SOW_Neurocognative SME 2024.pdf

STATEMENT OF WORK (SOW)

1.0 TITLE

Neuropsychology Subject Matter Expert in the Translation, Cultural Validation, and Normative Testing for Three Neurocognitive Tools used in NCI Clinical Trials

2.0 BACKGROUND

The NCI Division of Cancer Prevention (DCP) is leading a project to translate, validate and establish normative values for three performance-based neuropsychological measures for Spanish-speakers living in the United States (U.S.) and potentially for French-speakers in Canada. As part of this effort, DCP requires an individual with specialized knowledge in neurocognitive testing and familiarity with NCI’s National Community Oncology Research Program (NCORP) and the NCI Clinical Trials Network (NCTN) to provide scientific and technical input into this project's planning and implementation.

As background, this project is part of the National Cancer Institute (NCI) Moonshot Initiative, “Translation and Validation of Patient Reported Outcome Measures to Address an Accrual Barrier to Minority and Underserved Participation in Symptom Clinical Trials,” which is funded to produce translated, linguistically, and psychometrically validated and culturally adapted patient-reported outcomes (PROs) to improve clinical trial enrollment, facilitate equitable selection of subjects and improve the generalizability of clinical trial results. In addition to translating PROs, several adult neurocognitive performance-based measures are frequently used in NCI-sponsored adult and adolescent/young adult trials and require translation and validation. However, these measures are very specialized, and the translation and validation processes are more complex than those associated with patient-reported outcomes.

Specifically, these performance-based measures require testing to establish normative values as a component of the validation process.

2.1 OBJECTIVE

DCP requires an academic expert in neuropsychological testing in cancer clinical trials. This expertise is necessary to define efficient methods for recruiting participants, conducting cultural and linguistic (content) validity studies, and performing normative testing to aid in test interpretation.

3.0 SCOPE

The Contractor shall interact with NCI staff, NCORP Research Base Staff, and other organizations or contractors as directed by the NCI. These interactions will take place via telephone or video calls and email communication. The purpose of these interactions is to plan, coordinate, evaluate and oversee the activities necessary to define a scientifically rigorous strategy and conduct the translation, validation, and normative testing of three neurocognitive tests (Hopkins Verbal Learning Test-Revised, Trail Making Test, and Controlled Word Association Test). In addition, the Contractor shall provide verbal guidance and written reports, conduct literature reviews and examinations of other research data, communicate with key professional contacts, draft and review documents, edit planning documents, and provide input for the Government’s preparation of manuscripts for publication.

4.0 PURCHASE ORDER REQUIREMENTS

4.1 TASKS

The Contractor shall perform the following tasks:

4.1.1 Participate in bi-weekly one-hour remote project team meetings to update and provide input to DCP on the process and requirements for translation, validation, and normative testing of neurocognitive tools. Remote one-hour ad hoc meetings (not exceeding 12) may be required. Prepare and deliver a monthly progress report detailing bi-weekly/ad hoc meetings.

4.1.3 For each test, define and document requirements for sample size, study design, data elements to establish norms and a reliable change index, data collection, and data analysis.

4.1.4 Present potential participant recruitment strategies.

4.1.5 Present strategies for recruiting, training, and monitoring test administrators.

4.1.6 Participate in manuscript planning and preparation by drafting, reviewing, and editing one or more scientific manuscripts for the Government’s approval.

4.2 PERSONNEL QUALIFICATIONS

• Familiarity with the design and conduct of clinical trials in adult and young adult populations that use neurocognitive tests for study endpoints.

• Experience conducting trials with neurocognitive endpoints in the NCI Division of

Cancer Prevention (NCORP) and the NCI Cancer Therapy Evaluation Program’s (NCTN) networks.

• Knowledge and experience in translating, validating, and normative testing of neurocognitive tools.

• Active participation in neurocognitive research as evidenced by peer-reviewed publications.

• Ph.D.-prepared, board-certified neuropsychologist with at least five years post-doctoral experience in an oncology clinical research setting.

4.3 PROHIBITION AGAINST PERSONAL SERVICES

The Contractor shall not perform personal services under this contract. Contractor personnel are employees of the Contractor or its subcontractors and are under the contractor's administrative control and supervision. A Contractor supervisor must assign all individual Contractors and give them daily work direction. The Government shall not supervise or direct Contractor employees in the performance of their assignments.

If at any time the Contractor believes that any Government action or communication has been given that would create a personal service relationship between the Government and any Contractor employee, the Contractor shall promptly notify the Contracting Officer of this communication or action.

The Contractor shall not perform any inherently governmental functions under this contract.

No Contractor employee shall represent or give the appearance that he or she is a Government employee, agent, or representative. No Contractor employee shall state orally or in writing at any time that he or she is acting on behalf of the Government.

