Onsite GCP Review and Update including the all-important `Investigators Responsibility 2018

Topics

• What is the essence of GCP
• What was the reason the ICH was formed
• The PI/Investigators role in GCP
• How does You QA group insure GCP
• What is the end result of Dose response studies
• The Sponsors role in GCP
• How following the signed Protocol is GCP
• Does your Unit/CPU/CRU follow the 13 GCP Principles?
• How following GCP helps assure a clean Audit
• Investigators key role in the Clin. Research process
• How is the investigator is responsible for the IC?
• What are the main Investigator responsibilities?
• Why is Financial Disclosure information important?
• What is the legal language of the FDA form 1572?
• The Pi responsibility in the Protocol development
• The Primacy of the study Protocol
• How to be sure the protocol is safe for the subjects
• The Sponsors Responsibility in Protocol development
• How to insure the to protocol is ethically valid
• How to be sure the protocol is scientifically valid
• The Regulatory requirements for handling protocol deviations and violations
• What is a Protocol "Deviation" and other terms
• What is the reason different IRBs define deviations and violations differently
• Importance of documentation of protocol deviations
• The historical background of why accurate data is essential for ensuring safety of study participants/Pt
• What is the basis of the difference between a "Deviation" and a "Violation"
• The regulatory requirements for care of source documents
• The purpose of ensuring that all data is accurate, legible, contemporaneous, original and attributable
• What documents does the FDA review - always?
• What "To Do" and "Never Do" with regard to data including corrections?
• The CFR definitions of AEs, SAEs, and many more
• How to Assess and report AEs and SAEs
• Understanding laboratory AEs and the "Reference Range" concept
• How to know an Adverse Event and when to report it
• Reporting of Adverse Events - when and to whom
• Common Mistakes in AE / SAE Reporting
• The Sponsor`s responsibility in quality monitoring
• How Data safety Monitoring in Protects Volunteers
• What does a Monitor look for?
• Why Monitor Clinical Studies
• What are the strategies to improve an audit outcome?
• How does a Sponsor or Site prepare for an Audit
• What types of studies are targeted for auditing
• What does the FDA look at when Auditing/Inspecting a study?
• How SOPs are set up
• The function of/reasons for an SOP in a CPU/CRU
• Who creates an/the SOPs
• What areas of CPU management need SOPs
• Who is responsible for the Unit`s SOPs

Who should Attend

• Principal Investigators and sub investigators
• The Study Sponsors
• Safety Nurses
• Clinical Research Scientists (PKs, Biostatisticians...)
• Recruiting staff, QA / QC auditors and staff, & Clinical Research Data managers
• Clinical Research Associates (CRAs) and Coordinators (CRCs)