Attachment 3 - Task Order 3 - CTRO - Amendment 3_0003.pdf

Attachment 3: Task Order 3 – CTRO Solicitation 140D0421R0007

Clinical Trials Reporting Office (CTRO) Support Services

SECTION 1 – TASK ORDER INTRODUCTION

1.1 GENERAL

This task order requirement is for Clinical Trials Reporting Office (CTRO) Support Services.

1.2 SUBMISSION OF QUESTIONS

Contractors shall submit questions in accordance with the instructions provided in the IDIQ Solicitation.

1.3 ANTICIPATED AWARD TYPE

The Government anticipates awarding a Time-and-Materials (T&M) task order. Travel and Other Direct Costs (ODCs) are anticipated in performance of this task order.

SECTION 2 – TASK ORDER STATEMENT OF WORK

2.1 PURPOSE

The purpose of this Statement of Work (SOW) is to acquire professional Clinical Trials Reporting Program (CTRP) and CTRP’s Clinical Trials Reporting Office (CTRO) services for the National Cancer Institute (NCI) Center for Biomedical Informatics and Information Technology (CBIIT). Support shall include the following:

Contract, task order, project, and task management;

Biomedical informatics and information technology support;

Program and project planning, development, and tracking support;

Enterprise architecture support;

Application, system, and database definition, design, and maintenance support;

Semantics operations support;

Biomedical informatics and IT consulting and subject matter expertise support; and Website maintenance, content management and updates.

2.2 BACKGROUND

The National Cancer Institute (NCI), a major healthcare research institute within the National Institutes of Health (NIH), coordinates the nation’s research program on cancer prevention, detection, diagnosis, treatment, rehabilitation, survivorship and control. As a result of the 1971 National Cancer Act legislation, the NCI has built a research community that includes regional and community cancer centers, physicians who are cancer specialists, cooperative groups of clinical researchers, and volunteer and community outreach groups. NCI also has initiated cancer control programs to hasten the application of knowledge gained through cancer research.

NCI has developed research programs supported by an infrastructure for discovery composed of support mechanisms, organizations, and networks that link scientists, facilities, and information.

This infrastructure is the underpinning for activities that encompass all aspects of cancer prevention, detection, diagnosis, treatment, rehabilitation, survivorship, and control. In addition, the infrastructure supports basic, translational, and clinical cancer research, which culminates in a significant contribution of scientific advances in all areas of cancer research based on the efforts of thousands of scientists supported by the NCI.

NCI invests several hundred million dollars annually to sponsor and conduct clinical trials in the areas of cancer therapy, prevention, diagnosis, and epidemiology. Studies are conducted both at the NCI and at NCI-funded organizations nationwide. These organizations include the NCI-designated Cancer Centers; the NCI Clinical Trials Cooperative Groups; the Specialized Programs for Research Excellence (SPOREs) along with several smaller trial consortia. The major NCI Centers and Divisions sponsoring clinical trials include NCI Center for Cancer Research (CCR), Division of Cancer Prevention (DCP), Division of Cancer Epidemiology and Genetics (DCEG), Division of Cancer Control and Population Sciences (DCCPS), and Division of Cancer Treatment and Diagnosis (DCTD). These research activities, the institutions where these activities are performed, and the personnel conducting these activities, are collectively referred to as the NCI Clinical Research Enterprise.

In support of NCI’s basic research efforts and the NCI Clinical Research Enterprise, CBIIT is responsible for a range of biomedical informatics research, research support, data management and sharing policy and process, and associated program and project management and administrative support. This support includes several general categories of program, project, and resource management, biomedical informatics, and biomedical research, clinical analyses or translation, and scientific program and policy implementation support. This includes but is not limited to providing subject matter expertise across the full range of activities: application, system, and database definition, design, development, documentation, testing, implementation, update and maintenance; program and project communications support; policy and process implementation, biomedical IT and biomedical informatics training, and other biomedical informatics, biomedical research, and data science management support services.

CBIIT also provides biomedical informatics support and integration capabilities to the cancer research community and the NCI and serves as a focal point for cancer research informatics planning worldwide and works with research organizations, biomedical informatics groups and standards bodies to facilitate the identification and adoption of information exchange standards, thus connecting research information sources wherever they may reside.

Major ongoing initiatives and programs include, but are not limited to, a comprehensive Clinical Reporting and Research Informatics (CRRI) initiative that include elements of the Cancer Moonshot and Precision Medicine Initiative (PMI). CRRI will include Precision Medicine Activities, Correlative Study Management (CSMS), the Clinical Trials Reporting Program (CTRP) and CTRP’s Clinical Trials Reporting Office (CTRO), as well as ancillary support services. Specifics include:

The Clinical Trial Reporting Program (CTRP) fulfills a recommendation made by the NCI Clinical Trials Working Group (CTWG) to the National Cancer Advisory Board.

CTRP is designed to be a comprehensive database of regularly updated information, including accrual, on all NCI supported clinical trials. This comprehensive database of the entire NCI portfolio will help identify gaps in clinical research and duplicative studies, as well as facilitate effective clinical trial prioritization, trial search and trial matching.

