---

Recorded Charles H Pierce How the Investigator's responsibilities and Legal commitment's in drug and device clinical research affects Study Conduct – The FDA point of view 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. Recorded View Anytime $295.00 Charles H Pierce How does compliance with 21 CFR Part 11 help ensure data integrity and subject safety in clinical research Electronic medical records and electronic handling of study data is increasingly common. Recorded View Anytime $295.00 Charles H Pierce The Secret of Study Conduct Documentation to ensure a successful Audit: What the FDA Inspectors look for All Clinical Research protocols have the procedures and processes needed to collect the data as it happens. Recorded View Anytime $295.00 Charles H Pierce What is the role of Data and Safety Monitoring in Clinical Research Involving Human Subjects - When and How? All Clinical Research protocols have a prominent safety monitoring plan as part of the overall research plan / protocol. Recorded View Anytime $295.00 Charles H Pierce Why is Drug Induced Liver Injury an Important Mirror of Drug Safety The recent media publicity of the FDA warnings about the OTC drug acetaminophen, which is the most common drug cause for liver transplants, has brought into focus the effects of drugs on the liver. Recorded View Anytime $295.00 << >>