Follow us on

Q of the week

Q: Define Individual Case Safety Reports??

Get the Answer: 

Confirmatory trials
The purpose of these trials is to obtain sufficient evidence about the efficacy and safety of the drug in a larger number of patients, generally in comparison with a standard drug and/or a placebo as appropriate. These trials may be carried out by clinicians in the concerned therapeutic areas, having facilities appropriate to the protocol. If the drug is already approved/marketed in other countries, phase III data should generally be obtained on at least 100 patients distributed over 3-4 centres primarily to confirm the efficacy and safety of the drug, in Indian patients when used as recommended in the product monograph for the claims made.

Use of GCP HelpDesk’s resources

Copyright notice
All documents and information on the GCP Helpdesk website are protected under intellectual property law, in particular by copyright.

The documents and information are available free of charge for public information only.

Reproduction and distribution of documents or information in whatever form and by whatever medium (including Internet) is authorized, except for commercial purposes, provided that their source is acknowledged by mentioning:
· GCP HelpDesk
· the URL
· the fact that the documents and information have been provided free of charge by the GCP HelpDesk.

However, prior permission of GCP HelpDesk is needed for any adaptation or translation of the documents or information.

Links to the pages on this site are permitted provided that the browser window does not contain any information other than that of the page of the present site to which the link is made and its address and none of the information provided on this site is modified.


Opinion Poll

Which one of the following do you think is the most common reason for participating in clinical trials?
This opinion poll provides an informal way for the clinical research community to express its views on current topics. The results are not a scientific poll and do not necessarily reflect the percentages of all clinical researchers who agree with these positions.