CRIMSON SOW_07.27.2022 (Final).docx

Attachment 1 Statement of Work (SOW) Clinical Research Data Management and Systems Support 06/28/2022 C

1 Background

The Division of Clinical Research (DCR) provides operational and technical support for clinical research data management for research studies within the Clinical Center at the National Institutes of Health (NIH) and for international outbreak response initiatives as directed by Clinical Director.

The Clinical Center at the National Institutes of Health (NIH) is the world’s largest hospital entirely devoted entirely to clinical research. It is a national resource that makes it possible to rapidly translate scientific observations and laboratory discoveries into new approaches for diagnosing, treating, and preventing disease. As part of the overall mission, the NIH Clinical Center provides the National Institute of Allergy and Infectious Diseases (NIAID) with clinical facilities and technology infrastructure required to support intramural clinical research. NIAID has developed the Clinical Research Information Management Systems of NIAID (CRIMSON) hosted on the Clinical Center infrastructure as a study specific documentation and workflow management tool to address many of the unique requirements of the NIAID Clinics. CRIMSON is a well-established mature clinical and scientific information system that has undergone generations of enhancements, improvements, and refinements in the past two decades. It provides mission-essential patient management, case report management, study management, adverse event reporting, study analysis and many other related activities. The formatted CRIMSON Progress Note is also an integrated element of the Clinical Center Hospital Medical Record.

The Division of Clinical Research (DCR) Data Management and System Support team leverages existing systems and expertise through the operations and technical capabilities provided through this contract. The mission of DCR has become increasing focused on supporting clinical research as part of an emergency response to disease outbreak. The evolution of the mission has resulted in the creation of the Clinical Trials Research Sections (CTRS) to develop and provide operational efficiencies and data integrity for special projects and rapid response initiatives. Primarily established in response to Ebola outbreak in West Africa and the COVID-19 pandemic, CTRS has become DCR’s core resource for study design, implementation, and data management for emerging disease responses. As part of this emerging mission DCR has developed an automated approach for defining, collecting, processing, and managing the use of Case Report Form (CRF) as a data collection process. The Study Tracking & Online Reporting Management (STORM) is early in its use but shows promise as a cornerstone for DCR remote data management workflows. It is a primary goal of this contract to support the data lifecycle of these studies or special projects

2 Scope The activities supported by this contract focus on the implementation, operations, and maintenance of systems and data processing workflows supporting NIAID clinical research studies. Although solutions will be required to remain agile and responsive to changing needs of the clinical research community, the goal is to continue to enhance and modernize the foundational core tools set. This foundational framework and tools will include project management, infrastructure and information technology support, user support and operations, and clinical research information system design, development, and implementation.

3 Technical Requirements Objectives of the proposed contract include support, enhancement, and development of Clinical Research Information Management systems across the complete research data lifecycle (definition, collection, storage, analysis, and reporting) of studies as requested by the NIAID Division of Clinical Research (DCR). The dynamic nature of DCR’s mission requires current systems be capable of not only supporting research studies within the NIAID clinics as part of the NIH Clinical Center, but also able to be deployed as part of a response to emerging disease outbreak in remote and diverse international locations. The primary focus of the contract is for the maintaining and expanding (if necessary) of stable and proven systems and technical platforms (e.g., CRIMSON, STORM etc..) to create a core capability of systems and expertise to provide DCR with consistent clinical research data management functionality that leverages the reusability of operational data management systems across projects, deceasing complexity of initiating new studies.

Three core task areas comprise the functional objectives supported by this SOW:

1. Project Management, Communication, and Collaboration

2. Infrastructure and Information Technology Support

3. User Support and Operations

The contractor will also serve as a key resource for NIAID DCR Deputy Director of Operations Management (DDOM) in the support of clinical research informatics within select projects. The three tasks provided by the contractor are described below.