The Clinical Trial Reporting Office (CTRO) provides task management, data abstraction, coding, characterization quality assurance, user support and reporting in support of NCI’s Clinical Trials Reporting Program (CTRP). The CTRO manages CTRP content, including abstraction of submitted clinical trial protocols, updating and maintaining the content of the CTRP database, ensuring the accuracy of content through quality assurance procedures, managing the NCI’s ClinicalTrials.gov account, and responding to queries from stakeholder in a timely and accurate manner.

2.3 OBJECTIVE

The objective of this SOW is to acquire contracted professional; data science; biomedical informatics; clinical and health science data sharing policy implementation, and biomedical IT and informatics subject matter expertise support and consulting services. The contract will assist CBIIT in planning, acquiring, developing, documenting, implementing, updating, and supporting biomedical research by focusing on providing biomedical informatics expertise and support resources. . This SOW does not include the direct development, implementation, or hosting of the CTRP system, applications, or databases.

The contract and resulting IT and informatics tools and applications will assist researchers and the NCI to meet scientific objectives in clinical and translational research, cancer research and genomics, semantic infrastructure and interoperability, data science, discovery biology, and data sharing.

2.4 SCOPE

The NCI seeks a Contractor with experience in biomedical informatics and IT, clinical and health sciences data sharing, and cancer clinical trial abstraction who can provide several classes of biomedical informatics and policy implementation support and consulting services to assist the CBIIT. The Contractor shall provide project management, data management, and reporting services; e.g., clinical trial data abstraction, quality assurance, user support and reporting in support of NCI Clinical Trials Reporting Program (CTRP); The contractor shall provide services that include, but not be limited to, the following:

Contract, program, project, task, and activity management;

Biomedical IT and informatics project management support including concept and business case development, cost and effort analysis, tracking, and reporting;

Data semantics support by proposing new terms to NCI’s Enterprise Vocabulary Services

(EVS) for creation in support CTRP Technical and business requirements analysis, tracking, mapping to functionality, and prioritization;

Design services, including business analysis, planning, requirements collection and analysis, data collection, modeling, and system, application, and database design;

Management of NCI’s ClinicalTrials.gov account User support, e.g., responding to incoming queries in a timely and accurate manner;

developing user training materials and presenting them to users, etc.;

Provide accurate and consistent abstraction, curation and coding of clinical trial administrative and scientific data;

These services shall include providing project and technical management, consulting, and technical support, including participating in efforts supporting other NCI Divisions, Offices, and Centers, in biomedical informatics, biomedical information technology, and cancer research projects in all stages of their life cycle, in accordance with the tasks specified below. These services require interaction with the government Program Manager or Officer, senior business and IT managers, program stakeholders, and other contractors.

The Contractor shall report directly to the Contracting Officer’s Representative (COR) and shall not play any role in directing or managing work of any other project or support contractor staff.

Work products shall include data files, information models, software design artifacts, , recommendations, system and program requirements, analyses, management reports, and briefings.

2.5 TASKS

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, as needed to perform task assignments at the direction of the COR in the Tasks specified below.

2.5.1 Task 1 – Task Order Management

The Contractor shall provide the technical and functional activities necessary for the management of this SOW and work performed to meet SOW requirements.

The Contractor shall provide a Task Order Management Plan outlining the tasks, sub tasks, and approaches to be used to provide the required services including the specific deliverable documents, analyses, and reports to be developed. When approved by the COR, this plan shall be used to monitor, control, and report progress, issues, and resource expenditure.

The Contractor shall participate in contract and project kickoff and management meetings and provide bi-weekly status updates and monthly status reports monitoring the performance and progress toward successful completion of this SOW.

Additionally, the Contractor shall provide and implement an approved Quality Assurance Plan outlining how assigned task work efforts will be controlled to ensure development and delivery of high quality services and products; provide insights into work processes; and provide positive guidance to improve work efficiency and acceptance of results.

As part of each assigned project or task, the Contractor shall provide the COR with a Work Plan for organizing, executing and monitoring the resource utilization, schedule, services and deliverables. This work plan when approved shall be incorporated into the Task Order Management Plan.

The Contractor shall support the development, maintenance, and document control/tracking, of project plans, roadmaps, protocol documents, spreadsheets, financial statements, and contract deliverable documents. The Contractor shall keep all documents secured in a system that allows folder/document/workspace management allowing for access to be granted to the Contractor, NCI, NIH, HHS, and any 3rd party designated by the NCI.

Additionally, the Contractor shall collect and provide government requested metrics and data that provide insight into the efficiency of processes needed to support this SOW; and provide recommendations for changes that improve work, management effectiveness, and end-user satisfaction and reduce costs.

2.5.2 Task 2 – Program and Project Management Services

The contractor shall provide consulting and technical services supporting CTRP program for planning, definition, design, development, implementation, testing, operation, and maintenance of services, applications, software, systems and infrastructures to support biomedical research, informatics, and care delivery. The Contractor shall apply expert level knowledge and best project management practices to ensure effective management of activities and achievement of project cost, schedule, and quality goals. Program and Project Management support will be prioritized based on CTRP, CBIIT, NCI, and NIH requirements.

