Attachment_3_SOW_N02CN85003-39.pdf

Attachment 3: Statement of Work

December 7, 2017 Page 1 of 8

RFP N02CN85003-39

Attachment 3

Statement of Work

Protocol Information Office (PIO) Support Services

Independently, and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, materials, equipment, and facilities, not otherwise provided by the

Government, as needed to perform the requirements set forth below.

SCOPE:

The objective of this requirement is to provide support to the NCI, DCP Protocol Information Office

(PIO). (A list of acronyms, terms and definitions are provided at the end of this Statement of Work.) The scope is divided into five fully integrated and cohesive project areas. The five project areas are:

Project Area 1: Abstraction of Key Elements from Protocol

Project Area 2: File Management

Project Area 3: Clinical Trial Review Support

Project Area 4: Manage People and Organizations Data in DESK-PIMS

Project Area 5: PIO Operational Support

SECTION 1 - GENERAL REQUIREMENTS

NOTE #1: The Government will provide a suite at 9609 Medical Center Dr., Rockville, MD which is comprised of five cubicles for all Contractor staff working on-site on this project. All on-site Contractor staff will have at their workstation a computer and phone as well as access to printers, copiers, fax machines and scanners to complete the tasks specified in this Statement of Work (SOW). In addition to the equipment listed above, the Government will provide the Contractor with the office supplies that are necessary to perform the tasks specified in this SOW.

1. The Contractor shall staff the PIO office each business day (Monday-Friday), except Federal holidays, during normal business hours (8:30 AM ET-5:00 PM ET).

2. The Contractor shall be responsible for the management and supervision of all Contractor employees (including any subcontractor employees, if applicable) that are working under this contract.

3. The Contractor shall utilize the Government-provided computer hardware, software, and other informatics IT tools. The Contractor shall monitor all equipment and office supplies provided for this project, and shall request replenishment/replacement of equipment and supplies, as needed, from the Contracting Officer’s Representative (COR).

4. The Contractor shall work with the Government to obtain the necessary email accounts, usernames, and passwords necessary to access all relevant IT systems, including but not limited to, NIH email, network folders, DCP Databases, and Cancer Therapy Evaluation Program

Enterprise System (CTEP-ESYS) applications.

5. The Contractor shall review and be familiar with the information provided on the DCP website, for purposes of understanding and explaining DCP policies and procedures, as needed. The

Contractor shall reference the website when communicating with various personnel, e.g., sites

December 7, 2017 Page 2 of 8 submitting information to DCP; Government personnel with queries regarding submissions, study development, and other DCP procedures.

6. The Contractor shall utilize a Government-provided PIO inbox address for receipt of all emails and document submissions related to DCP-sponsored studies. The Contractor shall triage all queries and submissions that are received in the PIO office and respond in a timely manner.

Although some queries take longer to resolve, an initial response to acknowledge receipt shall be provided within one business day. The Contractor shall seek advice from the Contracting

Officer’s Representative (COR) if needed.

7. The Contractor, as part of the Division of Cancer Prevention Protocol Information Office operations and support, shall:

a. Facilitate support in the development of quality clinical trial documentation

b. Facilitate the trial development and management administration for DCP staff and the extramural community.

c. Maintain clinical trials information in the DCP database, currently DCP Enterprise

Knowledgebase (DESK) and its PIO portal, the Protocol Information Management

System (PIMS) to support DCP program management, evaluation, and planning.

d. Abstract key data elements into the DCP database, DESK, regarding studies, reviews, and milestones to support study tracking and workload management for DCP staff.

e. Abstract key information including data elements, milestones and treatment descriptors into the Cancer Therapy Evaluation Program (CTEP) database currently known as the

Study Abstraction Review & Tracking System (START) for the NCI Community

Oncology Research Program (NCORP) trials, in addition to abstraction of those trials also into the DCP database.

f. Track study development from the early ideas for studies through review, approval, implementation, and completion.

g. Set up formal review meetings, coordinate and document results, and send reviews to investigative sites.

h. Provide reports, both routine and ad hoc, to DCP staff to aid in study tracking and program analysis and resource allocation.

i. Provide education to DCP staff and collaborators on administrative policies and procedures regarding clinical trial development and management.

SECTION 2 - SPECIFIC PROJECT AREAS

Note #2: Acceptable Quality Level (AQL) assignments referenced herein can be found in the Quality

Assurance Surveillance Plan (QASP) in Section J, Attachments.

PROJECT AREA 1: ABSTRACTION OF KEY ELEMENTS FROM PROTOCOL

1. The Contractor shall abstract information from protocol-related documents received for all DCP-sponsored trials, as well as other trials that DCP may review or include in the DCP and CTEP databases. The Contractor shall utilize DCP Standard Operating Procedures and other tools to determine how to extract key elements.

