Sources_Sought_(FBO)_4928849.pdf

Federal Business Opportunities (FBO)

SOURCES SOUGHT NOTICE

1. Solicitation Number: NIHDA201800273

2. Title: Clinical Site and Study Monitoring for Research Partnerships for Global

Mental Health

3. NAICS Code: 541720 – Research and Development in the Social Sciences and

Humanities

4. Size Standard: $20.5 Million

5. Description:

This is a Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources to perform a potential requirement.

This notice is issued to help determine the availability of qualified companies technically capable of meeting the Government requirement and to determine the method of acquisition. It is not to be construed as a commitment by the Government to issue a solicitation or ultimately award a contract. Responses will not be considered as proposals or quotes. No award will be made as a result of this notice. The Government will NOT be responsible for any costs incurred by the respondents to this notice. This notice is strictly for research and information purposes only.

Background: The National Institute of Mental Health (NIMH) Office for Research on Disparities and Global Mental Health (ORDGMH) coordinates the Institute’s efforts to reduce mental health disparities within and beyond the United States. As part of the NIMH’s Global Mental Health Research Strategy, ORDGMH sponsors research that addresses disparities in access to mental health care.

The mental health treatment gap (i.e., the proportion of persons who need, but do not receive care) exists globally, and collateral issues in low-resource settings make closing the treatment gap especially challenging. More than 80% of the world's population lives in low- and middle-income countries (LMICs) and the burden of disease associated with mental illnesses in these countries is rising. As of 1 July 2016, the World Bank defines low-income countries (e.g., Chile, China, India, and Kenya) as those with a gross national income (GNI) per capita, calculated using the World Bank Atlas method, of $1,025 or less in 2015; lower middle-income countries are those with a GNI per capita between $1,026 and $4,03. Moreover, the gap between treatment need and the allocation of human, scientific, and fiscal resources for mental health care in LMICs is great. The median number of psychiatrists per 100,000 people is 0.05 in LMICs, compared to 8.6 in high-income countries. The need for rigorous mental health research is immense, and research activity in this area is disproportionately lower than for other areas of health. At the same time, financing for mental health is insufficient: on average, there is a 200-fold difference between investments in low-income and high-income countries. These situational factors require innovative solutions for scaling up evidence-based mental health care in LMICs.

Purpose and Objectives: The purpose of this procurement is to acquire comprehensive clinical site and study monitoring services for a set of global mental health projects funded by the National institute of Mental Health (NIMH) and designed a) to increase the research base on scaling up the delivery of evidence-based mental health care in low-and middle-income countries, and b) to stimulate research partnerships that will conduct implementation research on closing health services gaps through expanded efforts to prevent, preempt, treat, manage, and otherwise minimize disability due to mental and substance use disorders. Examples of locations can be found here: Research Partnerships for Scaling Up Mental Health Interventions in Low-and Middle-Income Countries (U19) https://grants.nih.gov/grants/guide/pa-files/PAR-16-174.html (Reissue of RFA-MH-16-350) Implementation Science for the Prevention and Treatment of Mental and/or Substance Use Disorders in Low- and Middle-income Countries (U01) https://grants.nih.gov/grants/guide/rfa-files/RFA-MH-17-650.html.

Project 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, and provide staffing in selected World Bank defined Low and Middle Income Countries to conduct clinical:

o Site Initiation Visits o Interim Site Visits o Site Close-out Visits o Specialized Monitoring Visits

• The contractor shall work from its own site and at the specific locationsin Asia, South America,and Sub-Saharan Africa. The Global Mental Health Hub cities and sites will be finalized following contract award;however the regions 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 at the NIMH Office in Bethesda, Maryland for scheduled as well as short-notice meetings for urgent situations. While some travel expenses are authorized for this requirement per the “Travel” section below, travel to the NIMH Office in Bethesda, MD for meetings with the Government shall not be.

Please see the attached Statement of Work (SOW) for further details.

https://grants.nih.gov/grants/guide/rfa-files/RFA-MH-17-650.html

Delivery Schedule: The required period of performance for this requirement is a one-year base period from date of award as well as four (4) one-year option periods. The total contract duration shall not exceed five (5) years.

Capability statement /information sought. Please provide a capability statement, this includes:

• Provide evidence the respondent has performed services.

• Provide evidence of similar previous contracts of research of the same magnitude.

• Information regarding (a) staff expertise, including their availability, experience, and formal and other training; (b) current in-house capability and capacity to perform the work; (c) prior completed project of similar nature; (d) corporate experience and management capability; and (e) examples of prior completed Government contracts, references, and other related information.

Please provide your DUNS number, organization name, address point of contact, and size and type of business (e.g., 8(a), HubZone, etc.,) pursuant to the applicable NAICS code and any other information that may be helpful.

