This industry-leading GCP reference guide answers over 1,000 of the most common and difficult questions regarding the interpretation and implementation of US and international GCP standards for drugs, biologics, and medical device clinical trials.
The completely updated and expanded 2016 guide includes:
- Over 15 new contributing domestic authors with targeted expertise in QA, Monitoring, Compliance, Site Management and several other core GCP areas.
- Dozens new Q&As, including in-depth analysis from distinguished international GCP experts who address the most current and up-to-date information on global GCP requirements.
- New questions and answers related to GCP expectations, including risk-based monitoring, electronic informed consent and records, social media, HIPAA, and the role and responsibilities of IRBs.
- Completely updated sections featuring all the latest data and trends on the FDA and EMA’s clinical trial compliance inspections, inspectional findings, and common areas of GCP noncompliance.
- Updates to reflect the very latest FDA guidances, regulations, comments, and developments for both drugs and devices.
- Updates to information on Australia, Canada, China, India, Israel, Latin America, New Zealand, and Russia.
- Insights into FDA’s focus on sponsors’ quality systems and risk-based approaches, especially when GCP compliance issues are discovered at the clinical study site.
2. Clinical Study Safety Reporting
3. Clinical Trial Protocols/Protocol Changes/Protocol Violations
4. FDA and ICH GCP Standards for Clinical Research
5. Form FDA 1572-Statement of Investigator
6. Informed Consent
7. Institutional Review Boards
8. Investigator/Site Requirements
9. Patient Recruitment
10. Quality Assurance Activities/Study Auditing/FDA Inspections, Investigational Drug Accountability, Administration, and Labeling
11. Source Data/Documentation
12. State Standards and GCP
- Beat Wilder, PhD, Widler & Schiemann, (Switzerland)
- Bobby George, PhD, CCRA, Reliance Life Sciences, Pvt Ltd. (India)
- Dmitry Vorobiev, M.D., Ph.D., MRQA, Clinical Trials Audits and Quality Consulting (Russia)
- Earl Hulihan, EW Hulihan and Associates (USA)
- James Nickas, BioMarin Pharmaceuticals (USA)
- Jules Mitchel, PhD, Target Health Inc. (USA)
- Linda Houle, Linda Houle and Associates (Canada)
- M. Joseph Mardesich, Quality Compliance Consulting, Inc. (USA)
- Munish Mehra, PhD, Quantum Biopharma (USA)
- Sandra “SAM” Sather, Clinical Pathways Research (USA)
- Teri Stokes, PhD, GXP International (USA)