Clinical trials has to be conducted in accordance to good clinical practice, GCP. To ensure that all parties involved during a trial adhere to these principles and to ensure that high quality data is produced and maintained, sponsors sometimes perform audits. An audit is an “inspection”, where the Sponsor or their designee visits collaborating companies to check their adherance to GCP. It is the ultimate responsibility of the Project Manager that everything is in order before the audit. However, the Clinical Research Associate share this responsibility. Here we present some of the most common findings during audits. The skilled CRA will take notice of these issues onbeforehand and solve them before an eventual aidut. Pay some extra attention to these procedures while you’re monitoring.
Failure to ensure proper management and monitoring of the study
- Records missing in the TMF – the Trial Master File must be complete. In case a document is missing, there should be a file note describing what action has been taken to localize it, when it was lost, by whom etc.
- Originals vs. copies – at closing of a study all original documents should be collected from sites. Copies are only considered as temporary documents. Make sure to collect all original documents as soonas possible.
- Training files for Princial Investigators missing – a PI should have good knowledge in GCP, and it should be documented when and how this was achieved. Preferably a training certificate should be attached, no matter how many trials the PI have conducted before.
- Investigators statements – PI’s are busy persons, often they can only focus part time of their work on the study. Try to make sure that all statements made by PIs are documented.
Monitoring plan review
- Specified frequency of visits not adhered to.
- Visit dates and actual number of subjects enrolled at each time point not in accordance to the MP. According to the FDA the MP can be less specific since it’s difficult to follow a to strict plan.
- Lack of site compliance – If an Investigator does not comply with the general investigational plan, it should be documented which action was taken.
- IP stolen or “disappeared” – this is a serious finding and should be reported to the police. In case such an issue appears, make sure that proper actions are taken to prevent it from reoccurring, and document this.
Image courtesy of Winnond at FreeDigitalPhotos.net.