Online Clinical Courses

Good Clinical Practices

Overview of the Clinical Research Process — (1 Contact Hour/Credit)

This course is designed to give an understanding of the new drug, biologic and device approval process and the significance of how important it is to develop products that meet regulatory requirements for global registrations. ACPE Universal Program Number: 234-000-04-006-L04; California Board of Nursing Program Number: 47111-2004-CBT-213

Ethics as the Foundation of Clinical Research — (1 Contact Hour/Credit)

This course examines current ethical issues in clinical research with a focus on ethical principles in historical and current regulations. ACPE Universal Program Number: 234-000-04-015-L04; California Board of Nursing Program Number: 47111-2004-CBT-210

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CRA Curriculum

GCP/ICH Obligations of Sponsors, Monitors, and Investigators — (1.5 Contact Hours/Credits)

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. ACPE Universal Program Number: 234-000-04-002-L04; California Board of Nursing Program Number: 47111-2004-CBT-198

GCP Obligations of Sponsors and Monitors — (1.5 Contact Hours/Credits)

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. ACPE Universal Program Number: 234-000-04-004-L04; California Board of Nursing Program Number: 47111-2004-CBT-199

Obligations of Investigators in Conducting Drug and Biologic Trials — (1.5 Contact Hours/Credits)

This course addresses investigator requirements and responsibilities for the conduct of clinical trials in support of new drug and biologics applications. ACPE Universal Program Number: 234-000-04-001-L04; California Board of Nursing Program Number: 47111-2004-CBT-200

Obligations of Investigators in Conducting Medical Device Trials — (1.5 Contact Hours/Credits)

This course addresses investigator requirements and responsibilities for the conduct of clinical trials in support of new medical device applications. ACPE Universal Program Number: 234-000-04-003-L04; California Board of Nursing Program Number: 47111-2004-CBT-201

Ethical Review Boards — (2 Contact Hours/Credits)

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. ACPE Universal Program Number: 234-000-04-007-L04; California Board of Nursing Program Number: 47111-2004-CBT-208

Informed Consent — (2 Contact Hours/Credits)

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. ACPE Universal Program Number: 234-000-04-016-L04; California Board of Nursing Program Number: 47111-2004-CBT-207

Drug Safety and Adverse Event Reporting — (2 Contact Hours/Credits)

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. ACPE Universal Program Number: 234-000-04-014-L04; California Board of Nursing Program Number: 47111-2004-CBT-209

Ethics as the Foundation of Clinical Research — (1 Contact Hour/Credit)

This course examines current ethical issues in clinical research with a focus on ethical principles in historical and current regulations. ACPE Universal Program Number: 234-000-04-015-L04; California Board of Nursing Program Number: 47111-2004-CBT-210

The Role of The Clinical Research Associate — (2 Contact Hours)

This course discusses the role of the CRA in regards to clinical operations and monitoring activities. ACPE Universal Program Number: 234-000-04-009-L04; California Board of Nursing Program Number: 47111-2004-CBT-211

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CRC Curriculum

GCP/ICH Obligations of Sponsors, Monitors, and Investigators — (1.5 Contact Hours/Credits)

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. ACPE Universal Program Number: 234-000-04-002-L04; California Board of Nursing Program Number: 47111-2004-CBT-198

GCP Obligations of Sponsors and Monitors — (1.5 Contact Hours/Credits)

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. ACPE Universal Program Number: 234-000-04-004-L04; California Board of Nursing Program Number: 47111-2004-CBT-199

Obligations of Investigators in Conducting Drug and Biologic Trials — (1.5 Contact Hours/Credits)

This course addresses investigator requirements and responsibilities for the conduct of clinical trials in support of new drug and biologics applications. ACPE Universal Program Number: 234-000-04-001-L04; California Board of Nursing Program Number: 47111-2004-CBT-200

Obligations of Investigators in Conducting Medical Device Trials — (1.5 Contact Hours/Credits)

This course addresses investigator requirements and responsibilities for the conduct of clinical trials in support of new medical device applications. ACPE Universal Program Number: 234-000-04-003-L04; California Board of Nursing Program Number: 47111-2004-CBT-201

Ethical Review Boards — (2 Contact Hours/Credits)

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. ACPE Universal Program Number: 234-000-04-007-L04; California Board of Nursing Program Number: 47111-2004-CBT-208

Informed Consent — (2 Contact Hours/Credits)

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. ACPE Universal Program Number: 234-000-04-016-L04; California Board of Nursing Program Number: 47111-2004-CBT-207

Drug Safety and Adverse Event Reporting — (2 Contact Hours/Credits)

