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CDSCO rules for SAE do not differentiate between trials, study

Dr arun Bhatt
Wednesday, August 3, 2016, 08:00 Hrs  [IST]

What are the requirements, roles and responsibilities of medical monitor?

There is no regulatory guidance on medical monitoring. FDA BIMO Compliance Programme Guidance Manual for sponsors, CROs and monitors mentions that the medical monitor (MM) may have the responsibility for medical aspects of the study and may be a physician.
The MM is responsible for review of medical aspects of the study protocol – selection criteria, end points, safety - adverse events and lab data, etc.

The MM can review the review of selection criteria for subjects selected at sites and assist them in proper enrolment process. The MM assess serious adverse event (SAE) for clarity and completeness and coordinates regulatory reporting of SAEs. The MM reviews codes for disease conditions, and concomitant medications in the patient database.
In case of a change in consent form, how can we recruit new subjects till we receive EC approval?
NIsarg Patel

If there is any amendment in ICF, you have to obtain EC approval, before the ICF can be used. No new subjects can be recruited till ICF is under review by EC. New subjects can be recruited only after EC has given approval to the amended ICF.

Also, the ongoing patients have to be called and informed about any change which can impact their continuing participation. If the patient is willing to continue participation, this information should be documented in source notes and the patients should be asked to sign and date this consent.

Please advise whether the sponsor of a BE study required to report the SAEs as well as the AEs observed during the BE study to the CDSCO authorities? If subject has been admitted to hospital for less than 24 hours for diagnosis/monitoring of AE to understand whether it is drug induced or not. Are we required to report such an event SAE to the CDSCO?
Yuvraj chopra

The CDSCO guidelines/rules for reporting serious adverse event do not differentiate between clinical trials and BE study.

As per Rule 122-DAB - Compensation in case of injury or death during clinical trial, the definition of SAE is as follows:
A serious adverse event is an untoward medical occurrence during clinical trial that is associated with
•    Death,
•    In patient hospitalization (in case the study was being conducted on out-    patient),
•    Prolongation of hospitalization (in case the study was being conducted on in-patient),
•    Persistent or significant disability or incapacity,
•    A congenital anomaly or birth defect or is otherwise life threatening.
Also, the rule considers relationship to SAE to clinical trial and not causality to drug. CDSCO definition does not define duration of hospitalization. Hence, if the subject was admitted to hospital for any purpose – diagnosis/monitoring, it would be considered an SAE. This should be reported to CDSCO in 24 hours with a follow-up within 14 calendar days.
AEs have to be recorded and described in the study report.

Is it mandatory to obtain audio visual consent from all patients or only from vulnerable group? Are there any recent amendments to this?
Dr Sreevatsa

As per the Gazette notification Jul 2015,
•    An audio visual recording of the IC process in case of vulnerable subjects in clinical of new chemical entity or new molecular entity including procedure of providing information to the subject and understanding of his consent shall be maintained by investigator for record.
•    For anti-HIV and anti-leprosy only audio recording to be maintained.

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


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