Expand your knowledge and skills in study protocol design and review. This e-Learning course covers the anatomy of a protocol, hypothesis development, study design, subject safety and data integrity risk considerations, protocol feasibility and protocol amendments.
Improve protocol interpretation and implementation by understanding trial scope, design, conduct, data analysis, and the evaluation and reporting of safety and tolerability data. This eLearning course explores the International Conference on Harmonization’s E9 guideline Statistical Principles for Clinical Trials.
Gain confidence in making risk-based decisions and implementing actions related to quality control initiatives. This eLearning course covers key aspects related to risks in clinical trials, including: identification, analysis, planning, communication, change management and much more.
Assess your and your team’s training needs quickly by conducting an ICH gap analysis. This eLearning course uses a game to challenge the learner’s knowledge and application of these important efficacy guidelines.
The Statement of Investigator (Form FDA 1572) doesn’t have to be complicated – let us help you get it right the first time. This eLearning course answers the questions of why, when and how to complete the FDA 1572 to make everyone’s jobs easier.