good clinical practice (gcp) training requirement · gcp requirement •effective january 1, 2017,...

Good Clinical Practice (GCP) Training Requirement

GCP Requirement• Effective January 1, 2017, Good Clinical Practice (GCP) training is required

for all research personnel involved in the conduct, management and oversight of a clinical trial. – The NIH defines a clinical trial as “a research study in which one or more human subjects

are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on biomedical or behavioral outcomes.”

• GCP principles describe the responsibilities of investigators, sponsors, monitors and IRBs in the conduct of clinical trials.

• Training should be refreshed at least every three years in order remain current with regulations, standards and guidelines.

• More information on this requirement can be found: Lurie Children’s GCP

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GCP & IRB Protocols

• Beginning April 1, 2017, IRB approval of new or periodic review of any clinical trial will not be issued unless all research personnel are in compliance with the GCP education requirements.

• GCP training is required in addition to the current IRB Human Subjects Training, and is outlined in the IRB Policies and Procedures Manual, Section 6 Required Education and Training for Human Subjects Research.

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How to obtain GCP Training• ACRP GCP Modules

• NIH GCP Training

• CITI Program GCP modules

• Society of Behavioral Medicine GCP Training

• Industry sponsored GCP training (meeting institutional requirements)

• Clinical Research Coordinator (CRC) Basic Training offered by NUCATS

• Provide evidence of other applicable certification, training or conference attendance (e.g., SOCRA, ACRP, PRIM&R, etc.).

Options for training and directions for submitting proof of training are also outlined on the Lurie Children’s GCP page.

Contact GCP@luriechildrens.org with any questions. 4

ACRP GCP Training Modules

• To obtain a username and login please email: GCP@luriechildrens.org• Access modules by going here:

http://learning.acrpnet.org/ext/avectra/login/index.php

• 4 Courses

• Only need to complete 1

ACRP GCP Training Modules

• Scroll Down the page to find 1 of the 4 courses you want to take.

Helpful Hint: Once course is completed. You must complete Course Evaluation and then your Certificate becomes available (takes about 10 min).

ACRP GCP Training Modules

Example:

ACRP GCP Training Modules

Transcript:

ACRP GCP Training Modules

ACRP GCP Training Modules

YOUR NAME WILL BE HERE

GCP Documentation1. Keep documentation of your training in your personal files

2. Provide documentation of your training to the applicable research staff in your department for safe keeping

3. Provide documentation to the institution here: Lurie Children’s GCP

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GCP Documentation

Northwestern University Faculty / Staff

• You can choose to complete either NU or Lurie GCP, but both institutions will need the certificate for documentation.

• You may receive this email too:

• Having Issues, Need a login or have further questions? –Contact:• SharePoint Page: Lurie Children’s GCP

• Email: GCP@luriechildrens.org

GCP Questions