36C24522Q0228.docx

SUBJECT*

Cooperative Studies Program (CSP) - Clinical Training.

GENERAL INFORMATION

SET-ASIDE

VAMC

10 N Greene St Baltimore MD 21201

POINT OF CONTACT*

Contract Specialist John Ritter John.Ritter2@va.gov

PLACE OF PERFORMANCE

VAMC

10 N Greene St

Baltimore MD

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

AGENCY CONTACT’S EMAIL ADDRESS

DESCRIPTION

SOURCE SOUGHT NOTICE- Cooperative Studies Program (CSP) - Clinical Training.

This is a Sources Sought Notice; it is not a Request for Quote or Proposal.

The anticipated date of a solicitation is January 19th, 2022, with an expected period of performance starting February 2022 for 3 years (Base plus two 2 option years) using NAICS CODE 541720, Research and Development in the Social Sciences and Humanities, size $22 million Product / Service Code AF12- Education, Training, Employment, & Social Svcs R&d Svcs; Education Svcs R&d; Applied Research.

Vendors will not receive formal notification or feedback on any information submitted in this Sources Sought Notice. All future proposed submissions and solicitations requirements solicited on a Government Point of Entry (GPE) will be evaluated independently of any information submitted in response to this Sources Sought Notice. No vendor will be provided information on solicitations issued on a Government Point of Entry based on this Sources Sought Notice.

Potential Sources shall provide their Capability Statement and it must be clear, concise, and complete.

Interested contractors should respond to this notice via email to John.Ritter2@va.gov using the subject “Cooperative Studies Program (CSP) - Clinical Training.” by Tuesday, January 18th, 2022, 10:00 am EST, and provide:

· DUNS number.

· VIP verification standing, if any.

· GSA contract number, if applicable.

· Please limit response to 5 pages

There is no other information available currently. Responses to this notice may be used in determining an appropriate set-aside.

Thank you for your interest.

Sources Sought Notice Sources Sought Notice Cooperative Studies Program (CSP) - Clinical Training Statement of Work (SOW) is attached.

Sources Sought Notice

STATEMENT OF WORK (SOW)

1. CONTRACT TITLE: Veterans Affairs Cooperative Studies Program (CSP) - Clinical Training.

2. BACKGROUND: The VA Cooperative Studies Program CSP is a national clinical trial program with over 40 years’ experience providing collaboration for research design, statistical analysis, data management, regulatory, technical, education, and administrative coordination for clinical trials involving various scientific areas of research conducted to improve the health and care of the Veteran and the nation. Our multi-site trials involve drugs, device and treatment methodologies and are conducted nationally and internationally. The core of the program consists of five bio-statistical and data management coordinating centers located in Palo Alto, CA; Hines, IL; Perry Point, MD; West Haven CT; and Boston, MA; a Clinical Research Pharmacy Coordinating Center (CRPCC) located in Albuquerque, NM and five Epidemiology Research and Education Centers located in Seattle, WA; Boston, MA, West Haven, CT, Palo Alto, CA, and Durham, NC. CSP is also sponsoring an initiative referred to as the Network of Dedicated Enrollment Sites (NODES) and its goal is to establish a consortium of VA medical centers (VAMCs) that have teams (NODES) in place dedicated to conducting CSP studies to enhance the overall performance, compliance, and management of CSP multi-site research.

The training program shall provide CSP employees with an online educational opportunity to increase their knowledge base and competencies in areas that are critical to the conduct of clinical trial research. This includes Human Subjects Protection and Ethics, Quality Management, etc. and would be a tremendous benefit to the Veterans that participate in CSP/VA research, CSP personnel, and the VA Clinical research program. The VA’s Talent Management System (TMS) does not contain the special clinical training in professional development that is needed by its trial management teams. By acquiring this training, the CSP will be filling a professional developmental gap, that will ensure its researchers and staff are competitive to the industry standard.

3. SCOPE/OBJECTIVES:

The training program is a reoccurring yearly requirement for a total of three years (Base plus Two-year option) to the CSP Program. Additional training and/or increase of the membership above 250 personnel may occur throughout the duration of this contract. These modifications will be requested from the Project Lead through the COR to the CO, then to the Vendor.

This contract is a Fiscal year contract, with the base year to end 30 September 2022. It is primarily a membership subscription to allow the various clinical professionals of the CSP to fulfill additional training requirements and opportunities. Membership by the CSP is expected to grow and will eventually exceed the micro purchase threshold.

