Standard Operating Procedures (SOP) for:
Internal audit process
SOP Number: 22 Version Number: 004
Effective Date: April 2008 Review Date: September 2009
Author: Siobhan Lim, Research Governance & GCP Manager
Reviewer Nick Good, R&D Projects Manager
Name / Position Mr Gerry Leonard, Head of Resources
Purpose and Objective:
To identify and standardise the process of internal audit of research activity.
The purpose of audit is to assess compliance with the requirements of the Research Governance
Framework for Health and Social Care, 2005, the Data Protection Act, 1998, the Medicines for
Human Use (Clinical Trials) Regulations 2004, ICH Good Clinical Practice (GCP) guidelines
1996 for clinical trials of medicinal products in addition to local BLT/QMUL policies.
1. Research Governance Projects are identified for audit by several methods;
1. A project may be identified via the risk assessment process.
The ReDA database will generate a list of projects receiving a
high risk assessment score. (See SOP 23).
2. An individual investigator or department may request an audit.
3. A project may be identified via an allegation of research
misconduct or fraud or a suspected breach of regulations. (See
4. Projects may be selected at random. The Department of Health
states that Trusts should be auditing a minimum of 10% of all
5) Projects may be randomly selected for audit by an external
organisation (e.g. Medical Research Council).
2. Research Governance Ensure that the project has commenced by checking details on the
Team ReDA database and contact the Principal Investigator (PI) to
inquire about the recruitment figures. If the study has started and
the recruitment figure is satisfactory in comparison to the total
expected recruitment figure then go to step 3.
SOP Number 22 v 04 1
If the study has not started or the recruitment figure is low in
comparison to the total expected recruitment figure then choose
another project and return to step 1.
3. Research Governance Contact the PI and agree a suitable date for the audit in about 4
Team. weeks time in order to allow the research team sufficient time to
prepare for the audit. Once a date for audit is agreed, send the
invitation letter (Appendix A) and attach the list of essential
documents (Appendix B) and the audit leaflet (Appendix C) to
Also identify all the members of the research team for the project
and establish if there are any other departments involved e.g.
pharmacy or labs. Inform the PI that all members of the research
team will need to be available on the day of the audit for short
interviews and that access to any departments involved will also
be required on the day.
Randomly choose from the recruited participants which sets of
case report forms and medical notes will be required for review
on the day, e.g. participant 1, 5, 9 and so on depending on the
number recruited. If it is a small number of participants recruited
you may request to see all of their notes.
Advise the PI that a room will be required for reviewing the study
documentation on the day of the audit.
4. Research Governance Prepare and agree with the PI a timetable for the day of the audit.
Team. Offer any advice to the research team to help them prepare.
5. Research Governance Prepare for audit by reading the most up to date version of the
Team protocol and ethics documentation. Some of these documents
may need to be requested from the PI.
6. Research Governance Undertake the site visit and perform audit on the agreed date
Team using the relevant audit tools (Appendices D-J).
7. Research Governance Post audit, compile the audit report using audit report templates 1
Team and 2 (Appendix K). Pass the reports to the other auditor who
took part in the audit for their approval of the report and discuss
any changes required. Once changes (if required) are agreed,
amend reports and pass both reports to the R&D Planning and
Governance Manager for review and signature.
8. R&D Planning and Review audit reports and discuss with the Research Governance
Governance Manager Team if any changes are required. If no changes are required then
sign and date audit report 1 and pass reports 1 and 2 back to the
Research Governance Team.
9. Research Governance If any changes are required, amend reports and go back to step 8.
SOP Number 22 v 04 2
10. Research Governance Both auditors who audited the study must sign and date audit
Team report 1. Send audit report 1 to PI, a copy to the head of
department of the PI and if it a BLT study a copy to the Medical
Director or if it is a QMUL study a copy to the Dean of Research.
11. Research Governance File copies of audit report 1 and 2 to the project file and the
Team Research Governance Team audit folder.
12. Research Governance In the event of critical or major findings from the initial audit
Team report specify the actions required to address areas of non-
conformity together with deadlines (see appendix K) then a re-
audit should take place. Send copies of re-audit report to key staff
as in step 10 and update as in step 13.
13. Research Governance Record on the project cover sheet the date of the audit. Amend
Team ReDA database with the date the audit took place.
SOP Number 22 v 04 3
List of appendices
Appendix Appendix name Location
Appendix A Template audit invitation
Appendix B Essential documents trials
Appendix C Audit leaflet
Appendix D Audit questions for
Appendix E Audit questions investigator
Appendix F Audit questions clinical
Appendix G Essential documents audit
Appendix H Consent audit tool
Appendix I Health & Safety audit tool
Appendix J Source documents audit
Appendix K Audit report templates 1
and audit and interviews
report template 2
SOP Number 22 v 04 4