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GCP FDA Refresher

This refresher course provides retraining on GCP for clinical trials with investigational drugs and medical devices (U.S. FDA focus).


About this Course


GCP FDA Refresher reinforces the importance of concepts covered in the basic level GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus) course.

This course (English only) meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors. The course (both English and Spanish) is also considered acceptable training by the National Institutes of Health (NIH) in fulfillment of their GCP training policy (Policy on Good Clinical Practice Training for NIH Awardees Involved in NIH-funded Clinical Trials; NOT-OD-16-148) that says NIH-funded investigators and staff should be trained in GCP.

Language Availability: English, Spanish

Suggested Audiences: Individuals who have already completed a basic level GCP course

Organizational Subscription Price: Included in organizational subscription
Independent Learner Price: $110 per person


CE Credits and Units


To purchase CE credits and units, you need to be affiliated with an organization that subscribes to this course or buy it as an independent learner first.

Psychologists

CE Credit/Hour

3 Credits
(6 CE certified modules)
$50

30 June 2016
30 June 2019

Physicians

AMA PRA Category 1 Credit

3 Credits
(6 CE certified modules)
$50

5 Credits
(10 CE certified modules)
$70

30 June 2016
30 June 2019

Other Participants

Certificate of Participation

3 Credits
(6 CE certified modules)
$40

5 Credits
(10 CE certified modules)
$60

30 June 2016
30 June 2019


Course Content


Toggle Content GCP Refresher - International Conference on Harmonisation (ICH): GCP Requirements CME/CEU Badge New/Updated Badge

Provides a basic understanding of the ICH’s role and impact on conducting clinical research according to GCP. It describes the purpose of ICH and identifies the basic requirements for compliance with ICH GCP.

Recommended Use: Required
ID (Language): 16779 (English), 17371 (Spanish)
Author(s): Lisa Johnston, BScN, CCRP - Centre for Addiction and Mental Health (CAMH)

Toggle Content GCP Refresher - Investigator's Responsibilities and GCP CME/CEU Badge New/Updated Badge

Discusses the investigator’s role and responsibilities when conducting clinical research. It also reviews regulatory requirements and ICH E6 guidelines for the investigator.

Recommended Use: Required
ID (Language): 16780 (English), 17372 (Spanish)
Author(s): Lisa Johnston, BScN, CCRP - Centre for Addiction and Mental Health (CAMH)

Toggle Content GCP Refresher - Informed Consent CME/CEU Badge New/Updated Badge

Provides an overview of informed consent in clinical research. It describes the requirements for complying with the informed consent regulations, the process for obtaining informed consent, and the regulations for waiving informed consent.

Recommended Use: Required
ID (Language): 16781 (English), 17373 (Spanish)
Author(s): Lisa Johnston, BScN, CCRP - Centre for Addiction and Mental Health (CAMH)

Toggle Content GCP Refresher - Safety Management CME/CEU Badge New/Updated Badge

Covers safety management in clinical research. It defines adverse events and related terminology, describes the process for identifying events, and describes the investigator's requirements regarding recording/documenting and reporting events.

Recommended Use: Required
ID (Language): 16782 (English), 17374 (Spanish)
Author(s): Lisa Johnston, BScN, CCRP - Centre for Addiction and Mental Health (CAMH)

Toggle Content GCP Refresher - Investigational Product (Drug) Management CME/CEU Badge New/Updated Badge

Describes an investigator’s responsibilities when using investigational products according to GCP standards. It covers the management requirements for the use of investigational products and the requirements for storage and handling of drugs in clinical trials.

Recommended Use: Required
ID (Language): 16783 (English), 17375 (Spanish)
Author(s): Lisa Johnston, BScN, CCRP - Centre for Addiction and Mental Health (CAMH); Keri Durant, BSc., PGCR, CCRP - Sunnybrook Health Sciences Centre

Toggle Content GCP Refresher - Audits, Inspection, and Monitoring of Research Studies CME/CEU Badge New/Updated Badge

Reviews auditing, inspections, and monitoring of drug studies in clinical research.

