This seminar is designed to acquaint all Participants with the Rules and Regulations that form the background of what is know as the GCP of Clinical Research. To follow "The Good Clinical Practices" (GCP) is to follow the standard for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trails that provides assurance that the data and reported results are credible and accurate and, most importantly, that the safety, rights, integrity, and confidentiality of trial subjects is protected.
That all members of the team must know and practice "GCP" guarantees, that the Protocol is followed, that the Informed consent is complete, that the study conduct is according to the protocol, that Adverse Events are correctly recorded and that the Principal Investigator knows well her/his responsibilities to follow what "GCP" stands for
Why you should attend:
It is now reasonable to expect that the Sponsor's should become more discerning regarding the GCP qualifications and training of the staff of any unit conducting studies on human volunteers. Investigators, as well as all site staff, must know how to assess how well the unit is complying with the regulation and the essence of GCP to assure the safety of the volunteers as this ultimately affects the safety of the public. Following GCP is also an assurance of a clean audit.
Areas Covered in the Session:
What was the reason the ICH was formed
What is the essence of GCP
How does You QA group insure GCP
The PI/Investigators role in GCP
The Sponsors role in GCP
What is the end result of Dose response studies
Does your Unit/CPU/CRU follow the 13 GCP Principles?
How following the signed Protocol is GCP
Investigators key role in the Clin. Research process
How following GCP helps assure a clean Audit
What are the main Investigator responsibilities?
How is the investigator is responsible for the IC?
What is the legal language of the FDA form 1572?
Why is Financial Disclosure information important?
The Primacy of the study Protocol
The Pi responsibility in the Protocol development
The Sponsors Responsibility in Protocol development
How to be sure the protocol is safe for the subjects
How to be sure the protocol is scientifically valid
How to insure the to protocol is ethically valid
What is a Protocol "Deviation" and other terms
The Regulatory requirements for handling protocol deviations and violations
Importance of documentation of protocol deviations
What is the reason different IRBs define deviations and violations differently
What is the basis of the difference between a "Deviation" and a "Violation"
The historical background of why accurate data is essential for ensuring safety of study participants/Pt
The purpose of ensuring that all data is accurate, legible, contemporaneous, original and attributable
The regulatory requirements for care of source documents
What "To Do" and "Never Do" with regard to data including corrections?
What documents does the FDA review - always?
How to Assess and report AEs and SAEs
The CFR definitions of AEs, SAEs, and many more
How to know an Adverse Event and when to report it
Understanding laboratory AEs and the "Reference Range" concept
Common Mistakes in AE / SAE Reporting
Reporting of Adverse Events - when and to whom
how Data safety Monitoring in Protects Volunteers
The Sponsor's responsibility in quality monitoring
Why Monitor Clinical Studies
What does a Monitor look for?
How does a Sponsor or Site prepare for an Audit
What are the strategies to improve an audit outcome?
What does the FDA look at when Auditing/Inspecting a study?
What types of studies are targeted for auditing
The function of/reasons for an SOP in a CPU/CRU
How SOPs are set up
What areas of CPU management need SOPs
Who creates an/the SOPs
Who is responsible for the Unit's SOPs
- The Study Sponsor
- Principal Investigators and sub investigators
- Clinical Research Scientists (PKs, Biostatisticians, ...)
- Safety Nurses
- Clinical Research Associates (CRAs) and Coordinators (CRCs)
- Recruiting staff, QA / QC auditors and staff, & Clinical Research Data managers.
Day 1 Schedule
What is GCP and how does this concept improve data integrity and subject safety. The International Council on Harmonization leads the way
The Responsibilities of the Investigator and the relationship of the Investigator to the Sponsor and the IRB. The Regulations are quite clear in this regard. This includes the Informed Consent Process
In The Beginning: A solid Protocol; The basis of Drug Development starts with a medically sound Phase I Protocol, which defines Feasibility. Phase II and II Protocols must also be scientifically, medically, as well as ethically sound
How to Prevent or Handle Protocol Deviations and Violations to be GCP and Regulatory Compliant?
Day 2 Schedule
To conduct the Clinical Research study as if a persons life depended on it - because it does
The Importance of Proper AE Determination and Reporting: How to handle AE's not in the Investigators brochure (IB) and properly assess the relationship between the AE and the product.
The Value of the Monitoring Process to an FDA Audit: including how a site or CRO prepares for an Audit and what the Auditors are finding.
The Importance of Standard Operating Procedures (SOPs) in the operation of a FDA form 483 absent CPU/CRU
• The Study Sponsor
• Principal Investigators and sub investigators
• Clinical Research Scientists (PKs, Biostatisticians, ...)
• Safety Nurses
• Clinical Research Associates (CRAs) and Coordinators (CRCs)
• Recruiting staff, QA / QC auditors and staff, & Clinical Research Data managers.