STANDARD OPERATING PROCEDURE SOP 815. Clinical Data Management System LOCKING AND UNLOCKING THE DATABASE. Joint Research Office

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Ben Everitt Role Head of NNUH IT Signature Ben Everitt Date 09/05/2017 Authorised by Role Professor Alastair Forbes Chief of Research

1 STANDARD OPERATING PROCEDURE SOP 815 Clinical Data Management System LOCKING AND UNLOCKING THE DATABASE Version 2.1 Version date 19/06/2017 Effective date 08/08/2017 Number of pages 6 Review date June 2019 Author Joint Research Office Approved by Ben Everitt Role Head of NNUH IT Signature Ben Everitt Date 09/05/2017 Authorised by Role Professor Alastair Forbes Chief of Research and Innovation Signature Date 08/08/2017 COPIES PRINTED FROM THE WEBSITE ARE VALID ONLY ON THE DAY OF PRINTING SOP 815 v2.1 Effective Date: 08/08/2017 Page 1 of 6

2 It is the responsibility of all users of this SOP to ensure that the correct version is being used. All staff should regularly check the NNUH R&D website for information relating to the implementation of new or revised versions of SOPs. Staff must ensure that they are adequately trained in the new procedure and must make sure that all copies of superseded versions are promptly withdrawn from use. The definitive versions of all Joint NNUH/UEA health care research SOPs appear online. If you are reading this in printed form please check that the version number and effective date is the most recent one as shown on the NNUH R&D website. TABLE OF CONTENTS 1 ABBREVIATIONS 3 2 INTRODUCTION 3 3 SCOPE 3 4 RESPONSIBILITIES 3 5 CATEGORIES 3 6 DATA VALIDATION 4 7 DATABASE STATUS 4 8 PROCESSES Lock the Database Validate the Database Making a Locked Copy of the Database for Interim Analysis Unlocking the database 5 9 REFERENCE 6 10 RELATED DOCUMENTS 6 11 LIST OF APPENDICES 6 Appendix 1: Change Control, Revision and Review Sheet 6 SOP 815 v2.1 Effective Date: 08/08/2017 Page 2 of 6

3 1 ABBREVIATIONS CDMS CI DBM GCP ICH NCTU NNUH CI/PI SM SOP TT UEA Clinical Data Management System Chief Investigator Database Manager Good Clinical Practice International Conference for Harmonisation Norwich Clinical Trials Unit Norfolk and Norwich University Hospital Principal Investigator Study Manager Standard Operating Procedure Tools and Templates University of East Anglia 2 INTRODUCTION 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. 3 SCOPE This SOP applies to all healthcare research sponsored by NNUH or UEA which falls within the scope of the Research Governance Framework (2nd edition 2005). Where additional legislation applies, for example the Medicines for Human Use (Clinical Trials) Regulations 2004 (and amendments) or the Medical Devices Regulations 2002, required procedures will be indicated. External sponsors may require use of their own SOPs and this will be specified in site agreements. It is the responsibility of the local PI to ensure that study specific SOPs can be operated without conflict with this SOP and in accordance with all organisational polices related to research. 4 RESPONSIBILITIES Study Manager (SM) Database Manager (DBM) for trial specific documents for database/systems SOP 815 v2.1 Effective Date: 08/08/2017 Page 3 of 6

4 5 DATABASE LOCKING Locking a database is the process of removing the ability of users to add, edit or delete data. Locking may be partial (leaving certain areas of the database open for further edits) or full (no changes allowed). Partial locking may be useful towards the end of the study to allow verification and cleaning of sections of the database where data entry has finished, leaving other areas open for data entry to continue. 6 DATA VALIDATION There should a Data Validation Plan which lists all the checks that will be made post-lock to ensure that the dataset is in as good a state as possible. The Data Validation Plan should be executed on the database each time it is locked. Any checks arising should be resolved or accepted and documented by the study statistician. Details of the checks (e.g. database query code) should be retained so that they can also be re-run once the database has been re-locked after resolution. 7 DATABASE STATUS The DM Team should keep a record of the database status which may be one of the following: LIVE PARTIALLY LOCKED LOCKED and AWAITING VALIDATION LOCKED and VALIDATED 8 PROCESSES 8.1 Lock the Database A database lock should be requested by the SM, using a database lock request form based on an agreed template. The form should be completed, signed and submitted to the DBM who will arrange to lock the database at the requested time. On receipt of the Database Lock Request form the DBM will take the necessary steps to ensure that access to all users will be restricted to readonly. A full backup of the database will be taken and stored in the DM team study folder. The DM Team will record the status of the database as LOCKED and UNVALIDATED SOP 815 v2.1 Effective Date: 08/08/2017 Page 4 of 6

5 8.2 Validate the Database On locking the database, the DBM should run the queries, and so on, as specified in the Data Validation Plan to check for missing, invalid or inconsistent data. o Any validation failures should be submitted to the SM and/or the Study Statistician for agreement about resolution or otherwise. Appropriate actions for validation failures could be to unlock the database for corrections to be made, or acceptance of minor errors (to be listed in a report and signed by the CI/PI). When the database has been declared Validated, datasets for analysis may be requested by the study team, using a data request form based on an agreed template. o The DM Team will record the status of the database as LOCKED and VALIDATED 8.3 Making a Locked copy of the Database for Interim Analysis When data is required for interim analysis, a locked and validated dataset should be produced. Disruption to the live ongoing study database must be kept to a minimum. o The requester should complete a Dataset request form and ensure that it indicates that the request is for an interim analysis dataset. o The DBM will make a copy of the live database and name it <StudyName>_Interim. o The standard locking and validation process should then be run on the Interim database copy. o Corrections to any validation errors should first be made in the <StudyName>_Interim database but then should also be applied to the live database at the discretion of the CI/PI and the DBM. 8.4 Unlocking the Database There may be a need for the database to be unlocked if correction of validation errors is required. The CI/PI must complete a Database unlock request form, based on an agreed template, and submit it to the DBM. The DBM will set up access rights as required for the Study Team to make the necessary amendments. o The Data Management Team will record the status of the database as PARTIALLY LOCKED SOP 815 v2.1 Effective Date: 08/08/2017 Page 5 of 6

6 9 REFERENCES Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice (E6R2), Step 4 version, dated 9 November RELATED DOCUMENTATION SOP Start-up activities for a clinical trial SOP 815 Trial Data Management System LOCKING AND UNLOCKING THE DATABASE SOP 860 Trial Data Management System - DATA REQUEST 11 LIST OF APPENDICES Appendix 1: Change Control, Revision and Review Sheet Appendix 1: Change Control, Revision and Review Sheet Revision Form: SOP 815 Version No Change Date Reason for Change /01/2013 Re-written following MHRA inspection Reviewer: Signature and Date: 01/01/ /11/2013 Re-written following system wide review by NCTU Head of Data management and combining SOP control and revision sheets. Reviewer: Tony Dyer Head of Data Management, NCTU Signature and Date: 29/11/ /06/2017 Updated with CDMS and removal of references to NCTU Templates, reference to ICH-GCP updated, PI role now updated as CI/PI role. Reviewer: Martyn Pond Head of Data Management, NCTU Leodie Alibert QA Lead, NCTU Signature and Date: 19/06/2017 SOP 815 v2.1 Effective Date: 08/08/2017 Page 6 of 6

Version Control of Study Specific Documents

SOP Title Version Control of Study Specific Documents SOP No. SOP 10 Author Consulted Departments Lead Manager Sign and Print Name Julia Farmery Revision V2.0: Sarah Fahy Lincolnshire Clinical Research