Title 21, Part 11 - Electronic Records

Question 1

When must clinical trial registration information be submitted?

Answer 1

21 calendar days after the first human subject is enrolled

Question 2

Closed System

Answer 2

An environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system

Question 3

Open System

Answer 3

An environment in which system access is not controlled by persons who are responsible for the content of electronic records that are on system

Question 4

Controls for Closed System

Answer 4

Designed to ensure the authenticity, integrity, and when appropriate, the confidentiality of electronic records, and to ensure that the signer cannot readily repudiate the signed record as not genuine

Question 5

Controls for Open System

Answer 5

Designed to ensure the authenticity, integrity, and as appropriate, the confidentiality of electronic records from the point of their creation to the point of their reciept

Question 6

Signature manifestations must include…

Answer 6

1. the printed name of the signer
2. the date and time when the signature was executed
3. the meaning associated with the signature (like review, approval, authorship, etc)

Question 7

Electronic signatures components and controls

Answer 7

• employ at least TWO different identification components, such a s an identification code and
  -the first signing should be executed using all electronic sig. o=componens, subsequent signings shall be executed using at least one

Question 8

WHen an indi