2. The Contractor shall abstract all key words that are currently required by DCP. This would include, but not be limited to, such items as document title, identifying numbers, organizations, investigators, agents, review dates, reviewers, milestones, treatment assignment codes and

December 7, 2017 Page 3 of 8 descriptors, treatment arms and codes, and document and trial statuses. In addition, the Contractor shall extract additional elements and data as directed by the COR to accommodate changing business needs within DCP, NCI, NIH, or regulatory agencies.

3. The Contractor shall utilize the DCP database for abstraction of key elements and trial statuses.

This includes, but is not limited to, the original and each revised and/or amended submissions of protocols, LOIs, and concepts. Database abstraction shall be completely integrated into the document management workflow. Due to the criticality of this information, the contract shall place very high emphasis on ensuring complete, accurate, and timely abstraction of clinical trial information into the DESK/Protocol Information Management System (PIMS) and START databases. The requirements for database abstraction are:

a. New and revised protocol documents: The Contractor will receive new (original submission) and revised protocol documents from site staff, and occasionally DCP staff, and shall abstract the specified data elements and milestones into DESK/PIMS.

b. New and revised concepts and Letters of Intent (LOIs): The Contractor will receive new

(original submission) and revised concepts and LOIs from clinical sites and shall abstract the specified data elements into DESK/PIMS

c. Protocol Amendments: The Contractor will receive protocol amendment documents from clinical sites and shall abstract the specified data elements and milestones into

DESK/PIMS.

d. Other protocol-related documents: The Contractor shall abstract other protocol-associated information including, but not limited to, publications, budgets, data management plans, data monitoring plans, and other study-related information.

e. Other DCP protocols: The Contractor shall develop a plan to identify, inventory, collect, abstract and maintain grant protocols as requested by the COR.

f. The Contractor shall abstract key elements for NCORPs trials into the Cancer Therapy

Evaluation Program Enterprise System (CTEP-ESYS) database module known as

START. In addition, the Contractor shall abstract these trials into DESK/PIMS. An AQL has been established for this Project Area.

4. The Contractor shall utilize DESK/PIMS to enter appropriate milestones on each protocol-related record created in DESK when the mi1estone occurs, utilizing a list of values in DESK.

5. The Contractor shall develop, with COR approval, and implement a plan to assure that key data elements for previously abstracted documents are complete and correct. This plan for performing quality control (QC) checks and corrections includes abstracted information in DESK/PIMS and

START as well as the contents of the physical file folder. The Contractor shall perform all QC checks at defined intervals prior to the distribution of submission information and documentation to either DCP reviewers or the submitter.

The Contractor shall review, correct, and update any legacy data, as needed, to meet current

Government needs for database and document/trial monitoring.

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PROJECT AREA 2: FILE MANAGEMENT

1. The Contractor shall maintain complete and accurate electronic files (documents, correspondence, reports, and other related information) for all DCP clinical trials, in the location specified by the

COR.

2. Electronic storage: The Contractor shall save all clinical trials documents (concepts, LOIs, protocols, revisions, and amendments) and related correspondence to the DCP shared drive or other electronic location specified by the COR. An AQL has been established for this Project

Area (see Section J, Attachments).

3. Hard copy storage: The Contractor shall create hard copy files for new concepts, LOIs, and protocols and maintain hard copy files for all studies. Paper files shall be maintained in a standard format as defined by the COR and shall include copies of the documents, all e-mail correspondence related to the receipt, processing, and review of the trials. Files shall be complete and readily available to PIO and other DCP staff. Existing files shall be re-organized, as necessary, to conform to the filing standard. All files shall be maintained at the Government site.

The Government will supply filing cabinets, file folders and supplies for creating files.

4. Regulatory files: The Contractor shall establish and maintain a filing system for regulatory information including, but not limited to, Investigational New Drug (IND) annual reports (cover letters only), safety reports, and Food and Drug Administration (FDA) correspondence. These files shall be maintained at the Government site.

5. Inventory: The Contractor shall maintain an inventory of hardcopy protocol files and electronic files. The Contractor shall provide an inventory report to the COR on an annual basis. The content of the inventory report shall be developed with COR input. The first inventory will take place during the transition from the previous contract to the new contract. The Contractor shall perform the annual inventory thereafter based on the start of each contract year, with the final inventory at the transition to a new contract.

6. The Contractor shall assist DCP staff to locate the electronic or hardcopy file when requested by the COR.

PROJECT AREA 3: CLINICAL TRIAL REVIEW SUPPORT

1. The Contractor shall provide support for clinical trial review meetings, and return review documents to investigators in the most efficient manner possible. In performing these functions, the Contractor shall follow the existing Standard Operating Procedures (SOPs) as provided by the

COR. Review meetings may include, but not be limited to, Prevention Consortia meetings, LOI review meetings, Concept review meetings, and NCORPs meetings.

