SOCRA Exam Questions With 100% Correct Verified Answers
Electronic signature are currently accepted for any and all records, paper or electronic form.
... [Show More] True or False? - False. The general provisions for electeonic signature criteria apply to records that are
i. Created, modified, maintained, archived, retrieved, or transmitted, in electronic form
ii. The criteria do not apply to paper records that are or have been transmitted by electronic means.
If the electronic records meet the criteria specified in 21 CFR 11, thr agency will consider the electronic signatures, initials, and other general signing equivalent to full handwritten signatures, unless specifically excepted by regulations effective after August 20, 1997. True or False? - True
Electronic records cannot be used in lieu of paper records. True or False? - False.
Electronic records that meet the requirements may be used in lieu of paper forms, unless paper records are specifically required.
provisions are subject to whose inspection? - The FDA's inspection
Provided they meet the requirements, persons can use electronic records lieu of paper records, for records required to be maintained, but not submitted to the agency. True or False? - True.
Persons can use electronic records in lieu of paper records for documents required to be submitted to the agency provided the document has been identified as a type of submission that the FDA will accept in electronic format. T or F? - True.
Documents submitted to the FDA that are not specified in the public docket as acceptable in electronic form, will not be considered as official if they are submitted in electronic form. T or F? - True
Who determines the details for electronic submission (e.g. methods of transmission, media, file formats and technical protocol)? - The intended receiving agency unit will determine the details of electronic submission.
In the FDA's regulations covering electronic signatures, what does the term Act refer to? - Act means the Federal Food, Drug and Cosmetic Act.
In the FDA's Electronic Signatures regulation, what does the term agency refer to? - Agency refers to the Food and Drug Administration
What is the term that means a method of verifying an individual's identity based on measurement of the individual's physical feature(s) or repeatable actions(s) where those features and/or actions are both measurable and unique to that individual? [Show Less]