Complying with the HIPAA Privacy Rule in Research

This course will provide a comprehensive understanding of the Privacy Rule and its impact on research. It details the Rule’s impact from the investigator, sponsor and CRO’s perspective and discusses suggestions and considerations that can be used to create a HIPAA compliant clinical research operations model. It provides example protocol language, template documents ( Authorization and Notice), and validity checklists.

Learning Objectives

• Discuss the covered entity’s HIPAA requirements and its research impact with respect to the Notice of Privacy Practices, Access to Medical Records, and Business Associates.
• List the permitted use and disclosure of protected health information without an individual’s authorization.
• Identify the Privacy Rule provisions that allow researchers access to protected health information for research purposes such as aiding subject recruitment, developing protocols, and creating and accessing research databases and repositories.
• Describe the requirements in developing a valid research Authorization, and obtaining and revoking Authorization from the investigator and sponsor or CRO perspectives.
• Define the minimal necessary standard and accounting of disclosures and their application to research.
• Discuss the steps necessary to prepare and conduct a HIPAAcompliant clinical trial from the investigator and sponsor or CRO perspectives.

Who should take this course?

Anyone involved in industry or federally funded research.

• Research Practitioner (ie) Research Nurse, Pharmacist, Sponsors, CROs, and IRB or Privacy Board members.

Requirements for course completion

• A passing grade of 70% on the post test.
• Completion of course evaluation form.

Investigator Training Program

Investigator's Guide to Clinical Research

This course is designed with flow charts, checklists, and diagrams to enhance learning and accompanied by a textbook. The course begins with a brief overview of the drug, biologic, and device clinical research process and defines the investigator, sponsor, and monitor's role and responsibilities. It provides a comprehensive assessment of the investigator obligations and key sponsor obligations found under 21 CFR 312 Investigational New Drug, 21 CFR 812 Investigational Device Exemption, and 21 CFR 54 Financial Disclosure by Clinical Investigators. The course also contains a brief history of ICH and a detailed analysis of the similarities and differences between ICH GCP Consolidated Guideline (E6) Section 4: Investigator and ICH Guideline (E2A) Safety Data Management, versus 21 CFR 312 Investigational New Drug regulation. It also provides a comprehensive assessment of the regulations 21 CFR 50 Protection of Human Subjects and 21 CFR 56 Institutional Review Board. This assessment includes but is not limited to the IRBs operation and function, use of expedited IRB review, criteria for IRB approval, assenting children, consenting non-English speaking and illiterate subjects. The course details key components and strategies used to coordinate the ideal trial. The key components include subject recruitment, research authorization, informed consent, creating and maintaining source documentation, identifying, documenting, and reporting adverse and serious adverse events, assessing concomitant medication usage and performing study drug/biologic/device accountability.

Learning Objectives

• Describe the roles that the Investigator, Monitor, Coordinator, and sponsor play in the clinical research process.
• Discuss the regulations governing investigational drug studies versus investigational medical device studies.
• Identify the regulations used to protect the rights, safety, and well-being of study subjects.
• Recognize the methods and strategies used to conduct the ideal clinical trial.
• Review the differences and similarities between the ICH Guideline (E6) and the FDA regulations.
• List the steps involved in the investigator's assessment and reporting of AEs and SAEs.

Who should take this course?

Anyone involved in industry or federally funded research.

• Coordinators, Investigators, Sponsors, CROs, and IRB or Privacy Board members.

Requirements for course completion

• A passing grade of 70% on the post test.

A Coordinator's Guide to Conducting Clinical Research

A Coordinator's Guide to Conducting Clinical Research

The course begins with a brief overview of the drug, biologic, and device clinical research process and defines the investigator/coordinator, sponsor, and monitor's role and responsibilities. The course details key components and strategies used to coordinate the ideal trial. The key components include subject recruitment, research authorization, informed consent, creating and maintaining source documentation, identifying, documenting, and reporting adverse and serious adverse events, assessing concomitant medication usage and performing study drug/biologic/device accountability. It provides a comprehensive assessment of the investigator obligations and key sponsor obligations found under 21 CFR 312 Investigational New Drug, 21 CFR 812 Investigational Device Exemption, and 21 CFR 54 Financial Disclosure by Clinical Investigators. The course provides a comprehensive assessment of the regulations 21 CFR 50 Protection of Human Subjects and 21 CFR 56 Institutional Review Board. This assessment includes the criteria for IRB approval, assenting children, consenting non-English speaking and illiterate subjects. It reviews the differences and similarities between the ICH guidelines and FDA regulations. This course is designed with flow charts, checklists, and diagrams to enhance learning and is accompanied by a textbook and activity book. The activity book contains several exercises that allow the research coordinator to apply the concepts learned in the online course to the everyday requirements of conducting a clinical trial.

Learning Objectives

Describe the roles that the Coordinator, Investigator, Monitor, and sponsor play in the clinical research process.

Recognize the methods and strategies used to conduct the ideal clinical trial.

Discuss the regulations governing investigational drug studies versus investigational medical device studies.

Identify the regulations used to protect the rights, safety, and well-being of study subjects.

Review the differences and similarities between the ICH Guideline (E6) and the FDA regulations.

List the steps involved in the investigator's assessment and reporting of AEs and SAEs.

Who should take this course?

Anyone involved in industry or federally funded research.

• Coordinators, Investigators, Sponsors, CROs, and IRB or Privacy Board members.

Requirements for course completion

A passing grade of 70% on the post test.

GCP From The Investigator’s Perspective

Learn the methods of complying with GCP from the Investigator’s perspective.