Services provided shall include, but not be limited to:

Developing project and program Business Cases, work breakdown structures, management plans, effort and cost projections, and other required documentation;

Examining alternatives for the potential projects and systems, non-compliant areas, risk areas related to project requirements and activities;

Supporting project plan and business case updates, required cost analyses and cost tracking;

Supporting project governance processes and reviews;

Supporting data policy and process implementation for cancer research and clinical care initiatives;

Technical and business requirements analysis and gathering / tracking, artifacts and process for mapping to functionality, prioritization;

Program and Project Assessment and Evaluation such as strategies and process for evaluating progress and performance, development of metrics for success and processes for go-no-go decisions;

Identifying and implementing project management tools to support project needs;

Defining, distributing, and maintaining project schedules and project team task lists;

Defining, documenting, and assisting with milestone reviews, project schedules, tasks and assumptions;

Documenting and managing, project assumptions, risks, issues, and quality control;

Providing consulting and training support to individual government project and task managers to help ensure successful, on-time, within budget project completion;

Coordinating amongst teams and different CBIIT programs; and Developing and implementing communications strategies and mechanisms.

2.5.3 Task 3 – Clinical Trials Reporting Office (CTRO)

The Contractor shall provide project management, data management, and reporting services; e.g., data abstraction, quality assurance, user support and reporting in support of NCI Clinical Trials Reporting Program (CTRP); The contractor shall provide services that include, but not be limited to, the following:

Provide accurate and consistent abstraction, curation and coding of clinical trial administrative and scientific data;

Abstract new trial and amendment submissions; implement changes in trial status and participating sites;

Data semantics support by proposing new terms to NCI’s Enterprise Vocabulary Services

(EVS) for creation in support CTRP;

Manage updates to submissions; ensure automated solicitations are scheduled and sent to receive trial updates twice a year;

Manage the accuracy and curation of persons and organizations associated with clinical trials;

Provide workload, status, performance, data quality, and other reports upon request from the COR, Government lead, and/or designee;

Manage the reporting of clinical trial accrual into CTRP, ensuring the timeliness of reporting and compliance with accrual data reporting guidelines;

Develop and implement a continuous quality assurance plan to assure accuracy and consistency of data entered and maintained in CTRP;

Implement, maintain, and update Standing Operating Procedures (SOPs); identify departures from SOPs; recommend and implement appropriate changes in a timely manner;

Maintain a list of operational issues; seek guidance from the Contracting Officer’s Representative (COR), Government lead, and/or designee on how to prioritize the resolution of operational issues; work with the COR, Government lead, and/or designee to develop a timeline to resolve operational issues;

Implementation support services including evaluation and analysis of issues, development of recommendations for design, standards, and administration of systems, database management, data analysis, and reporting services;

Clinical and health science data policy implementation;

Maintenance, content management, and updating the CTRO wiki hosted within the NCI environment;

Meet with staff in NCI’s Coordinating Center for Clinical Trials (CCCT), other contractor staff, and internal and/or external NCI stakeholders upon request, to discuss topics, such as operational issues, technical issues and/or other related concerns;

Manage the NCI’s ClinicalTrials.gov Protocol Registration and Results System (PRS) account for NCI Sponsored trials registered in CTRP;

Manage compliance with results reporting for NCI sponsored trials and other trials directly funded by NCI, e.g., trials managed by NCI’s Cancer Therapy Evaluation Program (CTEP);

Provide user support, e.g., responding to incoming queries, sending messages regarding CTRP as directed to listservs, developing training materials regarding CTRP and providing information webinars and/or presentations upon request;

Manage the accuracy and curation of persons and organizations associated with clinical trials;

Clinical trial data policy implementation as directed by the Government;

Develop training and documentation materials, e.g., PowerPoint presentations, website content, etc., .and updates for CTRO related activities.

2.5.3.1 CTRO – Support Management of ClinicalTrials.Gov

The Contractor shall follow approved SOPs and as directed, support the accomplishment of the following tasks:

Manage the NCI’s ClinicalTrials.gov account to monitor and ensure Food and Drug Administration Amendment Acts (FDAAA) compliance for all NCI Sponsored trials, including compliance with all required results reporting;

Register all NCI sponsored trials in NCI’s ClinicalTrials.gov account prior to the enrollment of the first patient;

o Notify the Government Subject Matter Expert (SME) and the NCI ClinicalTrials.gov account manager of any ClinicalTrials.gov submission errors resulting from manual or automated ClinicalTrials.gov registration using CTRP generated XML. The NCI ClinicalTrials.gov account manager will evaluate the errors.

