Participants are crucial to the success of your clinical trial. With the right clinical trial data management software, you need quality participants to ensure that you get the right results, which aid in medicinal and therapeutic development. An important consideration in running a clinical trial is compensating clinical trial participates, as this can create a stronger incentive for patients to participate. The compensation is only considered an initiative to participate and not as a benefit that determines the benefits or risks of the trial. IRBs are responsible for overseeing the payment methods and deciding the disbursements’ timing. They’re responsible for ensuring that their payments do not exert undue influence. Let’s look at some other aspects of compensating clinical trial participants.
Compensating Clinical Trial Participants and Reimbursement
Compensation and reimbursements are two different things that shouldn’t be used interchangeably. Compensation involves payment to research participants willing to cooperate in the study. You can consider it a recruitment incentive or a token of appreciation for their time and inconvenience.
Reimbursements are actual costs that are repaid to the subject. These costs are incurred during study participation and include parking, transportation, childcare, etc. Reimbursements require some sort of verification, such as receipt submission.
IRB Review
The main focus of an IRB review should be whether the proposed payment structure has an adverse effect on a participant’s understanding of the risks involved in the study. It should also focus on whether the payment plan might affect the voluntariness of their decision to participate in the trial. These concerns often come to the fore when participants are paid excessive money.
If the research targets participants from a lower socio-economic background, the payment proposal comes under a lot more scrutiny from the IRB. Such payments may be of significant importance for these participants as they would make a financial difference in their lives. Therefore, it comes under IRB review for exerting undue influence.
In saying that, the regulations don’t have a set threshold or definition for compensation limits. IRBs are instructed to review the compensation plans for research, and many have built internal protocols to examine these plans. As a clinical site, you need to provide a robust and foolproof plan for your proposed compensation structure and back it up with evidence and documentation to promptly approve your plan without any hiccups.
Apart from compensation plans, other areas of clinical trials would demand your attention. Most notably, you’d need high-end tech tools to optimize your trials. At the top of your shopping list should be an efficient EDC system that helps you conduct trials efficiently.
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