Tuesday, November 25, 2014

Six Questions to Determine FDA Clinical Trial Site Compliance

Drug accountability management is one of the key items that can ensure that all aspects of running a clinical trial - from data integrity, staying on a the clinical trial time line, managing costs and more.  In a recent white paper from Cenduit focusing on electronic drug accountability systems.


What are the six questions that a site can ask to ensure compliance?

  1. 1.  Who is authorized to administer or dispense the investigational drug?
  2. 2. Has the investigational drug been supplied to any unauthorized person?
  3. 3. Can the records for investigational drug inventory be reconciled, i.e., the quantities shipped, received, used, and returned or destroyed?
  4. 4. Can drug shipments, dispersals, and returns be verified?
  5. 5. Is the drug stored in the manner mandated by the protocol?
  6. 6. Does the storage of drugs with the potential of abuse meet the federal regulations for controlled substances?
In the white paper, they focus on the different aspects of keeping records to verify the questions above.  As trials evolve, they call for the evolution of record keeping as well and set forth options for the systems to keep these records electronically providing electronic drug accountability.  A simple error in a paper based system is hard to detect and trace.  As accountability becomes more complex, considering a more dynamic system is important and can help trace and keep companies compliant by doing the following:

Interactive response technology (IRT) systems are used in many clinical trials for a myriad of tasks, from patient randomization to drug supply management and allocation. IRT is ideal for drug accountability because it tracks drug dispensing units by warehouse, depot, and site location, and by batch, bulk lot, packaging step, label group, and patient allocation.

Do you use an IRT system for your drug accountability management?  What's the biggest benefit of doing this electronically?

Data keeping is just one way to optimize clinical trials.  This April at Partnerships in Clinical Trials, the track Clinical Operations Optimization will focus on how operations, including  speeding up clinical trials and the tools to do so will be covered.  For a preview of the sessions in this track, download the agenda.  As a reader of this blog, when you register to join us and mention code XP2000BLOG, you can save $100 off current rates.




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