Assuring protocol compliance without checklists
At a site monitoring visit, the CRA works on assuring protocol compliance. Assuring protocol compliance is one of the 3 pillars of GCP: The 3 pillars of GCP (good clinical practice) 1. Patient safety 2. Protocol compliance 3. Data quality (We note that setting the focus on the primary clinical and safety end-points results in […]
Dealing with information junkies in decentralized clinical trials
DecentraIized clinical trials software vendor Medable is doing an outstanding job in understanding and executing an online work-flow between sites and patients at home.. This understanding and execution is a necessary but insufficient condition for the success of decentraIized clinical trials. At their core, decentraIized clinical trials and hybrid studies have the same issues as any clinical research project. These […]
