GCP ICH Refresher

This refresher course offers retraining on GCP for clinical trials with investigational drugs and biologics (ICH focus).

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About this Course

GCP ICH Refresher reinforces the importance of concepts covered in the basic level GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus) course.

This course 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.

CITI Program GCP training is used by over 1,500 institutions – (including many leading hospitals, academic medical centers, universities, and healthcare companies) – to meet their GCP training needs. The National Institutes of Health (NIH)* requires completion of GCP training that demonstrates that individuals have attained the fundamental knowledge of clinical trial quality standards for designing, conducting, recording, and reporting trials that involve human research participants.

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* 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) states that NIH-funded investigators and staff should be trained in GCP. The NIH does not endorse any specific training programs. CITI Program offers several GCP courses that are considered acceptable by many leading organizations to meet their training needs per NIH policy released on 16 September 2016.


Language Availability: English

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

Organizational Subscription Price: Included with Good Clinical Practice series, available as part of an organizational subscription package or for $1,000 as an add-on to current subscriptions.
Independent Learner Price: $129 per person

Demo Instructions


Course Content

GCP Refresher - International Conference on Harmonisation (ICH): GCP Requirements CME/CEU 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)

GCP Refresher - Investigator's Responsibilities and GCP CME/CEU 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)

GCP Refresher - Informed Consent CME/CEU 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)

GCP Refresher - Safety Management CME/CEU 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)

GCP Refresher - Investigational Product (Drug) Management CME/CEU 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

GCP Refresher - Audits, Inspection, and Monitoring of Research Studies CME/CEU 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

GCP Refresher - Sponsor Responsibilities and GCP CME/CEU 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)


CME/CEU Credits

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.

Physicians
AMA PRA Category 1 Credit
3 Credits
(5 CE certified modules)
$60
1 June 2021
31 May 2024
Psychologists
CEP Credit/Hour
3 Credits
(5 CE certified modules)
$60
1 June 2021
31 May 2024
Pharmacists
CPE Contact Hour
3 Credits
(5 CE certified modules)
$60
1 June 2021
31 May 2024
Dentists
ADA CERP Credit
3 Credits
(5 CE certified modules)
$60
1 May 2022
31 May 2024
Optometrists
COPE CE Credit
3 Credits
(5 CE certified modules)
$60
1 May 2022
31 May 2024
Nurses
Nursing Contact Hour
3 Credits
(5 CE certified modules)
$50
1 June 2021
31 May 2024
Dietitians
CDR CPEU
3 Credits
(5 CE certified modules)
$50
1 May 2022
31 May 2024
Social Workers
Ethics CE Credit
3 Credits
(5 CE certified modules)
$50
1 June 2021
31 May 2024
Athletic Trainers
Category A hour/CEU
3 Credits
(5 CE certified modules)
$50
1 May 2022
31 May 2024
Other Participants
Certificate of Participation
3 Credits
(5 CE certified modules)
$50
1 June 2021
31 May 2024


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