The Contractor is responsible for ensuring that all employees assigned to this contract understand and are committed to following the requirements of the Contract.

5.0 TYPE OF ORDER

This is a firm fixed price purchase order.

6.0 PERIOD OF PERFORMANCE

The period of performance shall be for twelve (12) months from the date of award.

7.0 PLACE OF PERFORMANCE

The required tasks shall be performed remotely from the Contractor’s facility. No government equipment is to be supplied.

8.0 REPORT(S)/DELIVERABLES AND DELIVERY SCHEDULE

DELIVERABLE DELIVERABLE DESCRIPTION / FORMAT REQUIREMENTS DUE DATE

1 Monthly Progress report to include:

• Bi-weekly/ad hoc meetings outcomes

• Identification of issues related to copyrights, licenses, and costs or limitations of use

• Participant recruitment strategies

Within 30 calendar days of contract award, and on the 15th day of

• Recommended strategies for recruiting, training, and monitoring test administrators

Format: MS Word each subsequent month.

2 PowerPoint presentation to include:

• Overview of the translation and validation process for neurocognitive tools,

• Relevant guidelines and standards for translating and adapting tests

• Considerations for research settings.

Format: PowerPoint presentation

Within 30 calendar days of contract award.

3 Provide a table that defines the validation and normative testing requirements for HVLT-R, TMT, and COWA, to include sample size, study design, data elements to establish norms and a reliable change index, data collection, and data analysis.

Format: MS Word Document

Within 3 months of award.

4 Provide draft manuscript for government review.

Format: MS Word Document

Within 60 calendar days of assignment.

9.0 INSPECTION AND ACCEPTANCE CRITERIA

Pursuant to FAR clause 52.212-4, all work described in the SOW to be delivered under this contract is subject to final inspection and acceptance by an authorized representative of the Government. The authorized representative of the Government is the NCI TPOC, TBD, who is responsible for inspection and acceptance of all services, materials, or supplies to be provided by the Contractor.

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.

Remediation of any materials that do not comply with the applicable Section 508 requirements as set forth below, shall be the responsibility of the Contractor.

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

Per Section 508 and as mandated under HHS Policy for Section 508 Compliance and Accessibility of Information and Communications Technology (ICT) (07/2020) all documents or electronic files provided to the NIH NCI under contract must be conformant with Section 508 standards and accessible to persons with disabilities. Conformance shall be confirmed by use of material provided at HHS OS Factsheets & Reference Guides and verified through the use of the HHS Checklist Documents (WCAG 2.0 Refresh); in addition, contractors and vendors are encouraged to make use of the instructional materials and checklists at GSA Section 508.gov’s Create Accessible Digital Products

10.0 PAYMENT

I Invoice Requirements

Payment shall be made upon completion of work as indicated with submitted invoice. Payment authorization requires submission and approval of invoices to the TPOC and NIH OFM, in accordance with the attached payment provisions listed below:

The following clause is applicable to all Purchase Orders, Task or Delivery Orders, and Blanket Purchase Agreement (BPA) Calls: Prompt Payment (Jan 2017) FAR 52.232-25. Highlights of this clause and NIH implementation requirements follow:

A. An invoice is the Contractor's bill or written request for payment under the contract for supplies delivered or services performed. A proper invoice is an "Original" which must include the items listed in subdivisions 1 through 12, below, in addition to the requirements of FAR 32.9. If the invoice does not comply with these requirements, the Contractor will be notified of the defect within 7 days after the date the designated billing office received the invoice (3 days for meat, meat food products, or fish, and 5 days for perishable agricultural commodities, dairy products, edible fats, or oils) with a statement of the reasons why it is not a proper invoice. (See exceptions under II., below.) Untimely notification will be considered in the computation of any interest penalty owed the Contractor.

1. Vendor/Contractor: Name, Address, Point of Contact for the invoice (Name, title, telephone number, e-mail and mailing address of point of contact).

2. Remit-to address (Name and complete mailing address to send payment).

https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-ict-refresh/final-rule/text-of-the-standards-and-guidelines https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-ict-refresh/final-rule/text-of-the-standards-and-guidelines https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-ict-refresh/final-rule/text-of-the-standards-and-guidelines https://www.hhs.gov/web/governance/digital-strategy/it-policy-archive/hhs-policy-section-508-compliance-accessibility-information-communications-technology.html https://www.hhs.gov/web/governance/digital-strategy/it-policy-archive/hhs-policy-section-508-compliance-accessibility-information-communications-technology.html https://www.hhs.gov/web/section-508/additional-resources/index.html https://www.hhs.gov/web/section-508/accessibility-checklists/index.html https://www.section508.gov/ https://www.section508.gov/ https://section508.gov/create

3. Remittance name must match exactly with name on original order/contract. If the Remittance name differs from the Legal Business Name, then both names must appear on the invoice.

