RFP 75N91020R00037 Attachments final.pdf

ATTACHMENT 1 PACKAGING AND DELIVERY OF PROPOSAL

75N91020R00037 Page 1 of 2

Attachment 1 - Packaging and Delivery of Proposals for Use with the NIH electronic Contract Proposal Submission (eCPS) Website

I. PROPOSAL SUBMISSION

A. eCPS

1. Proposals must be submitted via the electronic Contract Proposal Submission (eCPS) website at https://ecps.nih.gov.

2. Proposals submitted by facsimile or e-mail will not be accepted.

3. Follow the “How to Submit an Electronic Proposal” instructions provided on the eCPS website at: https://ecps.nih.gov/home/howto. Please note that creating an account to submit may take up to three (3) business days. Please apply for a new account early to allow enough time for the registration process.

4. Offerors are solely responsible for submitting proposals and any modifications or revisions so as to reach the Government office designated above by the date and time specified in the solicitation.

B. Creating and Naming Files:

1. Create one PDF file of your Technical Proposal, including all attachments. The

Technical Proposal should be created in a PDF format that enables word searches to the maximum extent practicable. Forms and/or documents requiring signature(s) may be scanned, but must be merged into the Technical Proposal PDF file.

2. Create one PDF file of your Business Proposal, including all attachments:

The Business Proposal should be created in a PDF format that enables word searches to the maximum extent practicable. Forms and/or documents requiring signature(s) may be scanned, but must be merged into the Business Proposal PDF file.

Additionally, the “Breakdown of Proposed Estimated Costs (plus Fee) with Excel

Spreadsheet” (http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/spshexcl_dec2012.xlsx) must be included in the Business Proposal.

3. Create your Business Document Excel. The Excel file should be the “Breakdown of

Proposed Estimated Costs (plus Fee) with Excel Spreadsheet”

(http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/spshexcl_dec2012.xlsx) included in the Business Proposal in its original Excel format, not PDF. Multiple Excel files may be included, as necessary.

4. Each of the proposals, Technical and Business, must be separate and complete in itself.

Do not reference one proposal in another.

https://ecps.nih.gov/ https://ecps.nih.gov/home/howto http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/spshexcl_dec2012.xlsx http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/spshexcl_dec2012.xlsx http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/spshexcl_dec2012.xlsx http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/spshexcl_dec2012.xlsx

ATTACHMENT 1 PACKAGING AND DELIVERY OF PROPOSAL

75N91020R00037 Page 2 of 2

5. File naming convention: It is requested that the filenames for your Technical Proposal, Business Proposal, and Excel Workbook include the name of the offeror, the solicitation number and the type of proposal (i.e., Technical, Business, or Excel Workbook).

Examples:

Technical Proposal: XYZ Company_NIHAI2012001_Technical.pdf

Business Proposal: XYZ Company_NIHAI2012001_Business.pdf

Excel Workbook: XYZ Company_NIHAI2012001_Business.xlsx

II. FORMATTING AND PAGE LIMITATIONS:

A. Formatting for proposals

1. Proposal page layout shall be letter size 8.5” x 11" for all pages.

2. Proposals shall not include links to internet web site addresses (URLs) or otherwise direct readers to alternate sources of information.

3. Proposals shall not include audio or video files of any type.

4. Font size must be 10 to 12 points.

5. Spacing should be no more than 15 characters per inch. Within a vertical inch, there must be no more than six lines of text.

6. Margins must be at least one-inch on all sides.

7. Failure to adhere to the formatting requirements above may impact whether your proposal is reviewed in its entirety.

B. Page limitations:

1. The total page count of the Technical proposal shall not exceed 150 pages.

2. Total page count does not include:

a. Title and Back Page; Table of Contents; Section Dividers that do not contain information other than title of Section; and

b. The Human Subject and Clinical Trial Information Form, if required by the solicitation.

3. Each Curriculum Vitae (CV) shall not count toward page number.

4. Pages exceeding limitations will be removed from the proposal and will not be considered.

perryd Sticky Note Total Page count is 150 pages in the ATPI. Please revise

PROPOSAL INTENT RESPONSE FORM

RFP No:

RFP Title:

Please review the Request for Proposal (RFP). Furnish the information requested below and return this page to the Contracting Officer/Contract Specialist identified on Section A-Solicitation/Contract Form by

Your expression of intent is not binding but will greatly assist us in planning for proposal evaluation.

Choose one of the following Options:

Do intend to submit a proposal Do Not intend to submit a proposal

If you are not responding to this RFP, please provide your reason(s):

Please provide the following contact information:

Name (First, Middle Initial, Last):

Title:

Organization:

E-mail:

Proposal Intent Response Sheet 75N91020R00037

Attachment 2

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STATEMENT

OF WORK

Section 508 of the Rehabilitation Act, as amended by the Workforce Investment Act of 1998 (P.L. 105-

220) requires that when Federal agencies develop, procure, maintain, or use information and communication technology (ICT), it shall be accessible to people with disabilities. Federal employees and members of the public who have disabilities must have access to, and use of, information and data that is comparable to people without disabilities.

