What do you think of the fact that the ICH has a guidance on GCP but not GLP?
. In section 4.3.4 of the ICH E6 guidance, it states that a patient involved in a clinical trial is not required to give a reason for withdrawing from the trial but that the investigator should make a “reasonable effort” to ascertain the reason. What do you think qualifies as a “reasonable effort,” and is it ever necessary for a patient to give a reason for withdrawing from a trial?
2. What do you think of the fact that the ICH has a guidance on GCP but not GLP?
3. From your perspective, is it necessary for the ICH to develop its own GLP guidance? Why?