Site and Study Monitoring for Scale-Up Hubs
Added: Jan 12, 2017 12:00 pm Clinical Site and Study Monitoring forResearch Partnerships for Scaling-Up Mental Health InterventionsCompetitive Combined Synopsis/Solicitation NIH-NIDA-SSSA-CSS-17-001INTRODUCTIONThis 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. This acquisition is being conducted in accordance with the procedures of FAR Part 13--Simplified Acquisition Procedures, FAR Subpart 13.5--Test Program for Certain Commercial Items, and FAR Part 12--Acquisition of Commercial Items.The solicitation number is NIH-NIDA-SSSA-CSS-17-001 and the solicitation is issued as a request for proposal (RFP). NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODEThe intended procurement is classified under NAICS code 541990 with a Size Standard of $15 Million.SET-ASIDE STATUSThis acquisition is unrestricted. Businesses of any size classification may respond.ACQUISITION AUTHORITY 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--Test Program for Certain Commercial Items, and FAR Part 12-Acquisition of Commercial Items, and IS expected to exceed the simplified acquisition teshold. The solicitation document and incorporated provisions and clauses are those in effect tough Federal Acquisition Circular 2005-89 dated July 14, 2016. The resultant contract will include all applicable provisions and clauses in effect tough this date. DESCRIPTION OF REQUIREMENTBackgroundThe 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. PurposeThe 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 Support: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 (two sites - Rangoon, Myanmar and Myitkyina, 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 Kenya (tee sites - Entebbe, Uganda; Kampala, Uganda; and Nairobi, Kenya) and will be a Hybrid Type II effectiveness-implementation RCT with tee 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 Freetown, 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 shall take place in Pakistan (two sites- Islamabad, Pakistan and Rawalpindi, Pakistan) and 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 (two sites - Bogota, Colombia and Duitama, 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 RequirementsIndependently, 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 MaterialsThe 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 VisitsThe 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 VisitsInterim 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.htmhttps://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.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.2. Clinical Site Monitoring VisitsThe 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 PersonnelThe 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 dialectsRecruitment 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 VisitsThe 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 criteriaiii. Reporting of protocol violationsiv. Accuracy and completeness of the reporting of protocol exemptionsv. Documentation and reporting of Serious Adverse Events (SAEs)vi. Documentation of informed consent and adherence to informed consent proceduresvii. Documentation of findings, including verification of endpointsviii. Maintenance of appropriate source documentationix. Adherence to federal and country-specific regulatory requirements, GCP and ICH guidelines, and NIMH policies and proceduresx. Adequacy of operations, performance, and management related to protocol-specific requirementsxi. Regulatory review to assess the adequacy of procedures for ensuring compliance with regulatory requirementsxii. Adherence to other protocol specific requirementsFor 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 VisitsThe 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 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.D. Options for Increased QuantityAdditional site initiation, interim monitoring, and closeout visits may be required in each contract period beyond those identified in the scope of work. Further, remedial or for-cause visits may be required as needed. 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 toughout the course of the research project; however, it is expected that the scope of remedial or for-cause visits shall be the same for any such visit required.Accordingly, tee (3) options for increased quantity for each type of clinical site visit shall be proposed for each contract period. Therefore, offerors shall propose tee optional site initiation visits, tee interim monitoring visits, tee remedial visits, and tee 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. Offerors shall also propose one (1) option for increased quantity for remedial or for-cause visits for each contract period.3. Facilities, Equipment, and Other Resource RequirementsThe 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 OversightThe 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.5. Contract ManagementThe 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 tough this contract. Contract management shall also oversee quality assurance and control.Key PersonnelThe 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 overseeing the Scale-Up Hub Site Managers, 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 services/implementation research projects in international settings.Deliverables/Status Update Meetings/Reporting RequirementsThe Contractor shall provide the following deliverables, status update meetings, and reports:A. Contract Kick-Off MeetingWithin 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. Monthly Progress Review Meetings and ReportsThe 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 tee (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 ReportThe 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 his/her designees, 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..D. Ad-Hoc Meetings and ReportsAt the request of the COR, the Contractor shall arrange teleconferences and/or meetings with the COR and his/her designee 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 tee (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. Small Business Subcontracting PlanThe 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.F. Draft Training PlanThe 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 tough 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 WorkG. Final Training PlanA final Training Plan, with updates per COR comments, shall be delivered to the Government no later than tee (3) working days after the Contract Kick-Off Meeting.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.TravelThe 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 tee nights for each site visit/trip. Assume tee roundtrips to each hub site, excepting Kampala, Uganda and Freetown, Sierra Leone for which six roundtrips are anticipated. The Government anticipates one traveler per trip.