Course Home:

SOCRA Preparation

Last Week:

Week 5 Overview

For this week:

Next Week

Resources

For MONITORING Content:

  1. FDA 2013 Risk-Based Monitoring Guidance - https://www.fda.gov/downloads/Drugs/Guidance/UCM269919.pdf
  2. ICH E6(R3) Guideline - https://www.ich.org/page/efficacy-guidelines
  3. TransCelerate Monitoring Resources - https://www.transceleratebiopharma.com/
  4. 21 CFR 312.32 - https://www.ecfr.gov/current/title-21/section-312.32

For ALCOA+ & Data Integrity:

  1. 21 CFR Part 11 - https://www.ecfr.gov/current/title-21/part-11
  2. FDA Data Integrity Guidance - https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidance-industry
  3. GAMP Data Integrity Resources - https://www.gamp.org/
  4. ICH E2A (Clinical Safety Data Management) - https://www.ich.org/page/safety-guidelines

For QUALITY ASSURANCE & Management:

  1. ICH E6(R3) Quality Principles - https://www.ich.org/page/efficacy-guidelines
  2. ISO 14971 Risk Management - https://www.iso.org/standard/72704.html
  3. FDA Compliance Guidance - https://www.fda.gov/regulatory-information/search-fda-guidance-documents
  4. TransCelerate Quality Resources - https://www.transceleratebiopharma.com/

For AUDITS & Compliance:

  1. FDA Form 483 Database - https://www.fda.gov/drugs/compliance-data-center
  2. FDA Warning Letters - https://www.fda.gov/drugs/enforcement-actions-fda/warning-letters-related-human-drug-compounding
  3. 21 CFR Part 56 (IRB) - https://www.ecfr.gov/current/title-21/part-56
  4. SOCRA Standards - https://www.socra.org/

For GCP & Ethics:

  1. ICH E6(R3) GCP - https://www.ich.org/page/efficacy-guidelines
  2. Declaration of Helsinki - https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/
  3. Belmont Report - https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html
  4. 21 CFR Part 50 - https://www.ecfr.gov/current/title-21/part-50