Questions Ask question Search Order By: ActiveCategoryClear Filter 0 Votes 1 Ans What is the Scope of the FDA Guidance? 1.80K viewsClinical Research 0 Votes 1 Ans What are the Electronic Systems Owned or Managed by Sponsors and Other Regulated Entities? 1.71K viewsClinical Research 0 Votes 1 Ans What are the Outsourced Electronic Services? 1.50K viewsClinical Research 0 Votes 1 Ans What are the Key Concepts About 21 CFR Part 11, Electronic Records and Signatures? 1.36K viewsClinical Research 0 Votes 1 Ans Does Part 11 apply if we’re keeping both electronic AND paper copies (i.e. wet ink copies are scanned and saved to our shared drive)? 1.37K viewsClinical Research 0 Votes 1 Ans Do network shared drives really need to be validated? 1.51K viewsClinical Research 0 Votes 1 Ans How do you decide what is “critical” and should be tested? 1.63K viewsClinical Research 0 Votes 1 Ans How does this apply to resident/fellow research being tracked on in-house excel files? 1.59K viewsClinical Research 0 Votes 1 Ans Does this presentation is refer to general computer systems or the electronic health records (EHR)? My understanding is that the FDA does not oversee the EHR? 1.48K viewsClinical Research 0 Votes 1 Ans I often hear the terms Validation and Qualification when referring to computerized systems. What’s the difference between those two terms, if any? 1.69K viewsClinical Research 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? 1.59K viewsClinical Research 0 Votes 1 Ans Does FDA consider the mobile technology to contain the source data? 1.52K 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? 1.26K 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? 1.58K 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? 1.44K 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? 1.65K viewsClinical Research 0 Votes 1 Ans What methods may be used to create valid electronic signatures? 1.52K 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)? 1.23K 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)? 1.26K viewsClinical Research 0 Votes 1 Ans What requirements must electronic signatures based on biometrics meet to be considered an accepted biometric method? 1.52K viewsClinical Research « Previous 1 2 … 108 109 110 111 112 … 283 284 Next » Question and answer is powered by anspress.net
