How to Design an Auditor Friendly Clinical Study

Knock, Knock! The BIMO (or FDA QSR) auditor is at the door. It’s time to race around, retrieve documents from file cabinets, and make them easily digestible.

Or is it? If your study is designed with audits in mind, you can relax instead of panicking. But how? One of our industry leading clients shared some of their ideas with us recently. We were excited to hear that Prelude’s eClinical platform provides tools and capabilities that help our user community smoothly navigate common audit challenges. Let’s explore several of these.

Personnel Training – Auditors are always asking “how do we know your clinicians have been trained and have the right credentials?”. Why not keep training records and credential certificates in the study database? User forms can be configured to upload and store copies of paper documents – making them accessible directly from the EDC. These forms can be reviewed and finalized by study Monitors as part of their normal activities.

Informed Consent – You know auditors will want to verify that trial participants have been informed about the purpose and risk of the clinical trial and have consented to participate in it. eConsent is becoming more and more popular in the age of COVID-19. Implement eConsent with electronic signatures as part of your study. This helps eliminate problems with missing or incomplete information and ensures your consent documentation will pass inspection.

Summaries – When the auditor asks for a list of Adverse Events, Deviations, or Notes to File – you don’t have to navigate through all subjects and sites to find them. Instead, implement summary forms in your study that capture all occurrences directly from the study database. Now there is only one place to look.

Dosing Records – Too often, subjects or their owners are given paper dosing forms that then must be transcribed into the EDC database. Why not implement these forms directly in the EDC and either allow subject log in or provide subjects with access to an ePRO app. Either of these mechanisms will allow the entry of dosing information directly into the EDC – and best of all, the data is fully attributable.

Owner/Dose Administer Training – One question that comes up frequently is whether dose administrators have been given the proper training – and if you can show evidence of this. Remember, if it’s not documented, it didn’t occur. Record evidence of dose administrator training directly in the study database for easy reference. Also, allow for training of multiple dose administrators to handle the case where a substitute (e.g., another family member or boarding facility staff) will be required to administer the dose.

The Prelude data capture platform supports Subject/Owner log in, ePRO, custom summaries, and an HTML archive capability. These tools combined can have you and your clinical team confident and ready for when that inevitable knock on the door comes.