Manage amendments/updates to NCI Sponsored trials in the NCI ClinicalTrials.gov account;

Monitor trial status dates for NCI sponsored trials to ensure compliance with FDAAA results reporting timelines, e.g., monitor the Primary Completion Date for all NCI Sponsored trials to ensure compliance with FDAAA basic results reporting timelines and monitor the Trial Completion Data for FDAAA reporting of secondary outcomes;

Track results reporting designees and monitor the progress of all required results reporting for all NCI Sponsored trials;

o Track the staff identified as results reporting designees, and grant them limited access for the purposes of results reporting on NCI sponsored trials

Manage the review and approval of basic results reporting with the NCI Cancer Therapy Evaluation Program (CTEP) or Division of Cancer Prevention (DCP) Protocol and Information Office (PIO);

Upon request, provide reports regarding registration and results reporting for NCI managed trials;

Track the registration record during the period of results reporting, identify any major changes to the registration record introduced by the results reporting designee, and reconcile the registration record;

Develop, update, implement and maintain ClinicalTrials.gov account management SOPs;

Develop related documentation in liaison with Government and other staff;

Provide training to CTRP users in:

o Using CTRP;

o Registering trials and reporting accruals and results in CTRP;

o Uploading trial data from CTRP into ClinicalTrials.gov using the “Upload from

CTRP” function;

Generate monthly reports verifying that trial status has been updated within the last 12 months;

Generate monthly reports regarding NCI Sponsored trials (i.e. NCI sponsored trials from NCI Cancer Therapy Evaluation Program (CTEP) or Division of Cancer Prevention (DCP) Protocol and Information Offices) that are reaching their primary completion date as well as those that are due to report results.

2.5.3.2 CTRO – CTRP New Trial/Amendment Processing

The Contractor shall ensure new trial/amendment registration and abstraction within 10 business days after submission into CTRP. Within these 10 business days, the submitter receives one or more of the following notifications - 1) the new trial registration record has been accepted in CTRP; 2) the trial has been rejected in CTRP, when appropriate, and the reason for the rejection;

3) the trial is on-hold in CTRP and the reason that the trial was placed on hold, e.g. missing documentation or information necessary to finalize the abstraction, etc.; and/or 4) the review and approval of the Trial Summary Review (TSR) is required of the submitter.

At time of registration, the submitter will categorize the trial in one of the following two categories:

Complete: Trials in this category include National, Externally Peer-Reviewed and, Institutional trials (https://www.cancer.gov/about-nci/organization/ccct/ctrp/registration) o Complete Trials require submission of the full clinical trial protocol and informed consent documents.

o Patient level accrual (https://www.cancer.gov/about-nci/organization/ccct/ctrp/accrual) is reported at least once each quarter.

Abbreviated: Trials in this category include, but are not limited to, Industrial trials and trials submitted by NCI’s Center for Cancer Research. This category also includes some trials where the lead organization is not directly funded by NCI, such as a cancer center that is not NCI-Designated.

o The submitter provides the NCT number (the number assigned to the trial following registration in ClinicalTrials.gov) and indicates their participation.

o Abstraction includes, but is not limited to, application of coding terms and NCI specific information, e.g., grant numbers.

o Cumulative patient accrual (https://www.cancer.gov/about-nci/organization/ccct/ctrp/accrual) is reported at the end of each quarter.

2.5.3.3 CTRO – Abstraction of Complete Trials

For each complete trial, the Contractor shall validate the trial by completing the following tasks:

Review the header information (i.e. Title, Lead Organization, Trial ID, etc.) of each trial;

Search CTRP to ensure that the protocol has not been previously submitted;

Review documents submitted at registration. Critically review the title, lead organization, principal investigator, and trial identifier with the elements registered by the submitter in CTRP to ensure that they are consistent;

Review all administrative data elements to ensure that they are complete and correct as specified in the SOP. These include, but are not limited to:

o Review of the official title and correct capitalization and formatting, as specified in the SOP;

o Delete duplicate identifiers and add any additional identifiers associated with the trial. Specifically, additional identifiers should be added to trials found in CTEP’s information systems, e.g., ESYS, SMART, IPAD, DCP’s information system, ClinicalTrials.gov, and/or the protocol document;

o Verify that the Principal Investigator is the same as that listed in the protocol document;

o Review information and validate the Sponsor and ensure that NCI Sponsored trials per FDAAA are correctly identified;

o Review the Study Source and ensure that the category chosen for the trial is correct and meets the definition;

o Review funding information to ensure the accuracy and comprehensiveness of the submitted grant and contract information.

Tag the trial with appropriate NCI program code if applicable e.g. NCTN, NCORP, BIQSFP, Steering Committee, etc.;

Abstract the scientific content of the protocol document and code it to support precise search and retrieval, as specified in the SOP. Abstraction and coding include, but are not limited, to the following:

o Reviewing the trial to ensure that it is correctly characterized as:

Interventional;

Non-interventional/observational; or Non-interventional/ancillary-correlative;

o Reviewing and, if necessary, correct the primary purpose (e.g., treatment);

o Preparing the brief title and brief summary;

o Abstracting the detailed description, trial design, outcomes, and eligibility criteria;

o Applying disease/condition, and intervention terms from the NCI thesaurus or request new terms from NCI’s Enterprise Vocabulary Services (EVS), if needed;

o Selecting lead disease from the list of abstracted disease(s);

o Applying “anatomic sites’ from NCI’s Office of Cancer Centers;

o Abstracting Biomarkers.

