EmbraceHealth Coordinating Center SOW - November 12 2026.pdf

RFP: 75N94027R00003 ATTACHMENT 1

Statement of Work – 11-05-26

IDIQ

STATEMENT OF WORK – IDIQ BASE

EMBRACEHEALTH CLINICAL RESEARCH NETWORK COORDINATING CENTER

I. BACKGROUND AND INTRODUCTION

The National Institute on Minority Health and Health Disparities (NIMHD) leads scientific research that takes a population health approach to improve health by identifying, understanding, preventing, and treating or intervening in diseases, disorders, or other conditions that are more common in specific populations compared with the general population. There is an urgent need to understand and address these adverse health differences. NIMHD is dedicated to addressing critical research gaps by providing evidence for factors that contribute to disparities and identifying solutions them – with the overarching goal of improving American public health.

Advancing the NIMHD mission includes a comprehensive range of clinical research and health services research initiatives as outlined in the priority areas below.

(1) Clinical Research and Treatment Delivery Within Healthcare Settings

Promotes and supports research to: (a) study clinical and pre-clinical presentations (phenotypes) and/or manifestations of health conditions; (b) reduce health disparities through the identification of novel tests, methods and strategies to prevent, screen, diagnose, treat, and/or manage health conditions, especially those associated with the highest morbidity and mortality, within the health care context; and (c) facilitate collaborations across healthcare settings to improve the quality and safety of care, care coordination, and clinically improved patient outcomes.

(2) Patient-Clinician and Patient-Health Care System Interactions

Promotes and supports research to: (a) explore in-depth how interactions between patients and clinicians or patients and health care systems (including non-clinical personnel) affect clinical outcomes and health care disparities, and interventions to improve them; and (b) explore and enhance patient-clinician and/or patient-health care system engagement and their roles in shared decision-making.

(3) Health Care Utilization and Outcomes

Promotes and supports research to: (a) identify patterns of healthcare availability, utilization, quality and their influence on health outcomes in a variety of settings including those outside of traditional healthcare settings/systems; and (b) identify/examine interventions to enhance the timeliness and quality of health services and procedures, and their subsequent effect on health disparities and clinically meaningful health outcomes.

(4) System-Level Health Services Research

Promotes and supports research to understand how health care settings factors, like care coordination and integration, influence health disparities and clinical outcomes.

The nation is witnessing rapidly evolving advances that address population-wide health challenges, and opportunities to re-think and re-design strategies to attain optimal health across the lifespan. However, the benefits of those advances are not yet fully manifested among some individuals, families, or communities. For instance, the prevalence of chronic conditions (more often coexisting than isolated) continues to increase across the nation, especially among children, as emphasized by the Make America Healthy Again (MAHA) Initiative, and the White House MAHA Report. Yet, individuals and communities from low socioeconomic backgrounds and resources, and specific Office of Management and Budget (OMB)-defined racial and/or ethnic categories, tend to have a high prevalence of chronic health conditions and/or a high risk of developing them. Moreover, the levels of awareness, treatment and control for some of the most prevalent chronic conditions tend to be significantly lower among individuals from the populations mentioned above. This translates into a higher risk of developing preventable, long-term health complications, and a shorter life expectancy.

Consistent with the NIH Director’s Priorities, NIMHD supports solutions-oriented health disparities research that is based on scientifically valid measurable health outcomes, and is rigorous, replicable and generalizable across the range of its projects and initiatives. NIMHD has funded a variety of clinical trials and other interventions, many of them embedded within the context of health care settings.

NIMHD has also ensured that its funded research reflects population and public health trends and addresses important research opportunities and gaps as they arise.

