SOURCES SOUGHT
R -- Clinical Site and Study Monitoring for Research Partnerships for Scaling-Up Mental Health Interventions
- Notice Date
- 7/7/2016
- Notice Type
- Sources Sought
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, Station Support/Simplified Acquisitions, 31 Center Drive, Room 1B59, Bethesda, Maryland, 20892, United States
- ZIP Code
- 20892
- Solicitation Number
- HHS-NIH-NIDA-SSSA-SBSS-16-490
- Archive Date
- 8/4/2016
- Point of Contact
- Lauren M. Phelps, Phone: 3014802453
- E-Mail Address
-
lauren.phelps@nih.gov
(lauren.phelps@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Request for Information/Sources Sought Notice HHS-NIH-NIDA-SSSA-SBSS-16-490 Clinical Site and Study Monitoring for Research Partnerships for Scaling-Up Mental Health Interventions Contracting Office Address: Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, Station Support Simplified Acquisitions, 31 Center Drive, Room 1B59, Bethesda, MD 20892, UNITED STATES. Introduction: 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: (1) the availability and capability of qualified large business and small business sources, (2) whether they small businesses are small businesses; HUBZone small businesses, service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) large and small business size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. 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. 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. ORDGMH has established Research Partnerships for Scaling-Up Mental Health Interventions (i.e., Scale-Up Hubs) to increase the research base on scaling up the delivery of evidence-based mental health care in LMICs. Five regional hubs constitute the Scale-Up Hub Network; each hub involves a multidisciplinary research group of investigators and their collaborators spanning multiple countries. The five hubs operate in Africa (2), Latin America (1), Asia (1), and the Eastern Mediterranean (1). They conduct implementation research, build research infrastructure, and develop local/regional research capacity. Each hub's research study is implementation science designed to study the scale up of an evidence-based psychosocial intervention in a low-or-middle-income country. Purpose and Objectives for the Procurement: The purpose of this procurement is to acquire comprehensive clinical site and study monitoring services for Research Partnerships for Scaling Up Mental Health Interventions in Low-and Middle-Income Countries (i.e., Scale-Up Hubs). The Scale-Up Hubs is a set of cooperative agreements funded by the National institute of Mental Health (NIMH) and designed to increase the research base on scaling up the delivery of evidence-based mental health care in low- and middle-income countries. Scale-Up Hubs Requiring Suppor t: The Scale-Up Hubs studies for which services shall be provided are listed below by hub. Minor aspects of the studies are subject to change. A.Asia Pacific Research for Mental Health Services (ASPIRE-MHS): ASPIRE-MHS is a collaborative effort of investigators and stakeholders from Myanmar, Papua New Guinea, Timor-leste, and Vietnam. The research study, which will take place in Myanmar, will use a quasi-experimental interrupted time series design to evaluate integration of the Common Elements Treatment Approach (CETA) into schools, primary care clinics, non-governmental organizations, and government military hospital and care centers using range of providers, e.g. teachers, community health workers, nurses, doctors, psychiatrists. B.African Regional Research Partnerships for Scaling Up Child Mental Health EBPs: The Africa regional Research Partnerships involves collaboration among researchers and stakeholders in Uganda, Ghana, Kenya, and South Africa. The research study will take place in Uganda and will be a Hybrid Type II effectiveness-implementation RCT with three arms to compare two experimental approaches (plus control group) for delivering multi-family group intervention for disruptive child behavior and behavioral functioning. C.Youth FORWARD: Capacity Building in Alternate Delivery Platforms and Implementation Models for Bringing Evidence-Based Behavioral Interventions to Scale for Youth Facing Adversity in West Africa: Youth Forward involves collaboration among researchers and stakeholders in Sierra Leone and Liberia. The research study, to take place in Sierra Leone, is a Hybrid Type II effectiveness-implementation, cluster randomized trial with waitlist control to compare two different approaches for implementing the Youth Readiness Intervention (YRI). D.The Eastern Mediterranean Partnership to implement the Regional Framework for Mental Health: Going to scale with school mental health (EMRO-SMHI): EMRO-SMHI is a collaborative effort of investigators and stakeholders from Pakistan, Egypt, Jordan, Iran, and the United Kingdom. The research study is a hybrid effectiveness-implementation, cluster randomized trial with qualitative evaluation to assess effectiveness of both an intervention (EMRO SMHI) and two implementation methods - conventional versus technology-assisted delivery of teacher training, guidance of child intervention, and monitoring of outcomes. E.Scaling up Science-based Mental Health Interventions in Latin America: Scaling up Science-based Mental Health Interventions in Latin America is a partnership among researchers and stakeholders in Colombia, Chile, Peru, Brazil, Guatemala, and Ecuador. The research study will take place in Colombia. The study design is a staggered scale up with "wait-list" matched controls to examine a model for delivering Square 2, an intervention that combines behavioral activation, problem-solving therapy, cognitive-behavioral therapy, and community reinforcement for treating comorbid depression and substance abuse. Project Requirements: Independently, and not as an agent of the Government, the Contractor shall provide services and materials for the following tasks: 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 •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/GuidancesInformationSheetsandNotices/ucm219433.htm https://humansubjects.nih.gov/nih-human-subjects-policies-guidance •Remedial or For-Cause Visits Remedial or for-cause visits will be conducted following the identification of non-compliance with study procedures and/or regulations. Each remedial or for- cause visit will be customized based on the specific concerns identified throughout the course of the research project. •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. 