3.1 Task 1: Project Management, Communication and Collaboration

The requirements that must be fulfilled by the contractor under this task will include the following:

· The contractor shall maintain ongoing Clinical Research Data Management operations.

· The contract Program Manager shall report monthly on status of the portfolio including timeline assessments, budget, and resourcing requirements.

· The contractor shall follow the work process flow, methodology, procedures, deliverables, and best practices that facilitates both program and goal comprehension

· The contractor shall develop and document a transition plan 14 days after award, subject to the approval of the COR, to assure minimal disruption during a transition period.

· The contractor shall provide in depth project management, which shall include:

· communication and collaboration oversight detailing the roles and responsibilities to facilitate comprehensive communication of project strategies, milestones, planning, changes, and project documents review.

· Ensure all requisite contractor personnel receive the required security access protocols required to access NIH and NIAID facilities to maintain and/or operate CRIMSON and other systems. NIH badges will be required to access systems and onsite locations

· Intranet based strategy for user communication, application manuals, and help documentation available to CRIMSON users and stakeholders. Current tools available include SharePoint and Tableau.

· posting of a library of confidential information to a secure Intranet

· Periodic evaluation of all-user no less frequently than twice per year. Available tools include SharePoint and Survey Monkey.

· Establish a change management plan to assure NIAID Program review and appropriate prioritization and weighting of projects, enhancements, and changes.

· The contractor shall attend user and governance meetings as requested by COR.

· The contractor must follow HHS, NIH, and NIAID Enterprise Performance Lifecycle (EPLC) processes and standards

· The contractor shall, in conjunction with NIAID Office of Cyber Infrastructure and Computational Biology (OCICB), tailor and adapt the EPLC for usage within DCR.

· The contractor shall provide NIAID OCICB with technical information as required for EPLC.

· The contract shall participate in NIAID OCICB EPLC stage gate reviews as required.

· The documentation required by the EPLC is largely developed in Microsoft (MS) Office, such as Word, Visio, Excel, PowerPoint, and Project.

· The contractor shall document the technical architecture, including proposed additions or alterations, including the impact on production capabilities 90 days after award.

· The contractor shall assess and document networking, hardware, and software capabilities 90 days after award. The contractor shall also produce a gap analysis of required capabilities if deficiencies are found.

3.2 Task 2: Infrastructure and Information Technology Support The contractor shall provide services for the continued maintenance, coordination, and support of the technical infrastructure required to support existing capabilities of the CRIMSON and STORM applications and associated operational and data processing workflows. The deployment and operational support of clinical research information system within DCR Clinical Research, require software, hardware and networking infrastructure that is compliant with policies and practices established by the National Institute of Standards and Technology (NIST), NIH, and NIAID. As such, the contractor shall maintain an operational relationship with support teams housing and providing data center services e.g., the NIAID Office of Cyber Infrastructure and Computational Biology (OCICB) as well as the Division of Clinical Research Informatics (DCRI) within the NIH Clinical Data Center.

As a tenant within these organizational data center facilities, the contractor will operate within the guidelines and practices established by that organization. This will require both a strategic and planning coordination as well as a tactical day to day communication and collaboration. This support will center on four core subtasks:

1. Availability and Operational Support

2. System Maintenance

3. Development, Modernization, and Enhancement

4. Security and Privacy

The continued implementation and support of the CRIMSON applications within NIAID clinics and STORM system for remote data collection and processing as the backbone of the DCR Clinical Research Data Management. Support for these objectives will require the immediate assumption of the current systems without user disruption, and continued coordination and integration with both the technical and operational environment of the NIAID Clinics and the DCR CTRS, primary tasks include.

Additionally, system security and privacy must be considered a critical attribute of all task areas and cannot be minimized, as certain systems may be required to contain PHI and PII or hold regulated data.

These subtasks have direct impact on the operational effectiveness of the NIAID ability to conduct clinical research and are an essential priority for the contract.

