SCRS Collaborates on RBM Reflection Piece

SCRS President, Christine Pierre has co-authored a reflection piece on the shifting monitoring paradigms associated with risk-based monitoring. A collaborative effort between SCRS and Linking Leaders, the piece examines widely differing perceptions about the impacts of Risk Based Monitoring (RBM).  It makes a case for the importance of sponsor-site alignment on risk-based approaches for clinical standards to reach new levels.  The study was based on data collected through an SCRS survey on RBM and a Linking Leaders industry survey.

Among the key outcomes:

• Sites expect workload increases, while sponsors expected slightly decreased workload
• Sites expect no change to data quality, while sponsors expect greatly increased data quality
• Sites expect an increase in resource needs, while sponsors expect only a small increase in required resources
• Sites expect budget increases that sponsors do not anticipate
• Sites expect slight decreases in study volunteer safety, while sponsors expect enhanced safety

The piece notes that “without a seat at the table and due to an insufficient focus on socializing RBM with the clinical site community, many sites misunderstand how RBM is defined and what it is intended to accomplish.”

Through the work of SCRS (including this article), sites now do have a seat at the table.  SCRS is committed to amplifying and unifying the voice of the sites, through advocacy, by publishing thought pieces and with initiatives such as the recently announced Site Advocacy Group (SAG) initiative.  One of the first SAGs to be deployed is a joint collaboration between SCRS and TransCelerate BioPharma on RBM.  Learn more about the milestone SCRS/TransCelerate SAG partnership here. 

This article was published in the June/July edition of Applied Clinical Trials.

To read more: please to link to the online magazine, or here to read the piece online on the Applied Clinical Trials website.