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FBO DAILY - FEDBIZOPPS ISSUE OF JULY 25, 2014 FBO #4626
DOCUMENT

R -- Monitoring IDIQ - Good Clinical Practice (GCP) Research Associate Svcs - Attachment

Notice Date

7/23/2014
 

Notice Type

Attachment
 

NAICS

541611 — Administrative Management and General Management Consulting Services
 

Contracting Office

Department of Veterans Affairs;SAOW/NCO 18;4135 S. POWER RD. STE 103;MESA, AZ 85212
 

ZIP Code

85212
 

Solicitation Number

VA25814I0774
 

Response Due

7/28/2014
 

Archive Date

8/27/2014
 

Point of Contact

ENRIQUE J. RIVERA
 

E-Mail Address

e.rivera@va.gov<br
 

Small Business Set-Aside

N/A
 

Description

Monitoring IDIQ contract for Good Clinical Practice (GCP) Clinical Research Quality Associate (CRQA) Services The VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center (CSPCRPCC), located in Albuquerque, New Mexico, has a requirement to provide monitoring and auditing GCP CRQA services for the clinical trials conducted by the VA Cooperative Studies Program (CSP). These trials are conducted at VA facilities and associated non-VA facilities throughout the United States. CSP clinical trials vary over time in number, size and design, but typically consist of 25 trials conducted at 300 to 400 investigative sites. The purpose of this Sources Sought Notice is to solicit interest for establishing a multiple-award Indefinite Delivery, Indefinite Quantity (MAIDIQ) contract to acquire the services of an experienced Contractor to serve as a provider of clinical trial site monitoring and auditing CRQA services. 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 SMART mandate is to ensure that the clinical trials of the VA CSP are conducted in compliance with the scientific and ethical principles embodied in the GCP regulations and guidelines. The SMART accomplishes this task by assuring that VA personnel conducting or supporting clinical trials are trained in GCP and that any compliance problems at participating research sites are identified and resolved through a program of site CRQA visits. 1.SPECIFIC TASKS Clinical Research Quality Associate (CRQA) visits and associated services required: 1.1Task 1 - CRQA visits (with pre and post work) a.Subtask 1 - Site Initiation Visits The CRQA shall conduct site initiation visits as defined by the CRQA Plan with the support of a Lead CRQA from the SMART. The visits shall be scheduled after the Investigator's Meeting. When conducting a site initiation visit, the CRQA shall perform all 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 b.Subtask 2 - Conduct routine CRQA visit for assigned site The CRQA shall conduct the routine CRQA visits as defined by the CRQA Plan with the support of a Lead CRQA from the SMART. When conducting a routine CRQA visit, the CRQA shall perform an evaluation of the following tasks, if appropriate: "Check for protocol compliance "Review Essential Document Binder "Conduct subject data review "Verify CRF data against Source Documents "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 c.Subtask 3 - Conduct study closeout visit for assigned site The CRQA shall conduct study closeout visits as defined by the CRQA Plan with the support of a Lead CRQA from the SMART. Visits shall be conducted after all subjects have completed the study and all data has been submitted, or earlier if so directed by the SMART. When conducting a study closeout visit, the CRQA shall: "Discuss site close-out procedures with staff "Assure submission of data "Review Essential Document Binder for completeness "Check for final disposition of investigational product "Retrieve documents for Sponsor files "Discuss record retention with investigator d.Subtask 4 - Conduct focused or specialized Quality Associate Visits The CRQA shall conduct periodic focused or specialized QA visits per the SMART SOPs to inspect VA investigators for compliance with GCP and with VA and CSP Research policies: "Review subject and investigator study records for compliance with GCP, VA and CSP research policy "Know and comply with VA Privacy and Data Security Policy during site visits "Provide to the SMART Chief immediate feedback of significant discoveries made during site visits "Provide guidance during site visits on study conduct and use of GCP tools to improve study site practices "Prepare reports after each inspection for the SMART, citing opportunities for improvement (OFIs) and providing recommendations for correcting problems and improving practice "Conduct periodic site inspections per the SMART SOPs to inspect offices of CSP Management (the Sponsor) for compliance with GCP and with VA and CSP research policies "Assess effectiveness of interactions between the investigator site study team and the CRQA and other representatives of CSP e.Subtask 5 - Prepare site visit reports and summary letters Within two weeks (ten work days) of site visit, the CRQA shall: "Complete