3.2.1 Subtask 2.1: Availability and Operational Support

When established all systems, supporting hardware and network connectivity will be monitored and key objectives for performance and uptime availability will be established. the contractor will serve as the custodian and caretaker of DCR research information systems, leading and facilitating end-user systems support needs and organizational data and infrastructure resources.

The contractor shall:

· The contractor shall deliver failure-free performance that does not exceed 8 hours of unplanned failure per year. It is noted that the product depends on collateral systems over which the contractor has limited or no control and outages in those systems are excluded from this metric but must be reported in periodic reports.

· The contractor shall provide all new and continuing technical support for the installation and maintenance of the CRIMSON application on approximately 250 computers. The contractor shall work with NIH, Clinical Center, and NIAID technology and security staff to assure access, hardware, and network performance in support of CRIMSON.

· The contractor shall begin to provide technical and application support for software and infrastructure problems within one hour of notification or outage during duty hours (currently 0700-1530, Monday-Friday) and within four hours during non-duty hours. Technical support must be documented to industry standards and reported.

· The contractor shall provide assurance of continued high-level performance, reliability, usability, integrity, and user support of the existing CRIMSON and STORM applications.

B.

3.2.2 Subtask 2.2: System Maintenance.

The contractor team will work with data center teams to assure updating and patching of all infrastructure and operating systems as technology evolve. Additionally, as new hardware or networking infrastructure are introduced into the datacenter the contractor will coordinate with datacenter technical teams to assure transition and continued support of DCR clinical research information systems that may be affected.

The contractor shall:

· The contractor shall provide maintenance and support of DCR Clinical Data Management Systems.

· The contractor will assure compliance and coordination with policies and best practices for the deployment of technology resources at the Clinical Center or within the OCICB infrastructure (cloud or on-premise data center), as defined by the respective data center. The COR will rely on the Program Manager and the Principal System Engineer to coordinate and communicate with these resources and to communicate the impact of changes to management.

· The contractor shall be responsible for the curation and monitoring of data workflows and application functional components (to assure data and system integrity)

· The contractor shall be responsible for tuning and optimization of hardware, software, and operational workflows (to enhance data and systems performance).

· The contractor shall be responsible for delivering the system functionality when and where required by prescribed workflows (providing system sustainability and reliability).

· The contractor shall be responsible for providing the research community an intuitive interface for optimal use of these systems in implementing operational workflows (optimizing workflow and data efficiencies).

· The contractor shall provide a point of contact during non-duty and holiday hours in the event emergency services are required.

· The contractor shall provide support for the selection, procurement, implementation, and oversight of hardware and software resources as needed for the configuration, development, and maintenance of CRIMSON and STORM.

· The contractor shall assure that NIAID Property representatives inventory any covered equipment purchased by the contractor as evidenced by a NIH Property Tag secured to the equipment.

· The contractor shall collect and report no less frequently than quarterly (as part of periodic reporting) metrics related to performance testing that include load and stress tests.

· The contractor shall support HL-7 and other normalized vocabularies for health care and research that apply to structured sources including laboratory results, diagnostic imaging, electrophysiological studies (e.g., EEG, ECG), and structured clinical observations (e.g., progress notes, problem lists, and medication coding,).

· The contractor shall support import/export and transformation of health care and research data.

· The contractor shall establish a code integrity plan that conforms to industry norms 45 days after award that assures the quality of new code before it is deployed.

· The contractor shall establish a data integrity-testing plan for assuring the accuracy and consistency of data over the entire data lifecycle 60 days after award.

· The contractor shall establish a technology platform that leverages open source or commercial applications, that support configuration over software development.

· The contractor shall provide technical SMEs to support operational workflows that may have impact on data workflows and support informatics systems design.

· The contractor shall provide new and continuing technical support for the continued enhancement and deployment of the LabKey (or other LIMS) platform and the STORM application, to support deployment in remote and technically underserved locations.

