Recorded Webinars

Charles H Pierce

FDA Clinical Trial Auditing and the Due Diligence Companies Should Conduct as Part of their Monitoring Program

The main principle is to follow exactly the signed and approved (IRB + PI) Protocol to the letter. This, in fact, is included on the FDA Form 1572. In the current regulatory climate, GCP Investigator site audits are a part of the clinical trail process. Sponsors should anticipate more inspections and information requests regarding monitoring practices. Many monitoring systems lack components that ensure proper management of the research site. Monitoring systems should include specific components to ensure control of investigational product, data integrity, oversight of investigators as well as other areas. The components of a quality monitoring system will be presented so that participants can assess their current practices for identifying gaps and risks, particularly in relation to preparing for regulatory inspections.

Charles H Pierce

The GCP Responsibilities of the Principal Investigator in Clinical Research - What the PI Needs to Know

When the PI signs the FDA form 1572 (for IND studies) or the "Statement of the Investigator (for IDE studies), she / he is signing a legally binding document committing themselves to follow all of the appropriate regulations. This talk, by a physician investigator, will go over the regulations in a user friendly way. Learn also how the International Conference on Harmonization (ICH) has been the most outspoken as to what GCP is including a formal listing of the "Principles of GCP". Covered also will be what the practices are that ensure subject safety and credible data, which are the hallmarks of GCP.

Charles H Pierce

How to Prevent or Handle Protocol Deviations and Violations to be GCP and Regulatory Compliant

Deviations and Violations from the agreed upon protocol may very well affect the scientific validity of the research. For this reason, a well-written protocol, taking onto account the role of all the Inclusion and Exclusion criteria in subject enrollment is a key element in having deviation free study conduct.

Charles H Pierce

How Accurate Adverse Event Reporting is the Key to Subject Safety of Approved Drugs?

The principal objective in a new drug development program is to assess the benefit / risk ratio. Learn what the risk information is that must be collected, documented and reported accurately. Learn why the single most important function of the Principal Investigator and the study conduct team is the awareness, assessment, and management of Adverse Events occurring during the conduct of clinical research with drugs or devices utilizing human subjects.

Charles H Pierce

21 CFR Part 11 Compliance - Ensuring Data Integrity and Safety in Clinical Research

Electronic medical records and electronic handling of study data is increasingly common. To involve computer systems in clinical research implies knowledge of 21 CFR Part 11 (ELECTRONIC RECORDS; ELECTRONIC SIGNATURES) and all of the ramifications of this Part of the code is essential.

Charles H Pierce

Using Independent Data Safety Monitoring in Clinical Research – How and Why

All Clinical Research protocols have a prominent safety monitoring "plan" as part of the overall research plan / protocol. This "plan" is to ensure the safety of participating subjects and to ensure the validity and integrity of the data. Safety monitoring is mandated in 21 CFR 312.50, 312.56, and 600.80 for drugs and biologics and 21 CFR 812.40 and 812.46 for devices. Depending on the nature of the test agent, the vulnerability of the study population, the length of the study, or the number of sites conducting the clinical study. The "Plan" increasingly has the "Charter" of what is called a Data Monitoring Committee (DMC) or Data and Safety Monitoring Board (DSMB).




Filters