It is the policy of Atlanta VA Clinical Studies Center (CSC) that ALL research projects involving contact with human subjects must have a "Research Clinic" in the VISTA computer system. The guidelines and procedures described in this SOP must be followed to develop a Research Clinic.

• To capture workload performed for research purposes
• To distinguish research visits from standard medical care
• To give Research Eligibility to participant subjects in research studies
• To prevent and avoid research subjects from being billed for visits tests and/or procedures performed for research purposes
• To link documentation of each research subject visit to the specific Research Clinic created for the specific research project
• To ensure that documentation of the research visits done in the patient's medical record is performed and supported by the appropriate CPT/ICD-9 codes

Compliance must be maintained whereby providers only report codes, following official coding & documentation guidelines, based on their licensure, scope of practice and appropriateness of the service provided.

Human research studies performed at the Atlanta VA Medical Center that have been approved by both the Emory Investigational Review Board (IRB) and the R&D Committee should have a Research Clinic created in VISTA. This is particularly important whenever ancillary services are involved in the conduct of the study. The Principal Investigator and/or research coordinator/associate is responsible for initiating the process to create a new Research Clinic. Research Clinics are initiated through the Clinical Studies Center.

The following must be done:

• Complete and sign a Clinic Profile Form
• Complete New Research Clinics Information Form
• Complete an Encounter Form with the appropriate CPT and ICD-9-CM coding
• Obtain access to appointment management menu in VISTA

Each time a new research subject is enrolled, Sandy Cooper or Cheryl Wills, from the business office should be contacted.

Provide the following information: For veterans participants, if the research subject has VA eligibility at the Atlanta VA Medical Center provide his/her name, social security number, and research study title (same as research clinic name), including date of enrollment. For non-veteran research participants, provide name, date of birth, social security number, address (including county), telephone number, next of kin, religious preference, and research study title (same as research clinic name) including date of enrollment. When all activities in the study are finished and follow up for the study is completed, the research coordinator is responsible for notifying Sandy Cooper or Cheryl Wills for deactivation of the Clinic. It is important that when a study subject completes his participation in the study that the coordinator notifies the business office.

• David Worley, Administrative Assistant, Clinical Studies Center, 404-321-6111 ext. 4934.
• Marybeth Wash, Director of Clinical Studies Center, 404-321-6111 ext. 6933.
• Sandy Cooper, Business Office, 404-321-6111 ext. 6206
• Cheryl Wills, Business Office, 404-321-6111 ext. 7674
• Donndra Hall, Computerized Patient Record System (CPRS) training, 404-321-6111 ext. 2964