This course provides a solid foundation to the key concepts and principles outlined in ICH GCP E6(R3). Through focused microlearning modules, real-world scenarios, and relevant knowledge checks, you’ll gain a deeper understanding of the guideline’s application in clinical trials to navigate the complexities of clinical research.
This webinar highlighted best practices in various areas of clinical research management of investigator-initiated trials (IITs) and detailed how to navigate common challenges. The information included in this comprehensive review of IIT operations is experience-based and built upon good clinical research practices in alignment with NIH Regulations.
How the Investigational Drug Services (IDS) Pharmacy utilized by your clinical trials team works shouldn’t be a mystery, when it can instead be one of your biggest allies in research. This webinar provides “insider insights” from an IDS pharmacist on facts you should have at hand about IDS services when sponsors are considering your site for studies, or are sending monitors to keep track of ongoing projects.
The ICH E8(R1) Guideline on General Considerations for Clinical Studies from the International Council for Harmonization guides the clinical development lifecycle for experimental therapies, including quality requirements for clinical study designs and data sources. Principles and practices for the conduct of clinical trials tied to this guideline, already in effect in such regions as the U.S., Canada, and Europe and forthcoming elsewhere, will be reviewed.
Ensuring a more equitable and accessible healthcare system starts with the healthcare professionals engaged for pre-drug launch and marketing, with the site investigators recruited by sponsors to run clinical trials, and with the location and availability of the study in terms of diverse and underrepresented populations of potential participants. Here’s a historic overview of what has been lacking in clinical trials when it comes to diversity and inclusion, how federal guidelines are beginning to turn the conversation within big pharma toward health equity, and more.