SOCRA Electronic Records and Electronic Signatures (21 CFR Part 11)

Question 1

Under 21 CFR Part 11, what must a computer-generated audit trail record?

Accepted Answer

The date and time of operator entries and actions that create, modify, or delete records, without obscuring earlier entries

Answer

Section 11.10(e) requires secure, computer-generated, time-stamped audit trails of operator entries and actions. Changes must not obscure previously recorded information.

Question 2

A non-biometric electronic signature must use at least:

Accepted Answer

Two distinct identification components, such as a user ID and a password

Answer

Section 11.200(a) requires non-biometric e-signatures to use at least two distinct identification components, such as an ID code and a password.

Question 3

Which information must appear in a signed electronic record's signature manifestation?

Accepted Answer

The signer's printed name, the date and time of signing, and the meaning of the signature

Answer

Section 11.50 requires the printed name of the signer, the date and time the signature was applied, and its meaning, such as review, approval, responsibility, or authorship.

Question 4

Before or at the time of using electronic signatures, organizations must certify to the FDA that:

Accepted Answer

Electronic signatures are intended to be the legally binding equivalent of handwritten signatures

Answer

Section 11.100(c) requires a certification, submitted on paper with a traditional handwritten signature, that the organization's electronic signatures are the legally binding equivalent of handwritten signatures.

Question 5

Under Part 11, an electronic signature must be:

Accepted Answer

Unique to one individual and never reused by or reassigned to anyone else

Answer

Section 11.100(a) requires each electronic signature to be unique to one individual and not reused by or reassigned to anyone else.

(SOCRA) Society of Clinical Research Associates Practice Test

(SOCRA) Society of Clinical Research Associates Practice Test

SOCRA Electronic Records and Electronic Signatures (21 CFR Part 11)