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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).

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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 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 is also considered acceptable training byt 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.

Disponibilidad del idioma: English

Audiencias sugeridas: Individuals who have already completed a basic level GCP course

Organizational Subscription Price: Included in organizational subscription
Independent Learner Price: $129 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.

Physicians

AMA PRA Category 1 Credit

Credits
( CE certified modules)
$

Psychologists

CE Credit/Hour

Credits
( CE certified modules)
$

Nurses

Contact Hour

Credits
( CE certified modules)
$

Other Participants

Certificate of Participation

Credits
( CE certified modules)
$


Course Content


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

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.

Uso recomendado: Required
ID (Idioma): 16779 (English)
Autor (es): Lisa Johnston, BScN, CCRP - Centre for Addiction and Mental Health (CAMH)

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

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

Uso recomendado: Required
ID (Idioma): 16780 (English)
Autor (es): Lisa Johnston, BScN, CCRP - Centre for Addiction and Mental Health (CAMH)

GCP Refresher - Informed Consent CME/CEU Badge New Content

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.

Uso recomendado: Required
ID (Idioma): 16781 (English)
Autor (es): Lisa Johnston, BScN, CCRP - Centre for Addiction and Mental Health (CAMH)

GCP Refresher - Safety Management CME/CEU Badge New Content

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.

Uso recomendado: Required
ID (Idioma): 16782 (English)
Autor (es): Lisa Johnston, BScN, CCRP - Centre for Addiction and Mental Health (CAMH)

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

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.

Uso recomendado: Required
ID (Idioma): 16783 (English)
Autor (es): 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 New Content

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

Uso recomendado: Required
ID (Idioma): 16784 (English)
Autor (es): 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 New Content

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.

Uso recomendado: Required
ID (Idioma): 16785 (English)
Autor (es): Lisa Johnston, BScN, CCRP - Centre for Addiction and Mental Health (CAMH)

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

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.

Uso recomendado: Required
ID (Idioma): 17205 (English)
Autor (es): Daniel Redline, BA - Gilead Sciences

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

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.

Uso recomendado: Required
ID (Idioma): 17206 (English)
Autor (es): Daniel Redline, BA - Gilead Sciences

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

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.

Uso recomendado: Required
ID (Idioma): 17207 (English)
Autor (es): Daniel Redline, BA - Gilead Sciences

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

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.

Uso recomendado: Required
ID (Idioma): 17208 (English)
Autor (es): Daniel Redline, BA - Gilead Sciences

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

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

Uso recomendado: Required
ID (Idioma): 17209 (English)
Autor (es): Daniel Redline, BA - Gilead Sciences

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

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).

Uso recomendado: Required
ID (Idioma): 17210 (English)
Autor (es): Daniel Redline, BA - Gilead Sciences