Cooperative Studies Site monitoring and auditing for VA medical studies.
Sources Sought Notification
Cooperative Studies 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) conducts clinical studies at VA facilities and associated non-VA facilities throughout the United States. To ensure the trials follow Good Clinical Practice (GCP), Clinical Research Quality Associate (CRQA) services are required. The CSPCRPCC s Site Monitoring, Auditing and Resource Team (SMART) supports the current workload, but the success of an expected full workload relies on experienced contractors to support. The trials vary over time in number, size and design, but typically consist of 25 trials conducted at 300 to 400 investigative sites. The VA intends to award a single Firm Fixed Price, Indefinite Delivery and Indefinite Quantity (IDIQ) contract to provide clinical trial site monitoring services for the research 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:
Notify the Lead CRQA and SMART of recurrent and/or serious compliance deficiencies immediately of becoming aware of such deficiencies
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 interview with study team to discuss site status
Assist during and after the visit as necessary with development and implementation of Corrective Actions and/or Preventive Actions (CAPAs) to mitigate recurrence of compliance deficiency
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 and Behavior and as assigned - to be completed prior to start
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.
Contracting Officer: Michael Haydo
michael.haydo@va.gov
Michael.Haydo@va.gov
