REIMBURSEMENT
Purpose
This SOP describes the procedures involved in reimbursement to the study subject for their involvement in the research and research-related activities as agreed in CTA and mentioned in ICF.
Scope
This SOP applies to all study team members who are engaged in study-related activities and delegated in the delegation log for research-related reimbursement (if applicable) to all subjects who participated in the studies being conducted on site.
Procedure
Information regarding reimbursement
Subjects may be paid for the inconvenience and time present. and should be reimbursed for expenses incur red. in connection with their participation in research. They may also receive free medical services. However. payments should not be so large or the medical services so extensive as to induce prospective subjects to consent to participate in research against their better judgment (inducement). All payments, reimbursement, and medical services to be provided to research subjects should be approved by the IEC. Care should be taken:
o When a guardian is asked to give consent on behalf of an incompetent person, no remuneration should be ordered except around of out of pocket expenses:
o When a subject is withdrawn from research for medical reasons related to the study the subject should get the benefit for full participation;
o When a subject withdraws for any other reasons he/she should be paid 111 proportion to the amount of participation.
o Reimbursement must be done as agreed by the investigator and sponsor /CRO in the Clinical Trial Agreement (CTA) and as defined in the Informed consent document.
Procedure for reimbursement
CTC as designated will reimburse the amount to the patient as mentioned below:
o Should open a particular study account in the SITE accounts department and maintain the account ' number. Always deposit the cheque in the same account received by the sponsor /CRO.
o Keep a track of patient's visits as mentioned in the protocol, travel, and concomitant medication prescribed for adverse events (if any). and if any unscheduled visit is scheduled during the study period for reimbursement.
o Must reimburse travel cost. upon presentation of a receipt of a valid ticket (if available or as agreed in the CTA) or bills of the protocol specified visits or unscheduled visits if any.
o Must collect the original bills from the patient for the above-listed things for reimbursement
o Payment voucher must be prepared for the same; it will include the patient's hospital case number, name, amount to be paid, study account number, and reason for reimbursement.
o Investigator or designee will approve and sign the voucher. The patient will sign or put his/her thumb impression in case patient is illiterate on the copy of the voucher (patient will sign/ thumb while submitting the voucher to the accounts department):
o Copy of signed voucher (by investigator/designee and subject) and bills should be filed in a
separate tile.
o Original voucher and bills will be forwarded to the concerned authority as per the hospital policy for approval.
o The voucher and bills will be forwarded to the accounts department of the SITE.
o The competent authority from the accounts department will sanction and release the amount.
In case of a Serious Adverse Event (SAE) that is found to be related to the IP, Pl/ Co I will make sure that subject should get reimbursed for every expense that occurred during the management of the adverse event.
CTC will always keep a copy of the updated account statement to make sure the account has sufficient
balance for reimbursement.
CTC should send the expense invoices to the sponsor at regular intervals, to receive the amount on time.
Applicable Staff
This SOP applies to all the existing personnel or the clinical research team and any new member appointed who may be responsible for reimbursing the study subject as mentioned in this SOP (as per the delegation log).
These include the following:
• Investigator
• CTC
• Research Team (listed in the delegation log)
END OF THE DOCUMENT
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