Patient Compensation

For many clinical trials, the enrollees may receive compensation for their participation – money or reimbursement of expenditure. For a study, the compensation may be activity-wise depending on their participation for all or limited number of activities. And, it can be decided in the Protocol even before the study begins that compensation be for entire study or activity-wise. Compensation is also subject to audit and review by Ethics Committee and/or Regulatory bodies.

Voluntary Informed consent plays a vital role in financial compensation which emphasizes the elimination of coercive nature and undue advantage and influence for the said study.

Keeping in mind the complexity of studies – right from volunteer enrolment, them competent enough for the study, also, completing the entire study and so many other challenges; over and above maintaining good practices throughout, Sarjen has included the compensation module designed such that compliance is not compromised.

Features:

Secure, audit-trailed, with different payment options

Fully compliant – Part 11, OHRP (informed consent and payment disbursement), and Others (example, US FDA’s payment disbursal activity-wise and participants may not finish the study to receive payment. EUPATI’s standard that participants may be compensated for participation, reimbursed for certain costs. Govt. of India’s managing and compensating medical injuries/death in clinical trials without getting participants being lured into studies without proper knowledge.)

Can define Compensation in Protocols – may vary for each protocol

Compensation for Screening as well as Study with predefined approval cycle

Activity-wise payment + provision for additional compensation, if any

Biometric driven compensation for additional security and assurance

Integrated with Finance/Accounts department

MIS reports, Handy Dashboard available for analytics

Regulatory compliant, multi-functional Clinical trials management software solution for CROs

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