SUBMITTING A PROTOCOL TO THE COMPLIANCE CORE – What do you need to do?
All research studies utilizing VA resources or facilities or which involve VA patients or staff, including part-time staff; without compensation employees (WOC); fee-basis contract and consultants, must be approved by the R&D Committee and its appropriate subcommittees. No research project may commence prior to final approval by the R&D Committee. These Procedures apply to all research projects regardless of funding source.
All initial submission documents and IRB approvals must be submitted to the Research Office, room E584-1 and signed in on the clipboard or mailed to Regina Trent (151B). Refer to the memorandum for Meeting Dates and Submission Deadlines.
NOTE: It is the Investigator’s responsibility to submit the protocol to the Health Science Center IRB (IRB-01 at UF). Modifications requested by the IRB must be submitted to the Compliance Core for review, and vice versa. If you have questions, please contact Regina Trent, 376-1611 x. 4982. Forms and instructions can be accessed on the web at IRB under the heading “Other Offices – HURRC, IBC, VA”
Please submit to the UF-IRB-01 first. Once you have IRB approval, then submit the following items to the Compliance Core:
Submission Document Checklist
Please submit 1 COMPLETE paper copy (including signatures) and 1 COMPLETE electronic copy of the following: (Submit electronic documents in Word and Excel format. Only Protocols will be accepted as PDF documents.)
If this is your FIRST submission to the Compliance Core you must complete:
Informed Consent(If already IRB approved, submit copies of the stamped approved informed consent and the signed IRB approval letter.) Please see the “Compliance Core Checklist” for required details and items in Informed Consent and Introductory Questionnaire.
Adequacy of Resources – To verify the availability of resources to safely conduct your research at the North Florida/South Georgia Veterans Health System, this form must be completed, signed and included will all Full Board and Expedited protocols submitted to the Compliance Core for review regardless of funding source or administration. Please provide letters of support from the Service Chief for resource utilization of VA departments or sections other than your own (radiology, laboratory, etc.).
Data Security Checklist and PI Certification: This is a VHA Mandate as per memorandum dated February 6, 2007 by the Deputy Under Secretary of Health. The complete ORD Directive can be reviewed on the ORD website. The Memorandum and Data Security Forms can be found in the “Forms” section of the Compliance Web site main page.
Abstract – Also, PLEASE include an electronic copy of the abstract with your study submission to Regina Trent. No study may be initiated without an Abstract.
For studies using Investigational Drugs, also include: (Submit each of the following electronic documents in Word or PDF format with your study submission.)
VA Form 10-9012. Please submit a workable electronic copy of the 10-9012 to Matthew Morrow prior to the submission of your study. Mr. Morrow will review the form for completeness and correctness and return the electronic copy to you. You must submit the complete, correct 10-9012 with an original PI signature along with the submission of your study. (See instructions)
*All submissions for Human Subjects protocols involving investigational drugs requiring IND # need to include copies of the FDA 1572 form submitted to the FDA for the trial. Please remember that the VA must also be copied on the amended FDA 1572 forms. The Investigational Drug Service will refuse to fill all orders/prescriptions for study drug if FDA 1572 has not been submitted. Submission of the FDA 1572 is required by the FDA and the VA, and is necessary in order for us to remain in compliance with federal regulations governing research studies involving human subjects. All investigational drugs administered or prescribed for patients and/or non-patient volunteers within the confines of the Department of Veterans Affairs Medical Center must be dispensed by the VA Pharmacy Service.
For studies using Investigational Devices, also include: (Submit each of the following electronic documents in Word or PDF format with your study submission.)
ALL New Studies must be submitted to the Safety Committee
1.
If you have answered “yes” to Question 3a, 3c, 3e, 3f, 3j and/or 3K of the Introductory Questionnaire, you must contact the Safety Committee Secretary Darion Glover ext. 6481 to discuss the the completion of the Research Protocol Safety Survey and subsequent review by the Subcommittee for Research Safety. Hand written submissions of the Safety Survey will not be accepted. Please do not submit Research Protocol Safety Surveys to Regina, submit one paper copy and one elctronic copy of your study submission to *Darion Glover.
Radiation, Radioactive Materials, Biological Specimens, Gene Therapy or Genetic Testing:
2.
If you have answered “yes” to Questions 3e of the Introductory Questionnaire, you must submit two additional paper copies of your study submission to the Compliance Core for approval by the Radiation Safety Committee.
Training:
Please make sure that all of the following Training has been completed. If the listed trainings have not been completed or are not up to date, this will cause a delay in your new study being approved.
VA Human Subjects Protection and Good Clinical Practices
**Please select Gainesville – 573 for the Institution.
Other Required Documents:
In addition to the above training, all non-M.D. members of the research team including the principal investigator, co-investigator, sub-investigators, study coordinators, and research assistants (including WOC’s who perform independent clinical activities) must provide:
For more information about training, contact Elizabeth Newkirk at extension 4204, Room E556-1.
WOC Employment:
Prior to conducting research in any capacity at the VA, any research support staff member who is not VA-compensated must be completely processed as a VA-WOC (Without Compensation)) by contacting the Research Service Program Support Assistant at ext. 4204, Room E-579-1.
Electronic Medical Record (CPRS) Entry of Research Participation for VA subjects:
The purpose of CPRS documentation is to make pertinent research information readily available to providers and to comply with mandated Federal standards. The electronic document eliminates the need to file the Informed Consent in the subject’s paper medical record. The template must be added to CPRS on the date that the subject signs the informed consent. Study drugs will not be dispensed until the consent is in the subject’s CPRS record. It is very important that you check to make sure that the patient is not already on another study by looking at the patient’s clinical notes for any research titles, also checking for future and past appointments in Research. Some studies prohibit dual enrollment and all VA Cooperative studies prohibit dual enrollment unless pre-approved by the respective Co-op office. If the patient has past or future appointments in Research please contact the study coordinator to determine if the patient is allowed to participate in an additional study. It is the responsibility of the research coordinator to prevent dual enrollment. Investigators and Research Coordinators must have VA computer access to enter research information for VA subjects in the electronic medical record (CPRS). If you have not previously received access, please complete the CPRS Access form and return it to Elizabeth Newkirk, ext. 4204. New VA and WOC employees receive their initial VISTA access when processed, if you do not have VISTA access contact IRM (ext.6901). If you have CPRS Access, but cannot access the Research Consent Progress Note, please contact Elizabeth Matheny, ext. 4946.
VA Research & Development Committee (R&D) Approval:
R&D Committee approval is required for all human subject research protocols conducted at the VA or utilizing VA resources. R&D Committee approval is contingent upon prior approval by the Scientific Projects Committee (SPC) through the Compliance Core and Health Science Center IRB and evidence of appropriate grants administration. SPC and IRB approved protocols are reviewed at monthly R&D meetings. Research may begin following R&D Committee approval and completion of all training and staff clearance. A VA approval form (form 10-1223) will be sent to you in addition to a letter from the ACOS/R as confirmation of VA Research and Development Committee approval.
NOTE: VHA Directive 2001-028 states that children can not be included in VA-approved research conducted by VA investigators while on duty or conducted at VA facilities or approved off-site locations unless a waiver has been granted by the Chief Research and Development Officer (CRADO). Please contact the Research Office for details.
* VA is committed to protecting your privacy - please review our Privacy Policy.
In particular, please note that e-mail communication may not be secure against interception across the Internet. Please do not include sensitive information such as medical records or financial information, drug prescriptions, or your social security number.
