It is crucial to verify the components of an ICF and compliant signature requirements as part of the site monitoring process. The informed consent form is the means by which subjects are informed of the risks, benefits, and obligations of participation in an investigational study. It is the responsibility of the CRA to give ICF review the highest priority while onsite, and to ensure that all signature and date requirements are completed by those individuals conducting the ICF discussion, as well as the subject consenting to study participation. Additionally, informed consent form requirements have evolved to include HIPAA, tissue and PK categories, pediatric status, as well as individual state regulations and documentation. This course details the various categories of the ICF components, the various IRB signature requirements, and how to correctly review and confirm an ICF during onsite monitoring.
- Review all signature and date requirements for the subject and person conducting ICF discussion
- Review the different types of ICFs and requirements (pediatric assents, tissue and PK samples, HIPAA and PHI, specific state regulations)
- Review the need for ICF revisions, safety information, and the accurate documentation of ICF process in source
- Sponsor/CRO Study Teams
- Investigator/CRC Site Study Teams
- Ethics Committee Members
Elizabeth Weeks-Rowe, L.V.N., C.C.R.A.
Click here for complete trainer biographies
1.5 hours; 1:00 - 2:30 p.m. Eastern
May 12, 2011
Hold this course at your company! For more information, contact Naila Ganatra at (215) 413-2471.