Addressing the burden of redundant or irrelevant training requirements.

The working group is focused on how Site Initiation Visit Training translate into early operational friction, with the goal of  identifying pathways that directly improve clinical trial readiness, execution, and early operational performance.

Initiatives:

The Site Initiation Visit (SIV) Training Effectiveness Survey is the first of its kind, intended to collect industry-wide data on site initiation visit quality and effectiveness. It correlates "Readiness Gaps" and initial patient enrollment to identify how early training impacts downstream clinical performance in interventional clinical trials.

Responses gathered will be used for quality analysis and anonymized before being leveraged for insights. 

Focusing on financial management challenges, with emphasis on the prevalent issues around clinical research sites not being paid on time or in accordance with their clinical trial agreements.

Initiatives:

The members have developed a sponsor payments survey to capture real world data on complications with payment timeliness. This will enable  insights which can be leveraged to improve this process across sites and sponsors.

Optimizing feasibility processes, with focus on reducing redundancy and improving efficiency.

Initiatives: 

The group is currently developing a standardized set of feasibility questions, which when leveraged across sponsors, can reduce survey turnaround times and site burden.

A site-driven pilot of these standardized questions is underway. Participating sites will fill out the standard questions and proactively share them with sponsors prior to completing brand new feasibility requests.