If we are using marketed comparator drug from XYZ company in our trial and an SAE occurs with that drug, then do we need to inform XYZ company?
Om
ICH E2A 1. Reactions Associated with Active Comparator or Placebo Treatment
It is the sponsor's responsibility to decide whether active comparator drug reactions should be reported to the other manufacturer and/or directly to appropriate regulatory agencies. Sponsors must report such events to either the manufacturer of the active control or to appropriate regulatory agencies.

What are the guidelines and whom it can be reported if any study sponsors or CRO don’t follow the ICH GCP?
Dr Surendra
5.20.1Noncompliance with the protocol, SOPs, GCP, and/or applicable regulatory requirement(s) by an investigator/institution, or by member(s) of the sponsor's staff should lead to prompt action by the sponsor to secure compliance.
5.20.2

If CRO or sponsor staff does not comply with protocol, SOPs, GCP, and/or applicable regulatory requirement(s), you can complain to their superiors. If CRO is noncompliant, you can complain to the sponsor. If the sponsor is noncompliant, you can complain to regulatory authorities.

In clinical trial, when a condition or event is not considered as an adverse event?
Jaic
ICH GCP 1.2 Adverse Event (AE)

Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product

The crucial text in the definition is "temporally associated with the use of a medicinal (investigational) product:". This means any event
■ that is untoward in nature
■ occurs after the administration of investigational product.
If the event is not untoward or has not occurred after administration of IP, it is not an adverse event.

Is expedited reporting required in India for SAE cases from trial sites in US/other territory?
Dr Muzaffar
There is no explicit mention of SUSARs from other countries in Schedule Y/Indian GCP. However, most sponsors follow international reporting timelines.

What is the role of legally acceptable representative (LAR) and impartial witness in consent process?
Dr. Sunita Vashishtha
■ If the subject is illiterate, than an impartial witness should be present during the consent process and should sign the consent form.
■ If the subject is incapable of giving consent, LAR should sign in place of the subject.
■ If the LAR is illiterate, an impartial witness should be present during the consent process and should sign the consent form.
LAR can serve as an impartial witness. However, in such a case, the person should sign as impartial witness.



Dr Arun Bhatt is currently,president, ClinInvent,Research Pvt Ltd, Mumbai. Readers can send their queries
at: arunbhatt@clininvent.com