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Documents on e-TMF should remain complete and legible

Wednesday, June 30, 2021, 08:00 Hrs  [IST]

A sponsor is willing to offer only travel compensation for participation in a clinical trial. But the sponsor refuses to cover other expenses. Is there any guidance on compensation for participation in a clinical trial?
Dr Ramesh Varaiya

As per New Drugs and Clinical Trials Rules 2019, “Good Clinical Practices Guidelines” means the Good Clinical Practices Guidelines for conduct of clinical studies in India, formulated by the Central Drugs Standard Control Organisation and adopted by the Drugs Technical Advisory Board.

If the study is academic, it would be considered biomedical and health research. As per New Drugs and Clinical Trials Rules 2019 any biomedical and health research shall be conducted in accordance with the National Ethical Guidelines for Biomedical and Health Research Involving Human Participants as may be specified by the Indian Council of Medical Research from time to time.

Indian GCP and ICMR Guidelines recommend as follows:

Indian GCP compensation for participation
Subjects may be paid for the inconvenience and time present, and should be reimbursed for expenses incurred, in connection with their participation in research. They may also receive free medical services.

ICMR 2017 payment for participation
If applicable, participants may be reimbursed for expenses incurred relating to their participation in research, such as travel related expenses. Participants may also be paid for inconvenience incurred, time spent and other incidental expenses in either cash or kind or both as deemed necessary (for example, loss of wages and food supplies).
The sponsor should comply with the above guidelines and agree to reimbursement of all expenses incurred in connection with their participation in research.

Is it necessary for investigator to contact sponsor staff before unblinding?
Dr Mohan Subrahmanyam

As per GCP guidelines, the investigator is responsible for the medical care of the individual trial participant. This includes medical decisions such as whether to start or stop treatment or institute alternative treatment if required. In emergency situations the investigator may need to break the treatment code immediately, or as quickly as possible if he/she finds it is in the best interest of the trial participant. Hence, the investigator should  have unrestricted and immediate access to break the treatment code.
Sometimes the sponsor’s code breaking system requires that only after discussion with the representative, the investigator receives information that unblinds the treatment. The guidelines require that the responsibility to break the treatment code in emergency situations resides solely with the investigator. So, the sponsor cannot  insist on being involved in the decision to unblind, stall or delay in any way the unblinding of trial subject treatment in emergency situations. The investigator should have direct access to Interactive Voice Response System in order to break the blind without the interference of the sponsor in any way.

What are the expectations of regulatory inspectors for electronic trial master file (e-TMF)?
Reshma Sharma

Regulatory inspectors expect the e-TMF to meet following attributes:
e-TMF should allow review in an efficient manner, similar to that possible with paper TMFs.

Access to e-TMF should permit efficient, straightforward navigation and opening of documents permitting searching and browsing.

Regulatory inspectors should have direct access to the documents in the e-TMF.

Documents in an e-TMF should be evidently authentic, complete, and legible copies of the original documents.

The e-TMF system should have validated methods for preventing any changes being made to the TMF documents.

The process for transferring original TMF documents to e-TMF should be robust and have been validated to prevent failure of transfer the entire content of the original TMF without loss.

Documents on e-TMF should remain complete and legible in all aspects giving information about the way the document was prepared.

Dr Arun Bhatt is a Consultant - Clinical Research & Development, Mumbai. Readers can send their queries at:arun_dbhatt@hotmail.com


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