Abstract:

BACKGROUND

Clinical trial monitoring is broadly based on protecting the rights and the well-being of the human research subjects, overseeing the progress of the trial, and ensuring that the trial is conducted in compliance with the applicable regulations, SOPs and study documents ^[1]. The systematic application of the recently introduced Risk Based Monitoring (RBM) technique is facilitating a collaborative vigilance approach, and a new definition of clinical trial monitor is evolving. A clinical trial monitor no longer seems to be a single entity but a group of people from cross functional teams that share joint accountability for overall data monitoring and quality governance framework.

OBJECTIVE

To explore the evolving role of a clinical trial monitor and other key study team members in the Risk Based Monitoring landscape.

METHOD

A literature search was conducted, followed by several discussions and brain storming sessions with key functional study team members currently working in the RBM pilot trials. Some limitations with this methodology were a lack of available literature specific to the topic under study, as well as the lack of sufficient industry experience in the implementation of the RBM practices at present.

CONCLUSION

Conventional monitoring was based mostly on data review in silos by the monitors. RBM and the associated technologies have created an opportunity to assess the study and center specific risks at each level of the data hierarchy by the appropriately qualified study team members for a continuous governance of clinical study data. The roles and responsibilities of these core study team members are continuously shifting and it is likely that this shift, along with training and continuous adaptation, will re-define the face of a clinical trial monitor while also leveraging the quality of clinical trial outcomes overall.

References:

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3.      E6 Good Clinical Practice: Consolidated guidance for the industry, April 1996. Available at: http://www.fda.gov/downloads/Drugs/Guidances/ucm073122.pdf. Accessed Oct 2, 2014.

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8.      PMDA. Basic Rules of the Risk-Based Approach to Monitoring Clinical Trials. Available at: http://www.dmb-asso.org/wp­content/uploads/2014/02/JapanGuidanceforRBMJuly2013.pdf. Accessed October 10, 2014.

9.      Quintiles. The Role of Data Management in Risk-Based Monitoring: A Critical Element in Data-driven Trials. August 2014. http://www.youtube.com/watch?v=SsDQ952rSBw. Assessed July 22, 2014

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