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. ACPE Universal Program Number: 234-000-04-014-L04; California Board of Nursing Program Number: 47111-2004-CBT-209

Ethics as the Foundation of Clinical Research — (1 Contact Hour/Credit)

This course examines current ethical issues in clinical research with a focus on ethical principles in historical and current regulations. ACPE Universal Program Number: 234-000-04-015-L04; California Board of Nursing Program Number: 47111-2004-CBT-210

The Role of The Clinical Research Coordinator — (2 Contact Hours)

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. ACPE Universal Program Number: 234-000-04-008-L04; California Board of Nursing Program Number: 47111-2004-CBT-212

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Investigator Curriculum

GCP/ICH Obligations of Sponsors, Monitors, and Investigators — (1.5 Contact Hours/Credits)

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. ACPE Universal Program Number: 234-000-04-002-L04; California Board of Nursing Program Number: 47111-2004-CBT-198

Obligations of Investigators in Conducting Drug and Biologic Trials — (1.5 Contact Hours/Credits)

This course addresses investigator requirements and responsibilities for the conduct of clinical trials in support of new drug and biologics applications. ACPE Universal Program Number: 234-000-04-001-L04; California Board of Nursing Program Number: 47111-2004-CBT-200

Obligations of Investigators in Conducting Medical Device Trials — (1.5 Contact Hours/Credits)

This course addresses investigator requirements and responsibilities for the conduct of clinical trials in support of new medical device applications. ACPE Universal Program Number: 234-000-04-003-L04; California Board of Nursing Program Number: 47111-2004-CBT-201

HIPAA — Impact on Clinical Research — (1.5 Contact Hours/Credits)

This course will provide an introduction to the Health Insurance Portability and Accountability Act (HIPAA). You will learn the history of HIPAA implementation, legal entities involved in HIPAA oversight and compliance, and the impact HIPAA has on clinical research in the United States.ACPE Universal Program Number: 234-000-04-005-L04; California Board of Nursing Program Number: 47111-2004-CBT-202

Ethical Review Boards — (2 Contact Hours/Credits)

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. ACPE Universal Program Number: 234-000-04-007-L04; California Board of Nursing Program Number: 47111-2004-CBT-208

Informed Consent — (2 Contact Hours/Credits)

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. ACPE Universal Program Number: 234-000-04-016-L04; California Board of Nursing Program Number: 47111-2004-CBT-207

Ethics as the Foundation of Clinical Research — (1 Contact Hour/Credit)

This course examines current ethical issues in clinical research with a focus on ethical principles in historical and current regulations. ACPE Universal Program Number: 234-000-04-015-L04; California Board of Nursing Program Number: 47111-2004-CBT-210

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Regulatory Affairs

Overview of the Preparation Requirements for the ICH Common Technical Document — (2.5 Contact Hours)

This course will provide an overview of the organization and common format for the preparation of a well structured ICH Common Technical Document (CTD).ACPE Universal Program Number: 234-000-04-010-L04;
California Board of Nursing Program Number: 47111-2004-CBT-203

Preparation Requirements for ICH CTD M4E — Efficacy — (2.5 Contact Hours)

This course will provide an overview of the organization of the ICH Common Technical Document (CTD), specifically the section on efficacy. ACPE Universal Program Number: 234-000-04-011-L04; California Board of Nursing Program Number: 47111-2004-CBT-204

Preparation Requirements for ICH CTD M4S — Safety — (2.5 Contact Hours)

This course will provide you with the common format for the preparation of a well-structured ICH Common Technical Document (CTD), specifically the section on safety. ACPE Universal Program Number: 234-000-04-013-L04; California Board of Nursing Program Number: 47111-2004-CBT-206

Preparation Requirements for ICH CTD M4Q — Quality — (2.5 Contact Hours)

This course will provide an overview of the organization and common format for the preparation of a well structured ICH Common Technical Document (CTD), specifically the section on quality. ACPE Universal Program Number: 234-000-04-012-L04; California Board of Nursing Program Number: 47111-2004-CBT-205

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Clinical Courses are $175.00 each. Note: Macromedia Flash Player® required. A free download is available from Macromedia Flash. View other technical requirements (.pdf).

Continuing Nursing Education The California Board of Registered Nursing approves the Association of Clinical Research Professionals (ACRP) as a provider of continuing nursing education. Program Numbers 47111-2004-CBT-198 through 47111-2004-CBT-213). Continuing Pharmacy Education The Association of Clinical Research Professionals is accredited by the Accreditation Council on Pharmacy Education as a provider of continuing pharmacy education. ACPE Universal Program Numbers 234-000-04-001-L04 through 234-000-04-016-L04