The scale and urgency of today’s population health challenges demand a research initiative capable of operating effectively in real-world care settings. This requires a research infrastructure embedded within health care systems, particularly those serving large numbers of low-resourced patients, where study findings can be rapidly translated into practice and benefit a broad range of communities. However, conducting biomedical research in these environments presents unique challenges and requires a collaborative, multidisciplinary infrastructure grounded in systematic, rigorous practices. A well-established research infrastructure can accelerate the implementation of research activities and drive measurable https://www.hhs.gov/maha/index.html chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https:/www.whitehouse.gov/wp-content/uploads/2025/05/MAHA-Report-The-White-House.pdf chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https:/www.whitehouse.gov/wp-content/uploads/2025/05/MAHA-Report-The-White-House.pdf improvements in health outcomes, clinical practice, and public health, particularly in response to emerging or urgent community health needs.

For this purpose, NIMHD requires a multi-site Clinical Research Network (EmbraceHealth CRN). The network will comprise approximately five (5) Research Consortia (RCs) and a Coordinating Center (CC). This contract-based initiative will enable NIMHD to efficiently acquire the expertise needed to design and execute solutions-oriented clinical studies that improve health outcomes in clinically meaningful and measurable ways and reduce health disparities.

II. SCOPE AND OBJECTIVES OVERVIEW

A. Scope

The purpose of this coordinating center contract is to provide centralized scientific, statistical, methodological, data management, electronic data capture, technical, and administrative support to NIMHD and the EmbraceHealth Clinical Research Network (CRN) Research Consortia (RCs) for the development, implementation, monitoring, analysis, and completion of multisite clinical, behavioral, and health services research studies.

The Coordinating Center (CC) shall provide services including but not limited to support and/or guidance on research protocol development and coordination;

biostatistical and methodological consultation; data management, electronic data capture, standardization, harmonization, and analysis; research regulatory and quality assurance support; study implementation monitoring; consortium governance and administrative coordination; training and technical assistance; and preparation and dissemination of research findings internally across the RCs and externally. The CC shall provide these services across participating RCs to support consistent study implementation, data quality, and coordination of network-wide research activities.

Additional services may include coordination of biospecimen collection, maintaining centralized research information systems, data repositories, convening scientific working groups, and other specialized technical expert panels to support and facilitate necessary network-wide research activities, as specified in individual task orders.

The CC shall work collaboratively with NIMHD and participating Research Consortia (RCs) to promote consistent research practices, scientific rigor, efficient network operations, and timely completion of research activities. The RCs remain responsible for conducting research activities within their respective consortia sites, including participant recruitment and enrollment, implementation of study protocols, participant follow-up, and site-level data collection.

Individual RCs may conduct distinct research studies, while other studies may involve collaboration among multiple RCs up on direction from NIMHD. The CC shall provide support to each RC on study-specific scientific, methodological, biostatistical, informatics, and research coordination expertise and develop or adapt research protocols, analytical approaches, data management procedures, and coordination processes based on the scientific objectives, populations, methodologies, and regulatory requirements of each approved study. The CC Contractor shall maintain the capacity to support multiple concurrent studies with differing research designs, timelines, and operational and interventional requirements.

B. Objectives

The overarching objectives of the EmbraceHealth CRN are to attain clinically meaningful and measurable improvements in health outcomes and reduce health disparities across the life course by advancing scientific knowledge and approaches that enhance timely screening and diagnosis, prevention, treatment, and optimal control of chronic, acute, urgent, and emerging health conditions in accordance with evidence-based clinical guidelines.

These objectives will be accomplished through the establishment and maintenance of an efficient and nimble research infrastructure that supports the generation of rigorous, actionable scientific evidence, the translation of research findings into clinical practice, and the scalability of effective interventions. The EmbraceHealth CRN will also leverage data science, super intelligence (SI) methods, and health technology, as appropriate, to conduct rigorous research studies embedded into healthcare settings that address emerging, urgent, acute, or chronic health needs and priorities of populations and communities experiencing health disparities.

