Clinical Research Clinical Research 367 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans I’ve never had a sponsor send Part 11 compliance documentation to the site. Is this a standard thing sites are asking for in the study start up process? 1.70K viewsClinical Research 0 Votes 1 Ans Does FDA consider the mobile technology to contain the source data? 1.62K viewsClinical Research 0 Votes 1 Ans What should sponsors consider when implementing audit trails on data obtained directly from study participants using the mobile technology in the clinical investigation? 1.41K viewsClinical Research 0 Votes 1 Ans What should sponsors consider when using a risk-based approach to validation of mobile technology used in clinical investigations? 1.71K viewsClinical Research 0 Votes 1 Ans What security safeguards should sponsors implement to ensure security and confidentiality of data when mobile technology is used to capture, record, and transmit data directly from study participants in clinical investigations? 1.61K viewsClinical Research 0 Votes 1 Ans Does FDA expect sponsors, clinical investigators, study personnel, and study participants to be trained on the use of a specific mobile technology if the technology is used in a clinical investigation? 1.74K viewsClinical Research 0 Votes 1 Ans What methods may be used to create valid electronic signatures? 1.63K viewsClinical Research 0 Votes 1 Ans How should sponsors and regulated entities verify the identity of the individual who will be electronically signing records as required in 21 CFR 11.100(b)? 1.33K viewsClinical Research 0 Votes 1 Ans When an individual executes a series of signings during a single, continuous period of controlled system access, could the initial logging into an electronic system using a unique username and password be used to perform the first signing and satisfy the requirements found in 21 CFR 11.200(a)? 1.37K viewsClinical Research 0 Votes 1 Ans What requirements must electronic signatures based on biometrics meet to be considered an accepted biometric method? 1.65K viewsClinical Research 0 Votes 1 Ans Does FDA certify electronic systems and methods used to obtain electronic signatures? 1.62K viewsClinical Research 0 Votes 1 Ans Will the FDA cite you for 21 CFR 11 non-compliance? 1.81K viewsClinical Research 0 Votes 1 Ans Does the FDA conduct random 21 CFR 11 only inspections? 1.61K viewsClinical Research 0 Votes 1 Ans Do I need to validate commercial software like Microsoft Word or Excel? 1.42K viewsClinical Research 0 Votes 1 Ans What should sponsors and other regulated entities consider when deciding to validate outsourced electronic services that are used in clinical investigations? 1.90K viewsClinical Research 0 Votes 1 Ans Under what circumstances would FDA choose to inspect the electronic service vendor? 1.67K viewsClinical Research 0 Votes 1 Ans What does Electronic Systems Primarily Used in the Provision of Medical Care ? 1.51K viewsClinical Research 0 Votes 1 Ans What access controls should sponsors implement for mobile technology accessed by study participants for use in clinical investigations? 1.83K viewsClinical Research 0 Votes 1 Ans When using mobile technology to capture data directly from study participants in clinical investigations, how do sponsors identify the data originator? 1.71K viewsClinical Research 0 Votes 1 Ans If sponsors and other regulated entities outsource electronic services, who is responsible for meeting the regulatory requirements? 1.42K viewsClinical Research « Previous 1 2 3 4 5 6 7 … 18 19 Next » Question and answer is powered by anspress.net