Products, platforms and services delivered as part of this work statement that are ICT, or contain ICT, must conform to the Revised 508 Standards, which are located at 36 C.F.R. § 1194.1 & Apps. A, C & D, and available at https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-ict-refresh/final-rule/text-of-the-standards-and-guidelines

Applicable Functional Performance Criteria: All functional performance criteria apply when using an alternative design or technology that achieves substantially equivalent or greater accessibility and usability by individuals with disabilities, than would be provided by conformance to one or more of the requirements in Chapters 4-6 of the Revised 508 Standards, or when Chapters 4-6 do not address one or more functions of ICT.

Applicable requirements for software features and components: All WCAG Level A and AA Success Criteria, 502 Interoperability with Assistive Technology, 503 Application

Applicable requirements for hardware features and components: All requirements apply

Applicable support services and documentation: All requirements apply

The applicable Privacy Act System of Records Number is 09-25-217 and shall be used in any design, development, or operation work to be performed under the resultant contract. Disposition of records shall be in accordance with SECTION C of the contract, and by direction of the Contracting Officer's Representative (COR).

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 Statement of Work, as set forth below.

OBJECTIVES

The National Cancer Institute’s (NCI) Cancer Therapy Evaluation Program (CTEP) is responsible for administration and coordination of extramural clinical trials supported by the NCI’s Division of Cancer Treatment and Diagnosis (DCTD). This includes the activities of the NCI National Clinical Trials Network (NCTN), the Experimental Therapeutics Clinical Trials Network (ETCTN), several smaller trial networks, and the recipients of investigator-initiated grants and cooperative agreements relating to the development of anti-cancer agents and promising new cancer treatments. The Government is seeking a Contractor to provide direct organizational, project management, information management, and logistical meeting support for these scientific and clinical trials programs. In addition, CTEP, DCTD, and the Coordinating Center for Clinical Trials (CCCT) need support in the acquisition, review and analysis of data to assist in the development, planning and conduct of clinical trials and related scientific programs.

The work is divided into five major Sections. They include but are not limited to:

I. Contract Transition (Phase-In)

II. Clinical Trials Information Support

III. Clinical Trials and Scientific Program Project Management

Statement of Work August 7, 2020

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A. Coordinate, Track and Support Accrual to CTEP-Sponsored Trials from Activation to Completion

B. Provide Project Management Support and Coordination to DCTD Correlative Science Studies (CSS), CCCT Scientific Steering Committees, and the Clinical Trials and Translational Research Advisory Committee (CTAC)

C. Provide Project Management to NCI Precision Medicine Trials D. Provide Project Management support to NCI’s Early-Phase Development Projects E. Provide Project Management support to NCI Cancer Moonshot Networks and

Projects, Other Congressionally Mandated Projects and National Health Emergency Projects

IV. CCCT Scientific, Administrative and Logistical Meeting Support

A. Scientific Steering Committee and Task Force Support B. Clinical Trials and Translational Research Advisory Committee (CTAC) and CTAC

Subcommittee Support C. Working Group (Ad-hoc) Support D. Additional Administrative Support for Scientific Steering Committee and CTAC

Related Activities as needed

V. Option for Contract Transition (Phase-Out)

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DESCRIPTION OF WORK

I. CONTRACT TRANSITION (Phase-In)

The Contractor shall submit the final Contract Transition (Phase-In) plan to the COR within seven (7) days of contract award. This plan shall describe the Contractor’s approach to implementing a seamless transition and maintaining ongoing work, as well as, outline potential Phase-In related risks and corresponding mitigation measures. The entire Phase-In process shall occur and be completed by the contractor within the first 45 days of contract award. The final contract transition phase-in plan shall be followed to ensure an orderly, secure, efficient, and expedient transition of all contract activities.

Concerns anticipated or encountered shall be immediately communicated to the COR and an approved resolution pursued. Should a phase-in transition be required, the transition period shall occur in the first 45 days of the contract. The Contractor shall work on implementing the transition plan and executing the Statement of Work to provide continuous support to all the activities as most of the work is time sensitive.

II. CLINICAL TRIAL INFORMATION SUPPORT

The Contractor shall provide support to the NCI professional staff in the acquisition of information and analysis of data to support developing new studies. Contractor staff, herein referred to as the Contractor, shall also assist in analysis of data that result from clinical research and other program analyses needed. All data for analyses is deidentified by the NCI grantees prior to submission to the NCI as part of their standard procedures. These activities support NCI's mission of evaluating, prioritizing, coordinating, and analyzing planned and ongoing clinical trials and clinical research through mechanisms such as concept evaluations, scientific strategy and program meetings, clinical trial planning meetings, and special drug development meetings.

The Contractor shall:

A. Conduct literature searches from currently available databases (e.g., CANCERLIT, MEDLINE, and PubMed) and prepare tables, data synthesis, and other written material for presentation, publications and/or distribution. Perform database searches and analyses including, but not limited to, Index Medicus, National Library of Medicine (NLM) databases, Physician Data Query (PDQ), CLINPROT, The Cancer Genome Atlas (TCGA), Micromedex, NCI Clinical Trials Reporting Program (CTRP), and CTEP information systems. The literature and database searches with analyses shall support DCTD and CCCT activities including but not limited to:

DCTD, CTEP and CCCT scientific meetings NCTN Group Concepts including analysis of ongoing activities and assistance in the form of literature searches and reviews of similar studies Risk tables of agents in CTEP trials for use in NCI informed consent risk sections Assist in the writing and preparation of manuscripts, abstracts, posters or other publications for scientific publication with preparation of initial drafts, copy editing, reference checking, and preparation of graphics.