· The contractor shall provide consultative and operational services for external data integration (e.g., Health Level 7 (HL7), REDCap, FHIR) to be consumed by DCR clinical research systems or integrated with external sources at the direction of the COR.

· The contractor shall serve as a resource to DCR in the use and delivery of data and use of data integration tools, providing support for the routine execution and daily management of the data processing pipeline.

· The contractor shall support data integration using XML, SOAP, Web Services, HL7 interfaces, DICOM, and similar integration services.

· The contractor shall support terminology standardization and the use of controlled vocabularies to include but not limited to ICD-9, MedDRA, and CDISC SDTM.

· Maintain and operate data management pipelines, including data processing and integration workflows as part of system integration and data collection workflows.

· The contractor shall develop, maintain, and support automated data integration interfaces (e.g., BTRIS, CRIS. Frederick Laboratory GRIS etc..), when possible, leveraging an open-source ETL engine.

· The contractor shall support data cleaning and loading strategies as required, interfacing with study design teams and operational leads, again when possible leverage automated workflow engines, however when required manual data review may be required.

3.2.3 Subtask 2.3: Development, Modernization, and Enhancement In addition to routine support and operations the contractor shall provide continued development, modernization, and enhancement (DME) of the existing systems. For the systems to continually adapt to the changing business requirements, technology drivers and federal regulations, DME projects will be needed. A distinction between functional enhancements to be delivered as part of the ongoing operational support and the more formal DME project process by level of effort and operational urgency shall be made. These DME projects primarily include the more complex initiatives, that will require specific strategies for definition, prioritization, execution, and management. The approval and prioritization of DME projects shall be managed through a formal change control and governance process involving stakeholder input and COR oversight. These projects provide the ability to extend system capabilities as technical requirements and DCR operational needs change.

An essential part of the requested work will be leveraging custom built, open source or commercial applications to establish a core application platform to support Clinical Research operations within DCR. Using well proven system development practices the contractor will collect and analyze the operational requirements and potential solution strategies. Once approved, the proposed solution design will be developed. These solutions may include continued modification or modernization of the CRIMSON and suite of tools or systems supporting the emerging needs of DCR and special projects requires configuration and deployment of existing data collection and management tools, such as REDCap, BiobankPro, LabKey, Tableau, and/or DFdiscover. Many of these solutions may include the tailoring and use of commercial database management platforms such as PostgreSQL, MySQL, or Microsoft SQL Server. These systems will be required to adapt and evolve as the mission and objectives of the division respond to emerging situations and technology changes. As solutions are deployed the objective will be to establish a library of tools that can be rapidly adapted for a given study or response scenario

The contractor shall:

· The contractor shall define and present impact and resource requirements to key stakeholders, including the COR for prioritization and project management activities.

· The contractor shall define a means of review and prioritization of proposed DME activities, that include timeline and budget impact for COR approval

· For each DME project approved, the contractor shall establish an activity, schedule, and resource plan to monitor resource utilization and milestone delivery.

· The contractor shall submit their process for DME request review, analysis and prioritization tailored to the requirements and portfolio management strategy of the contract, no later than 30 days post award and reviewed annually.

3.2.4 Subtask 2.4: Security and Privacy

System Security and Privacy is a critical attribute of all supported systems and operational activities using those systems Core Task Areas. The current operating environment and data sensitivity (CRIMSON is currently a FISMA High) require an ongoing and proactive security and privacy auditing process. This process will comply with the policies and practices required to operate on the NIH network regarding subject privacy and cybersecurity issues. The contractor will coordinate any required desk audits, privacy assessments, documentation, or reviews mandated by NIAID and Clinical Center ISSOs.

The contractor shall:

· The contractor shall maintain access control lists (ACLs) for supported DCR Clinical Data Research applications. ACLs and similar controls shall be reviewed no less frequently than quarterly. Changes to ACLs shall be documented in periodic reporting.