One (1) copy of the response is required and must be in Microsoft Word or Adobe PDF format using 11-point or 12-point font, 8-1/2” x 11” paper size, with 1” top, bottom, left and right margins, and with single or double spacing.

The information submitted must be must be in and outline format that addresses each of the elements of the project requirement and in the capability statement /information sought paragraphs stated herein.

The response is limited to one to two (1-2) page limit. The 1-2 page(s) does include the cover page, executive summary, or references, if requested.

All responses to this notice must be submitted electronically to the Contract Specialist and Contracting Officer. Facsimile responses are NOT accepted.

The response must be submitted to Danielle R. Brown, Contract Specialist, at Danielle.brown2@nih.gov.

The response must be received on or before Wednesday, June 27, 2018 at 11:00AM, Eastern Standard Time.

mailto:Danielle.brown2@nih.gov

No extensions to the deadline will be granted.

“Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work.

Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation.

Confidentiality: No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).”

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

STATEMENT OF WORK (SOW) – SERVICES

GENERAL INFORMATION

Title of Project:

Clinical Site and Study Monitoring for Research Partnerships for Global Mental Health

Statement of Need and Purpose:

The purpose of this procurement is to acquire comprehensive clinical site and study monitoring services for a set of global mental health projects funded by the National institute of Mental Health (NIMH) and designed a) to increase the research base on scaling up the delivery of evidence-based mental health care in low- and middle-income countries, and b) to stimulate research partnerships that will conduct implementation research on closing health services gaps through expanded efforts to prevent, preempt, treat, manage, and otherwise minimize disability due to mental and substance use disorders. Examples of locations can be found here:

Research Partnerships for Scaling Up Mental Health Interventions in Low-and Middle-Income Countries (U19) https://grants.nih.gov/grants/guide/pa-files/PAR-16-174.html (Reissue of RFA-

MH-16-350)

Implementation Science for the Prevention and Treatment of Mental and/or Substance Use Disorders in Low- and Middle-income Countries (U01) https://grants.nih.gov/grants/guide/rfa-files/RFA-MH-17-650.html

Background Information and Objective:

The National Institute of Mental Health (NIMH) Office for Research on Disparities and Global Mental Health (ORDGMH) coordinates the Institute’s efforts to reduce mental health disparities within and beyond the United States. As part of the NIMH’s Global Mental Health Research Strategy, ORDGMH sponsors research that addresses disparities in access to mental health care.

The mental health treatment gap (i.e., the proportion of persons who need, but do not receive care) exists globally, and collateral issues in low-resource settings make closing the treatment gap especially challenging. More than 80% of the world's population lives in low- and middle-income countries (LMICs) and the burden of disease associated with mental illnesses in these countries is rising. As of 1 July 2016, the World Bank defines low-income countries (e.g., Chile, China, India, and Kenya) as those with a gross national income (GNI) per capita, calculated using the World Bank Atlas method, of $1,025 or less in 2015; lower middle-income countries are those with a GNI per capita between $1,026 and $4,03. Moreover, the gap between treatment need and the allocation of human, scientific, and fiscal resources for mental health care in LMICs is great. The median number of psychiatrists per 100,000 people is 0.05 in LMICs, compared to 8.6 in high-income countries. The need for rigorous mental health research is immense, and research activity in this area is disproportionately lower than for other areas of https://grants.nih.gov/grants/guide/pa-files/PAR-16-174.html https://grants.nih.gov/grants/guide/rfa-files/RFA-MH-16-350.html https://grants.nih.gov/grants/guide/rfa-files/RFA-MH-16-350.html health. At the same time, financing for mental health is insufficient: on average, there is a 200-fold difference between investments in low-income and high-income countries. These situational factors require innovative solutions for scaling up evidence-based mental health care in LMICs.

Period of Performance:

The required period of performance for this requirement is a one-year base period from date of award as well as four (4) one-year option periods. The total contract duration shall not exceed five (5) 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 and Site Training Materials, and provide staffing in selected World Bank defined Low and Middle Income Countries to conduct clinical:

o Site Initiation Visits o Interim Site Visits o Site Close-out Visits o Specialized Monitoring Visits

• The contractor shall work from its own site and at the specific locationsin Asia, South America,and Sub-Saharan Africa. The Global Mental Health Hub cities and sites will be finalized following contract award;however the regions 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 at the NIMH Office in Bethesda, Maryland for scheduled as well as short-notice meetings for urgent situations. While some travel expenses are authorized for this requirement per the “Travel” section below, travel to the NIMH Office in Bethesda, MD for meetings with the Government shall not be.

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.

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.

• 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.

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.

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:

http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/Guida ncesInformationSheetsandNotices/ucm219433.htm https://humansubjects.nih.gov/nih-human-subjects-policies-guidance

• 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.

