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Compliance In Focus
Posted by Sandra Maddock on Wed, Aug 1, 2012

The Challenges in Monitoring Electronic Regulatory Compliance

Challenges Electronic Regulatory ComplianceAccording to 21 CFR 812.110 an Investigator is responsible for conducting an investigation in accordance with the signed agreement with the sponsor, the investigational plan, this part and other applicable FDA regulations, and any conditions of approval imposed by an IRB or FDA.

This means that an investigator must follow their IRB’s policies regarding adverse event reporting during the investigation which it has granted approval for.  Thankfully, according to 21 CFR 56.108 (b), IRBs are required to follow written procedures for ensuring prompt reporting to the IRB, appropriate institutional officials, and FDA of any unanticipated problems involving risks to human subjects or others.  Having access to IRB policies helps ensure that a site is meeting their reporting requirements for unanticipated problems to their IRB.  However;

  • As previously noted in a recent blog posting titled “Going Green in Clinical Research Trials,” sites are moving towards utilizing means of electronically storing documents and conducting clinical trials
  • More and more sites are utilizing electronic medical records and their IRBs are moving towards utilizing an electronic submission process
  • What was once typed out, printed, and physically signed by the principal investigator is now replaced with an electronic submission that monitors often don’t readily have access to
  • It can be difficult at times to determine what unanticipated problems have been submitted and when due to the vagueness of some of these new electronic systems

So how does one successfully monitor whether or not a site has reported unanticipated problems appropriately within the timeframes specified by the IRB when they are using these electronic systems?

It can be challenging and does require some additional steps on behalf of the monitor and the research coordinator, but I assure you it can be done!  In fact, it must be done in order to ensure that a site is in compliance.  Hopefully, as advances in electronic IRB systems are made, more transparent documentation of what was submitted and when will become common place.  Or perhaps methods to allow monitors a form of limited access to these electronic systems (much like can be done with electronic medical records at times) will be developed.  After all, making it easier for a monitor to help a site stay in compliance is a win for overall human subject’s protection.

Have you come up with any tips for monitoring electronic regulatory compliance?  If so, we would love to hear from you.

Photo Credit: f_shields




Topics: 21 CFR 812.110, Electronic Regulatory Compliance, Clinical Monitoring


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