ICF

Question 1

The process through which potential study participants are informed about all aspects of a trial and make a voluntary confirmation of their willingness to participate

Answer 1

INFORMED CONSENT

Question 2

Usually in the form of an official written document developed by the researcher

Answer 2

INFORMED CONSENT

Question 2

Not only required for clinical trials but is an essential prerequisite before enrolling participants in any type of research involving human subjects

Answer 2

INFORMED CONSENT

Question 2

The Nuremberg Code

Answer 2

1947

Question 3

CIOMS Guidelines

Answer 3

1982

Question 3

Declaration of Helsinki

Answer 3

1964

Question 4

The Belmont Report

Answer 4

1979

Question 5

ICH-GHP

Answer 5

1996

Question 6

THE IC FORM HAS TWO PARTS

Answer 6

1. Information Sheet
2. Certificate of Consent

Question 7

The certificate of consent is to be signed and dated by the _______

Answer 7

participant

Question 8

When the participant is illiterate or physically unable, by a _______

Answer 8

literate witness

Question 9

The certificate of consent is NOT a

Answer 9

standalone document

Question 10

Everything you need to know

Answer 10

Information Sheet

Question 11

Signature
Date

Answer 11

Certificate of Consent