2. Clinical Site Monitoring Visits

The Contractor shall conduct both routine and specialized monitoring visits to NIMH ORDGMH sponsored Global Mental Health grants clinical sites to ensure compliance with: (1) 21 CFR 312—GCP; (2) 45 CFR 46—“Human 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 two monitoring visits to each study site in each 12-month contract period and one specialized site monitoring visit to approximately 10 study sites in LMICs such as Chile, China, India, Kenya, and Thailand in each 12-month contract period.

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.

http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/GuidancesInformationSheetsandNotices/ucm219433.htm http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/GuidancesInformationSheetsandNotices/ucm219433.htm https://humansubjects.nih.gov/nih-human-subjects-policies-guidance

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 ORDGMH CHIRMH-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 that examine provider-level, clinic-level, and system-level factors affecting the delivery of mental health care.

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

• 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 trials will be conducted and where clinical records are not maintained in English, including local languages and regional dialects

Recruitment of at least 75% of all site monitors required for active clinical trials and clinical trials planned for imminent implementation must be completed within thirty (30) calendar days of the effective date of the contract; 100% of all site monitors must be hired and trained within sixty (60) calendar days of the contract effective date.

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 ORDGMH. 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 two (2) routine (i.e. SIV, IMV, COV) site monitoring visits to each study site in each twelve-month contract period (approximately ten (10) to twelve (12) routine site monitoring visits overall in each twelve-month contract period). It is estimated that two (2) routine site visits shall be conducted each quarter of each 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 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. 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.

The Contractor should anticipate conducting one specialized site monitoring visit to approximately two (2) study sites in each 12-month contract period, with approximately one specialized site visits to be conducted every six months.

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.

3. 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 within and outside of the U.S., as identified in this statement of work, and to provide ready access to monitoring staff and services for domestic and 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 both domestic and foreign clinical sites.

4. 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.

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 1000 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, status update meetings, and reports:

A. Contract Kick-Off Meeting

Within two (2) weeks of the effective date of the contract, the Contractor shall participate in a one-day 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 at the NIMH Offices in Bethesda, Maryland, or by teleconference if the Contractor is not local to NIMH. 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. Small Business Subcontracting Plan

The Contractor shall submit a Small Business Subcontracting Plan at time of proposal submission that includes at a minimum the information prescribed in the solicitation. The Small Business Subcontracting Plan shall be submitted as a supplement to the offeror’s written technical proposal. The Small Business Subcontracting Plan shall ensure that small business, veteran-owned small business, service-disabled veteran-owned small business, HUBZone small business, small disadvantaged business, and women-owned small business concerns will have the maximum practicable opportunity to participate in contract performance consistent with its efficient performance and the following goals:

33% for small business, 5% for small disadvantaged business, 5% for women-owned small business, 3% for HUBZone small business, and 3% for veteran-owned small business and service-disabled veteran owned small business.

The Small Business Subcontracting Plan shall be evaluated by the Government for adequacy. The Contracting Officer reserves the right to negotiate the Small

Business Subcontracting Plan. The Small Business Subcontracting Plan must be approved by the Contracting Officer at the time of contract award. The successful offeror shall be required to comply in good faith with the requirements of the approved Small Business Subcontracting Plan.

C. 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

D. 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.

REPORTING REQUIREMENTS

A. Monthly Progress Review Meetings and Reports

The Contractor shall plan and conduct contract progress review meetings or teleconferences for the Government each month. 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.

Monthly Progress Review Meetings/Teleconferences shall include the COR, other COR-designated NIMH Staff, 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.

B. Annual Progress Review Meeting and Report

The Contractor shall plan and conduct annual progress review meetings of two days in duration. The meetings shall be held at the NIMH offices in Bethesda, Maryland. The purpose of the meetings will be for NIMH staff to review and discuss: common issues identified across the hubs and recommendations to address them (e.g., common data quality issues, common 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.

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 common issues identified across the hubs and provides recommendations to address them (e.g., common data quality issues, common 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..

C. 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.

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. It is anticipated that lodging will be for approximately three nights for each site visit/trip. 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 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 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 psychosocial interventions and services/implementation research projects in international settings.

Information System Security Plan:

The statement of work does NOT require the contractor to (1) develop, (2) have the ability to access, or (3) host and/or maintain a federal information system(s), the information security policies and procedures re applicable to the requirement. A "federal information system" is defined as an information system used or operated by an executive agency, by a contractor of an executive agency, or by another organization on behalf of an executive agency. [40 U.S.C., Sec. 11331]

Data Rights:

The National Institute of Mental Health shall have unlimited rights to and ownership of all deliverables provided under this procurement including reports, analyses, recommendations, briefings, work plans, created SOPs and all other deliverables. 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 contractor is NOT required to write and publish articles of data produced as a result of the requirements of the SOW.

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). Whenever the Contractor is uncertain with regard to the confidentiality of or a property interest in information under this contract, the Contractor should consult with the Contracting Officer prior to any release, disclosure, dissemination, or publication.