B. Attend meetings (e.g. Clinical Trial Planning Meetings (CTPMs), NCTN Chairs, Management &

Operations Meetings, Clinical trial concept review meetings outside the standard Scientific Steering Committee mechanism, ETCTN and other scientific meetings) at the Contracting Officer’s Representative’s (COR) direction and prepare detailed minutes or summaries of these meetings.

The meeting minutes and/or summaries shall be submitted to appropriate NCI staff within the time frame specified by the COR for comments and corrections and revised accordingly. The timeframe could be within one (1) business day but shall not be more than 10 business days. Since the meeting minutes may be used for internal purposes or as a basis for NCI-generated scientific publications, the time frame for returning meeting minutes will be determined at the meeting.

Tracking of action items and outcomes of meetings may be required.

NOTE FOR SUBPARTS A AND B: These meetings are usually held in the metropolitan

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Washington D.C. area, but some meetings require travel. Contractor travel to work at scientific meetings shall be approved in advance by the COR.

C. Provide technical advice to NCI-sponsored investigators and their teams in the development of new Common Data Elements (CDE) as the scientific and/or trial need arises. NCI’s CBIIT (Center for Biomedical Informatics and Information Technology), CCCT and CTEP work in collaboration with the NCTN and ETCTN on a Network Medidata Rave Data Standards Committee (NRDS) to standardize the most widely analyzed CDEs utilized in NCI- sponsored clinical trials. This is part of a continued harmonization of data standards effort initially focused on NCI Networks (ETCTN and NCTN) currently using a common electronic Clinical Data Management System (eCDMS) (current system is Medidata Rave). Specifically, the Contractor shall:

1. Provide technical expertise to NRDS and investigators to assist in the creation of new data elements as necessary to keep up with changing science. This may include education and support to NCI-sponsored investigators to assist in the implementation of standardized Rave data elements, as well as capturing investigator requests to extend existing CDE standards and handling those requests appropriately.

2. Participate in relevant NCI and Network data standards meetings, such as NRDS and its working groups, harmonization meetings, and appropriate CTEP and CBIIT meetings.

Provide input to ensure that the NCI investigator community needs are well described.

Utilize training materials developed for the community adoption of data standards. Provide feedback and support to CBIIT as they develop and update training materials, such as a user instruction manual to guide the successful use of CDEs in a Network eCDMS.

D. Develop and maintain websites and/or databases for data sharing activities, including but not limited to the NCTN data sharing archive dataset (https://nctn-data-archive.nci.nih.gov/). Also, maintain websites and/or databases for scientific committees outside of the Scientific Steering Committee mechanism, including but not limited to the Gynecologic Cancer Intergroup Committee (GCIC), North American Breast Cancer Group (NABCG) and the Head and Neck International Group (HNIG).

1. For the NCTN data sharing archive dataset (NCTN/NCORP Data Archive), provide ongoing support will be needed to review data requests for completeness, clearness, and congruence with the associated publication (projected to be at least 3 to 4 per month) according to the data sharing policies and procedures established by NCI.

Provide coordination will also be needed with NCI experts to review data request processes and provide input on any issues related to the processes or database that may need revision or enhancements over time. Additional tasks include development of detailed user guides; coordinating the development of agreement documents and modifications of agreement language (e.g., Data Use Agreement); coordinating communications with the pharmaceutical companies involved in trials; coordinating sharing across existing archives (e.g., TCIA); tracking of submissions and requests;

organizing and facilitating meetings with NCI; processing requests for data; and communicating regularly with the Archive programmers. Datasets eligible for the Archive include primary manuscripts from phase III clinical trials as well as related manuscripts from non-primary publications (e.g., correlative and QOL studies). NCI’s Precision Medicine and other NCI high priority trials may be prioritized for inclusion in the data archive.

E. Enter, retrieve and maintain information in various NIH, NCI and CTEP databases, which may include:

1. The CTEP Enterprise System (CTEP-ESYS) including IPAD, and the NCTN Per Case Funding Management (PCMF) System

2. Cancer Trials Support Unit (CTSU) Regulatory Support Service (RSS) Reports

3. Secondary AML/MDS Database

4. Funding Information and Accrual Tracking System Database (FIATS)

5. The NIH RePORT (Research Portfolio Online Reporting Tools) website

Statement of Work August 7, 2020

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6. NCTN/NCORP Data Archive

7. NCTN Navigator – Clinical Trial Biospecimen Resource

F. Design data collection instruments (including databases) and develop data collection procedures for use in analysis of NCI-sponsored cancer clinical trials. Pertinent data might relate to any or all aspects of a subset (e.g. disease and stage specific) of cancer clinical trials, including study design, methodology, results, and quality of conduct (OMB Clearance is not required). At the direction of the COR, the Contractor shall review the project needs to determine whether systems integration with other CTEP and NCI systems will be necessary.

