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Stage
Conduct and Oversee Project
Topic
Manage research participants
Subtopic

Participant management and payment

Need assistance with participant management and payment?

Managing participant activities in a research study is an important aspect of quality study conduct.  Activities that should be managed and documented, both electronically and on paper, start at the time of identification and recruitment, through consent and study visits, and all the way up until the time each participant is paid for their participation.

Guidance for Campus IRB research protocols

Research participant management

There is currently no system required to track research participant activities for campus IRB protocols.  However, research personnel are encouraged to follow best practices for recording a participant’s activity throughout the study.  This includes tracking the following dates and activities in a secure electronic location, such as REDCap:

  • Participant unique identifier
  • Recruitment and/or screening date
  • Date of informed consent
  • Planned and completed visit dates
  • Participant reports of unexpected or adverse events
  • Information related to payment
Compensating research participants

Though researchers are not required to provide payment for participation, compensation may be incorporated in studies as an incentive to participate. These incentives can be monetary or non-monetary, but must comply with institutional guidelines for participant compensation. Access the Campus IRB guidance for compensation options and regulations.

Guidance for DUHS IRB research protocols

Recording and tracking key activities and dates helps ensure that participants are engaging in the research, according to protocol.
Identify participant; screen participant; consent participant; complete study visit; document activities, AES; Payment
OnCore tip sheets

OnCore is the Clinical Research Management System (CRMS) utilized by all research DUHS IRB protocols at Duke for study management, enrollment tracking, and billing. 

Questions about OnCore can be directed to the OnCore team at OnCore@duke.edu. 

Maestro Care tip sheets

Researchers involving Duke Health patients in their projects will use Maestro Care for participant management activities. This can include linking research appointments to the study timeline, releasing and signing orders, etc.

eReg tip sheets

eReg is an electronic regulatory binder developed by Advarra Research Systems that interfaces with OnCore. eReg is a Part 11 compliant, electronic Regulatory Management System that allows regulatory coordinators to store protocol documents, track staff credentials and organizational regulatory documents, and share those documents between protocols. Staff can also manage INDs, SOPs, and subject-related documents within the system. eReg also allows for remote monitoring.

Compensating research participants

Though researchers are not required to provide payment for participation, compensation may be incorporated in studies as an incentive to participate. These incentives can be monetary or non-monetary, but must comply with institutional guidelines for participant compensation.

There are five approved methods of participant payment for all Duke University and Duke University Health System research protocols (the preferred method of payment for DUHS IRB protocols is ClinCard, although the other approved methods are allowable):

  1. Duke ClinCard (primary and preferred method)
  2. Duke check (preferred alternate method)
  3. Cash
  4. Gift card purchased with the Duke Corporate Card (contingent upon prior approval from Employee Travel & Reimbursement)
  5. Non-monetary item purchased with the Duke Corporate Card 

More information at: Duke Financial Services guidance on participant payment