21 CFR P11, Belmont, Helsinki, and No Nazis

Question 1

Purpose of Declaration of Helsinki: What Year?

Answer 1

Established the need for a legally authorized representative. The need for transparency in studies and independent ethics committes to ensure subject welfare and safety. (1964)

Question 2

Who is the Helsinki primarily addressed to?

Answer 2

Physicians

Question 3

Two essential features of Helsinki established for clinical research:

Answer 3

1) Independent ethics committees (IRBs) to monitor human subjects to ensure compliance with ethical standards
2) Reporting of AEs and unexpected problems. Findings need to be published transparently.

Question 4

When was the Nuremberg code drafted and what was it the foundation for?

Answer 4

1946-1949

It serves as the backbone for Declaration of Helsinki and GCP guidelines

Question 5

Purpose of Nuremberg Code:

Answer 5

Prevent unethical medical experiences in human trials

Question 6

Core principles of Nuremberg Code: (4)

Answer 6

1) Voluntary consent is essential
2) Scientific validity: ideas are based on sound principles that will result in benefit
3) Minimization of harm is critical and should be conducted by qualified staff.
4) Right to withdraw

Question 7

3 tenets of Belmont Report: What year?

Answer 7

1. Respect for Persons
2. Beneficence
3. Justice
   (1979)

Question 8

What does Belmont Report have to do for the individual?

Answer 8

Respect for Persons
-Individuals are autonomous agents
-Persons with diminished autonomy are entitled to protection

Question 9

What does Belmont Report have to do for benefits?

Answer 9

Beneficence
-Do not Harm
-Maximize possible benefits and minimize harms

Question 10

How does Belmont Report relate to distribution?

Answer 10

Distribution of burdens and benefits equally:
-Each person an equal share
-Each person according to individual need
-Each person according to individual effort
-To each person according to societal contribution
-To each person according to merit

Question 11

What is 21 CFR part 11?

Answer 11

Electronic systems, electronic records, electronic signatures

Question 12

The main difference between open and closed systems:

Answer 12

The level of control the organization has over the system and its environment. Closed systems offer more control and can be validated internally, while open systems require additional measures to manage external risks and ensure regulatory compliance.

Question 13

Under 21 CFR Part 11, what must be included in an electronic signature’s components? Im not sure
A. A combination of the user’s name and a digital certificate.
B. The user’s name, date/time stamp, and a password or other biometric identifier.
C. A barcode linked to the individual’s medical license.
D. A handwritten signature uploaded into the system.

Answer 13

B

Question 14

In compliance with 21 CFR Part 11, how long must electronic records be retained?
A. There is no specified retention period; it depends on the applicable regulations governing the specific type of record.
B. For at least 3 years.
C. For at least 10 years.
D. Indefinitely, until the FDA requests their deletion.

Answer 14

A

Question 15

When does 21 CFR Part 11 apply to electronic records?
A. Only when records are stored in a cloud-based system.
B. Only when electronic records are submitted to the FDA.
C. When electronic records are used in place of paper records for any purpose regulated by the FDA.
D. When electronic signatures are used instead of physical signatures for any purpose regulated by the FDA.

Answer 15

C

Question 16

What is required for individuals using electronic signatures under 21 CFR Part 11 to verify their identity?
A. They must submit a handwritten signature for comparison.
B. They must use two distinct identification components such as a password and an identification code.
C. They must submit biometric data for authentication.
D. They must submit a passport or government-issued ID to the FDA

Answer 16

B