FDA FDA 1501 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans Are CVs required to be signed and dated? 1.59K viewsFDA 0 Votes 1 Ans What address(es) should be entered in Section #3? 1.31K viewsFDA 0 Votes 1 Ans What qualifies as a research facility for Section #3? 1.33K viewsFDA 0 Votes 1 Ans If an investigator sees study subjects at more than one site, should the investigator list all sites on the 1572? 1.38K viewsFDA 0 Votes 1 Ans What qualifies as a clinical laboratory facility for Section #4? 1.52K viewsFDA 0 Votes 1 Ans If a laboratory is sending samples to satellite or other contract labs for additional testing, should these labs be identified in Section #4? 1.51K viewsFDA 0 Votes 1 Ans Does the IRB reviewing and approving the clinical study have to be at the same location as where the research is conducted? 1.52K viewsFDA 0 Votes 1 Ans Who should be listed as a sub investigator in Section #6? 1.54K viewsFDA 0 Votes 1 Ans Should research nurses, other nurses, residents, fellows, office staff, or other hospital staff be listed in Section #6? 1.57K viewsFDA 0 Votes 1 Ans Should pharmacists or research coordinators be listed in Section #6? 1.45K viewsFDA 0 Votes 1 Ans Is a statement of qualifications required for subinvestigators? 1.49K viewsFDA 0 Votes 1 Ans Do individuals who are listed in Section #6 on the 1572 have to submit information about their financial interests? 1.33K viewsFDA 0 Votes 1 Ans If a clinical investigation is not conducted under an IND or is for a medical device, must investigators sign a 1572? 1.65K viewsFDA 0 Votes 1 Ans Must a sponsor conduct a foreign clinical study under an IND? 1.66K viewsFDA 0 Votes 1 Ans Must investigators who conduct studies outside of the United States sign a 1572? 1.57K viewsFDA 0 Votes 1 Ans If a foreign clinical study is being conducted under an IND, what are the investigator’s responsibilities with respect to local laws and regulations? 1.36K viewsFDA 0 Votes 1 Ans For foreign clinical studies conducted under an IND, how can an investigator sign the 1572 when the investigator knows he/she cannot commit to all of the requirements on the form, specifically IRB membership (21 CFR 56.107)? 1.57K viewsFDA 0 Votes 1 Ans If a sponsor chooses to conduct a foreign clinical study (or operate non-US sites in a multinational study) under an IND and the investigators at these non-US sites comply with the ICH E6 Good Clinical Practice Consolidated Guidance, would the non-US investigators also be in compliance with FDA’s IND requirements under 21 CFR Part 312? 1.73K viewsFDA 0 Votes 1 Ans Must foreign clinical study sites in a multinational study that includes domestic sites be conducted under an IND? 1.34K viewsFDA 0 Votes 1 Ans How does a sponsor submit information to FDA about a foreign clinical study that was not conducted under an IND? 1.58K viewsFDA « Previous 1 2 … 61 62 63 64 65 … 75 76 Next » Question and answer is powered by anspress.net
