Q. In one of the BA/BE study, during the course of the study a subject was suffering from PILES for which he was operated on an outpatient basis. Will this qualify as an SAE?
● Bhumi Vyas

As the adverse event was reported after the administration of drug, and the subject was hospitalized this becomes an SAE. In this case the issue is how does one define hospitalization. Although the subject was operated on an outpatient basis, you need to find out how long was the subject in the hospital.

Common usage of "inpatient hospitalization" generally would include being treated by a physician in a hospital for at least a 24-hour period.

However, it is desirable to consult the study protocol, as sponsors may define specific terms in the context of the study, and provide criteria that would control whether other events should also be reported (e.g., an unscheduled office visit that results in administration of intravenous fluids; any emergency room visit lasting over four hours).

Q. Is it necessary for an investigator and sub-investigator in BA/BE study to have documented training in GCP?
● Anand Asam

GCP training is a must for the whole team. Relevant sections of ICH are cited below:

2.8 Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s).

ICH 4.1.3 The investigator should be aware of, and should comply with, GCP and the applicable regulatory requirements

4.2.4 The investigator should ensure that all persons assisting with the trial are adequately informed about the protocol, the investigational product(s), and their trial-related duties and functions.

Q. If I conduct a clinical trial for US FDA submission in India, I need to fill FDA 1572 and financial disclosure form. But my confusion is that before conducting a clinical trial in India, do I need to fill and submit investigator undertaking to DCGI?
● Atul Patel

Investigator undertaking is an Indian regulatory requirement for obtaining clinical trial permission. . Hence, you need to submit this to obtain clinical trial permission. Besides, as per GCP, all trials should be in compliance with protocol, GCP, SOPs and applicable regulatory requirements. In this case, applicable requirements refer to US FDA and Indian regulations.

Q. We have a novel device for delivery of medicines in the eye. We have entered into an agreement with Indian investigators to supply them with the device for their use in an investigator initiated study. The device is 510K-able in the U.S., so we can ship the device, providing we are not violating any Indian laws. Please advise us about laws governing import of these devices into India.
● Laretha Harris Randolph

CDSCO has issued new guidelines in Mar 2006 for import and manufacture of devices. We do not have separate rules for import of devices for clinical trials. As the device is for delivery of medicines in eye, this seems to be drug-device combination. Hence, all regulations for a drug trial will apply. I feel that you need to obtain regulatory clearance of protocol and import licence before you ship the devices to India.


Q. Do we need EC approval for post marketing trials (for the approved as well as unapproved indication)?
● Kannan M Narayana

All clinical trials, whether pre or post marketing trials require EC approval.

Q. Do we need EC for retrospective medical record reviews?
● Kannan M Narayana

AIt would be advisable to obtain approval of the head of your institution.