E6: Medical Care of Trial Subjects

Question 1

Medical Care of Trial Subjects

4.3.2

Answer 1

During and following a subject’s participation in a trial, the investigator/institution should ensure that adequate medical care is provided to a subject for any adverse events, including clinically significant laboratory values, related to the trial. The investigator/institution should inform a subject when medical care is needed for intercurrent illness(es) of which the investigator becomes aware.

Question 1

Medical Care of Trial Subjects

4.3.1

Answer 1

A qualified physician (or dentist, when appropriate), who is an investigator or a sub-investigator for the trial, should be responsible for all trial-related medical (or dental) decisions.

Question 2

Medical Care of Trial Subjects

4.3.3

Answer 2

It is recommended that the investigator inform the subject’s primary physician about the subject’s participation in the trial if the subject has a primary physician and if the subject agrees to the primary physician being informed.

Question 3

Medical Care of Trial Subjects

4.3.4

Answer 3

Although a subject is not obliged to give his/her reason(s) for withdrawing prematurely from a trial, the investigator should make a reasonable effort to ascertain the reason(s), while fully respecting the subject’s rights.