Clinical trials may offer subject compensation in the form of a fixed sum paid to the research subject for their participation (stipent), or as reimbursement for expenses incurred as part of their participation (such as parking, gas, hotels). It is important to follow proper procedure when working with clinical trials that provide compensation to ensure compliance.
Incorporating Subject Compensation and Reimbursement Information into Study Documents
When subject compensation or reimbursement is offered you will need to ensure this information is documented in the applicable study documents.
Informed Consent Form (ICF): The ICF must include the following information in the “Payment for Participation” section:
- the type of compensation or reimbursement being offered such as a per visit stipend or reimbursement for travel, gas, etc.
- the amount, frequency and method of payment, such as ClinCard, check or gift card. It is important to include the amount of time it will take to process payments.
- when the payment or reimbursement will be made, such as at study completion or when using ClinCard, within two business days of study visit.
- if subjects are offered travel reimbursement, any stipulations placed on the reimbursement should be included, such as a specific distance from the medical center.
Study budget and clinical trial agreement (CTA): Subject compensation or reimbursement (and associated fees) must be incorporated into the study budget and CTA. This information must be consistent with the information outlined in the ICF.
Processing and Distribution of Subject Compensation and Reimbursement
Reimbursements are processed after receiving supporting documentation, i.e. receipts, credit card statements and invoices, provided by the research subject. If utilizing ClinCard in your compensation efforts, please upload these receipts to the ClinCard system and keep originals on file.
It is the responsibility of the study team to ensure study compensation is issued in a timely manner and according to the language in the approved study documents.
If the subject reimbursement is an item included in the study budget, an invoice along with the applicable supporting documentation must be sent to the sponsor for processing.
When utilizing ClinCards or gift cards, it is important to create a tracking log to ensure that all necessary stipends and reimbursements have been paid to the subjects. The subject and the person responsible for distributing the payment should sign this sheet.
And to get started with ClinCard, we have made the following training materials available for your review: ClinCard administration demonstration video (click the image below to watch the video) and ClinCard administration demonstration printed instructions to follow along with the video. If you have any questions about initiating ClinCard on your project please contact ClinCard@med.cornell.edu. Additional information is provided in the ClinCard SOP in the Researcher’s Toolbox under Training and Education Tools and Templates.