a site visit report (using a pre-approved template) and prepare a follow-up QA summary letter, if applicable "Provide QA documents, which may include reports and follow-up summary letter, if applicable, to the SMART "All reports and letters will be legible, typewritten, and grammatically correct and sent to the SMART in the specified electronic format "Inform the SMART Lead CRQA of recurrent and/or serious compliance deficiencies "Assist with implementation of Corrective Actions and/or Preventive Actions (CAPAs) in order to mitigate recurrence of compliance deficiency f.Subtask 6 - Additional notes about preparing and conducting site visits "Scheduling - The CRQA shall schedule all site visits through the SMART Program Manager (PM). "Special Requirements - The CRQA's reporting requirements will necessitate computer program access and literacy in Microsoft Office Programs, e.g., Word, Excel, PowerPoint, as well as Internet capability in order to transmit documents and access email and correspondence. "Frequency of Visits - The frequency and timing of CRQA visits will be determined by SMART for each site "Preparing for Visits - Prior to the CRQA visits, the CRQA shall assemble all documents and resource materials needed to conduct the visit (i.e., correspondence, previously completed monitoring documents, etc.) 1.2Task 2 - CRQA Visits (without pre and post work) a.Kickoff Meeting /Investigator's Meeting The CRQA may be required to attend the Kickoff Meeting held prior to the clinical trial start where all trial participants will receive training for specific study procedures and requirements. The CRQA shall attend the Kickoff Meetings to receive training on study protocol and procedures. In addition to attending the meeting, the CRQA may be required to provide training to site personnel on the requirements of the monitoring plan. Attendance at Annual Investigator Meetings or other training meetings may also be required to receive or present additional study training. 2.SECURITY REQUIREMENTS All Contractor employees who require access to the Department of Veterans Affairs' computer systems shall be the subject of a background investigation and must receive a favorable adjudication from the VA Law Enforcement Training Center/SIC. 3.PLACE OF PERFORMANCE The Contractor will be required to perform work at different sites (hospitals and/or clinics) throughout the United States, at the Contractor's place of business and at the SMART office in Albuquerque, New Mexico. The Contractor must be available by pager or phone during business hours (8:00 am to 5:00 pm/MST) Monday through Friday. There may be times when the Contractor will need to be available beyond business hours. The North American Industry Classification System (NAICS) is 541611, Administrative Management and General Management Consulting Services. Any firms who wish to identify their interest and capability to provide the above listed services must provide written notice to the undersigned Contracting Officer no later than 5:00 P.M. EST, 7/28/2014. Such notification must include: "Documentation which shall contain credentials and certifications, both personnel and corporate, along with descriptions of how the firm will meet or exceed the Government's needs; "List of government or non-government contracts (to include awarding agency) awarded over the last 3 years, for similar and relevant services; "Contractor's socio-economic status, as certified in SAM, VetBiz, SBA and other federal sites (e.g. Small Business, Service-disabled Veteran-owned Small Business, Large Business, etc.). Notification shall be e-mailed or faxed to Enrique Rivera, Contracting Officer, (480) 361-9460 / enrique.rivera@va.gov. Upon receipt of any such notification, the Contracting Officer will determine whether to conduct a set-aside or unrestricted competitive procurement or proceed with a sole source acquisition. Responses received will be evaluated; however, a determination by the Government not to compete this proposed procurement based upon responses to this notice is solely within the discretion of the Government. THIS IS NOT A REQUEST FOR COMPETITIVE PROPOSALS OR QUOTES. DISCLAIMER This RFI is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this RFI that is marked as proprietary will be handled accordingly. In accordance with FAR 15.201(e), responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/PhVAMC/HMC/VA25814I0774/listing.html)
 

Document(s)

Attachment
 

File Name: VA258-14-I-0774 VA258-14-I-0774_1.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1519838&FileName=VA258-14-I-0774-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1519838&FileName=VA258-14-I-0774-000.docx

 

Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 

Record

SN03434305-W 20140725/140723234724-0cad467488c3b8e805586997d7009f1d (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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