Instructions for completing lab forms for research studies being done at the VA ECHCS

  1. Complete the “Pathology and Laboratory Medicine Service Approval for Research at ECHSC, Denver” (this is called the Pathology Lab Approval form on the COMIRB website under Download Forms).
  1. If all of the study labs are considered SOC (standard of care), please write “There are no research labs for this study” at the top of the form described under #1. Please read the instructions on this form for how to handle SOC labs. You must still include the following information on this form:
  1. COMIRB #
  2. Principal Investigator Name
  3. Have the PI sign the bottom of the form
  4. Answer questions #1 & #2 on the form
  1. If there are research labs to be done for your study, you must complete the following information:
  1. COMIRB #
  2. Principal Investigator Name
  3. Answer questions #1 and #2 on the form
  4. Include a billing contact person name, address and phone number for the lab to send a bill for the research labs
  5. Have the principal investigator sign the bottom of the form.
  1. The following items must be submitted to the VA Laboratory Service for approval to conduct your study at the VA:
  1. Research Impact Statement
  2. Completed “Pathology and Laboratory Medicine Service Approval for Research at ECHSC, Denver” form
  3. Copy of the Protocol Summary with a “sticky note” identifying the study calendar and required labs for the studyand a number to call when the signed form is ready for pickup.
  1. You are strongly encouraged to check with Shirley Nelson to be sure the VA includes all of your required lab tests and considers them SOC prior to submitting your Research Impact Statement and to obtain prices for any research labs you are having done. For example, many studies require a BUN with a creatinine, however, the VA Lab Service does NOT include the BUN as a SOC, therefore it must be ordered on the ”Research Laboratory Testing” form on colored paper (this is called the “Generic Research Lab Testing Form” on the COMIRB website under Download Forms).
  1. When requesting research lab tests for VA subjects, you must use the form titled “Research Laboratory Testing” on PINKpaper. This form must be sent to the lab with any blood being done as research for your study.
  1. Standard of care labs should be entered into CPRS. It is imperative that research labs are not entered into CPRS to avoid charges of billing fraud.
  1. Please read the instructions on the “Pathology and Laboratory Medicine Service Approval for Research at ECHSC, Denver “ prior to requesting both SOC labs and research labs for VA subjects.
  1. If you have questions regarding any process related to performing labs at the VA ECHCS, please contact Shirley Nelson at (303) 399-8020 x 2710.
  1. I have attached examples of each form to these instructions.
  1. Please remember that the PI is responsible for ensuring that this process is done correctly.