G. Abstract, compile, collate, and analyze data utilizing a variety of resources available within and outside of NCI. Resources include, for example, published literature references, NCTN Group minutes and agendas, research progress reports, scientific meeting proceedings and white papers, and research protocols. Summarize or otherwise process compiled data and provide assistance to NCI in developing a comprehensive understanding of past, current and future research strategies and priorities.

H. Assist in the review process for the NCTN Per Case Management Funding (PCMF) proposals submitted by the NCTN Groups during the protocol development phase and coordinate efforts with the CTEP Protocol Information Office (PIO), DCTD, CTSU, Division of Cancer Prevention (DCP) and others depending on the clinical trial.

I. Prepare drafts of reports for use by NCI staff in carrying out NCI’s mission of coordinating and maintaining an effective network of clinical trials organizations.

J. Assist in the retrieval and analysis of information on clinical trials necessary for entry of data into the National Institutes of Health (NIH) Inclusion Management System (IMS).

K. Assist the NCI and CTEP staff in the conduct, retrieval, and analysis of information from:

1. Early-phase trial meetings

2. Special drug and agent development sessions

L. Assist in abstracting planned accrual and planned accrual periods from original protocols for reporting on final trial outcome. To perform these tasks, the Contractor shall use data from NCI’s supported research networks, such as NCTN and ETCTN, CTEP Enterprise databases and develop and/or maintain custom tracking approaches and tools.

M. Perform assessments of the quality and timeliness of their work and make quality improvements based on provided feedback to meet the needs of NCI. The Contractor shall work with the COR to make any adjustments to improve monitoring and performance of tasks.

N. Participate, as needed, with NCI staff and other NCI designated Contractors to provide user feedback on software updates and needs to support NCI requested analyses and provide subject matter expertise for tasks involving the CTEP Enterprise System. At the direction of the COR, the Contractor’s systems supporting NCI projects shall share data electronically with other CTEP and NCI systems.

O. Develop and maintain and update a Policy and Procedures Manual at least annually. This manual shall contain detailed operational procedures used in accomplishing the tasks described and should be made available on request to the COR.

P. The Contractor and/or his or her representative shall be available for consultation and planning with the COR or other NCI staff, within 2 business days, to discuss data management and procedures, planning meetings, problems encountered, procedures employed and other matters relating to the central management of the work. The Contractor shall implement a project management and task approval system to track contract tasks, subtasks and overall performance of the contract

Q. Provide support to NCI to assist in the NCI Clinical Trials Stewardship Initiative. This includes but is not limited to revising standard operating procedures (SOP) to comply with NIH reforms &

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III. CLINICAL TRIALS AND SCIENTIFIC PROGRAM PROJECT MANAGEMENT

The Contractor shall provide clinical trials project management support across five-sub-task areas.

The Contractor shall work collaboratively with NCI Professional Staff to:

A. Coordinate, Track and Support Accrual to CTEP-Sponsored Trials from Activation to Completion B. Provide Project Management Support and Coordination to DCTD Correlative Science Studies

(CSS), CCCT Scientific Steering Committees, and CTAC C. Provide Project Management to NCI Precision Medicine Trials D. Provide Project Management support to NCI’s Early-Phase Development Projects E. Provide Project Management support to NCI Cancer Moonshot Networks and Projects and other

Congressionally Mandated Projects and National Health Emergency Projects

The Contractor shall work collaboratively with NCI staff and the CTEP PIO Contractors to ensure timely trial activation and tracking of accrual to all studies in accordance with CTEP polices. CTEP’s Protocol and Information Office (PIO) is the central coordinating and management unit for processing and organizing all protocol documents and will track Operational Efficiency Working Group (OEWG) trial activation timelines and implement the OEWG recommendations. Figure 1, below, illustrates major steps in the clinical trials development and completion process and distinguishes between the oversight from the Contractor and the CTEP PIO Protocol Specialists.

Figure 1. Major Steps in the Clinical Trials Development and Completion Process and Relevant Oversight from CTIMS Clinical Trials Project Managers (blue) and CTEP PIO Protocol Specialists (green).

The Contractor shall utilize NCI-developed guidelines for timely accrual and shall work with CTEP and NCI staff to implement a comprehensive plan to enhance accrual to clinical trials, including NCTN and ETCTN clinical trials.

Additional Project Management support shall be provided for NCI’s Precision Medicine clinical research projects to provide coordination to ensure their successful development, launch, completion and analyses, as well as to support the Early Drug Development Project (DDP) Teams.

The Contractor shall provide support for the four sub-tasks. The type of tasks requiring support includes, but is not limited to:

A. Coordinate, Track and Support Accrual to CTEP-Sponsored Trials from Activation to Completion

1. Interface with all trial support participants including NCI, NCI contractors and extramural professional and support staff to monitor trial progress.

2. Utilize existing NCI and site databases (including but not limited to CTEP-ESYS, IPAD, CTSU

RSS, Central IRB (CIRB) IRB Manager, and extramural investigator databases) to capture and

Statement of Work August 7, 2020

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3. Develop additional local databases as necessary to capture pertinent information to meet specific project needs (e.g. additional tracking of accrual barriers, interventions that helped successfully overcome accrual challenges and interventions that did not work as well).

