Questions Ask question Search Order By: ActiveCategoryClear Filter 0 Votes 1 Ans What is the Objective of the ‘clinical establishment’ Act? 1.74K viewsClinical Research 0 Votes 1 Ans Who is responsible for registering a clinical establishment under this Act? 1.47K viewsClinical Research 0 Votes 1 Ans Who is the registering authority for clinical establishment? 1.68K viewsClinical Research 0 Votes 1 Ans What is the composition of the District Registering Authority? 1.57K viewsClinical Research 0 Votes 1 Ans Does the CV or other statement of qualifications need to be updated during a clinical study? 1.47K viewsFDA 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? 1.53K 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? 1.58K viewsFDA 0 Votes 1 Ans Should pharmacists or research coordinators be listed in Section #6? 1.46K 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 « Previous 1 2 … 219 220 221 222 223 … 283 284 Next » Question and answer is powered by anspress.net
