Attachment 1-SOW.pdf

RFP 75N95023R00013 - Clinical Research Support Services Pre-SOL Attachment # 1

Statement of Work - SOW Page 1 of 7

STATEMENT OF WORK

Title: National Institute on Aging Clinical Research Support Services (NIA CRSS)

Background:

The National Institute on Aging (NIA) leads the federal government’s research efforts related to the health and well-being of older people. In recent years, NIA’s budget has substantially increased in recognition of growing public interest and urgency surrounding research on aging, particularly around Alzheimer's Disease (AD) and Alzheimer’s Disease-Related Dementias (ADRD). Through NIA’s extramural research program, the Institute oversees a clinical research portfolio, that includes four divisions (Aging Biology, Behavioral and Social Research, Geriatrics and Clinical Gerontology, and Neuroscience) and multiple disease areas.

Following the enactment of the National Alzheimer’s Project Act (NAPA) in 2011, NIA’s AD/ADRD clinical research portfolio has grown substantially. The NIA portfolio now spans pharmacological, behavioral, and social interventions. In addition, it includes care, caregiving, AD/ADRD prevention. NIA currently holds no Investigational New Drug Application (IND), and clinical research protocols and associated documents are developed by NIA grantees. The grantees are the Sponsors for any clinical trials that require INDs. Despite not holding INDs currently, the NIA needs support to maximize and ensure efficient and proactive oversight of its clinical research portfolio across the Institute.

The Office of Clinical Research (OCR) within the Division of Extramural Activities (DEA) was recently established to effectively manage, support administrative operations, and ensure that NIA is strategically and proactively planning, implementing, and monitoring best practices to comply with federal clinical research regulatory and policy requirements and achieve planned recruitment and inclusion goals.

Specifically, OCR coordinates and develops NIA-wide clinical research operations and procedures, provides regulatory guidance to grantees and program staff, establishes metrics to inform evaluations, and supports key recruitment activities for clinical studies that are of vital importance to the Institute and its many stakeholders, including Congress.

Statement of Need and Purpose:

Given the substantial increase in NIA’s clinical research portfolio, including AD/ADRD research, NIA’s OCR requires centralized support for clinical research management across the institute. The contract will provide a broad range of support services to assist NIA in managing the institute’s current and evolving clinical research portfolio. Support services include but are not limited to participant safety, data integrity and trials progress (including DSMBs/OSMBs, SOs, safety reporting, etc.), regulatory compliance, biostatistics, recruitment support, and training as needed. The contract shall assist with producing centralized procedures for tracking clinical research regulatory compliance and quality assurance/quality control activities. The overarching goal of the contract is to provide centralized, flexible, as-needed, easy-

Statement of Work - SOW Page 2 of 7 to-access recurring and ad hoc support for clinical research and to serve as a gap-filling mechanism to provide urgent or unanticipated services for emerging or evolving needs including prompt access to subject matter experts, consultants, etc.

Objectives:

The aim of the contract is to provide centralized and integrated administrative, regulatory, logistic, and statistical support for clinical research management across NIA. Support service areas include project management and implementation, regulatory expertise, quality assurance/quality control, promoting participant recruitment, statistical consultation, developing tools, templates, and trainings, and managing participant safety, data integrity, and trial progress.

1. SCOPE

The following distinct performance areas have been identified as follows:

• Work Area 1: Project Management

• Work Area 2: Regulatory Oversight and Support

• Work Area 3: Analytics Monitoring

• Work Area 4: Recruitment and Retention Support

• Work Area 5: Clinical Research Operations Support and Quality Assurance

• Work Area 6: Statistical and Methodological Consultation

• Work Area 7: Training of NIA Staff in Clinical Research Procedures

2. WORK AREAS/SPECIFIC TASKS

Independently, and not as an agent of the Government, the Contractor shall furnish all necessary services, qualified personnel, material, equipment, and facilities not otherwise provided by the Government under the terms and conditions of the contract as needed to perform the work set forth below.

WORK AREA 1 - PROJECT MANAGEMENT

NIA requires project oversight to help ensure successful completion of the Task Orders (TOs) awarded under the contract. The Contractor shall provide a Program Director who shall be responsible for overall management, integration, and coordination of all contract activities, including the management and coordination of activities carried out with each TO. The Contractor shall provide a technical and administrative infrastructure to ensure the efficient planning, initiation, implementation, and timely completion of all projects carried out under each TO, and effective communications with the Contracting Officer’s Representative (COR). At the direction of the COR, the Contractor shall work with the key subject matter experts in each NIA Division to meet the needs of the Division.

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The Contractor shall:

1. Provide monthly Financial and Cumulative Summary for the entire Contract, including Monthly Itemized Cost Sheet and a monthly Financial and Cumulative Summary for each individual Task Order.

2. Submit an overarching Communication Plan detailing the strategy to keep the NIA COR informed of progress of tasks and items requiring action on a routine basis, including communication frequency, personnel, and mode of communication. Include a plan for alerting the NIA COR about problems or issues that arise. For each awarded Task Order, provide a plan to ensure appropriate communication among COR, Contractor, and TO leads (when applicable). Each Task Order communication plan must include a summary of how the TO communications will be addressed to coordinate with the overarching communication plan.