4. Maintain NCTN and ETCTN active trial portfolio diagrams and spreadsheets, update them monthly, organize them by disease categories according to disease status, such as trials for newly diagnosed or advanced cancers. Provide hyperlinks to clinical trials database to increase awareness for investigators of NCTN and ETCTN trials. Coordinate first with NCI experts on their technical review and then coordinate with NCI staff and contractors to have them posted timely to the CTEP website. Also, communicate with the CTSU contractors that the monthly updates are completed so the CTSU contractors will update their website.

5. Collaborate with other NCI staff, contractors (e.g. CTSU, CIRB) and extramural study teams involved in trial activation and enrollment to minimize redundancy and address gaps in supporting trial accrual. It must be emphasized that the Contractor is not intended to replace, or duplicate activities currently being performed by other NCI contractors or government staff, but rather it is intended to complement existing efforts and provide proactive coordination to ensure that protocol accrual timelines are met.

6. Arrange teleconferences and/or meetings including appropriate participants (e.g. NCI staff, contractors, extramural study teams, NCTN members, and enrolling site staff) to discuss and resolve critical accrual issues when necessary. Provide meeting summaries and/or notes. Follow-up with participants to ensure agreed-upon next steps are taken and document actions and responses.

7. Participate in appropriate meetings to maintain ‘situational awareness’ of trial accrual progress (e.g. NCTN Accrual Core Team, CTEP, Clinical Investigations Branch (CIB) and Investigational Drug Branch (IDB) meetings).

8. Develop prompts or triggers to alert appropriate personnel (e.g. extramural study teams, NCI staff) at major accrual timeline points and when key accrual statuses are noted.

9. As needed, escalate awareness of any issues that might delay trial accrual to the COR and appropriate NCI and extramural site leadership.

10. Monitor accrual information regularly and maintain up-to-date electronic reports documenting current status of each protocol accrual. Ensure this information can be accessed on the CTEP shared drive. Reports shall be user-friendly and highlight and prioritize any potential or actual delays in accrual. The reports shall be able to be sortable by trial type (i.e. phase, lead site participant, disease, and CTEP coordinator). Reports shall reflect actual versus expected accrual.

PMs will review these reports at least monthly with CTEP lead investigator/reviewer.

11. Develop accrual projections of studies and timelines upon request, working closely with NCI biostatisticians and NCI leadership to ensure accurate calculations are used to develop projections.

12. Identify and implement with COR approval any other tasks and/or processes that will facilitate and improve the protocol activation and completion process in collaboration with NCI staff and contractors in the CTEP PIO; including but not limited to the development of trial-specific materials (e.g., site activation guides, patient handouts, tailored emails to clinicians) and the conduct of audience research to identify accrual challenges at the site level.

13. The Contractor shall receive or access monthly accrual for NCTN and ETCTN trials, track accrual and accrual milestones according to CTEP’s Early Stopping Guidelines for Slow Accruing Trials that will be provided to the Contractor. The Contractor shall provide summary information to Clinical Investigations Branch (CIB) and Investigational Drug Branch (IDB) investigators on trial slow accrual status and decisions or actions taken. Provide reports that reflect actual versus planned accrual rates and monitor and track patient demographics (race, ethnicity, gender, age) compared to the expected study patient population.

14. Identify potential impediments to achieve accrual goals (e.g. strict eligibility criteria, drug supply, scientific interest, results from other trials, industry contracts).

15. Maintain and organize minutes, drafts, and other pertinent documents in a local database suitable to meet project needs.

16. Coordinate with CTEP leadership, trial leadership and investigators regarding accrual corrective action plans (CAPS), including sending requests and coordinating and tracking CAPs received and outcomes.

17. Provide suggestions to address protocol specific and global impediments to patient accrual. Work with NCI staff, NCTN Groups and extramural investigators and their teams and others to collaborate on interventions to promote and enhance trial accrual.

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B. Provide Project Management Support and Coordination to DCTD Correlative Science Studies

(CSS), CCCT Scientific Steering Committees, and CTAC

1. Work with scientific leaders of DCTD and Center for Cancer Genomics (CCG) to coordinate the scientific review process for investigator proposals submitted to conduct CSS on specimens collected in NCI clinical trials.

2. Maintain up-to-date language for the CSS announcements and processes, including but not limited to the Genomic Characterization of Biospecimens collected from NCI studies and the NCTN Core Correlative Sciences Committee (NCTN-CCSC).

3. Work with steering committee (SC) scientific leaders and CCCT scientific staff to coordinate the scientific review process for NCTN/NCORP concepts submitted to conduct NCI clinical trials.

4. Provide project management and coordination for the two NCTN-CCSCs, NCTN/NCORP-SC concepts and other CSS reviews, including but not limited to the NCTN-CCSC and NCTN-SC regular meetings and coordination with NCI in planning the reviews. The Contractor shall utilize NCI CBIIT WebEx conferencing or other available NCI conferencing systems to run the meetings and reviews. The 2 NCTN-CCSCs, NCTN/NCORP-SCs, 18 SCs total, meet monthly. For additional detail see section IV, CCCT Scientific, Administrative and Logistical Meeting Support.

