Definition of Human Subjects Research (NIH) Am I Doing Human Subjects Research?
Guiding Principles for Ethical Research (NIH)
Institutional Review Boards and Protection of Human Subjects in Clinical Trials (FDA) Information governing human subject protection and conduct of clinical trials
Institutional Review Boards (Frequently Asked Questions)
Regulations: Good Clinical Practice and Clinical Trials (FDA)
CDRH – Center for Devices and Radiological Health (FDA) Oversight for medical devices and radiation-emitting products
Early Feasibility Studies (EFS) Program (FDA) Limited clinical investigation of a device early in development
Medicare Coverage Related to Investigational Device Exemption (IDE) Studies
Routine Costs in Clinical Trials (CMS)
![Clinical Research](https://sc-ctsi.org/uploads/resources/_standardWidth650/clinical-research.jpg)
A General Overview of Medical Product Clinical Investigations
Before medical devices become available to the public, clinical studies must be conducted to ensure their safety and efficacy. These studies, also known as trials, involve human participants. There are two stages for medical device clinical research conducted in humans that occur before marketing: Pilot/Early Feasibility studies and Pivotal studies. The selection of the appropriate study type depends on such factors as the stage of development, the type of marketing application, as well as the complexity of the product and the risks they pose to consumers.
Considerations for Medical Devices Clinical Trials
- Most clinical studies primarily support Premarket Approval (PMA); only a small percentage of 510(k) applications require clinical data.
- Clinical evaluation of new devices, modifications or new uses of legally marketed devices require investigational use, which, unless exempt, requires the submission of an Investigational Device Exemption (IDE). Having an IDE in place allows legal shipment of devices for investigation purposes.
- The Early Feasibility Studies (EFS) Program applies to devices subject to Premarket Approval (PMA), Premarket Notification [510(k)], De Novo classification, or Humanitarian Device Exemption. Eligible devices for EFS include those previously used under the Expanded Access pathway, used outside of the United States, or marketed devices for new indications.
- The pivotal stage (large-scale studies) gathers information to evaluate a device's safety and effectiveness for its intended use.
Resources
Click each title below to reveal the resources
Regulatory Toolbox – What is an IDE? (NIH) Includes IDE Exemption Criteria and Study Risk Determination, Initial IDE Submission, FDA Meetings, IDE Maintenance
Investigational Device Exemption (IDE)
IDE Contacts (FDA) Inquiries about medical devices (other than GCP questions)
Expanded Access – Information for Physicians Compassionate Use
Emergency Use Authorization
Clinical Trials Guidance Documents (FDA) Search for FDA guidance documents
Informed Consent
Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards
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
Design Considerations for Pivotal Clinical Investigations
Adaptive Designs for Medical Device Clinical Studies
Use of Data Monitoring Committees in Clinical Trials
Humanitarian Use Device (HUD) Designation Program
Protocol Templates for Clinical Trials
Clinical Research Study Investigator’s Toolbox
Forms and Logs for Clinical Study Start-Up and Conduct An A to Z repository of forms, logs, and checklists for participant charts, regulatory binders, investigational products, etc.
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 Continuing 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
EudraCT 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
MedSun: Medical Product Safety Network Adverse event reporting program
MAUDE: Manufacturer and User Facility Device Database of medical device reports submitted to the FDA
IRB Forms and TemplatesHuman Research Protection Program (HRPP)
iStar FAQ
Post [IRB] Approval Monitoring (PAM) USC Self-Assessment Tool to verify research is conducted as approved by IRB
Guide to Clinical Research at USC (SC CTSI)
USC Clinical Studies Directory (SC CTSI) Recruitment tool
Tools and Services for Conducting Research (SC CTSI)
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