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Compliance In Focus
Posted by Sandra Maddock on Tue, Oct 30, 2018

Ensuring Compliance After Your Medical Device Trial

medical-device-trialEntering the “home stretch” of a medical device trial is always an exciting time. You can see the finish line in sight. You’ve planned for success, and you’ve run the race well. But before you take your victory lap, you still have a few more hurdles to clear.

Here are the three biggest ones you’re likely to encounter as you prepare to close out your study.

Final Audits

The most pressing hurdle is the FDA’s review of your trial master file, or TMF. The trial master file tells the story of your entire medical device trial. Inspectors will review the documents in this file to determine how closely your trial followed your study plan and whether you complied with all regulations. They will look for any gaps in the data, any missing signatures, adverse events and anything that could potentially compromise the integrity of your study.

Given the significance of a trial master file review, it’s becoming more common for study sponsors to request an independent auditor to review their TMF before the FDA does.

After all the time, effort and money spent on your medical device trial, a trial master file audit is certainly a worthwhile investment. However, it can be daunting when you consider the costs involved. An electronic trial master file review eliminates the costs of travel, meals and the time required for your internal team to support the audit. In fact, it can reduce the total costs by as much as half.

Data Lock and Analysis

If your medical device trial is a race, your database is the trophy case. You’ve gone to great lengths to gather this data, and you need to protect it. A database lock is a crucial step to ensuring the integrity of your findings as you prepare for study closeout. This will prevent unauthorized or unintentional changes to your data after it has been reviewed and analyzed.

Clinical data management (CDM) is typically the responsibility of the principal investigator or research coordinator. If you don’t already have someone tasked with this, designate an authorized person. Then, follow these steps to complete the database lock:

  • Make sure you have received all data, including data from external sources
  • Review data for inconsistencies (an auditor can assist with this)
  • Resolve all data queries
  • Conduct a final audit to make sure all data is complete and accurate
  • Remove “edit” access from your database

Processing, analyzing and checking all this data can seem like a monumental task, especially if it falls on just one or two people. A contract research organization (CRO) can support your team by providing assistance with data entry and data review. Your CRO can also conduct the final database lock if needed.


Even after you’ve finalized and submitted the data for your medical device trial, you may not be out of the woods just yet. One of your clinical research sites could still receive a Form 483 or an FDA warning letter.

If that happens, it’s important to respond appropriately. You will also need to identify the cause of the violations and develop corrective actions to prevent future problems. This is another area where an experienced CRO can help. Professionals with expertise in monitoring and auditing will be able to identify any underlying compliance issues and devise a plan to mitigate them going forward.

When it comes to clinical research, the final leg of the race can also be stressful. But just as an Olympic track star can pass the baton to a relay team, you can delegate some of these responsibilities to a medical device CRO at any point during the trial. A CRO team can be there to coach and encourage you before your trial begins. They can step in at any point during the race to lighten your team’s load. And they can be there for you through that last strenuous lap to make sure you clear those final hurdles.

No matter where you are in your medical device trial, IMARC Research offers exceptional support to help you reach the finish line.

To learn more about working with us, contact us today.

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Topics: Compliance Partners


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