C. Research Framework, Activities, and Approaches

Research Consortia will consist of collaborations or partnerships between academic institutions and health care settings that provide ambulatory care, including family medicine, general internal medicine, and general pediatrics, as well as medical subspecialties with a component of chronic ambulatory care. Existing partnerships among academic health centers that serve a high proportion of patients from low-income backgrounds or low-resourced communities, with public health insurance (Medicare, Medicaid, CHIP) or no insurance, community health care settings linked to safety net hospitals, and Federally Qualified Health Centers (FQHCs) are encouraged to respond to this Solicitation.

Within the settings described above, EmbraceHealth CRN RCs will test and implement innovative clinical and behavioral interventions (e.g., clinical trials, comparative effectiveness research, implementation research) on chronic and acute conditions across age and sex groups that respond to the health needs of the local communities that are hypothesis driven and theoretically and scientifically supported. . These interventions will be designed to (1) achieve clinically meaningful health outcomes, (2) employ rigorous scientific methods and scientifically valid measures, and (3) demonstrate feasibility, scalability, and reproducibility.

Performing these interventions within the context of healthcare settings is expected to generate real-life insights fundamental to interpretation of study findings, and the eventual feasibility and scalability of the interventions.

Research designs may encompass randomized clinical trials, randomized cluster trials, pragmatic trials, comparative effectiveness research, implementation research, and hybrid Type 2 or Type 3 trials, among others. Upon awarding the selected Proposals, further refinement of the proposed interventions will be accomplished in collaboration with the EmbraceHealth Coordinating Center (CC) and NIMHD.

Super Intelligence (SI) and data science have advanced rapidly in health research and offer a powerful opportunity to accelerate progress toward reducing health disparities. As this field continues to evolve, the EmbraceHealth CRN data platform can provide a foundational resource for developing, validating, and applying innovative analytic approaches and algorithms that support earlier prevention and diagnosis, comparative effectiveness research, risk prediction and tailored clinical decision-making. These capabilities may help reduce the incidence of preventable complications and improve outcomes for populations experiencing health disparities. Accordingly, data-science driven studies, including modeling exercises on cost-effectiveness of the proposed interventions across RCs, are envisioned activities of the EmbraceHealth CRN.

As the EmbraceHEALTH CRN is established, future studies on emerging, urgent, chronic, and acute conditions, and/or associated risk factors, biomarkers, genetics/omics, or epigenetics/omics could be implemented. In addition, SI and data-science research on causal inference, machine learning, longitudinal data, and implementation science could be further explored. The goal of these evolving research areas conducted through the EmbraceHealth CRN is not simply to predict who is at high-risk, but to estimate what intervention works, for whom, under what circumstances, and at what point in a patient’s care trajectory.

Through the EmbraceHEALTH CRN, NIMHD seeks to identify and facilitate innovative research on reducing health disparities via technology-based studies, especially those that enhance patient self-reported data, interaction with clinicians and the health care system, and home-based biospecimen collection, remote monitoring, treatment and/or self-management.

EmbraceHealth CRN funded projects are envisioned to generate findings with the potential to inform formal implementation or revision of clinical practices, guide further research on implementation or scaling up, or generate new hypotheses for future studies.

D. Research Coordinating Center and Research Consortia Collaboration

The EmbraceHEALTH CRN Coordinating Center (CC) will serve as the central resource for coordination, technical assistance, data infrastructure, methodologic and analytic support, and cross-site collaboration amongst the EmbraceHEALTH CRN RCs. Each RC will be expected to work collaboratively with the CC, NIMHD, and other RCs to ensure that all EmbraceHEALTH CRN activities are implemented in a consistent, rigorous, timely, and policy-compliant manner.

The EmbraceHealth CRN CC will support RCs in developing and strengthening the research infrastructure needed to conduct clinical studies in real-world health care settings.

