Clinical researchers are constantly faced with new and changing guidelines, rules and regulations. We have compiled three important documents discussing FDA and GCP guidelines and regulations that serve as a great starting point for those who are new to research and provide a great refresher for those who have been in the research industry for years.
Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible.
“Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects” provides an overview of the responsibilities of any person who conducts a clinical investigation of a drug, biological product, or medical device. The goal of this document is to help investigators better meet their responsibilities with respect to protecting human subjects and ensuring the integrity of the data from clinical investigations.
This guidance provides recommendations to sponsors, Contract Research Organizations (CROs), clinical investigators, and others involved in the capture, review, and retention of electronic source data in FDA-regulated clinical investigations. In an effort to streamline and modernize clinical investigations this document promotes capturing source data in electronic form, and it is intended to assist in ensuring the reliability, quality, integrity, and traceability of data from electronic source to electronic regulatory submission.