Institutional Review Boards (IRBs) or Independent Ethics Committees (IEC)
An Institutional Review Board (IRB) or Independent Ethics Committee (IEC) is an independent body comprising medical, scientific, and non-scientific members, whose responsibility is to ensure the protection of the rights, safety and well-being of human subjects involved in a trial.
An IRB/IEC should carry out the following activities to guarantee the rights and safety of trial subjects:
- Review and approval of trial protocols and amendments
- The review and approval of methods and materials used to obtain and document informed consent of trial subjects
An IRB review is meant assure the following:
- Risks to subjects minimized
- Risks to subjects are reasonable
- Selection of subjects is equitable
- Informed consent will be obtained
- Data will be monitored
- Protection of subject privacy and confidentiality of data
- Additional safeguards for vulnerable subjects
- Expedited review procedures
The IRB review should include the following documents:
- Clinical trial protocol/amendments
- Written informed consent process
- Investigator's Brochure (IB)
- Payments/compensation to subjects
- Form 1572/CVs
- Subject recruitment procedures (ads)
- Subject information
The IRB review should provide the following for clinical trial documentation:
- Provide approval
- Modifications required
- Disapproval
- Termination/suspension
- Reasons for (if applicable) in writing
Clinical Trials and Good Clinical Practice
This Clinical Trials and GCP session describes the principles of Good Clinical Practice including drug development process and Specifics of GCP and quality as related to central laboratory work.
The Importance of ICH Guidelines and its Role in Achieving Good Clinical Practice
This presentation reviews the key concepts of GCP and correlates them to the ICH guidelines.
This Clinical Trial training provides a detailed review of the FDA regulations for Clinical Trials Process.
Price: $29.00
Price: $19.00
Price: $29.00
Price: $29.00