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 tough March 31, 2018 as well as tee (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 Procedures:Invoicing procedures shall be identified at time of award. NET30 invoicing with payment via Electronic Funds Transfer (EFT) is anticipated.CollaborationIt is required that all contractors involved with the National Institute of Mental Health community work collaboratively with federal staff and other contractors towards the NIMH mission and other affected organizations and follow the direction of the Contracting Officer's Representative (COR), and/or the designated Federal Project Manager(s)/Lead(s). This collaboration includes day-to-day activities, support, development, knowledge transfer and creating and sharing documentation when required.Confidential InformationThis 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.Information Technology Security Requirements Please see the Information Security Requirements detailed in Appendix A.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.Reference MaterialsReference information about the Research Partnerships for Scaling Up Mental Health Interventions in Low-and Middle-Income Countries (i.e., Scale-Up Hubs) may be found at the following web site:http://grants.nih.gov/grants/guide/rfa-files/RFA-MH-16-350.htmlQuestion and Answer PeriodInterested contractors may submit questions relating to this requirement. Questions shall be submitted to the contract specialists, Sneha Patel, via email at sneha.patel@nih.gov and Zenab Chowdy, zenab.chowdy@nih.gov by or before Thursday, January 19, 2017 at 5:00 PM Eastern Standard Time. Late questions shall not be accepted. Questions will be anonymized and answered. The answers will be provided as soon as possible after the question deadline via solicitation amendment. Should no questions be received, no amendment shall be posted. EVALUATION CRITERIAThe Government will award a contract resulting from this requirement 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:Factor 1: Technical ApproachThe 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: Management ApproachThe 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 as well as 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.a) 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 in monitoring of psychosocial interventions and services/implementation research projects in international settings.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.Factor 3: Past PerformanceThe 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 Organizationb) Description of Contractor's Responsibilitiesc) Contract Period of Performanced) Contact Name and Titlee) Telephone Numberf) E-mail addressPast 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 international clinical research studies. 2) Contractor's experience in the monitoring of psychosocial interventions and services/implementation research projects.3) Evidence of familiarity with regulatory approval processes associated with clinical research conducted in international settings as well as human subjects protection regulations and good clinical practice guidelines.EVALUATION METHODTechnical proposals will be evaluated using a summary adjectival rating in accordance with the following scale:Excellent Very GoodGood AcceptableMarginalUnacceptableAdjectival ratings shall be included in final technical evaluation summary documentation. Award shall be made to the contractor offering the greatest value in consideration of both technical factors and price. Award shall not be considered for proposals evaluated to be "unacceptable."RESPONSE FORMATResponses to this requirement must include clear and convincing evidence of the offeror's capability of fulfilling the requirement as it relates to the technical evaluation criteria. Each evaluation criterion must be addressed in a technical proposal. A separate price quote must be provided and include associated pricing for the requirements listed above. Please ensure that optional tasks are quoted separately from the required tasks. Please see the Price Schedule Template in Appendix C. Contractors must provide their Company Name, Dun & Bradstreet Number (DUNS), Taxpayer Identification Number (TIN), Business Size, Physical Address, and Point of Contact Information in their responses. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov."APPLICABLE CLAUSES AND PROVISIONSThe FAR clauses and provisions below shall apply to this solicitation.1. All Offerors MUST be actively registered in the System for Award Management (SAM) www.sam.gov.2. The provision at FAR clause 52.212-1, Instructions to Offerors - Commercial Items (April 2014), applies to this acquisition.3. A completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications - Commercial Items (March 2015), is required with any offer submitted. This requirement may be met by completion of the provision in the System for Award Management.4. FAR clauses 52.212-4, Contract Terms and Conditions - Commercial Items (May 2015) and 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items (June 2016) apply to this acquisition. (Please see Appendix B)5. The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement.6. FAR clause 52.217-5 Evaluation of Options (July 1990) applies to this acquisition.7. FAR clause 52.217-7 Option to Extend Services (November 1999) applies to this acquisition.8. FAR clause 52.217-9 Option to Extend the Term of the Contract (March 2000) applies to this acquisition.9. FAR clause 52.227-14 Rights in Data-General (May 2014) applies to this acquisition.10. HHSAR clause 352.237-75 Key Personnel (December 2015) applies to this acquisition.In addition, the Dun & Bradstreet Number (DUNS), 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." NOTEResponses to this solicitation must include sufficient information to establish the interested parties' bona-fide capabilities of providing the product or service. The price quote shall include: unit price, list price, shipping and handling costs, delivery days after contract award, delivery terms, prompt payment discount terms, F.O.B. Point (Destination or Origin), product or catalog number(s); product description; and any other information or factors that may be considered in the award decision. CLOSING STATEMENTAll responses must be received by the closing date of this announcement and must reference solicitation number NIH-NIDA-SSSA-CSS-17-001. Responses shall be submitted electronically via email to Sneha Patel, Contract Specialist, at sneha.patel@nih.gov.
HHS-NIH-NIDA-SSSA-CSS-17-001 Department of Health and Human Services National Institutes of Health
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