressing conformance issues. Instructions for preparing the HHS Section 508 Evaluation Template are available under Section 508 policy on the HHS website https://www.hhs.gov/web/508.

In order to facilitate the Government’s determination whether proposed EIT services meet applicable Section 508 accessibility standards, offerors must provide enough information to assist the Government in determining that the EIT services conform to Section 508 accessibility standards, including any underway remediation efforts addressing conformance issues.

(d) Respondents to this solicitation must identify any exception to Section 508 requirements. If a offeror claims its supplies or services meet applicable Section 508 accessibility standards, and it is later determined by the Government, i.e., after award of a contract or order, that supplies or services delivered do not conform to the described accessibility standards, remediation of https://www.hhs.gov/web/508 https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards…