Study documentation, data integrity, and regulatory recordkeeping

The manuals converge on careful, timely study documentation that matches source records, case report forms, and electronic systems. Across the extracts, the common pattern is accurate capture of visits, assessments, adverse events, medications, safety findings, and participant contacts, with several sources also stressing completeness, source verification, audit readiness, and consistency between source documents and transcribed database entries. They also converge on recordkeeping that supports monitoring, inspection, and regulatory review. Several manuals mention secure data capture, validated systems, audit trails, backups, retention, and preservation of source records, while others add requirements for IRB approval, GCP, sponsor procedures, or registry data element definitions. A few sources explicitly distinguish source documentation from the eCRF, or note that the eCRF itself is not source documentation. Sources differ mainly in emphasis. Some focus on psychotherapy session recording and fidelity, including audio or video recordings, coded IDs, and preservation for training or review, while others focus more on registry submission, protocol-linked data fields, or administrative record management. A smaller set gives more operational detail on data quality control, such as range and logic checks, master data dictionaries, database lock, and archival workflows, whereas others stay at the level of accurate clinical event recording and regulatory compliance.