Regulations & Guidances current as of :

(GCP-3) good clinical practice

Essential Regulations and Guidances for Clinical Research Site and IRB Personnel

US Code Of Federal Regulations Title 21: Food And Drugs
  • part 11—electronic records; electronic signatures
  • part 50—protection of human subjects
  • part 54—financial disclosure by clinical investigators
  • part 56—institutional review boards
US Code of Federal Regulations Title 45: Public Welfare
  • part 46—protection of human subjects
  • Part 46—Protection of Human Subjects (effective January 19, 2018) Including “edit marks” comparing the the current and upcoming versions)
FDA Guidances for Industry
  • “off-label” and investigational use of marketed drugs, biologics, and medical devices
  • a guide to informed consent
  • acceptance of foreign clinical studies
  • clinical investigator administrative actions – disqualification
  • Collection of Race and Ethnicity Data in Clinical Trials
  • Contract Manufacturing Arrangements for Drugs: Quality Agreements
  • cooperative research
  • Electronic Source Data in Clinical Investigations
  • emergency use of an investigational drug or biologic
  • evaluation of gender differences in clinical investigations
  • FDA inspections of clinical investigators
  • FDA institutional review board inspections
  • Frequently Asked Questions — Statement 0f Investigator (Form FDA 1572)
  • frequently asked questions about IRB review of medical devices
  • Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events
  • institutional review boards—frequently asked questions
  • investigator responsibilities — protecting the rights, safety, and welfare of study subjects
  • medical device reporting for manufacturers
  • non-local IRB review
  • Part 11, Electronic Records; Electronic Signatures—Scope and Application
  • pat — a framework for innovative pharmaceutical development, manufacturing, and quality assurance
  • Payment To Research Subjects
  • Principles on Conduct of Clinical Trials
    Communication of Clinical Trial Results
  • Quality Systems Approach to Pharmaceutical cGMP Regulations
  • questions and answers on good manufacturing practices for drugs
  • recruiting study subjects
  • Regulations and Guidance on HIPAA Privacy for Research
  • Screening Tests Prior to Enrollment
  • significant risk and nonsignificant risk medical device studies
  • Sponsor – Investigator – IRB Interrelationship
  • treatment use of investigational drugs
  • Use of Electronic Informed Consent Questions and Answers
  • Use Of Investigational Products When Subjects Enter a Second Institution
  • waiver of IRB requirements for drug and biological product studies
additional FDA guidance documents
  • The Belmont Report
  • The Nuremburg Code
  • The WMA Declaration of Helsinki (October 2013)
ICH guidelines (as included in the us code for federal regulations)
  • Clinical Safety Data Management: Definitions and Standards for Expedited Reporting
  • development safety update report e2f
  • Integrated Addendum to Good Clinical Practice
  • General Considerations for Clinical Trials