CRC Curriculum
GCP/ICH Obligations of Sponsors, Monitors, and Investigators
This course addresses the obligations of sponsors, monitors, and investigators who conduct and verify clinical research that is governed by US FDA regulations and ICH guidelines. California Board of Nursing Program Number: 11147-2004-CBT-198 — (1.5 Contact Hours/Credits)
GCP Obligations of Sponsors and Monitors
This course addresses the obligations of sponsors and monitors who conduct and verify clinical research that is governed by US FDA regulations and ICH guidelines. California Board of Nursing Program Number: 11147-2004-CBT-199 — (1.5 Contact Hours/Credits)
Obligations of Investigators in Conducting Drug and Biologic Trials
This course addresses investigator requirements and responsibilities for the conduct of clinical trials in support of new drug and biologics applications. California Board of Nursing Program Number: 11147-2004-CBT-200 — (1.5 Contact Hours/Credits)
Obligations of Investigators in Conducting Medical Device Trials
This course addresses investigator requirements and responsibilities for the conduct of clinical trials in support of new medical device applications. California Board of Nursing Program Number: 11147-2004-CBT-201 — (1.5 Contact Hours/Credits)
Ethical Review Boards
This course covers IRB/IEC members, investigators, and sponsors/CROs obligations in relation to the IRB/IEC and will be able to ensure that policies and procedures developed for compliance will protect and safeguard the research subjects. California Board of Nursing Program Number: 11147-2004-CBT-208 — (2 Contact Hours/Credits)
Informed Consent
This course will introduce you to informed consent regulations and guidelines, the informed consent process, and the roles and responsibilities of clinical research professionals in ensuring the protection of human subjects through the informed consent process. California Board of Nursing Program Number: 11147-2004-CBT-207 — (2 Contact Hours/Credits)
Drug Safety and Adverse Event Reporting
This course will introduce you to the regulatory requirements in the clinical trial and post-marketing environments, as well as educate you on drug safety monitoring efforts internationally. California Board of Nursing Program Number: 11147-2004-CBT-209 — (2 Contact Hours/Credits)
Ethics as the Foundation of Clinical Research
This course examines current ethical issues in clinical research with a focus on ethical principles in historical and current regulations. California Board of Nursing Program Number: 11147-2004-CBT-210 — (1 Contact Hour/Credit)
The Role of The Clinical Research Coordinator
This course discusses the role of the CRC in regards to daily clinical trial activities and overall responsibility in study conduct under the supervision of the clinical investigator. California Board of Nursing Program Number: 11147-2004-CBT-212 — (2 Contact Hours)