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

ROLE%OF%THE%RESEARCH%COORDINATOR

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

Monday, February 3, 14

Objectives

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

? To explain the informed consent process

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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.

h0p://watch?v=A2cjzVINzsc

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Monday, February 3, 14

UCSF%Best%Prac.ce

%Obtaining%Consent%of%Poten.al%Pa.ents

? 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

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Steps%to%Effec.ve% 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

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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

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Monday, February 3, 14