This section describes best practices for screening potential research subjects and the steps involved in the subject enrollment process.
Best Practices for Screening and Enrolling Research Subjects
Step 1: Identifying a Potential Subject
Once a potential research subject is identified, the first step is to obtain informed consent and a signed HIPPA research authorization. Informed consent must be obtained prior to the initiation of any study specific screening procedures. It is important to ensure that the subject has signed the most recent version of all documents and that all other parties have properly signed and dated the Informed Consent Form (ICF). The investigator or person obtaining informed consent should document the informed consent process in the subject’s medical record in accordance with Good Clinical Practice guidelines and WCM IRB policy.
Step 2: Screening
During the screening process, study specific procedures may be required. In order to schedule these procedures the subject’s study enrollment information must be available in Epic. The process to centrally register a subject is completed through the JIRA system. Step by step instructions for this process can be found in the Sidebar on this page.
Enrollment data entered in JIRA will be processed by the JCTO within two hours of submission. The subject enrollment will automatically become available in Epic after the registration is completed. This is the mechanism by which enrollment data flows through the Clinical Research Enrollment and Study Tracking System (CREST). Therefore, it is important to complete this process as soon as the subject has provided informed consent so that the visit can be linked to the study in Epic.
If required, register the subject with the sponsor as “in screening” per the protocol.
Step 3: Eligibility Review
Part of the screening process is verification of subject eligibility. The eligibility checklist is a useful tool to assist in the eligibility review process.
While reviewing eligibility, ensure the electronic medical record (EMR) contains documentation verifying all eligibility criteria. For guidance on source creation please visit EMR and Source Documentation. The person determining eligibility must indicate that the research subject is either eligible for enrollment or a screen failure and must sign and date the checklist. If the subject is determined to be a screen failure, a JIRA ticket should be created to remove the subject from the study. Step by step instructions for the disenrollment process can be found in the Sidebar on this page. If the person determining eligibility is a designee of the PI, the PI should also sign and date the eligibility checklist.
Step 4: Complete Sponsor Specific Enrollment
Industry sponsors, foundations, and academic medical centers generally require a centralized subject enrollment process. This process should be completed per the study protocol as applicable.
Step 5: Notify Pharmacy of Subject Enrollment
Orders for investigational drug should be sent to the pharmacy using the listservs below. A copy of the first and last page of the signed informed consent form is also required.
Step 6: Institutional Disenrollment Process
After a subject has completed participation in a research study, the subject should be removed from the study using the JIRA disenrollment process. Step by step instructions for this process can be found in the Sidebar on this page. Subjects should only be disenrolled when there are no longer billable services.
How to Identify a Research Subject in Epic
- You can view all research studies a patient has been enrolled on in the Research Studies tab.
- A red “R” appears in the heading for each individual enrolled on a research study. This “R” will remain part of the record forever.
- A pink beaker will appear on the physician schedule for subjects who have an active LAR
- A blue beaker will appear in the chart review section for each visit that has been “linked” to the research study.
- Subjects should only be removed when there are no longer “billable” events occurring on the research study.