5. Coordinate with appropriate CTEP Operations and Informatics Branch (OIB), CTEP PIO and other NCI staff to integrate processes of the CSS with the standard operating procedures (SOP) for review of trial specimen studies. This includes the cost effective and efficient processes and SOPs required to coordinate and disburse payment to extramural reviewers of CSS, including but not limited to the NCTN-CCSC. For outside clinicians, scientists, advocates, and other experts who are non-Federal employees, payment for their time reviewing and critiquing CSS proposals shall be provided by the Contractor. These honoraria payment amounts shall be determined in accordance with the polices of the Department of Health and Human Services (herein called the Department). The payment amounts will be set annually, and the COR will inform the Contractor if there is any change to the payment amount as determined by the Department. Regular honoraria payments will be based on meeting attendance records kept by the Contractor and approved by the CTEP. The Contractor shall provide NCI bi-monthly reports to summarize the funding disbursed.

6. Provide regular updates to NCI scientific leaders on status of correlative science studies and NCTN/NCORP clinical trial concepts in the review process.

7. Provide project management and coordination to support CTAC and CTAC subgroup activities.

8. Work with CTEP and NCI leaders to leverage use of IT tools for tracking correlative science studies and analyzing for NCI program evaluation.

C. Provide Project Management to NCI Precision Medicine Trials

1. Provide meeting support for working groups in trial/study development. This includes, but is not limited to, setting up webinars, taking and/or transcribing minutes for review by working group chairs, sending out revised minutes to the working groups, and prompting and/or reminding study teams to address issues and action items in a timely fashion.

2. Interface with outside collaborators (e.g. pharmaceutical, labs and device companies) to arrange meetings with trial/study investigators or working groups.

3. Attend working meetings; most meetings will be held in the Washington DC area, but some travel may be required when approved in advance by the COR and Contracting Officer (CO).

4. Make slides/presentations/summaries for information to NCI, NIH and other officials, as well as other interested or involved parties.

5. As needed, escalate awareness of any issues that might delay trial progress in planning or accrual to the appropriate NCI and extramural site leadership.

6. Develop accrual projections of studies and timelines upon request, working closely with NCI biostatisticians and NCI leadership to ensure accurate calculations are used to develop projections. Meet regularly with study leaders to ensure progress and identify barriers to goals.

7. Develop additional local databases as necessary to capture pertinent information to meet specific project needs (e.g. additional tracking of accrual barriers, interventions that helped successfully overcome accrual challenges and interventions that did not work as well).

8. Maintain and organize minutes, drafts, and other pertinent documents in a local database suitable to meet project needs.

9. Working with NCI investigators and others, prepare documents for CIRB and CTEP

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10. Identify and implement any other tasks and or processes that will facilitate and improve the protocol activation and completion process in collaboration with NCI staff and contractors in the CTEP PIO.

11. Participate in appropriate meetings to maintain ‘situational awareness’ of trial accrual progress (e.g. Working Group, NCI leadership, OEWG, CIB and IDB meetings).

12. Provide suggestions to address protocol specific and global impediments to patient accrual or other deliverables. Work with NCI staff, NCTN Groups, other NCI groups and contractors and extramural investigators and their teams and others to collaborate on interventions to promote and enhance trial/study accrual.

13. Provide meeting support for working groups that review study arm results. Coordinate the review of new labs, assist in the onboarding of new labs, and arrange ongoing calls as needed with the new labs of a precision medicine trial lab network. Prepare quarterly reports for pharmaceutical collaborators as needed.

D. Provide Project Management Support to NCI’s Early-Phase Development Projects

1. Work with NCI staff to execute Confidential Disclosure Agreements (CDAs) and vet Conflicts of Interest (COIs) of Project Team (PT) members that are extramural scientists and investigators collaborating with NCI.

2. Work in coordination with the Investigational Drug Steering Committee (IDSC) to enable the Drug Development PTs to identify members and provide operational support for team meetings including but not limited to scheduling conference calls, providing call summaries, and collating presentations and materials.

3. Maintain timelines of ETCTN agents moving through the PT, Cooperative Research and Development Agreement (CRADA), IDSC and Senior Advisory Committee (SAC) review process.

4. Assist in the development and finalization of the PT presentation to the IDSC.

5. Assist in the development and management of the Share Point Drug Development and Drug

Project Team site for the Investigational Drug Branch (IDB).

6. Provide coordination and meeting support to the early drug development initiative for pediatric oncology known as the Pediatric Early Phase Clinical Trials Network (PEP-CTN). This will include providing meeting support to the PEP-CTN Agent Prioritization Committee and the PEP-CTN Pharmaceutical Relations Committee.

7. Provide support to NCI staff for and coordination of ETCTN project supplements such as, but not limited to, the ETCTN supplements for ETCTN sites piloting electronic collection of patient reported outcomes (ePROs) and ETCTN Biomarker supplements.

E. Provide Project Management support to the NCI Cancer Moonshot Networks and Projects or

Other Congressionally Mandated Projects and National Health Emergency Projects

In December 2016, Congress passed the 21st Century Cures Act and authorized funding for Cancer Moonshot Initiatives. As part of this effort, NCI launched several new scientific networks and projects, including the Cancer Immune Monitoring and Analysis Centers & Cancer Immunologic Data Commons (CIMAC-CIDC) Network and Drug Resistance and Sensitivity Network (DRSN). The Contractor shall:

1. Provide project management support as needed to assist in the coordination of new cancer networks and related projects. Provide meeting support for overall project coordination with NCI program leaders and with grantees and networks. This includes setting up webinars, taking and/or transcribing minutes for review by working group leaders, sending out revised minutes and action items to the working groups, and prompting and/or reminding study teams to address issues and completion of action items in a timely fashion.

