Onsite GCP Review and Update including the all-important `Investigators Responsibility 2018 is a seminar that covers topics such as:
- 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
Onsite GCP Review and Update including the all-important `Investigators Responsibility 2018 brings together:
- 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)
