Unified Site Methodology Program
Lotus ensures consistent data across the ERG site network with an intensive, multi-tiered training program.
In-Person Study-Specific Training
- As each Lotus site is brought on to a study, all staff undergo a full-day in-person training
- Provide dedicated training centered on endpoints, study druh, placebo response mitigation and other key topics
- Staff participate in didactic training, role-playing, hands-on excercises and Q&A
- Staff review written summaries and complete a post-test to ensure comprehension
Training and Testing on Key Methodology Topics
- Quarterly deep dives on methodology topics
- Staff participate in periodic online sessions featuring didactic video training followed by a comprehension test
- Provide case study scenarios and other tools designed to ethically reduce unnecessary early terminations and other outcomes that can result in missing data
Quality Control via Review of Site Data
- To ensure that Lotus’ methodology training is optimally implemented at all sites, leadership team regularly reviews study data provided by each site
- The team inspects data for consistent/expected placebo response and other key variables, across sites
- Outlier sites are reviewed/retrained
