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, VISION, 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 VISION data capture platform supports Subject/Owner log in, ePRO, eConsent, 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.

Best Practices in Clinical Trial Application Grantsmanship

Applying for a clinical trial grant can sometimes feel like turning in a high school English paper. You could turn in the same exact paper on a different day of the month and get very different grades based on factors that seem out of your control (like whether the teacher is having a good day). However, some critical ingredients can help an application stand out to Federal regulators (e.g., FDA and NIH). Organizations who select eClinical technology partners prior to submitting their application can strengthen their case by detailing data flows, risk mitigation measures, and proven best practices. Demonstrating familiarity and competence with identified technology partners shows that the applicant has the knowledge and experience needed for success in their efforts.

What are some best practices regulators look for?

Excite Your Audience Present the research in a way that will drive curiosity and interest from peer reviewers.  The bigger the research’s impact, the more exciting the project will be. Look to quantify in large terms the level of impact the investigative product will have on the broadest number of recipients. Like a tech startup seeking venture funding, tell your audience how you are going to change the world.

Study Planning – Demonstrate your preparedness by talking about the study build, site onboarding, and enrollment strategies. What is your plan and how will this process be monitored? What are the risks and how will those be mitigated? Have you identified any tools that will help you measure and track your progress? Lay out your plan in detail and include discrete sequential steps.

eClinical Technology Partner – Once your audience is excited about the project and understands your preparedness, they will need to be convinced that the right team is in place for successful project execution. Who will you be collaborating with and how are they specifically qualified for this trial? An eClinical technology partner will provide more than the software that houses the clinical data. They are someone who knows how to leverage technology to minimize execution risk throughout the trial, from designing CRFs and facilitating site training to maximizing data quality and removing human error almost entirely.

Prelude Dynamics has been an eClinical technology partner for many Federal grant recipients. We routinely provide language for applicants to include in their applications and have also provided letters of support for clients. In our experience, early collaboration with researchers adds detail, depth, and substance to Federal clinical applications – streamlining the award/approval process.

We are your eClinical Technology Partner! Reach out and let us help you plan your next study!

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