2. Interface with collaborators to arrange meetings to consider impact on new, ongoing and completed NCI clinical trials.

3. Attend working meetings to provide support and take scientific notes to create summaries when needed; most meetings will be held in the Washington DC area, but some travel may be required as approved in advance by the COR and CO.

4. Prepare slides/presentations/summaries of information for NCI, NIH and other officials, as well as other interested or involved parties and prepare documents for meetings and presentations.

5. As needed, escalate awareness of any issues that might delay project progress in the cancer networks reaching their goals to the COR.

Statement of Work August 7, 2020

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6. Develop additional local databases as necessary to capture pertinent information to meet specific project timelines and needs (e.g. rosters of all the working group members, clinical trials under review, etc.).

7. Maintain and organize drafts and other pertinent documents suitable to meet project needs.

8. Identify and implement any other tasks and or processes that will facilitate and improve the coordination process among the cancer networks in collaboration with NCI staff and NCI contractors.

9. Participate in appropriate meetings to maintain ‘situational awareness’ of project progress (e.g. Working Group, NCI leadership, CDP and IDB meetings).

10. Provide suggestions to improve project management coordination and ensure reaching project goals in a timely fashion.

11. Coordinate the intake of biomarker plans for correlative studies involving the CIMACs, to become part of cancer clinical trials.

12. Provide project management support and study coordination for protocols, including but not limited to the NCORP Tissue Procurement Protocol: An NCI Cancer Moonshot Study, led by IDB and DCP.

13. Provide project management support and study coordination for NCI studies and related projects needed to be quickly activated during national health emergencies. This includes but is not limited to the NCI’s COVID-19 in Cancer Patients Study (NCCAPS) and Tocilizumab in Hospitalized Cancer Patients with Coronavirus 2019 (SARS-CoV-2) and Severe Complications of Coronavirus Disease 19 (COVID-19), led by DCTD.

IV. CCCT SCIENTIFIC, ADMINISTRATIVE AND LOGISTICAL MEETING SUPPORT

Scientific, administrative, and logistical support for CCCT is broken into four task areas:

B. Clinical Trials and Translational Research Advisory Committee (CTAC) and CTAC Subcommittee

Support C. Working Group (Ad-hoc) Support D. Additional Administrative Support for Scientific Steering Committee and CTAC Related Activities as needed

Scientific Steering Committee support includes support for Steering Committee meetings and Steering Committee concept evaluations. The Contractor shall work closely with CCCT Program Directors (PDs) to accomplish the following:

1. Provide Support for Steering Committee Meetings

1. Meeting Organization and Execution. The Contractor shall coordinate with CCCT PDs to oversee the administrative and logistic support of all steering committee related activities in conjunction with the Steering Committee co-chairs. Coordination requires, but is not limited to:

1.1 Obtaining a consensus of dates and times for conference calls, Webinars, in-person meetings and confirming meetings.

1.2 Setting up conference calls through the NIH Conference Call System or NCI CBIIT WebEx conferencing.

1.3 Developing, modifying, and managing monthly conference call schedules and agendas as directed by CCCT PDs.

1.4 Distribution of meeting information to the Steering Committee members and other participants as directed by CCCT PDs.

1.5 Working with the CCCT PD to provide an annual clinical trial landscape and strategic priority review. This may include a listing of NCI sponsored phase 1, 2 and 3 clinical trials, industry and international clinical trials. To this end the Contractor shall abstract, compile, collate, and analyze data utilizing a variety of resources available within and outside of the NCI. Resources include but are not limited to; clinicaltrials.gov, cancer.gov, NCI databases, published literature, and approved SSC concepts.

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2. Pre-Meeting Activities. In advance of Steering Committee meetings, the Contractor shall:

a. Collaborate with Steering Committee Co-Chairs, the NCI Medical Officer (MO) and CCCT PD to develop the agenda, including a confidential annotated agenda for the Steering Committee Chairs, and all meeting materials, making modifications as necessary.

b. Coordinate with CCCT PD to distribute the meeting materials to: 1) Steering Committee members, 2) NCI staff, and 3) Other participants as directed by CCCT PD and 4) post meeting materials to the appropriate website.

3. Meeting Activities. During the Steering Committee meeting the Contractor shall:

a. Take role and determine quorum status if needed;

b. Take notes to support post-meeting activities; and

c. Assist the CCCT PD in all meeting related activities.

