SOCRA CERTIFICATION EXAM | NEWEST
ACTUAL EXAM COMPREHENSIVE
QUESTIONS AND VERIFIED ANSWERS
GRADED A+ | 100% PASS | 2024 UPDATE!
When can an IRB use an expedited review method? - ✔✔✔ Correct
Answer > Research is no more than minimal risk OR minor changes to
previously approved research
Who receives the investigator's brochure? - ✔✔✔ Correct Answer >
Every participating clinical investigator
How long does a sponsor need to keep records after a marketing
application for a drug is approved? - ✔✔✔ Correct Answer > 2 years
What criteria must be met for an IRB to approve a study? - ✔✔✔
Correct Answer > -Risks are MINIMIZED
-Risks are reasonable in proportion to benefits
-Selection of subjects is equitable
-Informed consent will be sought
-Informed consent will be appropriately documented
-Data will be monitored for subject safety
,-Adequate provisions to protect privacy and confidentiality
-Additional safeguards are in place for vulnerable subjects
-All research is in complianace with FDA part 50, subpart D
Who is ultimately responsible for the proper conduct of a study? -
✔✔✔ Correct Answer > Sponsor. They select monitors and
investigators.
Do investigators need to supply sponsors with a whole host of
information, kind of like a grant application? - ✔✔✔ Correct Answer
> Yes
Can FDA inspect whenever they want? - ✔✔✔ Correct Answer > Yes i
think so
What are the responsibilities of the investigator? - ✔✔✔ Correct
Answer > Uphold their investigator's agreement and conduct study
according to plan. Obtain informed consent.
What type of records to investigators need to keep, and for how long
after marketing approval? - ✔✔✔ Correct Answer > Disposition of
drug records, case histories. For 2 years.
,Who submits annual reports to FDA, the investigator or the sponsor? -
✔✔✔ Correct Answer > The sponsor.
Who submits reports of SAEs, and to whom? - ✔✔✔ Correct Answer
> The investigators report to the sponsor, and also to the IRB i think
Can a clinical investigator be disqualified? Why might that be the case?
- ✔✔✔ Correct Answer > Yes - if repeatedly or deliberately failed to
comply with subparts, agreements etc, or falsified any information.
Is there a different set of regulations when it comes to life-threatening
/ debilitating diseases for which no good alternatives exist? - ✔✔✔
Correct Answer > Yes, evaluate the risk-benefit ratio differently
Can drugs be imported and exported for clinical trials? - ✔✔✔ Correct
Answer > Yes, under specified circumstances and with proper review
etc.
Can the FDA "rely" on an "external" FDA in a multi-national trial? -
✔✔✔ Correct Answer > Yes - you can accept foreign IND's if they
were conducted under GCP etc, if the FDA can validate the data, and
also need to submit lots of regulatory stuff.
Is an IND application automatically public knowledge? - ✔✔✔ Correct
Answer > No, it can be if investigator's want it to be.
, expanded access - ✔✔✔ Correct Answer > The use of an
investigational new drug (IND) outside of a clinical trial by patients with
serious or life-threatening conditions who do not meet the enrollment
criteria for the clinical trial in progress. Requires an application.
Can a special access be granted for small patient populations, i.e.
orphan drugs, orphan conditions? - ✔✔✔ Correct Answer > Yes -
special considerations.
Do the policies of devices largely mirror the policies for investigational
new drugs? - ✔✔✔ Correct Answer > Yes, mirrored closely
Federal Regulations Part 45/46 - ✔✔✔ Correct Answer > Protection
of Human Subjects - Protection of Public Welfare
Federal Regulations Part 21 - ✔✔✔ Correct Answer > Electronic
Records, Human Subjects (50), IRB, IND, Investigational Devices
04955D - ✔✔✔ Correct Answer > auth code smh
What types ofhuman subjects research could be considered exempt
from human subjects review/regulation? - ✔✔✔ Correct Answer >
Schools, educational tests, unidentifiable subjects, benign behavioral
interventions, secondary research, public services research,
ACTUAL EXAM COMPREHENSIVE
QUESTIONS AND VERIFIED ANSWERS
GRADED A+ | 100% PASS | 2024 UPDATE!
