FDA FDA 1501 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans Can leftover specimens be used in IVD studies without informed consent? 1.51K viewsFDA 0 Votes 1 Ans Can those who routinely conduct studies with IVDs (e.g., research hospitals) use a general informed consent to address future studies using samples collected in their own facility? 1.54K viewsFDA 0 Votes 1 Ans Can a human specimen that was initially collected in a study with the informed consent of the subject be used in a later study without a new consent process? 1.26K viewsFDA 0 Votes 1 Ans What information should the protocol include to ensure that the investigational IVD study will be scientifically sound? 1.65K viewsFDA 0 Votes 1 Ans Is it acceptable to develop new or to revise existing study hypotheses as the study progresses? 1.53K viewsFDA 0 Votes 1 Ans How should I determine appropriate sample size for a study? 1.61K viewsFDA 0 Votes 1 Ans What guidance is available for sponsors to determine how to estimate IVD performance in terms of sensitivity and specificity, how to handle discrepant results, and what to do when a study is performed without a truth standard (“gold standard”) (see the Glossary for definitions)? 1.60K viewsFDA 0 Votes 1 Ans Is it acceptable to eliminate data that appear to be out of line with the main body of the dataset (i.e., “outliers”)? 1.50K viewsFDA 0 Votes 1 Ans Can I add additional testing on the same subject to the dataset, particularly when it is hard to find study subjects? 1.58K viewsFDA 0 Votes 1 Ans How much precision is needed for measurement data, e.g., in terms of decimal places? 1.30K viewsFDA 0 Votes 1 Ans What records should help to ensure scientific soundness of an IVD investigational study? 1.40K viewsFDA 0 Votes 1 Ans What does FDA recommend be included in the final report of the investigation from the sponsor to all reviewing IRBs (and to FDA for significant risk studies) (21 CFR 812.150(b)(7))? 1.46K viewsFDA 0 Votes 1 Ans What is the scope of and implementation date for the FDA stability guidance? 1.66K viewsFDA 0 Votes 1 Ans What is a master file and how is one submitted? 1.42K viewsFDA 0 Votes 1 Ans How do I arrange to reference a MAF? 1.49K viewsFDA 0 Votes 1 Ans What does FDA consider to be valid scientific evidence? 1.39K viewsFDA 0 Votes 1 Ans Why should I review the information regarding the conduct of device studies found in the IDE regulation even if, after considering the exemption criteria in the regulation, I determine that my proposed studies are exempt from most IDE requirements? 1.47K viewsFDA 0 Votes 1 Ans Should I review the “International Conference on Harmonization; Good Clinical Practice: Consolidated Guideline” (“”ICHGCP””) published in the Federal Register Vol. 62, No. 90, May 9, 1997, pp. 25691-25709 or the draft ISO 14155, “Clinical Investigation of Medical Devices for Human Subjects,” when developing studies for devices that fall within the exemption at 21 CFR 812.2(c)? 1.63K viewsFDA 0 Votes 1 Ans Is FDA willing to review and discuss a study protocol even if the study is exempt from most of the 21 CFR Part 812 requirements? 1.65K viewsFDA 0 Votes 1 Ans Can I obtain a more formal evaluation of my study design or investigational plan through a determination and/or agreement meeting? 1.64K viewsFDA « Previous 1 2 … 8 9 10 11 12 … 75 76 Next » Question and answer is powered by anspress.net
