SOCRA Exam Prep - Study Start Up 1

Overview of Clinical Research Regulations

Responsible for protecting the rights, welfare, and wellbeing of volunteers who participate in research supported by the U.S. Department of Health and Human Services (HHS).

What is the Office for Human Research Protections (OHRP)?

It regulates clinical investigations of products under its jurisdiction such as biological products and medical devices.

Describe the FDA’s role in clinical research.

Regulations are found in chapter 21 of the CRF and human subject protection sub protection regulations are in parts 50, 56, 312, and 812. Other important sub parts are 11 and 54.

List the chapter and subject protection regulations of the U.S. Code of Federal Regulations for the FDA.

45 CFR 46 is the regulations for the protection of human subjects in research. It provides a robust set of protections for research subjects.

What is the “Common Rule”?

Institution agrees to apply HHS regulations to all research regardless of funding source.

What is a Federal Wide Assurance?

A research study in which one or more human subjects are prospectively assigned to one or more interventions to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.

What is the definition of a clinical trial under 46 CFR 46.102(b)?

The agency’s current thinking on the conduct of clinical trials/good clinical practice and human subject protection. They should be viewed only as recommendations, unless otherwise specified.

What are FDA Guidance Documents?

Created in 1990 as joint regulatory/industry project to improve efficiency of the process for developing and registering new medicinal products in Japan, Europe, and the U.S. This is done through the development of guidelines developed through scientific consensus with regulatory and industry.

What is ICH?

Clinical safety data management

What does E2A of ICH cover?

Good clinical practice (GCP)

What does E6 of ICH cover?

An ethical and scientific quality standard for designing, conducting, recording, and reporting of trials that involve human subjects.

Describe what GCP is.

1. Using a risk management approach to designing studies

2. Promoting the use of risk-based and centralized monitoring in managing studies

3. Addressing the reporting and follow-up of significant noncompliance

4. Addressing technology issues

5. Specify oversight responsibilities of sponsor and investigators

6. Improving data integrity (ALLCOA-C)

7. Ensuring both investigators and sponsors have access to study data and documents

List key features to the CPG revision?