Friday, August 19, 2011

In India, there is no separate guidance on pregnancy reporting

How will we conclude that the subject is illiterate?
Dr Prakash Atlam

The guidelines don’t use the term illiterate. Their focus is subject’s ability to read and/or write.

Schedule Y treats anyone who is unable to read or write in the same way. See the excerpt below.

If the subject or his/her legally acceptable representative is unable to read/write - an impartial witness should be present during the entire informed consent process who must append his/her signatures to the consent form.

While designing a protocol we found that there are high likely chances of worsening of some of the symptoms. Do we have to wait for these to happen and report it as SAE or in case we define them in the protocol upfront then can we prevent from expediting reporting it as SAE?

Please see suggested guidance from ICH. Exemption from reporting such events would require prior agreement with regulatory authorities.

ICH E3 12.2.2 Display of Adverse Events: All adverse events occurring after initiation of study treatments (including events likely to be related to the underlying disease or likely to represent concomitant illness, unless there is a prior agreement with the regulatory authority to consider specified events as disease related) should be displayed in summary tables (section 14.3.1). The tables should include changes in vital signs and any laboratory changes that were considered serious adverse events or other significant adverse events. In most cases, it will also be useful to identify in such tables "treatment emergent signs and symptoms" (TESS; those not seen at baseline and those that worsened even if present at baseline).