Clinical Research Clinical Research 367 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans Should sponsors or other regulated entities establish service agreements with the electronic service vendor? 1.43K viewsClinical Research 0 Votes 1 Ans Does FDA consider it acceptable for data to be distributed across a cloud computing service’s hardware at several different geographic locations at the same time without being able to identify the exact location of the data at any given time? 1.46K viewsClinical Research 0 Votes 1 Ans What should sponsors and other regulated entities have available on site to demonstrate that their electronic service vendor is providing services in accordance with FDA’s regulatory requirements? 1.70K viewsClinical Research 0 Votes 1 Ans Should sponsors and other regulated entities perform audits of the vendor’s electronic systems and products? 1.39K viewsClinical Research 0 Votes 1 Ans Under 21 CFR 11.10(d), what are FDA’s expectations regarding the use of internal and external security safeguards? 1.65K viewsClinical Research 0 Votes 1 Ans Under what circumstances are part 11 requirements not applicable for electronic copies of paper records? 1.67K viewsClinical Research 0 Votes 1 Ans Can sponsors and other regulated entities use and retain electronic copies of source documents in place of the original paper source documents? 1.66K viewsClinical Research 0 Votes 1 Ans Can electronic copies be used as accurate reproductions of electronic records? 1.68K viewsClinical Research 0 Votes 1 Ans Can sponsors and other regulated entities use durable electronic storage devices to archive required records from a clinical investigation? 1.44K viewsClinical Research 0 Votes 1 Ans Does FDA provide preliminary audit service to inspect an electronic system used in a clinical investigation to ensure compliance with part 11 controls? 1.23K viewsClinical Research 0 Votes 1 Ans If a non-U.S. site is conducting a clinical investigation, are records required by FDA regulations subject to part 11 requirements? 1.58K viewsClinical Research 0 Votes 1 Ans How do I know the Part 11 Toolkit will work with my database? 1.65K viewsClinical Research 0 Votes 1 Ans We are still in the development process and our application changes continually. Can I continue to modify my application after the Toolkit is applied to it? 1.32K viewsClinical Research 0 Votes 1 Ans After validating the completed application, can I continue to add read-only objects such as reports? 1.53K viewsClinical Research 0 Votes 1 Ans Is there anything added to the registry or to the desktop of the client computer? 1.70K viewsClinical Research 0 Votes 1 Ans What does an audit trail require to track? 1.54K viewsClinical Research 0 Votes 1 Ans How do you provide Excel Spreadsheets or Access databases with an audit trail? 1.71K viewsClinical Research 0 Votes 1 Ans What is the distinction between an event log and an audit trail. Does an event log meet this requirement? 1.63K viewsClinical Research 0 Votes 1 Ans For electronic systems owned or managed by sponsors and other regulated entities that fall under the scope of 21 CFR part 11, what will be FDA’s focus during inspections? 1.71K viewsClinical Research 0 Votes 1 Ans If a non-U.S. site is conducting a clinical investigation, are records required by FDA regulations subject to part 11 requirements? 1.51K viewsClinical Research « Previous 1 2 … 4 5 6 7 8 … 18 19 Next » Question and answer is powered by anspress.net
