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GCP Device Refresher

This refresher course provides retraining on GCP for clinical investigations of devices.

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About this Course


GCP Device Refresher reinforces the importance of concepts covered in the basic level GCP for Clinical Investigations of Devices course.

Disponibilidad del idioma: English

Audiencias sugeridas: Clinical Research Coordinators, Clinical Research Organizations (CROs), Key Study Personnel, Principal Investigators, Research Nurses, Research Staff, Research Teams Involved in Clinical Trials of Devices—Specifically, Sponsors, Study Coordinators

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


Course Content


GCP Refresher - Conducting Clinical Investigations of Devices 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 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 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 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 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 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