The document summarizes regulatory issues regarding electronic diaries (eDiaries) used in clinical trials. It discusses how regulations were originally written for paper diaries and do not fully address electronic records. It outlines approaches taken to conform with regulations, focusing on designating electronic records as the source document and maintaining investigator control and access. Ensuring data quality, privacy, and trustworthiness of electronic records is also discussed.

1. Regulating eDiaries from Planning to Retention of Archival eSource Records Stephen A. Raymond, PhD Chief Scientific Officer and Founder PHT Corporation

15. Typical eDiary System To support reconstruction of the trial for auditing the trustworthiness of the results

19. Example of Designating Source EHR record at institution. First record of “original data” items eRecord containing the original data items extracted And “certified” to have the same values and metadata by validated process or a manual check This is the source document, and it is under the (Part 11) controls of a clinical trial system This is an original document that is NOT the source for the Report and is under the controls of the EHR system Source Data Final report containing analysis, findings based on original data CRF or eCRF with original data items Clinical Database

23. Regulatory Anxiety How do you see the attitude of regulators, security consultants, IT towards ‘access’?