The EmbraceHealth CRN CC will also support the development, refinement, and implementation of research protocols across the EmbraceHealth CRN. RCs will be expected to collaborate with the CC on protocol finalization, study workflows, manuals of procedures, recruitment and retention strategies, data collection instruments, quality assurance and quality control procedures, and study implementation plans. The CC shall provide technical assistance to support study start-up, site readiness, recruitment and retention, clinical subject matter expertise, implementation troubleshooting, performance and clinical outcomes monitoring, and adherence to consortium-wide standards based on clinical research best practices.

The EmbraceHealth CRN CC will provide biostatistical, methodological, epidemiologic, informatics, and data science consultation to assist RCs with clinical study design, analytic planning, implementation, monitoring, and interpretation of findings. RCs will be expected to engage with the CC during study planning and execution to ensure that research questions, outcomes, measures, analytic approaches, and data submissions are aligned with EmbraceHealth CRN objectives and permit meaningful cross-site analyses. The CC shall conduct EmbraceHealth CRN -level analyses as well as site-specific analyses, in collaboration with participating RCs and NIMHD. The CC shall also conduct analyses, as required under applicable task orders, in collaboration with participating RCs and NIMHD.

The EmbraceHealth CRN CC will facilitate data management and sharing across EmbraceHealth RCs, including coordination with (National Institute of Health Science Collaborative for Health and Artificial intelligence Reduction of Errors (NIH SCHARE), a cloud-based research platform, for secure storage and access to deposited data. RCs will be expected to submit de-identified study data, electronic health record extracts, common data elements (CDEs), documentation, metadata, data dictionaries, and other required materials to the CC in accordance with https://www.nimhd.nih.gov/resources/schare https://www.nimhd.nih.gov/resources/schare approved timelines, formats, data use agreements, and NIH data sharing requirements, where applicable. RCs will also be expected to participate in data validation, harmonization, query resolution, and quality control activities led or coordinated by the CC.

The CC will facilitate the design and implementation of protocols across RCs for standard biospecimen collection, processing and storage, especially for future studies. Refinement and finalization of these protocols, as well as the establishment of a biospecimen repository will be accomplished in collaboration with NIMHD.

The CC will provide logistical, technical, administrative, and coordination support to promote efficient network operations. This may include coordinating consortium governance activities, convening working groups, scientific meetings, training sessions, technical assistance calls, protocol-specific meetings, data harmonization discussions, and in-person and/or virtual meetings. RCs will be expected to designate appropriate personnel to participate in these activities;

respond promptly to CC and NIMHD requests; provide required progress updates, deliverables, reports; and collaborate with other RCs on shared scientific, operational, and community-engagement activities.

Through this collaborative structure, the CC will help ensure that RC activities are scientifically rigorous, operationally coordinated, methodologically sound, and aligned with the overall goals of EmbraceHealth CRN. RCs are expected to actively engage with the CC, NIMHD, and other RC consortium partners to support high-quality study implementation, timely data submission, cross-site learning, dissemination of findings, and the generation of evidence that improves health outcomes and reduces health disparities.

E. Health Conditions and Research Focus

NIMHD anticipates that research/interventions will be proposed within the context of chronic, acute, and/or urgent health conditions (associated treatment and/or clinical procedures) that are highly prevalent among populations that experience health disparities and are associated with significant morbidity and mortality across the life course. These conditions include but are not limited to:

• Cardiovascular diseases (including coronary artery disease, cerebrovascular disease,) and risk factors

• Cardiometabolic diseases (including diabetes, prediabetes, overweight/obesity, hypertension, prehypertension, dyslipidemia) and risk factors

• Cancer

• Asthma and other chronic pulmonary conditions

• Sleep disorders

• Steatotic liver disease, hepatitis, and chronic liver disease

• Chronic kidney disease, and end-stage kidney disease

• Cognitive impairment/dementia

• Mental health conditions

• Substance use disorders

• HIV/AIDS and associated complications

• Pregnancy-related disorders and complications

• Acute and/or urgent health conditions

• Other conditions identified by the local community

Activities associated with such conditions require multiple scientific and clinical experts in the health conditions of interest, research methodology, data science, biostatistics and other relevant research expertise, depending on the on the nature, scope, and objectives of the research activities.

