According to ICH (2016) Section 4.8.10(n), informed consent must indicate access to what?

Informed consent, as outlined in ICH E6 guidelines, is a crucial element in clinical trials to ensure that participants understand their rights and the nature of their involvement in the study. Specifically, Section 4.8.10(n) emphasizes the importance of transparency regarding access to the participant's original medical records. This ensures that participants are aware that their personal medical information may be accessed for the purposes of the trial, which is essential for monitoring their safety and health throughout the study.

Access to original medical records allows investigators and sponsors to obtain critical health information that can impact the trial's safety and efficacy assessments. It fosters trust and respect for the participant's autonomy, as they must be fully informed about who can access their sensitive information and under what circumstances.

The other options pertain to various aspects of participant data and privacy, but they do not align with the specific requirements stated in the guideline regarding informed consent concerning access to medical records.