Final answer:
The ICH E6 Section 4.3.3 advises that an investigator should notify the subject's primary physician about their participation in a clinical trial, provided the subject consents to this communication. This is important to ensure the subject's safety and proper coordination of care.
Step-by-step explanation:
The question pertains to the ICH (International Conference on Harmonisation) E6 Section 4.3.3 guidance, which outlines the responsibilities of investigators in clinical trials. Specifically, the guidance advises that an investigator should notify the subject's primary physician about the subject's participation in the trial, assuming the subject has given permission for this communication. This communication is important for the safety of the subject, as the primary physician should be aware of the potential risks and benefits associated with the clinical trial, and possibly the subject's new medication or therapy.
This ensures ongoing coordination of care and takes into consideration any existing treatments. If the subject's clinical trial participation has potential implications for their medical care, the primary physician may need to adjust treatment plans accordingly.