SOCRA CERTIFICATION EXAM QUESTIONS WITH
CORRECT ANSWERS 2025
8 Basic Elements of informed Consent - ANSWER-1. statement explaining the study involves research.
2. description of risks or discomforts.
3. description of benefits.
4. alternative treatments/procedures.
5. confidentiality.
6. compensation for involvement and/or injury.
7. who to contact.
8. voluntary and can discontinue
Additional Elements of Informed Consent - ANSWER-1. unforeseeable risks to subject.
2. participation can be terminated by investigator.
3. any additional costs.
4. consequences of the subject's decision to withdraw
5. significant new findings will be shared
6. approx # of subjects in the study.
Belmont Report Principles and Application - ANSWER-There are 3:
1. Respect for persons = informed consent
2. Beneficence = risk/benefit analysis
3. Justice = appropriate selection of patients
Best practices of essential study documents according to section 4.9 of ICF GCP: - ANSWER-Organize
docs; file in chronological order; use a file note to explain missing docs; avoid duplicates; store in a
secure place; document inventory of items to be archived.
Can Case Report Forms be use as a source doc? - ANSWER-Yes, if it is the FIRST RECORDING of the
information was done on the CRFs. OG CRF must be signed, initialed, and date by the person recording
the information.
SOCRA CERTIFICATION EXAM QUESTIONS WITH
CORRECT ANSWERS 2025
, SOCRA CERTIFICATION EXAM QUESTIONS WITH
CORRECT ANSWERS 2025
Consent and Assent Requirements for research involving children - ANSWER-1. Parental consent from
one or both parents or LAR is required
2. Child assent may be required as determined by the overseeing IRB.
Difference between QA and QC - ANSWER-QC focuses on identification and correction vs QA focuses on
prevention
Differences between short and long informed consent form - ANSWER-Long = the standard consent
form.
Short = document states that the elements have been presented orally to and understood by the subject
or LAR.
Differences in final report for IND vs IDE to the FDA - ANSWER-Drug - no guidance in 21 CFR 312
regarding final reports, but section 5.22 of ICH GCP requires that sponsor submit clinical trial reports as
required.. For med devices - 21 CRF requires for sig. risk device: notify FDA within 30 days of
completion/termination and submit final report to FDA, all IRBs and all investigators within 6 months of
completion or termination. For non sig risk device: submit final report to all reviewing IRB within 6
months of completion/termination.
Does FDA specifically define source data or source documents? - ANSWER-No - it uses the term "medical
records" in 21 CFR 312 and 812. FDA considers medical records to be a part of case histories.
FDA inspections are done thru what program? - ANSWER-BIMO program
For unanticipated adverse device effects, within how many days does It need to be reported to
FDA/IRB? - ANSWER-Within 10 working days.
How are Medical Devices classified? - ANSWER-Class 1 - General Controls
SOCRA CERTIFICATION EXAM QUESTIONS WITH
CORRECT ANSWERS 2025
CORRECT ANSWERS 2025
8 Basic Elements of informed Consent - ANSWER-1. statement explaining the study involves research.
2. description of risks or discomforts.
3. description of benefits.
4. alternative treatments/procedures.
5. confidentiality.
6. compensation for involvement and/or injury.
7. who to contact.
8. voluntary and can discontinue
Additional Elements of Informed Consent - ANSWER-1. unforeseeable risks to subject.
2. participation can be terminated by investigator.
3. any additional costs.
4. consequences of the subject's decision to withdraw
5. significant new findings will be shared
6. approx # of subjects in the study.
Belmont Report Principles and Application - ANSWER-There are 3:
1. Respect for persons = informed consent
2. Beneficence = risk/benefit analysis
3. Justice = appropriate selection of patients
Best practices of essential study documents according to section 4.9 of ICF GCP: - ANSWER-Organize
docs; file in chronological order; use a file note to explain missing docs; avoid duplicates; store in a
secure place; document inventory of items to be archived.
Can Case Report Forms be use as a source doc? - ANSWER-Yes, if it is the FIRST RECORDING of the
information was done on the CRFs. OG CRF must be signed, initialed, and date by the person recording
the information.
SOCRA CERTIFICATION EXAM QUESTIONS WITH
CORRECT ANSWERS 2025
, SOCRA CERTIFICATION EXAM QUESTIONS WITH
CORRECT ANSWERS 2025
Consent and Assent Requirements for research involving children - ANSWER-1. Parental consent from
one or both parents or LAR is required
2. Child assent may be required as determined by the overseeing IRB.
Difference between QA and QC - ANSWER-QC focuses on identification and correction vs QA focuses on
prevention
Differences between short and long informed consent form - ANSWER-Long = the standard consent
form.
Short = document states that the elements have been presented orally to and understood by the subject
or LAR.
Differences in final report for IND vs IDE to the FDA - ANSWER-Drug - no guidance in 21 CFR 312
regarding final reports, but section 5.22 of ICH GCP requires that sponsor submit clinical trial reports as
required.. For med devices - 21 CRF requires for sig. risk device: notify FDA within 30 days of
completion/termination and submit final report to FDA, all IRBs and all investigators within 6 months of
completion or termination. For non sig risk device: submit final report to all reviewing IRB within 6
months of completion/termination.
Does FDA specifically define source data or source documents? - ANSWER-No - it uses the term "medical
records" in 21 CFR 312 and 812. FDA considers medical records to be a part of case histories.
FDA inspections are done thru what program? - ANSWER-BIMO program
For unanticipated adverse device effects, within how many days does It need to be reported to
FDA/IRB? - ANSWER-Within 10 working days.
How are Medical Devices classified? - ANSWER-Class 1 - General Controls
SOCRA CERTIFICATION EXAM QUESTIONS WITH
CORRECT ANSWERS 2025