Complete Submissions are submitted either:

1. Directly by the awardee (e.g., NCI-Designated cancer center or NCI grantee);

2. Registered in CTRP by the CTEP PIO via RESTful services or by the DCP PIO via

DCIM.

2.5.3.4 CTRO – Abstraction of Abbreviated Trials

The contractor shall:

Review the header information (i.e. Title, Lead Organization, Trial ID, etc.) of each trial;

Determine whether a ClinicalTrials.gov registry number (“NCT” followed by and 8-digit number, e.g.: NCT00000419) number has been provided during registration;

Search CTRP to ensure that the protocol has not been previously submitted;

For trials submitted without an NCT number, validate the trial following the SOP to ensure that sufficient information has been submitted for creating a trial registration record;

For all abbreviated trials:

o Apply disease, condition, and intervention terms from the NCI thesaurus or request new terms from NCI’s Enterprise Vocabulary Services (EVS) if needed;

o Select lead disease from the list of abstracted diseases;

o Apply “anatomic sites” from NCI’s Office of Cancer Centers; and o Abstract Biomarkers

2.5.3.5 CTRO – Accrual Submissions

The contractor shall:

Review quarterly accrual submissions and report the number of trials for which accrual was submitted in the last quarter;

Process requests for submitting accrual data to CTRP;

o Check that the requestor is associated with the trial and has a CTRP Registry account;

o Check that the trial has been registered and that the record has been accepted and successfully registered in CTRP;

o Add requested user in Manage Accrual Access utility; and o Notify requestor of the status of their request;

o Process requests for reconciling accrual discrepancies as well as reconciling accrual discrepancies upon request.

2.5.3.6 CTRO – Standard Operating Procedure Development and Maintenance The contractor shall develop, update, and maintain Standard Operating Procedures (SOPs) in an NCI repository that can be accessed by both the Government and the contractor, e.g., the NCI wiki hosted at CBIIT, to accomplish all tasks, including but not limited to:

Abstraction and coding of cancer clinical trials;

o Registration of new clinical trials o Amendment and update processing

Trial status updating;

Accrual reporting;

Management and abstraction of amendments to the trials that are registered;

Management of the NCI’s ClinicalTrials.gov account;

Person and Organization Curation;

Utilization of terminology for coding content in CTRP;

Collection and storage of data;

Quality assurance, control, and maintenance of data integrity; Protection of research subjects and maintenance of privacy and confidentiality;

Internal and external communication processes;

Tracking of data access conditions, including limitations on data use or subsequent disclosure and a corresponding role-based access controls;

Retention of data and retention of records related to collection of data.

The Contractor shall review and propose modifications, as needed, to each of the SOPs at least annually, and shall note in the monthly progress report(s) when modifications have been made.

2.5.3.7 CTRO – Communications

The contractor shall provide operational support, including daily receipt of requests from internal and external users via NIH email, phone, or mail in the NCI provided customer management system (CRM), ServiceNow (SN) or any other system deemed appropriate for usage by the Government.

The Contractor shall prioritize requests; make assignments to appropriate staff to resolve requests; and develop and implement a reporting framework after approval by the Government.

This framework shall ensure recording of communications received and acted upon daily in the

Protocol Abstraction and/or other record tracking systems determined appropriate by the Government. The types of tickets to expect are as follows: administrative, data cleanup, ClinicalTrials.gov, TSR feedback, outreach, accrual, policy, technical update required, etc.

The Contractor shall notify the Government on a weekly basis of significant communication matters that require Government decision or a change in policy.

Additionally, the Contractor shall complete the following tasks:

Escalate issues to the COR and/or Government lead, , or designee for resolution, as necessary;

Upon request, develop and distribute CTRP correspondence to the user community through the CTRP Listserv upon request. Materials to be distributed include, but are not limited to:

o Scheduled Maintenance announcements;

o CTRP Releases;

o User Account Updates;

o System Issues/Outages; and o General CTRP Updates

Develop training materials for use in and facilitate CTRP Registration and or Accrual Reporting Webinars with external users, e.g., NCI designated cancer centers to review clinical trial reporting policies and procedures and answer questions;

Generate monthly reports verifying trial Start Date for which accrual have been reported;

contact trial owner if Start Date is missing from any of the trials;

Generate monthly reports of trials that have reached Closed to Accrual, Closed to Accrual, Intervention or Complete Status and then reach out to the trial owner, as necessary, to verify the accrual values and the trial status, e.g., active, not recruiting vs.

terminated if the actual accrual value is<70% or >125% of the target accrual;

Respond to user needs from incoming emails that are tracked in SN or other Government successor systems(s) (in accordance with SOP). Types of queries include but are not limited to:

o General questions about the scope and purpose of CTRP;

o Questions regarding whether specific trial(s) are in scope for CTRP.

o Administrative updates;

o Trial status updates;

o TSR feedback;

o Requests for new permissible values for CDEs to support biomarker abstraction;

o CTRP Registration account and batch upload access, which will be escalated to the CTRP Engineering team;

o Account login assistance, which will be escalated to the CTRP Engineering team;

o Registration application errors, bugs, and timeouts;

o Accrual related inquiries/issues/errors;

o Data Table 4 related inquiries.