Recommended Use: Required
ID (Language): 16784 (English), 17376 (Spanish)
Author(s): Lisa Johnston, BScN, CCRP - Centre for Addiction and Mental Health (CAMH); Amr Sharaf, BS (Hons), CCRP, PGCR - Applied Health Research Centre (AHRC),The HUB, Li Ka Shing Knowledge Institute, St. Michael's Hospital

Toggle Content GCP Refresher - Sponsor Responsibilities and GCP CME/CEU Badge New/Updated Badge

Provides an overview of the sponsor's role and responsibilities in complying with GCP guidelines and applicable regulations. It also reviews the similarities and differences between the roles of a sponsor and sponsor-investigator.

Recommended Use: Required
ID (Language): 16785 (English), 17377 (Spanish)
Author(s): Lisa Johnston, BScN, CCRP - Centre for Addiction and Mental Health (CAMH)

Toggle Content GCP Refresher - Conducting Clinical Investigations of Devices CME/CEU Badge New/Updated Badge

Identifies investigator responsibilities in clinical investigations and discusses federal regulatory requirements and international guidelines for investigational trials of devices. It also identifies what documents and reports are due to the U.S. and international regulatory authorities, and describes the role of a sponsor-investigator in a clinical investigation of a medical device.

Recommended Use: Required
ID (Language): 17205 (English), 17362 (Spanish)
Author(s): Daniel Redline, BA - Gilead Sciences

Toggle Content GCP Refresher - Review of U.S. FDA Regulations for Investigational Devices CME/CEU Badge New/Updated Badge

Describes the U.S. regulatory requirements for various classes and categories of medical devices and explains the differences between significant risk (SR), non-significant risk (NSR), humanitarian, and exempt medical devices.

Recommended Use: Required
ID (Language): 17206 (English), 17363 (Spanish)
Author(s): Daniel Redline, BA - Gilead Sciences

Toggle Content GCP Refresher - Additional GCP Standards for International Clinical Investigations of Devices CME/CEU Badge New/Updated Badge

Discusses the international standards that address GCP for the design, conduct, recording, and reporting of clinical investigations of devices involving human subjects to assess their safety and/or performance. Further, it describes the ISO 14155:2011 GCP standard and compares the ISO 14155:2011 GCP standard to the FDA regulations.

Recommended Use: Required
ID (Language): 17207 (English), 17364 (Spanish)
Author(s): Daniel Redline, BA - Gilead Sciences

Toggle Content GCP Refresher - Informed Consent and Exceptions to the Requirement for Obtaining Consent for Clinical Investigations of Devices CME/CEU Badge New/Updated Badge

Describes the general requirements for obtaining and documenting informed consent, including orally without obtaining a signature on the consent form. It also describes the exception to the requirements for emergency use and emergency research and to the requirements for investigations of in vitro diagnostic assays.

Recommended Use: Required
ID (Language): 17208 (English), 17365 (Spanish)
Author(s): Daniel Redline, BA - Gilead Sciences

Toggle Content GCP Refresher - Oversight of Clinical Investigations of Devices CME/CEU Badge New/Updated Badge

Covers the oversight of clinical investigations of medical devices in the U.S. and internationally.

Recommended Use: Required
ID (Language): 17209 (English), 17366 (Spanish)
Author(s): Daniel Redline, BA - Gilead Sciences

Toggle Content GCP Refresher - Reporting Requirements for Clinical Investigations of Devices CME/CEU Badge New/Updated Badge

Explains the reporting requirements of 21 CFR 812 (the FDA regulations for the conduct of clinical investigations of devices) and International Organization for Standardization (ISO) 14155:2011 - Clinical Investigation of Medical Devices for Human Subjects – Good Clinical Practice (the international standard for the conduct of investigations of devices).

Recommended Use: Required
ID (Language): 17210 (English), 17367 (Spanish)
Author(s): Daniel Redline, BA - Gilead Sciences