Best Practices, Resources & Links

Links

• UNC Clinical Trials Quality Assurance (CTQA) Regulatory Templates

  research.unc.edu/clinical-trials/training/forms
• Guidance for Industry: Investigator Responsibilities – Protecting the Rights, Safety, and Welfare of Study Subjects

  fda.gov/regulatory-information/search-fda-guidance-documents/investigator-responsibilities-protecting-rights-safety-and-welfare-study-subjects
• Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by Clinical Investigators

  fda.gov/regulatory-information/search-fda-guidance-documents/financial-disclosure-clinical-investigators

Guidance for Clinical Investigators, Sponsors, and IRBs

• Statement of Investigator (Form FDA 1572) FAQs

  fda.gov/regulatory-information/search-fda-guidance-documents/frequently-asked-questions-statement-investigator-form-fda-1572
• Medical Devices FAQs

  fda.gov/regulatory-information/search-fda-guidance-documents/frequently-asked-questions-about-medical-devices
• Significant Risk and Nonsignificant Risk Medical Device Studies

  fda.gov/regulatory-information/search-fda-guidance-documents/significant-risk-and-nonsignificant-risk-medical-device-studies
• Data Retention When Subjects Withdraw From FDA-regulated Clinical Trials

  fda.gov/regulatory-information/search-fda-guidance-documents/data-retention-when-subjects-withdraw-fda-regulated-clinical-trials
• Exception From Informed Consent Requirements for Emergency Research

  fda.gov/regulatory-information/search-fda-guidance-documents/exception-informed-consent-requirements-emergency-research
• IND Applications – Determining Whether Human Research Studies Can Be Conducted Without an IND

  fda.gov/regulatory-information/search-fda-guidance-documents/investigational-new-drug-applications-inds-determining-whether-human-research-studies-can-be
• Safety Reporting Requirements for IND and BA/BE Studies

  fda.gov/regulatory-information/search-fda-guidance-documents/safety-reporting-requirements-inds-investigational-new-drug-applications-and-babe
• IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed

  fda.gov/regulatory-information/search-fda-guidance-documents/irb-responsibilities-reviewing-qualifications-investigators-adequacy-research-sites-and
• Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies

  fda.gov/regulatory-information/search-fda-guidance-documents/investigational-device-exemptions-ides-early-feasibility-medical-device-clinical-studies-including
• Adverse Event Reporting to IRBs – Improving Human Subject Protection

  fda.gov/regulatory-information/search-fda-guidance-documents/adverse-event-reporting-irbs-improving-human-subject-protection
• In Vitro Diagnostics (IVD) FAQs

  fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/guidance-industry-and-fda-staff-vitro-diagnostic-ivd-device-studies-frequently-asked-questions

International Council for Harmonisation (ICH)

• ICH Website

  ich.org/page/efficacy-guidelines
• ICH E2A Expedited Safety Reporting

  database.ich.org/sites/default/files/E2A_Guideline.pdf
• ICH E3 Guideline for Industry: Structure and Content of Clinical Study Reports

  fda.gov/regulatory-information/search-fda-guidance-documents/e3-structure-and-content-clinical-study-reports
• ICH E6 Guideline for Good Clinical Practice

  database.ich.org/sites/default/files/E6_R2_Addendum.pdf
• ICH E8 General Considerations for Clinical Trials

  database.ich.org/sites/default/files/E8_Guideline.pdf