ICH E6(R3) – A unique mark, symbol or entry in line with applicable regulatory requirements and/or practice to show expression of will and allow authentication of the signatory. Source Records Original documents or data (which includes relevant metadata) or certified copies of the original documents or data, irrespective of the media used. This may include trial participants’ medical/health records/notes/charts; data provided/entered by trial participants (e.g., electronic patient-reported outcome (ePROs)); healthcare providers’ records from pharmacies, laboratories and other facilities involved in the clinical trial; and data from automated instruments, such as wearables and sensors.