The Clinical Trials Office manages and oversees the Participant Payment program and ClinCard application for all clinical trials. Our team works closely with investigators and their teams, the IRB, and OSP to ensure that the Participant Payment Form matches the informed consent, follows the Institutional Handbook of Operating Policies, and is in alignment with the budget associated with industry-sponsored and federally funded studies.
Please see the process flow below that outlines the approval process of the Participant Payment Plan:
- The study team downloads the most current version of the Participant Payment Form (PPF) from the ERMS IRB Library and fills it out, ensuring that it matches what is outlined in the informed consent(s) for the study. Then, the study team will upload the PPF in the documents for the study in ERMS IRB and submit the record.
- The IRB analyst will assign an Ancillary Review to a CTO Participant Payment analyst to review the PPF and an Ancillary Review for the Participant Payment Personnel that have been assigned to fulfill the required roles for the study.
- The CTO analyst will review the PPF and ensure that the groups and payment milestones match what is in the consent form. If it is in alignment, the CTO analyst will approve the Ancillary Review for the PPF. The CTO analyst will also evaluate the Participant Payment Personnel to ensure that the individual listed for each participant payment role has completed the required training. If not, the CTO analyst will assign the training and reach out to the individuals to let them know they need to complete the required training. However, the document is not finalized in the CTO quite yet.
- The CTO analyst will request the PID used to fund the Participant Payments (if applicable). Once received, CTO will route the PPF to obtain the signatures from the investigator, custodian, authorized signatory, OSP (if the PID is from a restricted fund code), and the Dean (if the max per participant is over a certain threshold).
- Once signatures are received, if ClinCard is being utilized, the CTO analyst will build the study in ClinCard and grant access to the applicable Participant Payment Personnel roles that were filled out in ERMS.
- The CTO Analyst will send the final approved PPF to the study team and the Bursar’s Office (if applicable).
If at any time updates or changes need to be made to the PPF or the Participant Payment Personnel roles, a modification will need to be entered in ERMS IRB. The process above will occur again for each modification entered.
Once a study has been closed out or inactivated the study team will need to document this within ERMS IRB. An IRB analyst will assign an Ancillary Review to the CTO. We will inactivate the PPF and close out the study in ClinCard (if applicable). We will send the final report for all payments made to the study team and alert the Bursar’s Office (if applicable) that the study has been closed or inactivated.