When can an IRB use an expedited review method? - ✔✔✔ Correct
Answer > Research is no more than minimal risk OR minor changes to
previously approved research
Who receives the investigator's brochure? - ✔✔✔ Correct Answer >
Every participating clinical investigator
How long does a sponsor need to keep records after a marketing
application for a drug is approved? - ✔✔✔ Correct Answer > 2 years
What criteria must be met for an IRB to approve a study? - ✔✔✔
Correct Answer > -Risks are MINIMIZED
-Risks are reasonable in proportion to benefits
-Selection of subjects is equitable
-Informed consent will be sought
-Informed consent will be appropriately documented
-Data will be monitored for subject safety
,-Adequate provisions to protect privacy and confidentiality
-Additional safeguards are in place for vulnerable subjects
-All research is in complianace with FDA part 50, subpart D
Who is ultimately responsible for the proper conduct of a study? -
✔✔✔ Correct Answer > Sponsor. They select monitors and
investigators.
Do investigators need to supply sponsors with a whole host of
information, kind of like a grant application? - ✔✔✔ Correct Answer
> Yes
Can FDA inspect whenever they want? - ✔✔✔ Correct Answer > Yes i
think so
What are the responsibilities of the investigator? - ✔✔✔ Correct
Answer > Uphold their investigator's agreement and conduct study
according to plan. Obtain informed consent.
What type of records to investigators need to keep, and for how long
after marketing approval? - ✔✔✔ Correct Answer > Disposition of
drug records, case histories. For 2 years.
,Who submits annual reports to FDA, the investigator or the sponsor? -
✔✔✔ Correct Answer > The sponsor.
Who submits reports of SAEs, and to whom? - ✔✔✔ Correct Answer
> The investigators report to the sponsor, and also to the IRB i think
Can a clinical investigator be disqualified? Why might that be the case?
- ✔✔✔ Correct Answer > Yes - if repeatedly or deliberately failed to
comply with subparts, agreements etc, or falsified any information.
Is there a different set of regulations when it comes to life-threatening
/ debilitating diseases for which no good alternatives exist? - ✔✔✔
Correct Answer > Yes, evaluate the risk-benefit ratio differently
Can drugs be imported and exported for clinical trials? - ✔✔✔ Correct
Answer > Yes, under specified circumstances and with proper review
etc.
Can the FDA "rely" on an "external" FDA in a multi-national trial? -
✔✔✔ Correct Answer > Yes - you can accept foreign IND's if they
were conducted under GCP etc, if the FDA can validate the data, and
also need to submit lots of regulatory stuff.
Is an IND application automatically public knowledge? - ✔✔✔ Correct
Answer > No, it can be if investigator's want it to be.
, expanded access - ✔✔✔ Correct Answer > The use of an
investigational new drug (IND) outside of a clinical trial by patients with
serious or life-threatening conditions who do not meet the enrollment
criteria for the clinical trial in progress. Requires an application.
Can a special access be granted for small patient populations, i.e.
orphan drugs, orphan conditions? - ✔✔✔ Correct Answer > Yes -
special considerations.
Do the policies of devices largely mirror the policies for investigational
new drugs? - ✔✔✔ Correct Answer > Yes, mirrored closely
Federal Regulations Part 45/46 - ✔✔✔ Correct Answer > Protection
of Human Subjects - Protection of Public Welfare
Federal Regulations Part 21 - ✔✔✔ Correct Answer > Electronic
Records, Human Subjects (50), IRB, IND, Investigational Devices
04955D - ✔✔✔ Correct Answer > auth code smh
What types ofhuman subjects research could be considered exempt
from human subjects review/regulation? - ✔✔✔ Correct Answer >
Schools, educational tests, unidentifiable subjects, benign behavioral
interventions, secondary research, public services research,
