Monitoring is one form of checks and balances that research sponsors conduct to help ensure human subject protections and data integrity for their studies. The process of monitoring informed consent is presented, including monitoring the: ICF template content, proper completion, and documentation of the ICF process. Case examples are presented to promote understanding and stimulate questions for discussion.
- Identify required informed consent template content per regulations, including basic and additional elements
- Monitor the ICF: Clearly define who and what determines if consent has been adequately executed
- Monitor the informed consent process documentation throughout the subjects’ time on study
- Clinical Research Associates
- Research Assistants
- Project Managers
- CRA Managers
Sandra ”SAM” Sather, RN, CCRA, CCRC
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2 hours; 12:30 – 2:30 p.m. Eastern
March 29, 2010
Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471