Informed Consent Form Review and Compliance: Onsite Strategies May 2011

May 12, 2011
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Course Description 

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.



Learning Objectives 

  • 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

Who Should Attend 

  • Sponsor/CRO Study Teams
  • Investigator/CRC Site Study Teams
  • Ethics Committee Members


Elizabeth Weeks-Rowe, L.V.N., C.C.R.A.

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Course Length Time 

1.5 hours; 1:00 - 2:30 p.m. Eastern

Course Dates 

May 12, 2011

Hold this course at your company! For more information, contact Naila Ganatra at (215) 413-2471.