2024 ANNUAL NEALS MEETING

Site Management Training

The Site Management course will focus on site management methods, including topics related to feasibility, study start-up and activation, recruitment and retention strategies, informed consent form process, ensuring Good Clinical Practice (GCP), Institutional Review Board (IRB) submissions, utilizing the electronic Regulatory Document System (RegDocs), addressing staffing needs, and/or preparation for monitoring visits.

Outcome Measures Training

The Outcome Measures training is for new and experienced NEALS Clinical Trial Evaluators. The session will focus on training for the core outcomes measures: ALSFRS-R (ALS Functional Rating Scale, Revised), vital capacity. and muscle strength using handheld dynamometry. Attendance at this session will fulfill training requirements for new and re-certifying evaluators. Updates to outcome measure protocols as well as hands-on practice and technique checks will be part of this training.

EAP Training
 

The EAP Training session is specifically designed for NEALS clinicans and researchers to review Expanded Access Programs, show how they differ from other pathways through which patients can access experimental treatments, highlight some challenges, and review steps, resources, and tips for helping study teams launch these at their sites.