2. The Contractor shall be responsible for coordinating details of the review meetings, including recommending reviewers (in consultation with the COR), assigning and inviting reviewers, creating agendas, distributing documents for review, taking minutes when requested, supporting preparation of the response document, and abstracting review and reviewer information into the

DCP database. Review meetings may include, but not be limited, to Prevention Consortia meetings, LOI review meetings, concept review meetings, and CCOPs meetings. An AQL has been established for this Project Area (see Section J, Attachments)

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3. The Contractor shall include additional reviewers, committees, or process steps at the request of the COR to meet changing DCP, NCI, or National Institutes of Health (NIH) business needs.

4. The Contractor shall assist DCP staff to develop protocol-related correspondence by providing compilation of reviewer comments, word processing, document assembly and grammatical, format and content review. The Contractor shall ensure consistent document format by reviewing/modifying existing correspondence templates and developing new templates, as needed, for routine communications, as approved by the COR. The Contractor shall route documents according to the SOPs. Changes to this process may be necessitated by changing

Government needs.

5. The Contractor shall abstract into DESK/PIMS all specified fields related to review type, reviewer, reviewer statuses, review results, document status, study status and milestones.

6. The Contractor shall facilitate and track Central Institutional Review Board (CIRB) reviews for

DCP clinical trials portfolio.

PROJECT AREA 4: MANAGE PEOPLE AND ORGANIZATIONS DATA IN DESK-PIMS

1. The Contractor shall manage and perform quality control of data relating to people (persons such as investigators, coordinators, reviewers. etc.), organizations, and the relationships of people to organizations in DESK/PIMS.

2. The Contractor shall ensure that new information about people, organizations, and the associated relationships abstracted into DESK/PIMS is correct and complete. An AQL has been established for this Project Area (see Section J, Attachments)

3. The Contractor shall analyze existing DESK/PIMS people, organization, and relationship data and perform data reconciliation and clean-up as needed to ensure complete and accurate data.

4. The Contractor shall develop and document processes, procedures, and tools, as needed, to ensure accurate and timely maintenance of data.

5. The Contractor shall participate in meetings with other DCP and contract staff, as needed, to review business processes and abstraction rules.

PROJECT AREA 5: PIO OPERATIONAL SUPPORT

1. Leveraging Technology: The Contractor shall actively participate in seeking technology solutions to streamline the protocol development process and reduce the administrative burden of trial development on NCI and extramural staff. Although development of software is outside the scope of this project, the PIO support contract employees shall serve as subject matter experts providing recommendations and comments to the DCP COR and DCP informatics support Contractors, who will perform the actual software development. All recommendations will be reviewed and approved by the COR. The PIO support Contractor shall track all approved recommendations for implementation. The Contractor shall participate in testing of all new PIO-related software. The

Contractor shall track all change requests (CRs) sent to the informatics support Contractor until resolution.

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2. Preparing Reports: The PIO is responsible for providing routine and ad hoc reports from

DESK/PIMS to support the PIO, DCP and related contractors. The Contractor shall prepare reports and documents for PIO at the request of the COR. The Contactor shall propose new reports or methods that will augment DCP business needs. The Contractor shall use existing, or develop new, reports to track due dates for documents from DCP staff and investigators. The

Contractor shall alert Government staff when expected documents are overdue. The Contractor shall use existing, or develop new, reports to track participant accrual to DCP studies as requested by the COR. The Contractor shall alert Government staff when accrual is slow. An AQL has been established for this Project Area (see Section J, Attachments).

3. The Contractor shall develop and implement a plan to ensure that study status is consistent between CTEP-ESYS/P ATS and DESK/PIMS. An AQL has been established for this Project

Area (see Section J, Attachments).

4. The Contractor shall submit all DCP protocols and amendments to the Clinical Trials Reporting

Program’s (CTRP) Clinical Trials Reporting Office (CTRO) and/or other Government offices, as determined by Government needs and directed by the COR. The Contractor shall document the submission dates as milestones in DCP Database.

5. The Contractor shall review the existing DCP submissions to CTRO during the first six months following contract award to identify documents that have not been previously submitted to

CTRO. Missing documents shall be submitted as necessary.

6. The Contractor shall work with Government personnel within or outside DCP on matters that involve or affect DCP protocol development processes and activities, as determined by the COR.

7. The Contractor shall modify existing or create new Standard Operating Procedures (SOPs) for document processing, DESK/PIMS abstraction, START abstraction, file maintenance, correspondence management and other routine procedures, as needed. The Contractor shall review and update the SOPs semi-annually, with written approval of the COR.

8. The Contractor shall provide local/office project meeting support activities for the PIO and DCP clinical trials at the request of the COR. These activities will include meeting scheduling;

reserving rooms; preparing and distributing agendas, minutes, and other meeting artifacts.