3. Submit an Annual Performance Plan for overall contract management and covering each awarded TO. The Annual Performance Plan shall address the plan to accomplish the requirements of the contract and focus on quality, timeliness, and cost-control. The Annual Performance Plan must be reviewed and updated as needed, and when a new TO is issued.

4. Submit a Monthly Progress Report for overall contract management and covering each awarded TO which shall provide an accounting of progress of goals within the contract and each TO and the status of work accomplished.

5. Submit an Annual Progress Report for overall contract management and covering each awarded TO describing and summarizing the work performed during the 12-month period of performance and how it met the Annual Performance Plan.

WORK AREA 2 – REGULATORY OVERSIGHT AND SUPPORT

The Contractor shall provide regulatory support and safety monitoring. The regulatory support and oversight tasks shall include assisting in administrative tasks pertaining to Data and Safety Monitoring Boards (DSMB)/Observational Study Monitoring Boards (OSMB)/Safety Officers (SO), providing regulatory information and subject matter expertise on clinical trial-related requirements, and maintaining safety oversight. The Contractor shall ensure it has the most current and accurate information and certifications regarding the required and evolving clinical research regulations, policies, and guidelines (Federal-wide, NIH, and NIA-specific) related to human subject research, clinical trials policy, and Good Clinical Practice

(GCP).

1. Assist with needed DSMB/OSMB-related activities, such as:

a. Assist with the identification of individuals who are eligible to serve on DSMBs/OSMBs with relevant clinical expertise pertaining to specific clinical trials, such as, biostatisticians, Statement of Work - SOW Page 4 of 7 and investigators knowledgeable about current clinical research conduct and methodology, etc., conduct preliminary review of nominees’ expertise and conflicts of interest, coordinate nominations with NIA POs and grantees, and prepare all documents for nomination, including CVs and COI, for NIA review and approval.

b. Maintain study-specific roster of NIA-appointed DSMB/OSMB members and SOs and the studies for which they provide oversight.

c. Coordinate DSMB/OSMB logistics, including meeting scheduling, preparation, and attendance; facilitating review of relevant study materials and SO meetings with PIs; and summarizing DSMB meetings, including notetaking and dissemination and writing open and closed summary reports, etc.

d. Populate, maintain, and ensure the quality control of an NIA provided database of DSMB-or OSMB-related documents for all NIA-appointed DSMBs/OSMBs.

e. Provide honoraria for DSMB/OSMB/equivalent members.

f. Provide liability insurance coverage for the NIA-appointed DSMBs/OSMBs/SOs.

2. Complete all other DSMB- related tasks, such as ensuring that all Adverse Events (AEs)/Serious

Adverse Events (SAEs) are provided to the DSMB, as needed.

3. Serve as a knowledge base regarding applicable regulations and policies, such as Office of

Extramural Research (OER) policies and other regulations (such as FDA regulations and guidances) for any changes and ensure SOPs are up to date and reflect the latest guidance.

4. Provide consultancy, via the provision of subject matter experts, expert consultants, etc. as requested, for NIA’s clinical regulatory oversight research activities, for interpretation and implementation of quality assurance guidelines, new regulations, safety-related clinical research management, and other regulatory and administrative needs.

5. Provide logistical support for clinical study related advisory panels and monitoring bodies.

WORK AREA 3 – ANALYTICS MONITORING

NIA’s core tool to manage and monitor its clinical research is the Clinical Research Operations and Management System (CROMS). The Contractor shall assist in managing the quality of data and other information (e.g., study protocols, reports) entered into CROMS, and for any other tools that may be developed to assess and report on the performance of the NIA-funded clinical research portfolio. The Contractor will not be responsible for the CROMS technical oversight.

1. Assist with quality review and assurance of data entry in tools that support NIA clinical research, including NIA’s CROMS (e.g., track reporting completeness in CROMS for new and ongoing clinical studies, including timeliness, consistency, and accuracy of study data entry).

https://www.nia.nih.gov/research/grants-funding/nias-clinical-research-operations-management-system-croms

Statement of Work - SOW Page 5 of 7

2. Support NIA staff in the development of reports, presentations, peer-reviewed manuscripts, white papers, or other materials requiring analyses for clinical research activities and/or using NIA clinical research tools such as CROMS.

3. Assist OCR in conducting communication and outreach with users of NIA clinical research tools (e.g., CROMS) on an ongoing basis.

4. Provide NIA with digital support for clinical research data management, if needed.

WORK AREA 4 – RECRUITMENT AND RETENTION

The Contractor shall assist in coordinating activities that support recruitment and retention activities for NIA-funded studies. These tasks include but are not limited to contributing to the implementation of the NIA National Recruitment Strategy.

1. Use existing data, including from CROMS, to provide support to:

a. Identify grants that are successful at enrolling participants and codifying successful programs.

b. Identify grants that are experiencing challenges in enrollment and working with program staff to provide support to enhance enrollment efforts.

