10% of all NHS research projects need to be audited as part of the DoH's Research Governance Framework; Norwich PCT is responsible for all research projects conducted within the East Norfolk and Waveney Research Consortium.  My study was selected at random from all potentially auditable projects (apparently not many are suitable for audit due to the nature of the study, the location the study etc).

So what did the audit involve?

* all files held by R&D reviewed
* meeting with Chief Investigator i.e. me
* review of all my study documentation

.........and the audit findings?

* CI well organised and available to answer any questions from the auditor throughout the audit
* all study documentation available and appropriate i.e. correct versions in use.
* minor amendment to the study implemented without informing R&D (interestingly ethics do not need to be informed of minor amendments).
* consent forms scanned and filed in patients medical records but lack of obvious clarity as to what the consent form related to.
* some patients who were initially contacted were not on their TCA for depression and this required individual follow-up to address patient concerns about being labelled as having depression, it was really very emotive for some people.
* training and supervision appropriate for the level of the study.
* steering group meetings not happening but have been replaced with a quarterly newsletter, feedback to the clinical meetings, and my website which contains study updates.
* lone working policy being adhered to satisfactorily.
* storage is at my home so not reviewed; but confirmed that all computer records are password protected and all paperwork stored in a locked filing cabinet.

The audit recommendations?

* details of minor amendments sent to R&D for their files - done.
* subject notes have further entry made to provide clarity that the subject has participated in this research on depression - in progress.
* in any future study attempts should be made to eliminate any patient who might be on a medication for a reason other than the one under study; additionally the patient information sheet should include more detail to alleviate people's anxiety when asked to participate in the study.

Overall feedback indicates the audit went very well, no major findings/concerns arose and R&D generally happy with the way the study is being run.  I need to confirm that I have actioned the minor recommendations.  There is no need for any formal feedback process/further meeting to take place.

How did I find the process?

* threatening - this was an unexpected and interesting response, but having someone else go through all my documentation, and analyse the process of the study to date was quite stressful.
* it was useful to pull everything together and look at it as a complete package.
* reassuring in the aftermath (once report received!) that no major problems and an external audit process has reported favourably.
* worthwhile too I think as I had to summarise what I am doing, and justify my actions.  It also made me appreciate the input and support from the practice and from my supervisors.