Clinical Research Clinical Research 367 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans How do I find out if I (or my family member) might be eligible to participate in a clinical trial? 1.70K viewsClinical Research 0 Votes 1 Ans How will I know exactly what the study will involve? 1.70K viewsClinical Research 0 Votes 1 Ans How can I be sure that my safety will be protected? 1.50K viewsClinical Research 0 Votes 1 Ans What are the different phases of clinical trials? 1.55K viewsClinical Research 0 Votes 1 Ans Do clinical trials in children differ from studies in adults? 1.70K viewsClinical Research 0 Votes 1 Ans Are clinical trials just for advanced cancer? 1.54K viewsClinical Research 0 Votes 1 Ans What is a clinical trial protocol? 1.74K viewsClinical Research 0 Votes 1 Ans What is the trial “phase?” 1.68K viewsClinical Research 0 Votes 1 Ans What does “standard therapy” or “standard of care” mean? 1.53K viewsClinical Research 0 Votes 1 Ans What is an investigational treatment or procedure? 1.38K viewsClinical Research 0 Votes 1 Ans What is a control or control group? 1.55K viewsClinical Research 0 Votes 1 Ans What is a regulatory binder and why do I need one? 1.76K viewsClinical Research 0 Votes 1 Ans Do I have to have everything in a binder and in exactly the order of the tabs provided? 1.61K viewsClinical Research 0 Votes 1 Ans Why is the material with quality signatures for specifications not showing up in the selected list for project definition or Master Production Record bill of materials list? 1.82K viewsClinical Research 0 Votes 1 Ans Why can’t I make a Batch Record from the Master Record? 1.81K viewsClinical Research 0 Votes 1 Ans What Exactly Are cGMPs? 1.60K viewsClinical Research 0 Votes 1 Ans Not all cloud solutions are necessarily Part 11 compliant. How would one know? 1.50K viewsClinical Research 0 Votes 1 Ans Once a system is validated, does it need to be re-validated annually? 1.67K viewsClinical Research 0 Votes 1 Ans Regarding the application of Part 11 to our site, we utilize a cloud based CTMS which houses patient demographics (not procedure/health records). We have subjects who participate in NIH studies in the CTMS. Is the CTMS vendor responsible for being part 11 compliant? Is our site accountable in this case? 1.55K viewsClinical Research 0 Votes 1 Ans If sponsor is providing software, i.e. EDC software, are they responsible for validation? Or is the site required to have their own separate policy as well? 1.67K viewsClinical Research « Previous 1 2 3 4 5 … 18 19 Next » Question and answer is powered by anspress.net