2.5.3.8 CTRO – Person and Organization Curation

The Contractor shall establish and maintain processes for curating persons and organizations (including relevant SOPs) to ensure consistency and quality of data in the Person and

Organization system. The curation process typically involves the following sequence of actions:

reviewing, creating, modifying, inactivating, and nullifying person and organization information Cancer Therapy Evaluation Program Enterprise Core Model (CTEP-ECM) and by trial submitters.

2.5.3.9 CTRO – CTRP User Support

The Contractor shall continuously monitor the need for new user support from potential new users. The support will include, but not be limited to, the following:

Review and update CTRP User Guides;

Review and propose updates to CTRP publicly facing websites;

Establish webinars and customize user training sessions for new and existing CTRP users;

Develop open-ended assessments for users to obtain feedback on the CTRP User

Interface, utilization of training and documentation.

2.5.3.10 CTRO – CTRP Terminology Utilization

The Contractor shall use controlled terminology in NCI’s Enterprise Vocabulary Services (EVS), and the list of anatomic sites provided by NCI’s Office of Cancer Centers (OCC) as directed by the Government to code trial registration data. The Contractor shall also provide quality assurance of accrual coding. The terminology related activities include, but are not limited to the following:

Trial Terminology o Support maintenance of the Disease and Intervention Terminology in CTRP, as needed, to support trial coding; request new terms, when necessary, following the established SOP;

o Code trials utilizing the NCI Thesaurus terminology;

Biomarker Terminology o Code trials utilizing the NCI Thesaurus terminology, o Process requests for new biomarker terms in accordance with SOP;

Accrual Terminology o Review accrual data as directed by the COR and/or Government Lead, identify potential errors, e.g., inconsistencies with trial level coding, multiple lead diseases and/or anatomic sites and recommend corrective action;

Structured Eligibility Terminology, once policies and system processes are in place.

2.5.3.11 CTRO Reporting Metrics

The Contractor shall define, establish, collect, and report CTRO performance metrics once each month including, but not be limited to the following:

Total number of clinical trials in the CTRP database;

Number of active/approved trials and all other trials;

Number of new trials submitted each month “Complete” and “Abbreviated”;

Number of amendments submitted each month;

Status of all trials received and processed in the previous month (e.g. completed as a part of the Service-Level Agreement (SLA) within 10 business days, not completed as a part of the SLA and the reason why (e.g. on-hold, missing protocol document rejected out of scope, etc.);

Number of new and closed SN tickets - or other ticket tracking systems deemed appropriate for usage by the Government - including the status of open tickets during the previous month.

2.5.3.12 Database Administration and Issue Tracking

The Contractor shall develop and implement a process to produce ad hoc custom reports from CTRP using SQL query, as well as custom reports requested by CTRP users, following approval by the COR, Government lead or designee. The output from queries must be reviewed by the Government lead prior to distribution. Measures must be put into place to protect potentially sensitive data, e.g., sending sensitive data only via encrypted methods that have been approved in advance by the Government.

The Contractor shall document and report all technical bugs encountered to the CTRP Engineering Support Team.

A cumulative report summarizing outstanding technical issues encountered to date, their severity and impact on CTRP and/or its stakeholders, and date reported is to be reviewed at least monthly with the CTRP technical team and the COR, Government lead or designee.

Technical issues that are determined by CTRO to be of high significance shall be brought to the attention of the Government Lead as soon as possible for determination of proper course of action.

2.5.3.13 CTRO Management

The Contractor shall support all activities necessary to manage the CTRO.

The Contractor shall institute and maintain an effective, efficient, and responsive organization that is responsible for the management and oversight of all CTRP activities. The Contractor’s management organization will be responsible for ensuring that all work activities are performed in a timely and cost-effective manner while maintaining the highest quality of performance.

2.5.4 Task 4 – Other Services Required to Support SOW Requirements

The Contractor shall provide other technical and systems services in support of CBIIT tasks and projects within the scope of this SOW as required and directed by the Government’s assigned COR. Examples include end-user support and help desk.

2.5.5 Task 5 – Transition Planning and Support

The Contractor shall demonstrate in their response experience, and expertise in successfully transitioning an in-process cancer research clinical trial, biomedical research, and care delivery information systems contract of similar size and scope as prime contractor or subcontractor.

The Contractor shall work with CBIIT and other NCI support contractors to ensure that working relationships are cordial, professional, that incoming managers and staff fully absorb methodologies, experiences, and lessons learned to ensure all work, management, and reporting tasks and efforts are conducted rapidly and smoothly.

The Contractor shall ensure that proposed key personnel are available to begin work upon contract award and that all staff required to implement the Contractor’s proposed technical approach are available and onboard within 30 days of award.

