Clinical and translational science institute ctsi

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Clinical and Translational Science Institute / CTSI

at the University of California, San Francisco

Welcome to Online Training for Clinical Research Coordinators


Informed Consent and Informed Consent Process Best Practices IAW Protection of Human Subjects 21 CFR Part 50 Part 2

Monday, February 3, 14


? To describe the terms, requirements, process and documentation standards for study subject's informed consent(s).

? To explain the informed consent process


Monday, February 3, 14

Elements of Informed Consent

Q: Who is best person to approach subject for the study? A: Key Personnel

? Principal Investigator

? Person designated by the investigator (e.g. Nurse Practitioner, SubInvestigator) who is listed on the CHR application

? Appropriately qualified and completed CITI training; has medical knowledge as needed, understanding of adverse effects known to date [Investigator's Brochure, Comparator's Product Label)

? "Team Approach" involves research coordinator as protocol procedure manager to help subject navigate what is expected from their participation.



Monday, February 3, 14


? PI, NP, Qualified Research Nurse or CNS Responsibilities ? CRC Responsibilities ? Distribution of consent copies, after signatures ? Reference the Delegation of Responsibility and Staff Signature Log ? Utilize UCSF Informed Consent Documentation Form (HUB) ? Surrogate consents, Faxing signed consent, SFVAMC subjects ? Consent process for non-English speaking subjects

? ? "Short Form" consent procedure per CHR


Monday, February 3, 14 Informed%Consent%Process

? Discussion of Information by staff listed on CHR

application and sponsor delegation log

? Use the latest approved version from iRIS ? Consent and Signature-all fields completed ? Copy given to subject ? Documentation of the Process


Monday, February 3, 14

When%is%the%Most%Appropriate%Time% to%Obtain%Consent%from%a%Pa.ent?

Prior to participation in the trial

? Prior to changing or altering the potential subject's treatment plan, medications etc.

? Prior to screening, study-specific procedures ? Requires documentation in the subject's medical and/or

research record - Date and time informed consent obtained


Monday, February 3, 14

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