· The contractor shall inform CORs, and NIAID and CC ISSOs of a breach or exfiltration of CRIMSON data within 60 minutes of suspicion.

· The contractor shall conduct periodic “desk exercises” to include security and confidentiality vulnerabilities and mitigations. NIAID COR and ISSOs shall be invited. These desk exercises may be at the contractor’s, COR, or ISSO’s discretion but shall be at least once per year.

· The contractor shall provide consultation and support for information security and privacy protection to include newly deployed systems supporting special project efforts

· The contractor shall maintain existing system(s) at the current assessed FISMA level(s) and prepare documentation for security assessment(s) to preserve ATO according to the NIH and NIAID cyber security guidance.

· The contractor shall assume existing MOUs, current ATOs and review all system security and privacy audits.

· The contractor will provide communication and guidance between DCR operations and the NIAID and Clinical Center CIOs regarding the policies and practices required to operate on the NIH network.

· The contractor will provide specific attention and detail to subject privacy and cybersecurity issues.

· The contractor will coordinate any required desk audits, privacy assessments, documentation, or reviews mandated by NIAID and Clinical Center ISSOs.

3.3 Task 3: User Support and Operations

The deployed Clinical Research information systems within DCR may require continued support and facilitation by the selected contract resources. The breadth of operational support will be defined in the design and definition of the proposed solution and may range from staffing and running data management and processing pipelines application specific user training, help desk support and system maintenance activities.

The operational execution of data management pipelines will include the configuration and tailoring of systems to specific research protocols. In both the existing CRIMSON applications and the proposed CTRS solutions this will include working with studies teams in configuration of application user interfaces, the identification, integration, and execution of external data sources required to support operational workflows and the reporting and dissemination of data. Additionally, there will be effort in supporting data collection and processing as part of an integrated study team approach. The contract staff will serve as study data manager and augment the team in the day-to-day operational activities. The contractor will be required to staff and support the CTRS data management team as part of the DCR emerging disease response team All systems and solutions provided to DCR through this contract will be supported through active end-user operational training and technical application support

Thecontractor shall:

· When requested and approved the contractor will staff and support data collection, QC, and data processing as part of the integrated study team.

· For both the technical and operational data processing activities for a given study, the contractor may be required to provide dedicated resources that remain part of the study team for the duration of the study. These resources would primarily be detailed as part of the CTRS team and may include international travel. The resources include: data management team and/or software engineering team to operationalize the study for the duration of the study. Depending on the type of study, various systems or software tools may be needed by the Contractor.

· Maintenance, adaptation, and optimization of core functionality supporting evolving workflows of clinical studies, regulatory requirements of existing studies.

· The contractor shall staff and operate data management and processing activities supported within CTRS

· The contractor shall provide clinically trained staff to facilitate the configuration of the data management applications and data processing workflows aligned with the data management requirements details of the study plan.

· As a study changes the contractor shall adapt and modify system configuration to accommodate the changing workflows.

· In the event, specific workflow events cannot be accommodated by configuration changes, the clinical implementation will escalate for analysis and potential functional modification. This support shall include help desk team, training, and functional consultations. The clinical support team shall be conversant in the clinical operations being conducted and how the modules and functions of the application can or shall be applied.

· The contractor shall provide operational support for data management and clinical documentation of clinical studies external to the NIH Clinical Center. The functionality will include; protocol design and development, CRF creation, clinical research database development, data processing, report development and coordination with regulatory, safety and study monitoring team or related activities.

· The contractor shall provide operational data management support in remote locations as part of emerging disease outbreak response.

· The contractor shall coordinate data transmission and integration from studies or clinical partners outside the clinical center, to include clinical studies in remote or technically underserved areas.

· The contractor shall integrate NIH single sign-on and other collateral controls as needed to facilitate both user experience and appropriate security in access and use of both CRIMSON and STORM.

