CRC SOP 08d Electronic clinical data archiving V1
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THIS SOP REMAINS THE PROPERTY OF THE UCT FACULTY OF HEALTH SCIENCES
University of Cape Town
Clinical Research Centre
Title
Electronic clinical data archiving
Number
08d
Version
1
Name
Standard Operating Procedures
Title
Signature
Date
Reviewer
Authoriser
Effective date
Review date
1. Purpose
To provide instruction to those data management team members delegated responsibility for implementing and
maintaining an archive of electronic records that contain clinical data collected during a clinical study. This SOP
does not cover the archive of other Essential Documents, such as the protocol.
2. Scope
The Clinical Research Centre (CRC) will advise whether this document is mandatory for research where UCT’s
Faculty of Health Sciences (FHS) is the named sponsor or where CRC facilities are used (CRC SOP 02). This SOP
may, however, also be adapted for use for studies conducted by UCT clinical researchers where UCT is not the
sponsor.
3. Templates/forms
CRC 08d.1
Electronic data archive inventory form
4. Glossary/definitions
Clinical Research
Health-related research that involves people, their tissue (e.g. blood samples), behaviour and/or data.
Essential Documents
Documents which individually and collectively permit evaluation of the conduct of a clinical trial and the quality of
the data produced (See South African Good Clinical Practice Guideline, Second Edition. 2006. Appendix C).
Master File
Files for each project containing key documents (such as Essential Documents for clinical trials). The Master File is
in two parts – a Sponsor File and Investigator Site File (ISF).
Printed copies of this SOP should be checked against the original version on the CRC website (www.crc.uct.ac.za)
CRC SOP 08d Electronic clinical data archiving V1
Page 2 of 2
THIS SOP REMAINS THE PROPERTY OF THE UCT FACULTY OF HEALTH SCIENCES
5. Responsibilities and procedure
5.1. Database lock
5.1.1.After a study, the Clinical Data Management System (CDMS) used to collect clinical information
about study participants will be locked according to the process outlined in CRC SOP 08c.
5.2. Electronic data archive
5.2.1.Once the CDMS has been locked, all data, including user details and audit trails, will be extracted
and archived as an XML file to Clinical Data Interchange Standards Consortium (CDISC) standards.
The extracted data will be stored in a study-specific archive library in SharePoint, as provided by UCT
ICTS. The SharePoint archive library will be maintained according to ICTS standard internal
procedures/SOPs.
5.2.2.Where an Electronic Data Capture (EDC) system is used, images of the data entry screens will be
recorded and saved in pdf format. These will be archived with the CDMS in SharePoint.
5.2.3.In addition to the data archive in SharePoint, where required, a copy of the data archive will be
made and given to the sponsor.
5.2.4.Archived data will be retained in a secure manner for at least 15 years, or per sponsor’s request, or
per applicable regulation. After the specified retention period, the archive will be handled according
to ICTS standard practice.
5.2.5.The date, time and name of the person responsible for creating the archive and the contents, file
type and location will be recorded on an Electronic data archive inventory form (CRC 08d.1).
6. Document history:
Version No.
Date
Reviewer
Details of changes
Printed copies of this SOP should be checked against the original version on the CRC website (www.crc.uct.ac.za)