Event:
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Informed Consent Content and Process Requirements
- Hosted By:
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ComplianceOnline
- Start:
- Friday - Aug 16, 2013 10:00 AM
- End Time:
- Friday - Aug 16, 2013 11:00 AM
- Location:
- Online
- This clinical compliance webinar will discuss the fundamentals of the informed consent process, how to prepare for consenting and how to ensure an adequate consent takes place. It will will cover the ethics involved in consenting and the value of keeping consent documents simple.
Why Should You Attend:
There is risk in clinical research and clinical research is not the same standard of care. The value of this course will be that there will be a clear understanding of these differences.
The informed consent process will be covered in detail so that it is understood that this is an ongoing process and does not end with the signing of the consent documents. The role of the IRB will be discussed with respect to approval of consent documents. The responsibilities of the person consenting on behalf of the PI should understand this responsibility. The PI should have an understanding of the importance of the informed consent in order to ensure these responsibilities if they are delegated are done so appropriately. This course will provide the elements IRBs expect to see in a consent form and how to minimize risk in writing a consent form. The risks and benefits have to be clearly spelled out in a consent form.
Areas Covered in the Webinar:
- ICH guidelines and Good Clinical Practice (GCP)
- 21 CFR 50
- 21 CFR 312
- Version control of the ICF
- The ICF and the IRB
- Responsibility of consenters
- PI responsibility with delegation of responsibility
- Website:
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Visit the website for detail info