· The contractor shall provide live problem-based application support to users during normal operating hours of the NIH Clinical Center within one hour of request. In this case “live” may be defined as “desk side” or virtual with screen sharing as appropriate. All help requests and resolutions must be documented.

· The contractor shall prepare materials for presentation, training, and user support and provide a library of those materials on the user Intranet.

· The contract shall provide training and support materials to new users and conduct user briefings on substantial system changes. Trainings and briefings must also be documented.

a. The contractor’s trainers shall offer user seminars at minimum twice yearly to identify training gaps and review training objectives. These offerings may be part of a regular meeting.

b. The contractor shall provide expert staff to collaborate with investigators to create and maintain operational workflows and software configuration for clinical studies.

c. The contractor shall provide a clinical studies expert with a minimum three years of experience in the design, implementation, and closing of human studies.

d. The contractor’s expert in clinical studies must design tools and templates to assist Investigators in the design of studies and to assure rapid and efficient system configuration.

e. The contractor shall work with users to assure logical and intuitive interfaces, capable of adoption in 90% of cases without extensive training. Evidence of this effort must be included in periodic reports.

· The contractor shall provide consultation for and facilitation of data transformation, curation, and management associated with projects and programs coordinated by the DCR Deputy Director for Operations and Management and the Chief, Biostatistics Research Branch, DCR. Requests for support will be documented and subject to COR review

· The contractor shall provide support for analytical staff including mathematicians, biostatisticians, and clinical investigators to facilitate the analysis of DCR clinical research data.

· The contractor shall serve as a DCR resource or SME in the broader area of NIAID data collection, storage, transformation, and delivery.

4 Key Personnel The following are the requirements and qualifications for five key personnel:

1. Program Manager: The Program Manager shall be responsible for the performance of work. The Program Manager shall have full authority to act for the contractor on all contract matters relating to daily operation of this contract. The Program Manager shall be available between 8:30 – 5:00 Monday thru Friday except Federal holidays or when the government facility is closed for administrative reasons. The Program Manager will require a breadth of experience in managing a complex and diverse project portfolio combining technology and clinical research, having at least 15 years’ experience in managing a clinical research informatics team. Additionally, a demonstrated knowledge of the regulatory and security requirements mandated for patient care and clinical research data is required. The Program Manager will have budget and resourcing management experience of at least 5 years of leading of a program with a budget > 2 million annually and a direct responsibility of a staff of more than 10 FTEs. The name of the Program Manager shall be designated in writing to the contracting officer as part of the technical proposal.

2. Principal System Engineer: In the absence of the Program Manager, the Principal System Engineer shall have full authority to act for the contractor on all contract matters relating to daily operation of this contract and shall be available between 8:30 – 5:00 Monday thru Friday except Federal holidays or when the government facility is closed for administrative reasons. The Principal System Engineer will lead the technical implementation and operational execution of the hardware, software and infrastructure supporting the contract objective. A strong background in design, development, deployment, and support of diverse technologies is required. This expertise will be demonstrated by previous experience in deploying commercial or internally developed solutions supporting and clinical research or clinical care. Experience must include more than 10 years of management of a software development team, direct management of server and networking resources and oversight of data integration or data warehousing operations. The name of the Principal Systems Engineer shall be designated in writing to the contracting officer as part of the technical proposal.

3. Clinical Implementation Lead: The Clinical Implementation Lead will serve as primary interface for clinical staff concerning CRIMSON, STORM, and the use and delivery of information systems supported in this contract within NIAID Clinics. The Clinical Implementation Lead will be a health care professional with at least 5 years’ experience in the facilitating the deployment and adoption of information systems in clinical care or clinical research. This experience will include requirements documentation and coordination with technical resources as well as direct supervision of help desk or training staff. The role includes oversight of the CRIMSON Help Desk and presenting CRIMSON to both users and interested parties.

