Exam (elaborations) SOCRA certification / LATEST EXAM PREDICTIONS UPDATES, APPROVED.

SOCRA CCRP Exam Practice Questions and answers, VERIFIED/ 21 CFR part 11 regulates? - -Electronic Signatures What is the name of FDA Form 483? - -Inspectional Observation What does 21CFR56 regulate? - -Institutional Review Boards An application for Investigational Device Exemption is part of 21 CFR part ____________? - -812 Define Electronic Signature - -A computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be legally binding equivalent of an individual's handwritten signature 21CFR50, subpart D refers to safeguards for which population? - -Children in Clinical Investigations True or False? The regulations in CFR part 11 set forth the criteria under which that agency considers electronic records, electronic signatures, and handwritten signatures to electronic records to be trustworthy, reliable and generally equivalent to paper records and handwritten signature executed on paper. - -True What does 21CFR50 regulate? - -FDA Protection of Human Subjects In 21CFR11.1, subpart A, what requirements must electronic records meet? - -They must be in accordance with part 11.2, unless paper records are specifically required Define Clinical Investigation: - -Any experiment that involves a test article and one or more human subjects and that either: - Is subject to requirements for prior submission to the FDA under section 505(i) or 520(g) - Or is not subject to requirements for prior submission but the results of which are intended to be later submitted - Or held by inspection by the FDA as a part of an application for a research or marketing permit True or False? 21CFR11.2, subpart A is only for electronic records required to be maintained that must be submitted to an agency. - -False. CFR part 11.2, subpart A is for electronic records maintenance when submitting to an agency and also when not submitting to an agency.