Pre-clinical Research Step in the Drug Development Process (FDA) Good Laboratory Practice
Clinical Research Step in the Drug Development Process (FDA)
Am I doing Human Subjects Research? (NIH)
Institutional Review Boards and Protection of Human Subjects in Clinical Trials (FDA)
Regulatory Toolbox – Investigational New Drugs or Biologics (NIH) What’s an IND? Is this study IND exempt?
Regulations: Good Clinical Practice and Clinical Trials (FDA)
A General Overview of Medical Product Clinical Investigations
Before pharmaceutical or biologic products become available to the public, clinical studies must be conducted to ensure that these products are safe and efficacious. These studies, also called trials, involve human participants. There are four main types of studies involved in the medical product development process: Phase I, II, III, and IV. The type of study that needs to be conducted depends on the stage of development, the type of marketing application, as well as the complexity and risks associated with the product on consumers.
Considerations for Drug Substances/Generic Drugs Clinical Trials
- Phase I and II are conducted post-Investigational New Drug Application (IND) approval.
- Phase III studies are used for New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs).
- Studies for marketing approval of generics must demonstrate bioavailability or bioequivalence to the reference drug, often a brand-name drug. These studies can include animal studies or clinical trials but they are not always required.
Considerations for Biologics/Biosimilars Clinical Trials
- Clinical trials for biosimilars sometimes occur after the completion of analytical and animal studies to further address any clinically meaningful differences between the proposed biosimilar and reference biologic i.e., investigating pharmacodynamics and pharmacokinetics of the biosimilar in study participants.
- The FDA permits risky gene therapy trials involving the pediatric population, provided that the IRB can demonstrate that the risks of the trial are only slightly higher than the minimal risk of the investigation itself. This process is outlined in CFR 50.54 by the FDA.
Click each title below to reveal resources.
Clinical Trials Guidance Documents (FDA) Search for FDA guidance documents
Data Retention When Subjects Withdraw from FDA-Regulated Clinical Trials
Decentralized Clinical Trials for Drugs, Biological Products, and Devices
Enhancing the Diversity of Clinical Trial Populations – Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry
Human Gene Therapy for Rare Diseases
Citi (Collaborative Institutional Training Initiative) Program (GCP, HIPPA, and Human Subjects training)
Clinical Trial Quality Training Series (Monitoring, Auditing, Site Preparedness for FDA Inspection)
eMPACT Translational Workforce Development Course Catalog Continuation education credits
Society of Clinical Research Associates (SOCRA) Clinical Research Professional Certification
Association of Clinical Research Professionals (ACRP) Multiple certification types depending on role
Clinicaltrials.gov Online database of clinical research studies in the US and 200 other countries
EudrLinkaCT European Union Drug Regulating Authorities Clinical Trial Database
International Clinical Trials Registry Platform (ICTRP) International Clinical Trials Registry Platform
MedWatch: The FDA Safety Information and Adverse Event Reporting Program (FDA)
List of Registries + Registry FAQ (NIH)
Forms and Templates
Human Research Protection Program (HRPP)
Post [IRB] Approval Monitoring (PAM) USC Self-Assesment Tool to verify research is conducted as approved by IRB (available Jan. 1, 2024)
Southern California Clinical and Translational Science Institute (SC CTSI) Tools and Services for Conducting Research