The process of consenting a person for a clinical trial is important to the validity of the study and to maintaining the rights of participants. Consenting a participant requires more than just a signed document – it is an ongoing process where the participant must always be aware of risks related to their participation, new information learned about the clinical trial, and their options for continuing or withdrawing from the study.
Investigators and clinical staff must learn how to properly and ethically consent a participant for a study. They must also be aware of unique challenges faced when consenting specific populations, such as children who cannot consent for themselves or patients who must be consented in an emergency setting.
Attendance at this program has been approved for 0.20 contact hours of research specific continuing education on applications for Maintenance of ACRP’s CCRC®, CCRA®, CPI®, or ACRP-CP® certification designations.
The Society of Clinical Research Associates (SOCRA - www.SOCRA.org) accepts documentation of candidate participation in continuing education programs for recertification if the program is applicable to clinical research regulations, operations or management, or to the candidate’s clinical research therapeutic area. This program offers 0.20 hours of CE credit.
This training covers the following key topics:
- What is Informed Consent?
- Typical Consent Process, Part I: Preparing for the Conversation
- Typical Consent Process, Part II: Initial Contact
- Typical Consent Process, Part III: Check Understanding
- Non-English Speakers in Clinical Trials
- Consent Documentation
- Children in Clinical Trials
- Ongoing Consent Process
By completing/passing this course, you will attain the certificate Advarra Completion Certificate (No Expire)
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