Questions Ask question Search Order By: ActiveCategoryClear Filter 0 Votes 1 Ans Is an audit of QA activities required? 1.74K viewsDrugsPharmaceutical 0 Votes 1 Ans Who should sign the QA statement? 1.78K viewsDrugsPharmaceutical 0 Votes 1 Ans What should appear on a quality assurance statement? 1.72K viewsDrugsPharmaceutical 0 Votes 1 Ans What standard should be applied to the validation of methods which are used in GLP studies and how should it be applied? 1.79K viewsDrugsPharmaceutical 0 Votes 1 Ans Should method validation be completed prior to the initiation of a GLP study? 1.70K viewsDrugsPharmaceutical 0 Votes 1 Ans Following the early termination of a GLP study is there a requirement to produce a final report? 1.82K viewsDrugsPharmaceutical 0 Votes 1 Ans Under what circumstances can a GLP study be reopened after the final report has been finalised? 1.70K viewsDrugsPharmaceutical 0 Votes 1 Ans Section 2.8 of OECD Advisory Document Number 16 (Guidance on the GLP Requirements for Peer Review of Histopathology) indicates that where the peer reviewing pathologist’s findings were significantly different from the original interpretation of the study pathologist, a description of how differences of interpretation were handled and changes made to the study pathologist’s original interpretation should be discussed in the final report. Does this apply to both retrospective and contemporaneous peer review? 1.66K viewsDrugsPharmaceutical 0 Votes 1 Ans Section 2.5 of OECD Advisory Document Number 16 (Guidance on the GLP Requirements for Peer Review of Histopathology) indicates that all correspondence regarding the histopathological evaluation of the slides used for peer review between the sponsor and the representative of the test facility and the peer reviewing pathologist should be retained in the study file. Could the interpretation of this requirement be clarified? 1.39K viewsDrugsPharmaceutical 0 Votes 1 Ans Do software programmes which have been developed by outside vendors or academia to support calculations by test facilities using an OECD Test Guideline, and are referenced in OECD Test Guidelines, need to be validated by test facilities? 1.74K viewsDrugsPharmaceutical 0 Votes 1 Ans Can GLP studies be done in facilities that utilise other quality standards (GMP, GCP, ISO etc.)? 1.79K viewsDrugsPharmaceutical 0 Votes 1 Ans Is there a standard format and content for the Study Director’s statement? 1.90K viewsDrugsPharmaceutical 0 Votes 1 Ans What is a physical/chemical test system? 1.81K viewsDrugsPharmaceutical 0 Votes 1 Ans How can the GLP compliance status of a test facility or test site be checked? 1.80K viewsDrugsPharmaceutical 0 Votes 1 Ans What are the clinical trial information requirements for voluntary submissions under the regulation? 1.87K viewsFDA 0 Votes 1 Ans What is a “triggered” trial under the regulation? 1.50K viewsFDA 0 Votes 1 Ans When must clinical trial information for a “triggered trial” be submitted to meet the requirements for voluntary submissions under 42 CFR 11.60? 2.02K viewsFDA 0 Votes 1 Ans Why should I participate in medical research? 1.75K viewsFDA 0 Votes 1 Ans What should I expect if I join a research study? 1.65K viewsFDA 0 Votes 1 Ans What is informed consent? 1.79K viewsFDA « Previous 1 2 … 250 251 252 253 254 … 283 284 Next » Question and answer is powered by anspress.net