9. The Contractor shall provide administrative support to PIO staff and other DCP staff members in support of the DCP clinical trials. This support may include, but is not limited to, drafting correspondence for review and edit by staff; developing documentation for Office of

Management and Budget (OMB) clearance of DCP PIO forms and documents; creating and maintaining systems and files for tracking administrative information and documents related to clinical trials.

10. The Contractor shall develop educational programs related to PIO functions: 1) Orientation to

PIO and review processes for new DCP reviewers and/or new DCP staff; 2) Orientation to PIO submissions processes for new clinical trial site staff; 3) A presentation or poster exhibit for

DCP's annual educational sessions for clinical trial site staff; and 4) Other programs as identified by DCP staff or the Contractor staff, as approved by the COR.

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11. The Contractor shall provide a contingency plan to continue DCP administrative support in the event of a disaster, local outbreak of illness, or Government office closure for inclement weather.

The Contractor shall develop this plan in collaboration with the COR and shall include a communications plan and alternate workstations for contract staff.

12. Sixty (60) days prior to the completion of this contract the Contractor shall provide a detailed transition plan for contract closure and transition to a new Contractor. The Contractor shall develop this Plan in collaboration with the COR. This Plan shall include a complete inventory of electronic and paper files, with the location of such files, and all Standard Operating Procedures

(e.g., for document abstraction, routing and review, approval and disapproval). The Contractor shall provide an up-to-date report of all documents 'In Review' and studies in 'Approval on Hold' status. This Plan shall also include the process for the return of all identification badges, parking permits, and desk/file keys.

SECTION 3 - QUALITY ASSURANCE AND QUALITY CONTROL

The Contractor shall develop a quality control plan and procedures to assure compliance with the work-scope described above. The Government quality assurance measures, including methods, frequency and acceptable quality levels (AQL) are described in Section J, Attachments.

SECTION 4 - ACRONYMS, TERMS, AND DEFINITIONS USED IN DCP DOCUMENTS

Amendment - Any change to a protocol after DCP approval.

AQL - Acceptable Quality Level.

CIRB - Central Institutional Review Board.

Concept - A written, early idea for a study in the NCORPs Cooperative Groups within NCI-A group of researchers and institutions funded by the National Cancer Institute through grants designed to promote and support clinical trials of new cancer treatments. explore methods of cancer prevention and early detection, and study quality-of-life and rehabilitation issues as related to cancer treatments.

COR – Contracting Officer’s Representative.

CTEP ESYS - Cancer Therapy Evaluation Program Enterprise System: CTEP database System.

CTRO - Clinical Trials Reporting Office - The functional unit within the NCI that performs the operational work of the Clinical Trials Reporting Program (CTRP).

CTRP - Clinical Trials Reporting Program - The operational implementation of an initiative proposed by the Clinical Trial Working Group (CTWG), which is comprised of NCI policies and standard operating procedures, the staff in the Clinical Trials Reporting Office (CTRO) and supporting technologies

(database & portals for registration, abstraction, accrual & report generation).

DCP- Division of Cancer Prevention.

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DESK - DCP Enterprise System Knowledgebase - Enterprise database that support the scientific and administrative work of DCP and its mission.

FDA - Food and Drug Administration.

IND - Investigational New Drug Application: An IND is a request for authorization from the Food and drug Administration (FDA) to administer an investigational drug or biologic product to humans.

LOI - Letter of Intent: An idea for a Phase 0,1, or 2 clinical trial that is submitted to DCP for review and possible further protocol development.

OMB - Office of Management and Budget.

NCI- National Cancer Institute.

NIH - National Institutes of Health.

NCORPs - are consortia of community hospitals and/or oncology practices, and integrated healthcare systems. Sites accrue participants to cancer prevention, control, screening and post-treatment surveillance clinical trials conducted by NCORP and to NCI's National Clinical Trials Network (NCTN) treatment, imaging and quality of life trials. NCORP’s Cancer Care Delivery Research (CCDR) and comparative effectiveness research studies may include patients, providers and their health organizations.

NCORP Research Base - are hubs that design and conduct the NCORP multi-center cancer prevention, control, screening and post-treatment surveillance clinical trials and cancer care delivery research

(CCDR) studies.

PIMS - Protocol Information Management System: The module of DESK, the DCP database, where key elements of clinical trials are abstracted.

PIO - Protocol Information Office, in DCP, NCI.

Revision - Any change to a protocol document prior to DCP approval, as opposed to the Amendment, which is a change to a protocol after DCP approval.

START - Study Abstraction Review & Tracking (START) System: The database used by CTEP; part of

CTEP's Enterprise System.

QASP - Quality Assurance Surveillance Plan.