Clinical Research Clinical Research 367 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans If your clinical trial is coming to an end and you are moving into a commercial setting to recruit patients, do you still need to get IRB approval on media materials used commercially? 1.37K viewsClinical Research 0 Votes 1 Ans How should the packaging of IMP be performed? 1.53K viewsClinical Research 0 Votes 1 Ans How should the packaging be documented? 1.44K viewsClinical Research 0 Votes 1 Ans How should the containers be labelled? 1.59K viewsClinical Research 0 Votes 1 Ans How should IMP administration to the subjects be documented? 1.62K viewsClinical Research 0 Votes 1 Ans Can a sponsor prospectively approve deviations (so-called “protocol waivers”) from the inclusion/exclusion criteria of the approved protocol without additional approval of the ethics committee and competent regulatory authority? 1.38K viewsClinical Research 0 Votes 1 Ans GCP sets out responsibilities for the sponsor and the investigator, but tasks are increasingly undertaken by a range of contractors – how should this situation be addressed? 1.52K viewsClinical Research 0 Votes 1 Ans I overheard one of the members of our medical staff say that investigatorinitiated drug studies are easier to manage because they are exempt from FDA regulations. Is it true that FDA requirements do not apply to investigator-initiated studies? 1.37K viewsClinical Research 0 Votes 1 Ans How does a research site maintain compliance with IRB approval requirements if patient recruitment content is included in a blog? 1.39K viewsClinical Research 0 Votes 1 Ans If you collect emails in a database, how do you link them to specific diseases and maintain HIPAA compliance? 1.59K viewsClinical Research 0 Votes 1 Ans I am a principal investigator looking to sponsor a study that will investigate a new indication for a drug that has already been approved by the FDA. The manufacturer has agreed to provide the study drug to me free-of-charge and might fund the study as well. The sales representative said the company wants to send me, and my husband, on an all-expenses paid 10-day trip to Paris. They have an office there and have asked me to meet with company representatives to review my protocol. The company also wants me to meet other researchers based in Europe who are looking at new uses for the same drug; they think we should meet to discuss our respective protocols and share ideas, increase efficiencies, and perhaps collaborate rather than run separate studies. The meeting with the company representatives and the researchers will only take two days to complete. Is it OK to accept the free study drug, funding, and trip to Paris? 1.37K viewsClinical Research 0 Votes 1 Ans What is the Institutional Review Board (IRB) Review? 1.46K viewsClinical Research 0 Votes 1 Ans What are the Terminology of Clinical Trails? 1.27K viewsClinical Research 0 Votes 1 Ans What are the ICH guidelines on informed consent? 1.60K viewsClinical Research 0 Votes 1 Ans What is Informed Consent Document? 1.41K viewsClinical Research 0 Votes 1 Ans What are the Contents of Clinical Trial Protocols? 1.50K viewsClinical Research 0 Votes 1 Ans What is the Clinical Trial Protocol Amendments? 1.50K viewsClinical Research 0 Votes 1 Ans Complying with Clinical Trial Protocol? 1.25K viewsClinical Research 0 Votes 1 Ans What are GCP Guidelines? 1.58K viewsClinical Research 0 Votes 1 Ans What are the Regulatory Requirements for GCP? 1.72K viewsClinical Research « Previous 1 2 … 11 12 13 14 15 … 18 19 Next » Question and answer is powered by anspress.net