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 employees. •Detailed operational instructions addressing the site visit process. •Scheduling processes and procedures for preparing clinical site staff for monitoring visits. oThese 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 ORDGMH sponsored CHIRMH 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 1-2 study sites in each 12-month contract period. This shall result in a total of approximately 10-12 site visits, with approximately 2-3 visits to be conducted each quarter period of the 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. 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 CONUS 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 or his/her designee. Scheduling of "for cause" site visits will be determined by the COR or his/her designee 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 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. D.Options for Increased Quantity Additional site initiation, interim monitoring, and closeout visits may be required in each contract period beyond those identified in the scope of work. Accordingly, three (3) options for increased quantity for each type of clinical site visit shall be proposed for each contract period. Therefore, offerors shall propose three optional site initiation visits, three interim monitoring visits, and three closeout visits which may be exercised at the discretion of the Government during each contract period. The scope of work for these optional visits shall remain the same as described for the required visits. 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 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. 5.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. 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. 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 between three to four days for each site visit. Place of Performance: The contractor shall work from its own site and at the specific locations of the Scale-Up Hubs. The Scale-Up Hub cities and sites will be finalized following contract award, however the countries 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 above, travel to the NIMH Office in Bethesda, MD for meetings with the Government shall not be. Period of Performance: The required period of performance for this requirement is a one-year base period from April 1, 2017 through March 31, 2018 as well as three (3) one-year option periods. The total contract duration shall not exceed four (4) years. Contract Type: A firm fixed price contract with options for increased quantity and options to extend the term of the contract is anticipated. Invoicing shall be on a NET30 basis and payment made via Electronic Funds Transfer (EFT). Capability Statement: Contractors that believe they possess the ability to provide the required services/support should submit documentation of their ability to meet each of the project requirements to the Contract Specialist. The capability statement should include 1) the total number of employees, 2) documentation of ability to provide the required services/support 3) any contractor GSA Schedule contracts by which all of the requirements may be met, if applicable, and 4) any other information considered relevant to this program. Contractors must also provide their Company Name, DUNS number, Physical Address, and Point of Contact Information. Interested organizations are required to identify their type of business, applicable North American Industry Classification System Code, and size standards in accordance with the Small Business Administration. The government requests that no proprietary or confidential business data be submitted in a response to this notice. However, responses that indicate the information therein is proprietary will be properly safeguarded for Government use only. Capability statements must include the name and telephone number of a point of contact having authority and knowledge to discuss responses with Government representatives. Capability statements in response to this market survey that do not provide sufficient information for evaluation will be considered non-responsive. When submitting this information, please reference the solicitation notice number. All capability statements sent in response to this Sources Sought Notice must be submitted to Lauren Phelps, Contracting Officer, via email at lauren.phelps@nih.gov before the closing date and time of this announcement. All responses must be received by the specified due date and time in order to be considered. Note: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in the response. No proprietary, classified, confidential, or sensitive information should be included in your 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 review of the responses received, pre-solicitation and solicitation notices may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. The solicitation release date is pending. The Government anticipates negotiation of a firm fixed price contract.
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