2. Identify and coordinate best practices for clinical research recruitment, particularly for underrepresented populations, based on ongoing activities across NIA. This may include support related to virtual or hybrid clinical research.

WORK AREA 5 – CLINICAL RESEARCH OPERATIONS SUPPORT AND QUALITY ASSURANCE

The overall objective of the Clinical Research Operations Support and Quality Assurance work area is to ensure that the data resulting from NIA studies are of highest quality and are considered valid and credible within the scientific and clinical community. To accomplish this objective, the Contractor shall provide assistance and guidance from experts in clinical research quality assurance. This assistance may include but is not limited to the provision of scientific resources, support for documentation and quality assurance procedures, conducting study risk assessments, and tracking regulatory compliance, Institutional Review Board (IRB) approval, and NIA clinical risk management updates. The Contractor shall also assist in maintaining a database of NIA staff training compliance (e.g., Good Clinical Practice [GCP] certifications).

1. Monitor for changes in regulations, guidelines, and clinical trials enterprise standards to ensure integrity and data quality for NIA-funded clinical research studies.

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2. Assist with the development and maintenance of NIA clinical research SOPs and policies and ensure that these are updated to meet all applicable requirements, including institutional, regulatory and policy requirements.

3. Provide technical and administrative assistance (e.g., updates to the Clinical Research Study Investigator Toolbox), as needed, to facilitate interpretation and implementation of applicable quality assurance guidelines for NIA clinical studies.

4. Assist in the review of study documentation in CROMS, as needed, for quality, internal consistency and compliance with Good Clinical Practice and other Federal, State, and local laws/regulations including FDA, OHRP, HHS, NIH, and NIA.

5. Perform, coordinate, and manage site visits, in-person or virtually, for designated studies as needed by NIA, to monitor data quality and oversee the integrity of study procedures.

6. Assist NIA staff in the identification of events likely to have a negative influence on the clinical study, evaluate the risks, and compile reports for each study detailing findings and recommendations for risk reduction.

7. Assist NIA staff in the assessment of human subject safety and operational concerns and risks.

8. Collaborate, communicate with, and provide administrative regulatory oversight support to NIA staff and external collaborators (e.g., clinical research networks, researchers, etc.) to facilitate the conduct of research. This includes maintaining a portfolio of partnerships and answering external questions regarding recruitment, retention, safety, and regulatory guidelines.

9. Support communication and coordination between NIA staff and NIA-funded investigators with respect to monitoring Adverse Events (AEs)/Serious Adverse Events (SAEs), coordinating AE/SAE review and follow-ups, and reporting and tracking of adverse events and serious adverse events in CROMS.

10. Track regulatory compliance for NIA- funded clinical studies.

11. Track IRB approval across clinical studies and clinical research risk management updates and maintain a centralized database for NIA.

12. Review and process relevant regulatory documents to ensure compliance with all relevant NIA, NIH, HHS and FDA regulations.

13. Provide support as needed for protocol drafting and review.

WORK AREA 6 - STATISTICAL AND METHODOLOGICAL CONSULTATION

The Contractor shall provide support and consultation to the NIA staff in the area of statistics and clinical research methodology. Statistical consultation may be required to evaluate requests to submit applications for large clinical research studies, address methodological issues identified in ongoing clinical research projects, perform additional analysis of existing datasets, and de-identify trial data. Performance of activities under this work area will be conducted on an as-needed basis.

Statement of Work - SOW Page 7 of 7

1. Review and make recommendations in areas such as study design, sample size calculations, statistical analysis plan, methodology, randomization procedures, and data management consulting.

2. Serve as a resource for NIA staff by providing a list of advantages and disadvantages of the proposed methods when evaluating a request to submit a large clinical research project. Unusual methodology or particularly creative methods may be requested of the contractor.

3. Conduct statistical analyses to support needs of NIA staff, including meta-analysis, power analysis, and futility analysis.

4. Review and make recommendations to ongoing NIA-funded clinical research studies in areas such as statistical analysis plan, power calculations, need for interim analysis, subgroup analysis, outcome measurements, and treatment effect.

5. Assist NIA projects in the de-identification of study datasets in preparation for sharing data with the research community.

WORK AREA 7 - TRAINING OF NIA STAFF IN CLINICAL RESEARCH PROCEDURES

The Contractor shall assist with identifying tools and trainings where they exist, or developing new tools and trainings related to clinical trials policies, standard operating procedures, and management. These tools and trainings will provide support for NIA staff and grantees, throughout the lifecycle of a clinical study. Producing and disseminating these materials ensures the highest standards of regulatory compliance and data management for NIA-funded clinical research.

1. Assist with the development and dissemination of clinical research management tools, trainings, guidelines, templates, etc. that are subject-area specific (e.g., compliance, data quality, and reporting requirements for clinical research activities, administrative and regulatory procedures, etc.).

2. Provide up-to-date commercially available, industry standard trainings and training materials for clinical research (such as Good Clinical Practice, Human subjects Protections, etc.) for both internal and external use, as requested, and provide management of training completion and maintenance.

3. Support the creation of materials that explain clinical research best practices, including materials that are subject-matter specific.