The EmbraceHealth CRN CC will be expected to leverage the NIH SCHARE platform to establish and maintain a secure, centralized data hub containing de-identified data from clinical interventions contributed by each RC. The CC will support the RCs with the identification, definition and implementation of NIH-endorsed CDEs, as appropriate and/or relevant to the RCs proposed projects, based on the electronic health record and study data required to support standardized data collection, harmonization, when such cross-RC analyses are agreed-upon and feasible. Examples of data include:

• Demographic data

• Medical history and physical examination

• Vital signs, body weight and height, blood pressure

• ICD-10 and CPT codes

• Diagnostic laboratory tests and other biomarkers

• Pathology/radiology/surgery reports

• Radiology/echo imaging

• Medication profile

• Hospital and/or emergency department records

• Birth and/or death certificates or coroner’s reports

Findings derived from research projects funded through EmbraceHealth CRN will be shared with the participating research and clinical partners, patients and communities, and help direct future NIH studies.

III. TECHNICAL REQUIREMENTS

Independently and not as an agent of the Government, the Contractor will furnish all the necessary resources, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government under the terms of this Contract, as needed to fulfill the technical requirements outlined below and the specific requirements of task orders issued under this IDIQ contract.

The following task areas describe the types of activities that may be required under the IDIQ. The specific activities, performance requirements, deliverables, schedules, staffing expectations, and periods of performance will be established in individual task orders. The inclusion of an activity in this Statement of Work does not, by itself, require performance of that activity unless authorized under an applicable task order.

A. Support Core Research Operations and Research Infrastructure

The Contractor shall provide startup, coordination, and foundational support necessary to establish and maintain the Coordinating Center infrastructure and facilitate the readiness and effective operation of participating Research Consortia.

1. Core Research Operations and Project Management

a) Establish and maintain a Program Management Team responsible for coordinating CC activities, monitoring contract performance, overseeing CC subcontractors, and facilitating communication among NIMHD, participating RCs, and other collaborating organizations. The team shall include designated personnel responsible for program management, data coordination, statistical support, regulatory coordination as applicable, and financial and administrative management.

b) Develop and maintain a Network Operations Plan describing the organizational structure, key personnel responsibilities, communication procedures, coordination mechanisms with participating RCs, reporting requirements, performance measures, and processes for identifying and resolving operational issues. The plan shall be updated as necessary to reflect changes in network operations and approved procedures.

c) Establish standardized procedures for documenting, tracking, reviewing, and reporting protocol deviations and associated corrective and preventive actions (CAPAs). Participating RCs and their study investigators shall remain responsible for identifying and addressing deviations at their respective sites. The CC shall coordinate network-level tracking, assess recurring or systemic issues, and provide recommendations to NIMHD and the responsible study leadership.

Approval of CAPAs and decisions concerning protocol modifications shall remain with the designated responsible parties under the applicable study protocol, monitoring plan, and regulatory requirements.

d) Provide specialized scientific, methodological, statistical, technical, and operational coordination and support to participating in RCs in the development and implementation of RC-specific and collaborative research studies, as applicable. This shall include assisting with research protocol development and refinement; reviewing study designs, sample size considerations, and statistical analysis plans;

coordinating the development of study-specific workflows, recruitment and retention plans, data collection instruments, quality assurance and quality control procedures, and reporting requirements.