4. Concept Evaluation Organization and Execution. The Contractor shall coordinate with CCCT

PDs to manage the concept evaluation process in conjunction with the CTEP/DCP, their respective Protocol and Information Offices (PIO) and Medical Officer (MOs), and Steering Committee Co- Chairs. Coordination requires, but is not limited to:

a. After receipt of new and/or revised concepts, inform SSC Co-chairs and members of the date/time of the evaluation and poll for a quorum.

b. After discussion with SSC Co-Chairs and CCCT PD and NCI MO, contact potential reviewers by email or telephone to request their participation in the concept evaluation, keeping a running record (spreadsheet) of SSC members and the date and concepts evaluated.

c. Distribute concept(s) to reviewers and other participants as specified by CCCT PD along with all relevant meeting materials and information.

d. Notify Study Investigator(s) of the date and time for evaluation of their concept.

e. One week prior to the scheduled call, send a reminder to evaluators with a due date for their evaluations.

f. Collect and collate evaluations and anonymize reviewers’ identities in written documents.

g. Verify conference call/WebEx connection on the scheduled meeting day and call in 15 minutes prior to the scheduled call time, take roll and assure that an appropriate quorum of members is present for voting.

h. At the conclusion of the evaluation, email ballot to voting members.

5. Post-Meeting Activities. Following the Steering Committee meetings, the Contractor shall:

a. Tally votes and notify CCCT PD of the results within one business day of the meeting. After consultation with the CCCT PD provide the appropriate NCI staff and Steering Committee Co- chairs with voting outcome and comments.

b. Notify conference call participants of the outcome using standard language provided by CCCT and remind them of confidentiality.

c. Produce a summary of the meeting within three (3) business days of the meeting for conference calls and Webinars, ten (10) business days for in-person meetings.

The meeting summary shall be technically sound and reflect the scientific nature of the discussion.

d. Distribute preliminary meeting summary to the CCCT PDs and Steering Committee Co-chairs for their review prior to sending to the Steering Committee members.

e. Within two weeks, obtain Draft Consensus Evaluation document from DCP/CTEP MO.

f. Distribute the Draft Consensus Evaluation document to the non-recused SSC membership and CCCT PD for review. The non-recused SSC membership and CCCT PD have three (3) business days to submit comments.

g. Distribute the Final Consensus Evaluation document to the SC membership and CCCT within one business day after the comments have been finalized.

h. Coordinate with CCCT PD to post any additional meeting-related materials to the appropriate website.

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2. Provide Support for Steering Committee Task Force Meetings

a. Meeting Organization and Execution. The Contractor shall coordinate with CCCT PD to oversee the establishment of standing conference calls/Webinars in conjunction with the TF Leadership. The coordination of these meetings requires:

i. Obtaining a consensus of dates and times for conference calls/Webinars and confirm meeting dates and times with appropriate TF members and NCI staff.

ii. Setting up conference calls or NCI videoconferencing through NCI available systems.

iii. Distributing all meeting materials as directed by CCCT PD.

iv. Developing, modifying, and managing monthly meeting schedules and agendas as directed by CCCT PD.

b. Pre-Meeting Materials. In advance of TF meetings, the Contractor shall:

i. Collaborate with TF leadership and CCCT PD staff to develop the meeting agenda and meeting materials for each meeting and modify agenda and materials, as necessary.

ii. Distribute meeting materials and/or post to TF website.

iii. Set up the web-based tool(s) in use (if any) for TF meetings.

c. Post-Meeting Materials. Following the TF meetings, the Contractor shall:

i. Produce a summary of the meeting within three (3) business days of the meeting. The meeting summary shall be technically sound and reflect the scientific nature of the discussion.

ii. Distribute draft meeting summary to designated CCCT PD for review.

iii. Distribute meeting summary and other materials as directed by the CCCT PD and post final meeting minutes and approved materials to the Task Force website if applicable.

B. Clinical Trials and Translational Research Advisory Committee (CTAC) and CTAC Subcommittee Support

The Clinical Trials and Translational Research Advisory Committee (CTAC) provides advice to NCI on the entire NCI clinical trials enterprise. CTAC’s oversight includes early and late phase trials and translational research. CTAC also oversees the scientific steering committees. The Contractor shall:

1. Maintain CTAC membership and meeting database

a. Update and maintain database fields to include, but not limited to, name; title; address; email;

assistant’s info; gender; minority status; geographic location; discipline; disease expertise;

roles in cancer centers, NCTN groups, NCI grant programs, steering committees, professional organizations, and other NCI boards; term dates; CTAC meeting attendance;

CTAC meeting agenda items; and CTAC follow up actions.

b. CCCT will supply most of the information in above, however the Contractor shall support this task by assisting in researching information to enter into the database.

2. Assist in the retrieval and analysis of CTAC information

a. Prepare email distribution lists

b. Prepare rosters

c. Prepare CTAC meeting slate reports

d. Prepare other reports as needed

3. Provide administrative support to CTAC

a. Support includes, but is not limited to, scheduling meetings and conference calls, setting up webinars, drafting materials, distributing materials, preparing call summaries, and tracking of action items and outcomes.

b. Support CTAC chair planning calls by providing the support described in 1 and

2 above.

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c. Support CTAC subcommittees, working groups and subgroups, providing the support described in 1, 2 and 3 above and manage conflict of interest and lobbying forms for working group members.

C. Working Group (Ad-Hoc) Meetings

The Contractor shall work closely with CCCT staff to provide Support for Working Group (Ad-hoc) Meetings. Additional support provided by the Contractor shall include but not be limited to:

1. Provide project management support as needed to assist in meeting development.

2. Interface with meeting participants to coordinate planning meetings.

3. Attend planning meetings to provide support and take scientific notes to create summaries when needed.

4. Work with NCI staff on…