2.5.5.1 Transition-In Planning and Support

The Offeror shall provide a Draft Staffing and Transition-In Plan as a part of its proposal outlining how it proposes to quickly and successfully provide qualified staff to implement the proposed technical approach, transition current and ongoing tasks and activities, and ensure effective knowledge transfer from any outgoing contractor(s). After contract award and receipt of government comments and suggested changes, this Draft Staffing and Transition-In Plan shall be finalized and implemented to ensure a timely and successful transition.

The Staffing and Transition-In Plan shall provide a logical strategy and process to mitigate risk to the Government. The plan shall include the following as a minimum:

Overview of how transition shall be implemented and managed;

Staffing plan and approach;

Staffing plan implementation and management;

Transition of key personnel and non-key personnel;

Transition of Existing Efforts;

Resources required for the transition;

Roles and responsibilities;

Timeline;

Risks, issues, and associated implications; and Risk and issue mitigation processes and procedures.

Transition-in shall begin at contract award. The contractor shall complete all transition-in efforts in accordance with the approved transition plan (to include the Government’s validation of the Transition Plan, containing critical events, schedules and approach) and be prepared to begin performance immediately and to be completed no later than thirty (30) calendar days after award.

The contractor shall discuss the transition-in period and operational activities with the COR beginning not later than the 5th calendar day following award. The discussion shall address, at a minimum, those items identified as being key to the success of the transition identified in the plan, status, and any risks or issues identified.

2.5.5.2 Transition-Out Planning and Support

In the final year of the Contract, or in the event the Government requirements necessitate a re-compete of the requirements of this SOW, and prior to completion of this Delivery Order’s period of performance, the Contractor shall develop and deliver a Transition-Out Plan not later than 90 days prior to contract expiration. The purpose of the Transition-Out Plan is to ensure an orderly and successful transition of contract functions should the incumbent Contractor not be selected during the re-competition of the Contract.

This Transition-Out Plan shall include processes, procedures, and activities the Contractor shall use, if not selected for a follow-on contract, to adequately educate and train the successful contractor’s employees and smoothly and effectively transition work activities to the new Contractor. When tasked, the Contractor shall implement the Transition Plan and assist the NCI to transition knowledge, processes, tasks, activities, etc. to the follow-on contractor.

The plan shall detail transition-out activities to assure continuity of operations and the execution of a smooth and timely transition. Transition-out activities shall be coordinated through the COR and/or other designated federal staff. The outgoing contractor shall discuss the status of transition-out activities with the COR on a weekly basis beginning the 5th working day following the award of a successor contract. In the event the follow-on contract is awarded to an entity other than the incumbent, the incumbent Contractor shall cooperate to the extent required to ensure an orderly changeover to the successor Contractor.

2.6 NIH FISMA and FEDRAMP Information Security and/or Physical Access Security

Compliance Requirements

Prohibition on Contractor Involvement with Terrorist Activities The Contractor acknowledges that U.S. Executive Orders and Laws, including but not limited to E.O. 13224 and P.L. 107-56, prohibit transactions with, and the provision of resources and support to, individuals and organizations associated with terrorism. It is the legal responsibility of the Contractor to ensure compliance with these Executive Orders and Laws. This clause must be included in all subcontracts issued under this contract.

Information Security and/or Physical Access Security

A. POSITION SENSITIVITY DESIGNATIONS

All Contractor (and/or any subcontractor) employees must obtain a background investigation commensurate with their position sensitivity designation that complies with Parts 1400 and 731 of Title 5, Code of Federal Regulations (CFR). The following position sensitivity designation levels apply to this solicitation/contract:

[ ] Level 6: Public Trust - High Risk. Contractor/subcontractor employees assigned to Level 6 positions shall undergo a Suitability Determination and Background Investigation (MBI).

[ ] Level 5: Public Trust - Moderate Risk. Contractor/subcontractor employees assigned to Level 5 positions with no previous investigation and approval shall undergo a Suitability Determination and a Minimum Background Investigation (MBI), or a Limited Background Investigation (LBI).

[X] Level 1: Non-Sensitive. Contractor/subcontractor employees assigned to Level 1 positions shall undergo a Suitability Determination and National Check and Inquiry Investigation (NACI).

420 RFP Handbook 01/25/19

1. HOMELAND SECURITY PRESIDENTIAL DIRECTIVE (HSPD)-12

The Contractor (and/or any subcontractor) and its employees shall comply with Homeland Security Presidential Directive (HSPD)-12, Policy for a Common Identification Standard for Federal Employees and Contractors; OMB M-05-24; FIPS 201, Personal Identity Verification (PIV) of Federal Employees and Contractors; HHS HSPD-12 policy; and Executive Order

13467, Part 1 §1.2. For additional information, see HSPD-12 policy at:

https://www.dhs.gov/homeland-securitypresidential-directive-12)

Roster-

a. The Contractor (and/or any subcontractor) shall submit a roster by name, position, e-mail address, phone number and responsibility, of all staff working under this acquisition where the Contractor will develop, have the ability to access, or host and/or maintain a government information system(s). The roster shall be submitted to the COR and/or CO within fourteen