Establish and maintain appropriate processes for monitoring study progress, including recruitment and enrollment, participant retention, data quality, protocol adherence, and achievement of study milestones, as applicable to individual studies. The Contractor shall coordinate cross-RC research activities when studies involve multiple RCs and facilitate the use of NIH-endorsed common data elements (CDEs), common procedures and data standards where scientifically appropriate. The Contractor shall support the RCs in the establishment and maintenance of core research operations, including completion and ongoing maintenance of all required trainings and certifications;

implementation of research regulatory and oversight activities;

development, refinement, and implementation of standard operating procedures (SOPs); execution of memoranda of understanding (MOUs), data sharing protocols, data use agreements (DUAs), and other required agreements in collaboration with the CC and participating RCs; and establishment of appropriate governance and oversight structures. These structures shall include, as applicable, a Data and Safety Monitoring Board (DSMB), and others necessary to ensure scientific rigor, participant safety, regulatory compliance, transparency, and meaningful community input. Other responsibilities may include coordinating meetings, preparing reports and interim analyses, maintaining meeting documentation, tracking recommendations, and communicating approved recommendations to designated parties. The DSMB shall provide independent recommendations regarding participant safety, study integrity, and study continuation, modification, or termination. Final decisions shall remain with the responsible sponsor or other authorized decision-making authority, as applicable.

e) Provide coordination to ensure consistent implementation of consortium-wide research activities. The Contractor shall establish and maintain centralized electronic data capture, data management and coordination capabilities to support the secure receipt, validation, harmonization, analysis, and transfer of deidentified research data from participating RCs to NIH SCHARE, as applicable. The Contractor shall also coordinate biospecimen-related activities and transfers when required by individual study protocols and applicable task orders, in collaboration with participating RCs and designated repositories.

This shall include finalization of research study protocols; development of study workflows, recruitment and retention plans, data collection procedures, quality assurance/quality control processes, and reporting mechanisms; and coordination of cross-RC research activities. The Contractor shall also support infrastructure to transfer deidentified study data (including extracted and harmonized electronic health record data, CDEs, relevant training documents, and others) from all RCs and to NIH SCHARE. Similarly, the Contractor shall also transfer all biospecimens collected from each RC to a local repository or another repository identified by NIMHD following secure data/biospecimen transfer standards and requirements. The Contractor shall also oversee data management, safety, and quality for the trials conducted by the Research Consortia. This includes data capture, data management, data storage, and data sharing for the clinical trials data.

f) The CC shall coordinate and facilitate single Institutional Review Board (sIRB) arrangements for collaborative or multisite research studies, when required by applicable federal regulations and NIH policies. This shall include assisting participating RCs with the coordination of reliance agreements, submission requirements, protocol amendments, continuing review activities, and communication with the designated reviewing IRB, as applicable. The Contractor shall track required IRB approvals and related documentation to support timely study initiation and continued compliance with applicable human subjects protection requirements.

g) The DCC will collaborate with the RCs on the research activities, including review of all materials necessary for regulatory submissions in ongoing and future clinical trials conducted by the CRN or supported by the NIH, to ensure regulatory compliance and successful protocol implementation at RCs study activities.

h) Clinical site monitoring regulatory rigorous studies shall include: visits after first patient enrolled, interim (as needed or as directed by the NICHD COR), and close-out visits; assessment of the accuracy and completeness of case report forms, accuracy and completeness of source documentation, and all research records in accordance with FDA regulations for clinical trials conducted under IND applications.

B. Support Study Implementation, Close-Out and Transition

1. Study Implementation

a) Develop standardized study startup procedures and tools to support participating RCs in preparing for execution of approved research protocols. These procedures shall address, as applicable, protocol-specific data management requirements, statistical analysis planning, regulatory documentation, safety reporting procedures, site training, data submission requirements, and readiness assessments. The CC shall coordinate these activities with participating RCs while maintaining the distinction between network-level coordination and RC responsibilities for clinical research site operations.

b) Provide coordination, technical assistance, and monitoring support necessary for the execution of approved RC-specific and collaborative research studies, as applicable. The Contractor shall support participating RCs in recruitment and enrollment, intervention delivery and/or implementation, follow-up activities, clinical and research data collection, study monitoring, documentation, and adherence to approved protocols and SOPs.

