10 Revision history

Date Part number Description
21 September 2026 G58158-04

Reorganized the Import Electronic Health Record (EHR) data section and separated the Import EHR data procedure from its requirements and related information.

Improved content in Rollback a subject's last dispensation.

15 September 2026 G58158-03 Updated Sign data at the casebook level, Sign data at the form or visit level, and Enter data in a repeating form to clarify that changes to subject data—including adding or removing a repeating-form instance—can invalidate the applicable signed status and may require re-signing, depending on the study’s signature requirements.
27 August 2026 G58158-02 New version of the document published to correct rendering errors.
24 August 2026 G58158-01 Original version of this document.