4. System Security and Privacy Officer: SSPA will provide expertise and consultation on regulations and best practices in cybersecurity, Federal Information Security Management Act (FISMA), and Privacy Act as well as other common guidance in cybersecurity and privacy. The designated contractor will obtain within 60 days and maintain a certification equivalent to DoD 8140 Information Assurance Level 1 certification during the period of the contract. Such certification must include a thorough grounding in the Federal Information Security Management Act (FISMA).

5. Senior Clinical Data Manager: The Senior Clinical Data Manager will manage the clinical trial databases in support of the studies. Due to the possibility of having trials conducted internationally, the individual may be required to support DCR staff during non-duty and holiday hours. The Senior Clinical Data Manager will provide operational and strategic support to DCR in the design, execution, and maintenance of the clinical data management systems, and practices and policies used in the conduct of Clinical Research both nationally and internationally. A minimum of 10 years of experience in Clinical Data Management and 5 years of experience in Clinical Database Programming are required. The expectation is that the incumbent will be well capable of representing the operational role and activities of DCR and require little to no supervision on a day-to-day basis; as such, a deep mastery of the clinical research data process and resulting data workflows is required.

5 Period of Performance

The period of performance shall be for one (1) Base Year of 12 months and four (4) 12-month option years. The Period of Performance reads as follows:

Base Year - December 1, 2022 – November 30, 2023 Option Year 1 - December 1, 2023 – November 30, 2024 Option Year 2 - December 1, 2024 – November 30, 2025 Option Year 3 - December 1, 2025 – November 30, 2026 Option Year 4 - December 1, 2026 – November 30, 2027 Option Transition - December 1, 2027 – May 30, 2028

6 Place of Performance

The locations of where the contract will perform the work are Frederick MD, Bethesda MD, Rockville MD, and remote.

7 Transition

Initial Transition

The Contractor shall ensure the orderly, efficient, and safe transition of all contract activities and materials within three (3) months of effective date. This shall include the following Initial Transition activities and plans:

· Within fourteen (14) calendar days of the contract effective date, develop and submit, for COR review and approval, a Draft Initial Transition Plan to ensure full assumption of all contract responsibilities and functions no later than three (3) months following the contract effective date. The Draft Initial Transition Plan shall delineate the transition activities to be undertaken, timelines for the completion of each transition activity, and the staff to be assigned. Revise the Draft Initial Transition Plan to accommodate COR comments and submit the Final Initial Transition Plan no later than six (6) weeks after receipt of COR comments.

· Develop materials for and conduct orientation briefings for contract technical and administrative staff within six (6) weeks of the contract effective date. Work with the COR to incorporate into these orientation briefings information on NIAID policies and procedures.

· Contract materials and plans currently in use by the incumbent contractor shall be provided to the Contractor within fourteen (14) calendar days of the effective date of the contract. This includes security documentation, source codes, SOPs, project management and staffing plan, QA/QC plan, training plan, and overall monitoring strategy. Site monitoring visit reports and other monitoring materials shall be available to the Contractor via a method proposed by the contractor and approved by the COR.

· If necessary, participate in a series of joint meetings with the incumbent contractor, the COR and his/her designees to make sure the transition occurs smoothly with no disruption in all operations.

Final Transition The Contractor shall develop and implement a Final Transition Plan to ensure the orderly, efficient, and safe transition of all contract activities and materials. This shall include the following:

· Within six (6) months of the expiration date of the contract, develop and submit, for COR review and approval, a Draft Final Transition Plan delineating the transition activities to be undertaken, timelines for the completion of each transition activity, and the staff to be assigned. The Draft Final Transition Plan shall include a listing of and plans for transferring contract-generated materials. Revise the Draft Final Transition Plan to accommodate COR comments and submit the Final Transition Plan no later than four (4) months prior to the completion date of the contract.

· Implement the approved Final Transition Plan to ensure the completion of all transition activities and the transfer of contract RFP- generated materials to the successor contractor by the contract expiration date.

· Maintain contract operations at full staffing levels during the Final Transition period.