Spotlight: Clinical Trial Improvement Implementation & Education Recommendation

ACTSI key function programs are engaged in the implementation of the Clinical Trial Task Force recommendations including "Key Concepts in Clinical Research." This is an online course required for investigators working with human subjects developed upon advice and approval of the Clinical Trials Executive Committee, the Clinical Trials Task Force, the ACTSI Ethics & Regulatory program, and other clinical trials advisory groups to provide supplementary content to CITI certification for clinical investigators specific to clinical trials involving human subjects.

The curricula comprises a series of web-based training modules intended to:

• enhance an investigator's ability to comply with the requirements of Good Clinical Practices;
• properly delegate authority; manage clinical trial operations;
• recognize and avoid research misconduct;
• improve the outcomes of monitoring and audits performed by sponsors and the FDA.

Existing Emory investigators must complete all of the modules and all new investigators must complete them as a prerequisite for receiving IRB approval. The course is also available for ACTSI partners and to the national CTSA consortium.