NIDA VA Medical Study Site Monitoring Services

Sources Sought Notification

National Institute on Drug Abuse Medical Study Monitoring Services





This Sources Sought is being issued in accordance with Federal Acquisition Regulation Part 10, Market Research. It is for information, planning and market research purposes only and shall not be construed as either a solicitation or obligation on the part of the Veterans Administration (VA) or its Centers.



The purpose of this Sources Sought Notice is to determine the availability and capability of qualified small businesses (including Small Business Administration Certified 8(a) companies; firms in Historically Underutilized Business Zones (HUBZone); Service-Disabled Veteran-Owned small businesses; and Women-Owned small businesses); though the VA welcomes responses from all interested parties.



The VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center (CSPCRPCC) and the National Institute on Drug Abuse (NIDA) have partnered to fill a requirement to provide monitoring GCP CRQA services for the clinical trials conducted by NIDA. These trials are conducted at non-VA facilities throughout the United States. NIDA clinical trials vary over time in number, size and design, but typically consist of two to three trials conducted at 10 20 investigative sites. The Contractor shall serve as a study Clinical Research Quality Associate (CRQA) and shall provide services to the VA CSP through a division of the CSPCRPCC called the Site Monitoring, Auditing and Resource Team (SMART) located in Albuquerque, New Mexico.



The VA intends to award a single Firm Fixed Price, Indefinite Delivery and Indefinite Quantity (IDIQ) contract to provide site monitoring services for the NIDA program based in Albuquerque, New Mexico.



The required visits/services shall include the following information from the Performance Work Statement:



CRQAs will have access to PHI/PII data during performance.



CRQAs shall meet the minimum requirements:



Qualifications/Technical Abilities/Capabilities:

Degree/Professional Certifications required:

Bachelor s Degree or Licensed Health Care Professional

Five years or more clinical research monitoring experience

Technical Abilities/Capabilities:

Software knowledge in Microsoft Office products (Word, PowerPoint, Excel, etc.)



Task 1 Visits (with pre and post work)



Subtask 1 Site Initiation Visits - one to three days



The CRQA shall conduct site initiation visits. The vendor shall perform an evaluation of a minimum of the following, as relevant to the design of the trial:



Protocol procedures including inclusion/exclusion criteria

Subject informed consent process

Screening procedure

Randomization procedure

Investigational Product Accountability

Unanticipated Adverse Event reporting and Serious Adverse Event Reports

Source document requirements and availability

Case Report Form (CRF) completion, correction, QA procedures

Institutional Review Board (IRB) policies and procedures (i.e., adverse events and protocol deviations)

Regulatory and other study document completion and maintenance

Site correspondence with sponsor, CRQA and maintenance

Un-blinding procedures of a blinded study

Other related protocol procedures



The CRQA shall assure the following regulatory information is present in the site files:



Current IRB approval protocol/amendments

Current IRB approval consents(s)

Current IRB membership list or documentation of IRB compliance

Investigator agreements

Financial disclosures

Investigator curriculum vitae (CV)

Research and indemnity (if applicable) agreement

All training requirements GCP, Health Insurance Portability and Accountability Act (HIPAA) and Human Subjects Protections (HSP)



Additionally, the CRQA shall ensure the following Study Management Documents are completed (if applicable) and appropriately filed:



Delegation of Authority Form or CRF Authorization Log

IRB policy and procedures (i.e., adverse event and protocol deviation reporting)

IRB correspondence

Sponsor correspondence

Study contact list

Subject list

Site Visit Log

CRFs (all versions)

CVs

Medical license(s)



Subtask 2 Conduct routine CRQA visit for assigned site - one to four days



When conducting a routine visit, the CRQA shall perform the following evaluations, if appropriate:



Check for protocol compliance

Review Essential Document Binder

Conduct subject data review

Verify CRF data against Source Documents

Review timeliness of Query resolution

Review Source Documents for Adverse Events (AE)/Serious Adverse Events (SAE)

Review CRFs for accuracy and legibility

Check for CRF submission to Data Coordinating Center

Perform investigational product accountability

Determine follow-up actions to be taken

Provide relevant GCP Training

Hold exit interviews with study teams to discuss site status



Subtask 3 Conduct study final visit for assigned site - one to four days



The CRQA shall conduct study final visits. Timing of final visit shall be directed by the SMART Chief, Monitoring. During the visit the CRQA shall:



