STANDARD OPERATING PROCEDURE SOP 805. Clinical Data Management System - CDMS SET-UP. Joint Research Office. Chief of Research and Innovation

Transcription

1 STANDARD OPERATING PROCEDURE SOP 805 Clinical Data Management System - CDMS SET-UP Version 2.1 Version date 19/06/2017 Effective date 07/08/2017 Number of pages 7 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 07/08/17 COPIES PRINTED FROM THE WEBSITE ARE VALID ONLY ON THE DAY OF PRINTING SOP 805 v2.1 Effective date: 07/08/2017 Page 1 of 7

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 Staff must ensure that they are adequately trained in the new procedure and must make sure that all copies of superseded versions are promptly withdrawn from use.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 INITIAL APPROACH FROM CHIEF/PRINCIPAL INVESTIGATOR 4 5 DOCUMENTS REQUIRED BY THE DATABASE MANAGER 4 6 SETTING UP THE DATA MANAGEMENT PLAN 4 7 PRODUCTION AND ADOPTION OF THE DATA MANAGEMENT PLAN 5 8 REFERENCES 6 9 RELATED DOCUMENTS 6 10 LIST OF APPENDICES 6 Appendix 1: Change Control, Revision and Review Sheet 7 SOP 805 v2.1 Effective date: 07/08/2017 Page 2 of 7

3 1 ABBREVIATIONS CI CDMS CRF CTIMP DBM DM DMP GCP ICH NNUH PI R&D SM SOP UEA Chief Investigator Clinical Data Management System Case Report Form Clinical Trial of an Investigational Medicinal Product Database Manager Data Management Data Management Plan Good Clinical Practice International Conference for Harmonisation Norfolk and Norwich University Hospital Principal Investigator Research and Development Study Manager/Research Assistant in charge Standard Operating Procedure University of East Anglia 2 INTRODUCTION 2.1 The purpose of this procedure is to describe the setup and agreement of a data management strategy for the study. 2.2 The data management strategy covers the management and manipulation of the study data, and the development and/or validation of any tools used to collect, store and process the data. 2.3 The main deliverable from this procedure is a Data Management Plan (DMP) which outlines the details of the Clinical Data Management System (CDMS) to be set up, lists relevant documents and references relevant procedures. 2.4 The DMP should be in place and approved by the Database Manager (DBM) and the Study PI/CI by the time that study data collection begins. 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. SOP 805 v2.1 Effective date: 07/08/2017 Page 3 of 7

4 4 INITIAL APPROACH FROM CHIEF/PRINCIPAL INVESTIGATOR 4.1 Once a project has been funded, the DBM will (re)establish contact with the CI/CI/PI or SM to gather, refresh and confirm their data management requirements and to outline the Data Management processes and possibilities. 4.2 The DBM will set up an on-line folder to store any associated documents on a server with access, security and back-up controls in place in accordance with NNUH or UEA information systems policies. 4.3 The DBM will set up a DMP for the new project, based on an agreed design template. 5 DOCUMENTS REQUIRED BY THE DATABASE MANAGER In order to begin work on discussing and defining requirements the DBM should request the latest versions of all relevant documentation from the CI/PI or SM with assistance from the R&D Office as required. These may include: Protocol, Grant Application documents, trial specific CRFs and copies or references to pre-validated questionnaires. The documents and their locations should be referenced in the DMP. It is recognized that earlier versions may be used to inform initial discussions but the final versions of all documents should be provided to the DBM. 6 SETTING UP THE DATA MANAGEMENT PLAN 6.1 The development of the DMP will be led by the DBM but is a collaborative process between the Data Management team and the Study team. 6.2 The information gathering process is dependent on the nature of the trial and is by its nature an iterative process. The following points need to be addressed by the CI/PI or delegated member of staff with the advice and support of the DBM when developing the CDMS: a. Study team members and roles b. Data Management team members and roles for this study c. Other relevant Data Management procedures (including management of the blinding of the study where applicable) d. Data sources e. Systems SOP 805 v2.1 Effective date: 07/08/2017 Page 4 of 7

5 f. Validation g. Query process h. Quality assurance i. Quality control j. Handling protocol non-compliance k. Pharmacovigilance l. Training and documentation m. Database users n. Location of data o. Archiving and data return to sponsor 6.3 There will be discussion between DBM and CI/PI to note what is possible and what is required, noting that the most stringent requirements will apply to data management systems for CTIMPs and Medical Device trials. This may involve tailoring the specification of the CDMS according to cost or time constraints, and consideration should be given to the possible phasing of delivery. 7 PRODUCTION AND ADOPTION OF THE DATA MANAGEMENT PLAN 7.1 The DBM will be responsible for the initiation and maintenance of the DMP. All signed-off versions will be retained online in the study data management folder 7.2 The DMP will be developed and enhanced during the period leading up to the start of recruitment and data collection. 7.3 During development and during the period of the study, the PI/CI or SM should keep the DBM informed of any changes to system requirements that affect the DMP and the DBM will make the necessary amendments. 7.4 The DBM will keep the DMP up-to-date. 7.5 Any revisions to the DMP during the lifetime of the study must be agreed and signed off by the DBM and the CI or SM. 8 REFERENCES EU Directive 2001/20/EC SOP 805 v2.1 Effective date: 07/08/2017 Page 5 of 7

6 Medicines for Human Use (Clinical Trials) Regulations 2004 Integrated Addendum to ICH E6 (R1): Guideline for Good Clinical Practice (E6R2), Step 4 version, dated 9 November 2016 Research Governance Framework for Health and Social Care (DH 2005) 9 RELATED DOCUMENTS SOP 825 Trial Data Management System - VALIDATION 10 LIST OF APPENDICES Appendix 1: Change Control, Revision and Review Sheet SOP 805 v2.1 Effective date: 07/08/2017 Page 6 of 7

7 Appendix 1: Change Control, Revision and Review Sheet Revision Form: SOP 805 Version No Change Date Reason for Change /11/2013 Rewritten following system wide review by CTU Head of Data Management and combining SOP control and revision sheets. Reviewer: Tony Dyer Database Manager NCTU Signature and Date: 29/11/ /06/2017 TDMS changed to CDMS, references to NCTU templates have been removed, 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: 12/12/2016 (MP) 19/06/2017 (LA) SOP 805 v2.1 Effective date: 07/08/2017 Page 7 of 7