Good Clinical Practice (GCP) 51
- Evaluation of Sex-Specific Data in Medical Device Clinical Studies
- Written Procedures for Institutional Review Boards (IRBs): Content and Organization
- Informed Consent in Clinical Investigations: Requirements, Documentation, and Procedures
- Clinical Investigator Disqualification Procedures and Administrative Actions
- Patient Engagement in Medical Device Clinical Studies: Roles, Benefits and Best Practices
- Clinical and Non-Clinical Testing for Medical Devices to Treat Benign Prostatic Hyperplasia (BPH)
- Certificates of Confidentiality for Non-Federally Funded Research: Protection of Human Subject Privacy in FDA-Regulated Studies
- Civil Money Penalties Related to ClinicalTrials.gov Requirements
- Clinical Investigation Requirements for Prostate Tissue Ablation Systems
- Testing and Performance Requirements for Electrosurgical Devices and Accessories for General Tissue Cutting and Coagulation
- Humanitarian Device Exemption (HDE) Program: Operational Requirements and Benefit-Risk Assessment
- Humanitarian Use Device (HUD) Designation Requests: Content and Format
- Live Case Presentations During Investigational Device Clinical Trials
- Impact of Revised Common Rule on FDA-Regulated Clinical Investigations
- Acceptance of Clinical Data to Support Medical Device Applications and Submissions
- Investigational In Vitro Diagnostic Devices Used in Therapeutic Product Clinical Trials (DRAFT)
- Minutes of Institutional Review Board (IRB) Meetings - Content and Documentation Requirements
- Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies
- Clinical Trial Considerations for Neurological Devices Intended to Slow, Stop, or Reverse Disease Progression
- Bipolar Electrosurgical Vessel Sealers for General Surgery - Performance Testing and Labeling Requirements
- Adaptive Designs for Medical Device Clinical Studies
- Leveraging Existing Clinical Data for Pediatric Medical Device Indications
- Clinical Trial Design and Regulatory Considerations for Nail Appearance and Onychomycosis Treatment Devices
- Transfer of Clinical Investigation Oversight Between Institutional Review Boards
- Research Use Only and Investigational Use Only In Vitro Diagnostic Products - Labeling and Distribution Requirements
- Design Considerations for Medical Device Pivotal Clinical Studies
- Early Feasibility Medical Device Clinical Studies Including First in Human (FIH) Studies
- Electronic Source Data in Clinical Investigations
- IRB Responsibilities for Reviewing Investigator Qualifications, Research Sites, and IND/IDE Requirements
- Risk-Based Monitoring in Clinical Investigations of Medical Products
- Exception from Informed Consent Requirements for Emergency Research
- Financial Disclosure Requirements for Clinical Investigators
- Continuing Review of Clinical Investigations by Institutional Review Boards (IRBs)
- Exculpatory Language in Informed Consent Documents for Clinical Research (DRAFT)
- In Vitro Diagnostic Device Studies Exempt from Investigational Device Exemption Requirements
- Patient-Reported Outcome Measures: Development, Implementation and Evaluation in Clinical Trials
- Investigator Responsibilities - Protecting Human Subjects and Ensuring Data Integrity in Clinical Research
- IRB Registration Requirements and Procedures
- Adverse Event Reporting to IRBs Under FDA-Regulated Research
- Data Retention Requirements When Clinical Trial Subjects Withdraw from FDA-Regulated Studies
- Clinical Study Design Recommendations for Catheter Ablation Devices in Treatment of Type I Atrial Flutter
- Marketing and Distribution Requirements for Analyte Specific Reagents (ASRs)
- Neurothrombectomy Devices for Acute Ischemic Stroke Treatment - Pre-clinical and Clinical Testing
- Process for Clinical Investigations Involving Children Requiring Additional Safeguards
- Use of Leftover Human Specimens in IVD Device Studies: Requirements for IDE Exemption and Privacy Protection
- Establishment and Operation of Clinical Trial Data Monitoring Committees
- Pharmacogenomic Data Submissions in Drug Development and Biomarker Classification
- Electronic Records and Electronic Signatures - Scope and Application
- Software Validation for Medical Device Production, Quality Systems, and Device Components
- Categories of Research Eligible for Expedited IRB Review
- Design Controls for Medical Device Manufacturers