SOP 815 Clinical Data Management System – LOCKING AND UNLOCKING THE DATABASE
This SOP describes the standard procedures for locking and unlocking the database associated with Clinical Trials and a Clinical Data Management System.
The purpose of database locking is to provide a stable base for interim or final analysis. The authorisation and validation process for locking and unlocking the database will ensure that the database is in a known good state at the end of the study.
Clinical GuidelinesThis guideline has been approved by the Trust's Clinical Guidelines Assessment Panel as an aid to the diagnosis and management of relevant patients and clinical circumstances. Not every patient or situation fits neatly into a standard guideline scenario and the guideline must be interpreted and applied in practice in the light of prevailing clinical circumstances, the diagnostic and treatment options available and the professional judgement, knowledge and expertise of relevant clinicians. It is advised that the rationale for any departure from relevant guidance should be documented in the patient's case notes.
The Trust's guidelines are made publicly available as part of the collective endeavour to continuously improve the quality of healthcare through sharing medical experience and knowledge. The Trust accepts no responsibility for any misunderstanding or misapplication of this document.