Questions Ask question Search Order By: ActiveCategoryClear Filter 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? 1.74K 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 0 Votes 1 Ans Should a new form be prepared and signed when the OMB expiration date is reached? 1.57K viewsFDA 0 Votes 1 Ans Does FDA expect a double-sided 1572, or is a two-page document printed from the FDA website acceptable? 1.60K viewsFDA 0 Votes 1 Ans How should the 1572 be completed? 1.56K viewsFDA 0 Votes 1 Ans How should an investigator’s name appear on the 1572? 1.56K viewsFDA 0 Votes 1 Ans What address should be entered into Section #1? 1.51K viewsFDA 0 Votes 1 Ans Should co-investigators be listed on the 1572 in Section #1? Is it acceptable to have more than one investigator at a single site? 1.51K viewsFDA 0 Votes 1 Ans What is the purpose of Section #2? 1.62K viewsFDA 0 Votes 1 Ans How long does an FLSA case take? 1.35K viewsHuman Resources 0 Votes 1 Ans What are the time limits on FLSA suits? 1.51K viewsHuman Resources 0 Votes 1 Ans What are the “downstream consequences” of an FLSA case? 1.53K viewsHuman Resources 0 Votes 1 Ans Do all “similarly situated” employees have to participate in an FLSA suit if one employee decides to sue? 1.62K viewsHuman Resources 0 Votes 1 Ans What effect do the provisions of a collective bargaining agreement have on FLSA overtime rights? 1.59K viewsHuman Resources 0 Votes 1 Ans I’m a federal employee. Am I covered by the FLSA? 1.48K viewsHuman Resources 0 Votes 1 Ans Where do I get more information? 1.44K viewsHuman Resources 0 Votes 1 Ans What is the Statement of Investigator, Form FDA 1572? 1.55K viewsFDA « Previous 1 2 … 220 221 222 223 224 … 283 284 Next » Question and answer is powered by anspress.net
