As covered in an article by Zachary Brennan in raps.org, the ICH has updated their GCP guideline with the goal to simplify and cut the cost of clinical trials. The aim is to create a more “unified standard for the regulatory authorities in the EU, Japan, US, Canada...
After nearly twenty years with the current Good Clinical Practice (GCP) guidelines, ICH is publishing an addendum that will change definitions, principles and responsibilities for the future. These changes include new requirements of compliance and risk, many of which...
A recent report done by the European Medicines Agency (EMA) on good clinical procedures (GCP) found there were deficiencies around standard operation practices (SOPs). These deficiencies were found in monitoring, data management, and other documents for trials done in...
Do you work at a site as a clinical research coordinator and need a deeper dive into Good Clinical Practices (GCPs)? Are you a sponsor who has responsibility for oversight and training of site personnel? On July 26, 2013, Pearl Pathways’ own Ellen Looney will lead a...
Single IRB – A Guide to the Common Rule sIRB Mandate
The sIRB requirement is active. Is your study affected?
