Questions Ask question Search Order By: ActiveCategoryClear Filter 0 Votes 1 Ans Is an audit of QA activities required? 1.63K viewsDrugsPharmaceutical 0 Votes 1 Ans Who should sign the QA statement? 1.65K viewsDrugsPharmaceutical 0 Votes 1 Ans What should appear on a quality assurance statement? 1.58K 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? 1.60K viewsDrugsPharmaceutical 0 Votes 1 Ans Should method validation be completed prior to the initiation of a GLP study? 1.59K viewsDrugsPharmaceutical 0 Votes 1 Ans Following the early termination of a GLP study is there a requirement to produce a final report? 1.70K viewsDrugsPharmaceutical 0 Votes 1 Ans Under what circumstances can a GLP study be reopened after the final report has been finalised? 1.58K 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? 1.55K 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? 1.28K 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? 1.62K viewsDrugsPharmaceutical 0 Votes 1 Ans Can GLP studies be done in facilities that utilise other quality standards (GMP, GCP, ISO etc.)? 1.67K viewsDrugsPharmaceutical 0 Votes 1 Ans Is there a standard format and content for the Study Director’s statement? 1.79K viewsDrugsPharmaceutical 0 Votes 1 Ans What is a physical/chemical test system? 1.70K viewsDrugsPharmaceutical 0 Votes 1 Ans How can the GLP compliance status of a test facility or test site be checked? 1.70K viewsDrugsPharmaceutical 0 Votes 1 Ans What are the clinical trial information requirements for voluntary submissions under the regulation? 1.77K viewsFDA 0 Votes 1 Ans What is a “triggered” trial under the regulation? 1.43K 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? 1.83K viewsFDA 0 Votes 1 Ans Why should I participate in medical research? 1.63K viewsFDA 0 Votes 1 Ans What should I expect if I join a research study? 1.53K viewsFDA 0 Votes 1 Ans What is informed consent? 1.69K viewsFDA « Previous 1 2 … 250 251 252 253 254 … 283 284 Next » Question and answer is powered by anspress.net
