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

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

Important

Please, check the official conference website for possible changes, before you make any traveling arrangements

Prices are for evaluation only.

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