Discuss site close-out procedures with staff

Ensure submission of data and query resolution

Review Essential Document Binder for completeness

Check for final disposition of investigational product

Retrieve documents for Sponsor files

Discuss record retention with investigator



Subtask 4 - Prepare site visit reports and summary letters



Within seven (7) calendar days after completing site visit, the CRQA shall:



Complete site visit report and prepare a follow-up Quality Assurance (QA) summary letter, if applicable, that includes:



Date(s) of visit

Name of the CRQA who conducted the visit

Name and address of the Investigator

Identification of person(s) participating during the visit

QA activities performed

Summary of findings, conclusions, and any actions taken or planned to correct any deficiencies noted during the visit

Directed CAPA deficiencies



Subtask 5 Additional notes about preparing and conducting site visits



Scheduling The CRQA shall schedule all site visits through the SMART Manager.



Special Requirements The CRQA s reporting requirements will necessitate computer program access and literacy in Microsoft Office Programs, e.g., Word, Excel, PowerPoint, SharePoint as well as Internet capability to transmit documents and access email and correspondence. The CRQA shall provide all equipment and supplies necessary to perform the contract requirements set forth in the Request for Proposal (RFP) except for a laptop computer which shall be provided by the Government for use in CRQA services. Computer Access shall be maintained following VA regulations. Travel arrangements shall be the responsibility of the CRQA.



Frequency of Visits The frequency and timing of CRQA visits will be determined by SMART for each site based on the following



Study Team recommendations

Subject accrual rate at the site

Total number of subjects to be enrolled at the site

Complexity of the study protocol

Data collection and record keeping proficiency at the site

Observations and corrective actions from previous monitoring visits



Preparing for Visits Prior to the Monitoring visits, the CRQA shall assemble all documents and resource materials needed to conduct the visit such as:



Tentative Agenda

Estimated time needed on site with the Site Investigator/Coordinator

Specific documents needed for review



Task 2 CRQA Visits (without pre and post work) and other trial related activities



Subtask 1 Meeting or other visits - one to four days



Kickoff Meeting

Investigator s Meeting

SMART Annual CRQA training

Other



Subtask 2 -Support other CRQAs in the conduct of visits - one to four days on site



The CRQA may support another CRQA in conducting site monitoring visits.



Task 3 GCP QA Support / Hours



Lead activities

Develop Monitoring Visit Tools and Form

Create EDB / Participant Study Binder

Review and edit Protocol and Operations Manual

Develop Monitoring Plan

Develop Source Document Plan

Review and Edit Reports from other CRQAs

Attend Sponsor Calls (e.g. Executive Committee)

Address questions from sites and Sponsors

Other activities as required



All Monitors activities

Activities supporting other CRQAs such as training/retraining or remote monitoring.

Complete required study specific training.

Complete mandatory VHA training (Privacy, HIPAA, Ethics, Information Security, GCP Training, Rules & Behavior and as assigned - completed prior to start work).

Complete SMART and CSP policies and procedure training and orientation.



Training (additional guidance)



All contractor employees and subcontractor employees requiring access to VA information and information systems shall complete the required VA training before being granted access.



Sources Sought Response Requirements



Responses to this notice shall include:



A short (1 page or less) narrative capability statement in response to each of the individual draft Performance Work Statement (PWS) requirements.

The response shall be by electronic method (email) and include relevant experience and other information indicating and evidencing capability to successfully meet the aforementioned requirements. Responding to this not does not guarantee any opportunity for the contract, and is only used for VA planning purposes.

Description of the company s past performance and experience with implementation of this type of service that is of a similar scope and size. And information (Government or commercial entity, contract/purchase amount, etc.) relating to each of the past performance descriptions.

Business size classification of the company under the appropriate NAICS code.

Written confirmation of registration in SAM (www.sam.gov). Offerors should be registered to be considered as a source.



For questions regarding these services required for this requirement and to submit capability statements please contact Michael.haydo@va.gov or 412-822-3158.