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Version 2.1
Version date 19/06/2017
Effective date 10/08/2017
1 Number of pages 6
Review date June 2019
Signature
Date 10/08/2017
COPIES PRINTED FROM THE WEBSITE ARE VALID ONLY ON THE DAY OF PRINTING
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superseded versions are promptly withdrawn from use.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
5 ACCESS TO DATA 3
6 ENCRYPTION 5
7 AUDIT TRAIL 5
9 RELATED DOCUMENTS 5
10 REFERENCES 6
11 LIST OF APPENDICES 6
2 INTRODUCTION
This SOP describes the steps that are taken to ensure that trial data is:
3 SCOPE
This SOP applies to all healthcare research which falls within the scope of the
Research Governance Framework (April 2005) sponsored by the NNUH and/or UEA.
External sponsors of research may have their own systems for data management
and security, however the general principles of this SOP and Good Clinical Practice
in data management apply to all research conducted within the UEA and NNUH.
This SOP should be applied with reference to relevant organisations’ policies and
procedures.
Clinical data management systems reside either on the UEA or NNUH network and
are subject to the following institution-wide policies:
5 ACCESS TO DATA
Most data management systems designed for clinical trials are in two parts:
The user interface provides SUs with access to the database. Under normal
circumstances SUs will not have direct access to the database (but see DIRECT
ACCESS TO THE DATABASE below).
The user interface is programmed such that users must always log in with a
username and password to gain access to trial data.
Where users of underlying databases require access to the raw data in order to
write their own queries etc. (e.g. from MS Access or SAS), read-only access can
be provided. This allows read-only access to the data and does not give direct
access to update the underlying database.
Read-only access to the live database should only be made available to users
on the UEA network or with access via a secure remote link such as VPN.
Any direct access to the database should be restricted to the data that the
requester needs to see. Particular attention should be paid to prevent the
unblinding of a user who should remain blinded.
Login access to the server where the underlying database resides is restricted
to:
the Database Management Team
IT Services staff at UEA
Data may also be provided to users by exporting data sets from the database.
Any datasets containing randomization data or patient identifying data, and any
6 ENCRYPTION
Websites on the CTU server are set up so that web traffic between users and the
database is encrypted using SSL.
7 AUDIT TRAIL
CDMS are built with a special facility that keeps an audit trail of:
all data changes made
when the change was made
who made the change
Copies of the backup folder are taken offline daily using a procedure provided by
UEA’s ITCS department. The files are stored offsite at a location approved by UEA
external auditors.
On a regular basis, the Data Manager should request a random backup from the
last 3 months, restore it to a new location and check that the contents are
readable.
9 RELATED DOCUMENTS
10 REFERENCES
Research Governance Framework (April 2005) and its successors (inc. Annex
updated September 2008)
11 APPENDICES
Signature and
Re-written following Reviewer: Date:
1.1 01/09/2010
MHRA inspection. 01/09/2010
Rewritten following
system wide review by Reviewer:
CTU Head of Data Tony Dyer Signature and
2.0 01/01/2014 Management and Head of Data Date:
combining SOP control Management, NCTU 01/01/2014
and revision sheets.
Reviewer:
Updated with CDMS
Martyn Pond
(instead of TDMS), Signature and
Head of Data
2.1 19/06/2017 removal of references to Date:
Management, NCTU
NCTU Templates 19/06/2017
Leodie Alibert
QA Lead, NCTU