State Laws Governing Clinical Trial Regulatory Compliance скачать в хорошем качестве

State Laws Governing Clinical Trial Regulatory Compliance

Although many clinical trial sponsors and investigators focus primarily on FDA regulations related to the conduct and design of clinical trials, their failure to comply with state laws and regulations may expose sponsors, investigators, IRBs, institutions, or individuals may call into question the potential integrity of clinical data. Today’s U.S.-based clinical trials must meet not just federal requirements, but an increasingly complex array of state specific requirements, many of which are critical and foundational to clinical studies. The capacity to consent to experimental therapy has its foundational basis and is governed by state law. In this web seminar, we will review many of these key areas, and discuss specific differences. Learners will be provided with examples from more than a dozen practical areas, including age of consent, capacity to consent, IRB and clinical protocol requirements, notification of state agencies, experimental drug dispensing requirements, HIV testing rules, genetic testing, and legal representatives. Also, we will explore strategic considerations that certain states afford specific therapeutic classes. Learners will have the opportunity to ask direct questions regarding clinical trial requirements in their research state.