(14) calendar days after the effective date of this contract. Any revisions to the roster as a result of staffing changes shall be submitted within seven (7) calendar days of the change. The COR will notify the Contractor of the appropriate level of investigation required for each staff member. An electronic template, "Roster of Employees Requiring Suitability Investigations," is available for contractor use at:

https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/SuitabilityRoster_10- 15-12.xlsx .

b. If the Contractor is filling a new position, the Contractor shall provide a position description and the Government will determine the appropriate suitability level. Upon receipt of the Government's notification of applicable Suitability Investigations required, the Contractor shall complete and submit the required forms within 30 days of the notification.

c. Upon receipt of the Government's notification of applicable Suitability Investigations required, the Contractor shall complete and submit the required forms within 30 days of the notification.

d. The Contractor shall notify the Contracting Officer in advance when any new personnel, who are subject to a background check/investigation, will work under the contract and if they have previously been the subject of national agency checks or background investigations.

e. All contractor and subcontractor employees shall comply with the conditions established for their designated position sensitivity level prior to performing any work under this contract.

Contractors may begin work after the fingerprint check has been completed.

f. Investigations are expensive and may delay performance, regardless of the outcome of the investigation. Delays associated with rejections and consequent re-investigations may not be excusable in accordance with the FAR clause, Excusable Delays - see FAR 52.249-14.

Accordingly, the Contractor shall ensure that any additional employees whose names it submits for work under this contract have a reasonable chance for approval.

g. Typically, the Government investigates personnel at no cost to the Contractor. However, multiple investigations for the same position may, at the Contracting Officer's discretion, justify reduction(s) in the contract price of no more that the cost of the additional investigation(s).

h. The Contractor shall include language similar to this "HHS Controlled Facilities and Information Systems Security" language in all subcontracts that require subcontractor personnel to have the same frequency and duration of (1) physical access to an HHS-controlled facility; (2) logical access to an HHS-controlled information system; (3) access to sensitive HHS data/information, whether in an HHS-controlled information system or in hard copy; or (4) any combination of circumstances (1) through (3).

i. The Contractor shall direct inquiries, including requests for forms and assistance, to the Contracting Officer or designee.

j. Within 7 calendar days after the Government's final acceptance of the work under this contract, or upon termination of the contract, the Contractor shall return all identification badges to the Contracting Officer or designee.

TRAINING

1. Mandatory Training for All Contractor Staff- All Contractor (and/or any subcontractor) employees assigned to work on this contract shall complete the applicable HHS/NIH Contractor Information Security Awareness, Privacy, and Records Management training course at http://irtsectraining.nih.gov/ before performing any work under this contract. Thereafter, the employees shall complete NIH Information Security Awareness, Privacy, and Records Management training at least annually, during the life of this contract. All provided training shall be compliant with HHS training policies.

2. Role-based Training- All Contractor (and/or any subcontractor) employees with significant security responsibilities (as determined by the program manager) must complete role-based training annually commensurate with their role and responsibilities in accordance with HHS policy and the HHS Role-Based Training (RBT) of Personnel with Significant Security Responsibilities Memorandum. Read further guidance about the NIH Role-based Training https://ocio.nih.gov/aboutus/publicinfosecurity/securitytraining/Pages/rolebasedtraining.aspx

3. Training Records- The Contractor (and/or any subcontractor) shall maintain training records for all its employees working under this contract in accordance with HHS policy. A copy of the training records shall be provided to the CO and/or COR within 30 days after contract award and annually thereafter or upon request.

RULES OF BEHAVIOR

1. The Contractor (and/or any subcontractor) shall ensure that all employees performing on the contract comply with the HHS Information Technology General Rules of Behavior, and comply with the NIH Information Technology General Rules of Behavior https://ocio.nih.gov/InfoSecurity/training/Pages/nihitrob.aspx , which are contained in the NIH Information Security Awareness Training Course http://irtsectraining.nih.gov

2. All Contractor employees performing on the contract must read and adhere to the Rules of Behavior before accessing Department data or other information, systems, and/or networks that store/process government information, initially at the beginning of the contract and at least annually thereafter, which may be done as part of annual NIH Information Security Awareness Training. If the training is provided by the contractor, the signed Rules of Behavior must be provided as a separate deliverable to the CO and/or COR per defined timelines above.

Confidentiality and Nondisclosure of Information- Any information provided to the contractor (and/or any subcontractor) by HHS or collected by the contractor on behalf of HHS shall be used only for the purpose of carrying out the provisions of this contract and shall not be disclosed or made known in any manner to any persons except as may be necessary in the performance of the contract. The Contractor assumes responsibility for protection of the confidentiality of Government records and shall ensure that all work performed by its employees and subcontractors shall be under the supervision of the Contractor. Each Contractor employee or any of its subcontractors to whom any HHS records may be made available or disclosed shall be notified inwriting by the Contractor that information disclosed to such employee or subcontractor can be used only for that purpose and to the extent authorized herein.

The confidentiality, integrity, and availability of such information shall be protected in accordance with HHS and NIH policies. Unauthorized disclosure of information will be subject to the HHS/NIH sanction policies and/or governed by the following laws and…