Having a cohesive training strategy that includes conducting pre-study evaluation and training, as well as ongoing review of clinical evaluator (CE) performance and adherence to standardised procedures is an important contributor to success.
Toronto, ON (PRWEB) March 27, 2020
Join the live webinar on Tuesday, April 21, 2020 at 11am EDT (4pm BST/UK) with speakers Michelle Eagle, Managing Director at ATOM International Limited and Chad Leslie, Sr. Data Manager & Michelle Petersen, MS, Sr. Director, Clinical Trial Management both at Medpace.
Because clinical trial endpoints for rare diseases are often not well defined, consistency of endpoint assessments across study sites and over time are critical to ensuring data integrity. Having a cohesive training strategy that includes conducting pre-study evaluation and training, as well as ongoing review of clinical evaluator (CE) performance and adherence to standardised procedures is an important contributor to success.
For example, neuromuscular studies incorporate training of clinical evaluators at investigator meetings, support video-recording of patient assessments at study visits to review for quality control and perform periodic refresher training throughout the course of a study.
Topics will include:
- What does a comprehensive training program look like?
- How natural history data can inform endpoint selection (real-word examples)
- Rating assessment considerations and review (video QC and clinical assessment reliability)
- The role of data management – cleaning and coding of data to create structured output for review and reliability
This webinar is third in a 3-part series on rare disease clinical research:
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