Clinical Research Clinical Research 367 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans What are in vitro test strips? 1.73K viewsClinical Research 0 Votes 1 Ans What is difference between in vivo and in vitro? 1.59K viewsClinical Research 0 Votes 1 Ans Are cell lines in vivo? 1.70K viewsClinical Research 0 Votes 1 Ans What is an IVD? 1.76K viewsClinical Research 0 Votes 1 Ans What is the difference between a medical device and an IVD? 1.64K viewsClinical Research 0 Votes 1 Ans What is IVD used for? 1.90K viewsClinical Research 0 Votes 1 Ans When is required clinical trial results information due? 1.87K viewsClinical Research 0 Votes 1 Ans What is the role of the quality unit in approving changes to master production instructions during clinical trials? What is the quality unit’s role in reviewing and approving the master production instructions in phase I and phase II? 1.75K viewsClinical Research 0 Votes 1 Ans Some in the pharmaceutical industry have expressed concern that the ICH E3 guidance, Structure and Content of Clinical Study Reports (ICH E3), is intended as a requirement (i.e., a template that must be followed). The fact that the ICH M4 guidance for the Common Technical Document (CTD) refers to specific structural elements described in ICH E3 (e.g., Clinical Study Report (CSR) section headings) may have contributed to this interpretation. Interpretation of ICH E3 as a rigid template. 1.70K viewsClinical Research 0 Votes 1 Ans Is informed consent required when treating/diagnosing a patient with an HUD? 1.72K viewsClinical Research 0 Votes 1 Ans How will I know if I am eligible for a Clinical Trial? 1.86K viewsClinical Research 0 Votes 1 Ans What should people consider before participating in a trial? 1.94K viewsClinical Research 0 Votes 1 Ans Does a participant continue to work with a primary health care provider while in a trial? 1.72K viewsClinical Research 0 Votes 1 Ans What are the benefits and risks of participating in a clinical trial? 1.89K viewsClinical Research 0 Votes 1 Ans If my study is not a drug/device study, or if my study is not conducted under an IND or IDE, do I need to have a regulatory binder? 1.53K viewsClinical Research 0 Votes 1 Ans Do I have to keep documentation of all the outdated/expired sponsor protocols, IRB protocols, investigator brochures, etc.? This binder could get to be pretty large! 1.65K viewsClinical Research 0 Votes 1 Ans How do I go about updating the regulatory binder/files? 1.89K viewsClinical Research 0 Votes 1 Ans Is there a place where I can go to look for a listing of all the required documentation for a research study? 1.86K viewsClinical Research 0 Votes 1 Ans Should any documentation be maintained outside of the regulatory “binder?” 1.77K viewsClinical Research 0 Votes 1 Ans How can I find food allergy clinical trials? 1.73K viewsClinical Research « Previous 1 2 3 4 … 18 19 Next » Question and answer is powered by anspress.net