c) Establish and maintain processes to monitor the timeliness, completeness, accuracy, and quality of study data submitted by participating RCs and coordinate the secure receipt, validation, harmonization, and transfer of required data to NIH SCHARE, as applicable. The Contractor shall also coordinate the transfer of biospecimens to designated repositories when required by individual study protocols and task orders, ensure timely and accurate collection of study data and transfer of required data/biospecimens from each RC to the NIH SCHARE, the CC or another biorepository identified by NIMHD, in accordance with approved data sharing protocols, DUAs, privacy and security requirements, and NIH policies.

d) Establish and maintain standardized procedures, systems, and reporting tools to support the collection, tracking, reconciliation, and reporting of adverse events (AEs), serious adverse events (SAEs), and other reportable safety information, as applicable to individual studies.

The procedures shall identify the responsibilities of the RCs, study investigators, CC, NIMHD, Institutional Review Boards, and other responsible parties, including applicable reporting timelines and escalation procedures.

e) Establish an internal and public facing portal/website that will be used for communication with the EmbraceHealth CRN (i.e., RCs, CC and NIMHD) and the public. The internal portal will be accessible only to the EmbraceHealth CRN and will be primarily used for communication and coordination purposes. The external site will be for the general public to communicate general information about the EmbraceHealth CRN, the studies being conducted, newsworthy articles and other helpful contact information and items of potential interest. This portal/website shall be Section 508 compliant.

2. Study Close-Out Activities

a) The Contractor shall provide coordination and support of close-out activities for individual RC-specific and collaborative studies, as applicable, in accordance with the schedules and requirements established under the respective task orders. The Contractor shall coordinate with participating RCs to support finalization and documentation of all informatics, technology, and data transfer SOPs;

completion of data extraction, harmonization, validation, and transfer for all studies; resolution of data/biospecimen queries; final study monitoring and quality assurance activities; completion of required regulatory and administrative close-out procedures; and submission of final deliverables to NIMHD. The Contractor shall review and verify, within the scope of the CC's responsibilities, the completeness and accuracy of study records and datasets, documentation, and analytic files received from participating RCs, and ensure that CC-maintained records and data are appropriately maintained or transferred in accordance with applicable policies and contractual requirements.

b) The Contractor shall coordinate the resolution of outstanding data queries, reconciliation of required study records, finalization of statistical datasets, completion of applicable safety and regulatory documentation, and preparation of study-specific closeout reports.

3. Transition of Study Activities and Resources

a) The Contractor shall perform activities necessary to ensure an orderly transition of study activities, data, documentation, materials, biospecimens, tools, workflows, and other resources to another entity, as directed by NIMHD, participating RCs, receiving entities, and other stakeholders to minimize disruption to ongoing or future research activities.

b) The Contractor shall develop a transition plan identifying ongoing studies, critical coordination activities, active data management systems, data dictionaries, outstanding data queries, applicable safety monitoring activities, pending deliverables, and procedures for secure transfer of CC-maintained records and resources.

c) The Contractor shall ensure the orderly and secure transfer of centralized data management systems, databases, data dictionaries, standard operating procedures, study coordination records, and other CC-maintained resources, as applicable, to support continuity of network operations and ongoing research studies. The Contractor shall support continuity of operations by preparing transition plans, transferring relevant knowledge and documentation, assisting with data and resource migration, and coordinating with NIMHD, receiving entities, and other stakeholders to minimize disruption to ongoing or future research activities.

Note to Offerors:

For all years, costs incurred to prepare and distribute analytic data sets and/or biological samples to approved outside investigators must be covered by the investigators and not the contract. Furthermore, when new exam procedures, assays or genotyping in ancillary studies reveal potentially clinically actionable conditions, the costs associated with participant notifications must come from the ancillary studies and not the contract.