-
Guidance and Resources for New Investigators - Courses & Descriptions
CITI Good Clinical Practice Modules are described below - http://www.citiprogram.org
- CITI: FDA Regulated Research and ICH for Investigators - Addresses responsibilities of investigators, IRBs, and sponsors when they participate in a study of an FDA-regulated product.
- CITI: Conducting Investigator-Initiated Studies According to FDA Regulations and GCP - Describes the role of sponsor-investigator, help determine whether an IND or IDE is required for your study, and indicate what documentation is required by the FDA.
- CITI: Investigator Obligations in FDA-Regulated Clinical Research - Describes the commitments and obligations that investigators assume when participating in clinical investigations; to subjects, IRB, sponsor organization, and the FDA
- CITI: Managing Investigational Agents According to GCP Requirements - Describes the responsibilities of investigators when using investigational products according to GCP standards.
- CITI: Overview of U.S.FDA Regulations for Medical Devices - Describes the differences of research regulatory requirements for various classes and categories of devices.
- CITI: Reporting Serious Adverse Events - Identify criteria for reporting serious adverse events (SAEs) to regulatory agencies and defines serious and unexpected events which require immediate reporting.
- CITI: Audits and Inspections in Clinical Trials - Identifies different entities that can inspect or audit a clinical trial investigator and factors that determine whether an investigator will be audited