TGA is stepping up its oversight of medical device trials and we are likely to experience an increase in site audits. Historically, Australian sites have been audited more readily by FDA, if they’re participating in IDE trials or research supporting PMA submissions. One of the most common findings of an FDA audit are violations pertaining to standard operating procedures.
Inadequacies range from clinical sites not having procedures in place at all, to having SOPs and not following them correctly, to following their SOPs but having no written evidence of this.
It is the responsibility of the Sponsor, and/or CRO managing the clinical site to ensure that all clinical trial protocol related procedures are documented, followed and evidence of this is clear. Some highly experienced research sites have their own SOPs for certain research related activities, such as logging of investigation product, storage temperature regulation procedures, and procedures for ensuring all new staff are adequately trained.
Other sites rely on the protocol, study manuals and other mechanisms provided by the Sponsor for standardising their procedures. Ether way, during an audit, FDA (and TGA) expects to see quality control in place, through robust procedures, and documented evidence that those standard operating procedures are being complied with.