4. TASKS:

4.1 Vendor provides access to Licensee and all their authorized users.

4.2 Provides courseware for internal training purposes and professional development.

4.3 Vendor will coordinate with the Project Lead and/or Project Manager on specifics courses offered for training and professional development.

4.4 The Project lead will be the main coordinator and administrator working directly with vendor.

4.5 The Project Lead will be identified within 30 days of contract award.

4.6 Vendor will endeavor to ensure all courseware offered is current with national standards.

4.7 Provide training to the Program lead(s) as required on access and curriculum offered.

4.8 Vendor will conduct course ware reviews at a minimum of once bi-annually to ensure it is current and applicable.

4.9 Initial access to up to 250 CSP members.

4.10 Program Lead (the Licensee administrator) will be able to:

4.10.1 Add users to site license for the Program through CSP upload or manual input

4.10.2 Enroll users into Courseware that licensee has selected to be included in the Program

4.10.3 Access the training transcript report to view what learners have done in the Program, including Courseware status (passed, failed, in progress, etc.), start and completion dates, and Courseware scores.

4.10.4 Access individual learner transcripts.

4.10.5 Unenroll site license Program users from Courseware (remove their access from the Courseware).

4.10.6 Have a “Vanity” URL for licensee: a URL through which the licensee’s users log into the LMS.

5. SPECIFIC TASKS:

6.1 Customer agrees to:

6.1.1 Confidential information requirements.

6.1.2 Responsibilities of the Parties.

6.1.3 Intellectual Property.

6.2 This contract will be initiated for a base year and two option years.

6. PERFORMANCE MONITORING:

If required, the COR maybe required by the CO to complete annual CPARS requirement and submit to Contracting officer.

7. SECURITY REQUIREMENTS:

The C&A requirements do not apply and a Security Accreditation Package is not required. Nor are PO an ISSO signatures on the 6500.

7.1 NO Personal Identify Information is to be used in this contract.

7.2 Nor are any VA patient or facility information to be exchanged. This course structure is for the continued development of VA CSP professional personnel.

8. GOVERNMENT-FURNISHED EQUIPMENT (GFE)/GOVERNMENT-FURNISHED INFORMATION (GFI):

The contractor will not use GFE or need GFI to perform task identified above. Contractor may use government facilities to conduct report briefings to CSP employees and specified training.

9. OTHER PERTINENT INFORMATION OR SPECIAL CONSIDERATIONS:

9.1 The CSP Lead for this program will be identified with 30 days of contract award.

9.2 Modifications to the contract over the three-year contractual period are to be based on requirement needs and funding.

9.3 Additional training curriculum based on changing requirements can be task-ordered to add to the program. The contractor should produce professional certification and supporting expertise for additional curriculum.

9.4 Identification of Non-Disclosure Requirements: The extent of sensitive information disclosed to the contractor is limited to employee names and VA email addresses.

10. RISK CONTROL:

There is no risk involved in the delivery of the Training Programs. This is a web-based training program for CSP employees. This can be conducted on personal as well as work computers by accessing the Vendors website.

11. PLACE OF PERFORMANCE:

It shall be an online service providing CSP employees access via a website external to the VA firewall. Access will be from multiple locations including teleworking from personnel residence.

12. PERIOD OF PERFORMACE:

12.1 This request is for a multi-year contract (base year + two option years):

13. DELIVERY SCHEDULE:

BASE YEAR:

CLIN 0001: Provided a Training Program for up to 250 CSP employees.

CLIN 1001: Provided a Training Program for up to 250 CSP employees.

CLIN 2001: Provided a Training Program for up to 250 CSP employees.

TOTAL ESTIMATED COST

14. PAYMENT:

15.1 Payment is to be determined by the CO.

15.2 Payment will be in a one-time annual membership fee by year.

15.2.1 Additional Annual fees are subject to acceptance by the CO.

15. ACRONYMS:

A. CO – Contracting Officer. The Federal employee who is warranted by the Government to enter into contracts on behalf of the Government and is the only person authorized to make changes to those contracts.

B. COR – Contracting Officer’s Representative. Individual designated by the CO to place orders, furnish technical guidance, advice, certify invoices, and provide general supervision of the work performed under the executed contract.

C. CSP – Cooperative Studies Program.

D. CSPCC – Cooperative Studies Program Coordinating Center.

E. CSPCRPCC – Clinical Research Pharmacy Coordinating Center.

F. VAMC – Department of Veterans Affairs Medical Center.