4. Invoice date.

5. Unique invoice #s for all invoices per vendor regardless of site.

6. NBS document number formats must be included for awards created in the

NBS: Contract Number; Purchase Order Number; Task or Delivery Order Number and Source Award Number (e.g., Indefinite Delivery Contract number; General Services Administration number); or, BPA Call Number and BPA Parent Award Number.

7. Unique Entity Identifier (UEI) which is in the System for Award Management (SAM) and replaces the Dun & Bradstreet Data Universal Numbering System (DUNS) number.

8. Federal Taxpayer Identification Number (TIN). In those rare cases where a contractor does not have a UEI number or TIN, a Vendor Identification Number (VIN) must be referenced on the invoice. The VIN is the number that appears after the contractor’s name on the face page of the award document.

9. Identify that payment is to be made using a three-way match.

10. Description of supplies/services that match the description on the award, by line billed.*

11. Freight or delivery charge must be billed as shown on the award. If it is included in the item price do not bill it separately. If identified in the award as a separate line item, it must be billed separately.

12. Quantity, Unit of Measure, Unit Price, Extended Price of supplies delivered or services performed, as applicable, and that match the line items specified in the award.*

NOTE: If your invoice must differ from the line items on the award, please contact the Contracting Officer before submitting the invoice. A modification to the order or contract may be needed before the invoice can be submitted and paid.

Shipping costs will be reimbursed only if authorized by the Contract/Purchase Order. If authorized, shipping costs must be itemized. Where shipping costs exceed $100, the invoice must be supported by a bill of lading or a paid carrier's receipt.

B. The Contractor shall submit invoices to the Department of Treasury’s Invoice Processing Platform (IPP) at https://www.ipp.gov with a copy to the approving official, as directed below.

The Contractor shall submit a copy of the electronic invoice to the following TPOC:

Name- Email Address- (TBD at time of award) https://www.ipp.gov/

II. Invoice Payment

A. Except as indicated in paragraph B., below, the due date for making invoice payments by the designated payment office shall be the later of the following two events:

1. The 30th day after the designated billing office has received a proper invoice.

2. The 30th day after Government acceptance of supplies delivered or services performed.

B. The due date for making invoice payments for meat and meat food products, perishable agricultural commodities, dairy products, and edible fats or oils, shall be in accordance with the Prompt Payment Act, as amended.

III. Interest Penalties

A. An interest penalty shall be paid automatically, if payment is not made by the due date and the conditions listed below are met, if applicable.

1. A proper invoice was received by the designated billing office.

2. A receiving report or other Government documentation authorizing payment was processed and there was no disagreement over quantity, quality, or contractor compliance with a term or condition.

3. In the case of a final invoice for any balance of funds due the contractor for supplies delivered or services performed, the amount was not subject to further settlement actions between the Government and the Contractor.

B. Determination of interest and penalties due will be made in accordance with the provisions of the Prompt Payment Act, as amended, the Contract Disputes Act, and regulations issued by the Office of Management and Budget.

IV. PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS SUBCONTRACTORS, FAR

52.232-40 (November 2021)

(a) Upon receipt of accelerated payments from the Government, the Contractor shall make accelerated payments to its small business subcontractors under this contract, to the maximum extent practicable and prior to when such payment is otherwise required under the applicable contract or subcontract, after receipt of a proper invoice and all other required documentation from the small business subcontractor.

(b) The acceleration of payments under this clause does not provide any new rights under the Prompt Payment Act.

(c) Include the substance of this clause, including this paragraph (c), in all subcontracts with small business concerns, including subcontracts with small business concerns for the acquisition of commercial products or commercial services.

V. HHSAR 352.232-71 Electronic Submission of Payment Requests (February 2, 2022)

(a) Definitions. As used in this clause— Payment request means a bill, voucher, invoice, or request for contract financing payment with associated supporting documentation. The payment request must comply with the requirements identified in FAR 32.905(b), ‘‘Content of Invoices’’ and the applicable Payment clause included in this contract.

(b) Except as provided in paragraph (c) of this clause, the Contractor shall submit payment requests electronically using the Department of Treasury Invoice Processing Platform (IPP) or successor system. Information regarding IPP, including IPP Customer Support contact information, is available at www.ipp.gov or any successor site.

(c) The Contractor may submit payment requests using other than IPP only when the Contracting Officer authorizes alternate procedures in writing in accordance with HHS procedures.

(d) If alternate payment procedures are authorized, the Contractor shall include a copy of the Contracting Officer’s written authorization with each payment request.

(End of Clause) http://www.ipp.gov/