SOCRA CERTIFICATION STUDY GUIDE
QUESTIONS AND ANSWERS 2026 CORRECT
SOLUTIONS GRADED A+
⩥ When a short form is used for informed consent the witness must sign
the short form or the summary. Answer: False-they must sign both
⩥ What is FDA form 3454. Answer: Certification Financial Interests and
Arrangements of Clinical Investigators
⩥ What are the three main basic ethical principles of the Belmont
Report. Answer: Respect for persons.
Beneficence.
Justice.
⩥ Phase III. Answer: Study Participants: 300 to 3,000 volunteers who
have the disease or condition
Length of Study: 1 to 4 years
Purpose: Efficacy and monitoring of adverse reactions
, ⩥ Phase I. Answer: 20 to 100 healthy volunteers or people with the
disease/condition.
Length of Study: Several months
Purpose: Safety and dosage
⩥ Phase II. Answer: Study Participants: Up to several hundred people
with the disease/condition.
Length of Study: Several months to 2 years
Purpose: Efficacy and side effects
⩥ The main concept of 21 CFR 50 is. Answer: protection of human
subjects
⩥ 21 CFR 50 part D. Answer: protection of childern
⩥ A____________ can be any unfavorable and unintended sign)
including an abnormal laboratory finding), symptom, or disease
temporally associated with the use of a medicinal (investigational)
product, whether or not related to the medicinal (investigational)
product.. Answer: adverse event
QUESTIONS AND ANSWERS 2026 CORRECT
SOLUTIONS GRADED A+
⩥ When a short form is used for informed consent the witness must sign
the short form or the summary. Answer: False-they must sign both
⩥ What is FDA form 3454. Answer: Certification Financial Interests and
Arrangements of Clinical Investigators
⩥ What are the three main basic ethical principles of the Belmont
Report. Answer: Respect for persons.
Beneficence.
Justice.
⩥ Phase III. Answer: Study Participants: 300 to 3,000 volunteers who
have the disease or condition
Length of Study: 1 to 4 years
Purpose: Efficacy and monitoring of adverse reactions
, ⩥ Phase I. Answer: 20 to 100 healthy volunteers or people with the
disease/condition.
Length of Study: Several months
Purpose: Safety and dosage
⩥ Phase II. Answer: Study Participants: Up to several hundred people
with the disease/condition.
Length of Study: Several months to 2 years
Purpose: Efficacy and side effects
⩥ The main concept of 21 CFR 50 is. Answer: protection of human
subjects
⩥ 21 CFR 50 part D. Answer: protection of childern
⩥ A____________ can be any unfavorable and unintended sign)
including an abnormal laboratory finding), symptom, or disease
temporally associated with the use of a medicinal (investigational)
product, whether or not related to the medicinal (investigational)
product.. Answer: adverse event
