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.

Compensation Research subject in the clinical trial has been old and established practice. Compensation has been  given to the percipients  in clinical trial because of Monetary  benefits are provided for their time and effort for participating in the trial or money is offered as reimbursement for the expenses incurred by them, like travel, loss of daily wages because of  participating in the  trial as well as  provided the insurance in case of medical injuries happened during the study .

Informed consent plays a measure role in the details of the compensation. compensation given to the subject as per the IRB/IEC (Independent Review Board /Independent Ethics Committee ) approved Informed consent from in which all the details of the compensation as per the activity like Blood Loss, Housing, Number of Period in case of Withdraw or Dropped Out, Ambulatory Visit and checkout.

Sarjen Has been Provided the complete solution for the compensation details of the clinical trial participants and complete Audit trail tracking of the compensation like the subject received compensation  for screening and participate  in the study and other reimbursement provided to the subject all the details were maintained in the on e module and it been developed as per the compliance of the different regulatory authorities.

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

Define the Compensation as per IEC/IRB Approved Informed Consent Form

Manage the Compensation Details of Screening Activity and Study Activity

Compensation for Screening as well as Study with predefined approval cycle

Provision for Advance Payment to the Participants

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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