Bioequivalence and Bioavailability Forum • Informed Consent and Adverse events

Informed Consent and Adverse events [GxP / QC / QA]

posted by yogesh1004 – India, 2012-10-09 08:36 (4999 d 06:33 ago) – Posting: # 9345
Views: 6,856

Dear All,

When a Informed consent is designed for single dose two way crossover BABE study, is it necessary to document all the adverse events described in the label?

As the label will have the adverse events observed in the clinical studies (in patients, adverse events observed in combination studies and also the adverse events observed in multiple dose studies.

Is it is also necessary to document the adverse events reported for that molecule as mentioned in the label in Protocol and Informed consent form?

Or is it is sufficient to write the adverse events observed with out the study details and percentages.

recently FDA issued an 483 in this aspect to one of the CRO.

Please guide me in this regard.

Regards,

S.Yogesh

Edit: Category changed. [Helmut]

Complete thread:

Informed Consent and Adverse eventsyogesh1004 2012-10-09 06:36
- Informed Consent and Adverse events cakhatri 2012-10-09 07:38
  - Informed Consent and Adverse events yogesh1004 2012-10-10 06:29
- Informed Consent and Adverse events drgunasakaran1 2012-10-09 20:24
  - Informed Consent and Adverse events yogesh1004 2012-10-10 06:30