SoCRA CERTIFICATION EXAM AND PRACTICE EXAM ACTUAL EXAMS 400 QUESTIONS AND CORRECT DETAILED ANSWERS WITH RATIONALES (VERIFIED ANSWERS) | ALREADY GRADED A+

SoCRA CERTIFICATION EXAM AND PRACTICE EXAM 2023-

2024 ACTUAL EXAMS 400 QUESTIONS AND CORRECT

DETAILED ANSWERS WITH RATIONALES (VERIFIED

ANSWERS) | ALREADY GRADED A+

How long are IRB records required to be maintained after completion of

a study? - ANSWER- 3 years (and accessible!). FDA can shut it down if

IRBs are not keeping records appropriately

Are there a lot of required documentations and records by the IRB? -

ANSWER- Yes. Lots of written procedures, must keep copies of

meeting minutes, copies of correspondance, research proposals etc.

Everything needs to be documented!

Does the FDA have the power to shut down, stop studies, etc if an IRB

is not operating in compliance? - ANSWER- Yes! Can full on disqualify

if they repeatedly dont comply.

When does a research drug need an IND? - ANSWER- If it can't be

legally marketed or shipped, it needs an IND. If you're hoping for a label

change or a new indication for use, it needs an IND.

When does a research drug NOT need an IND? - ANSWER- It is

already legally able to be marketed. Your research doesn't aim to change

label or current use. If it doesn't increase risk, or go in unstudied

populations etc.

Do you need an IND for a placebo drug? - ANSWER- NO

Do you need an IND for a UNLABELED indication of an approved

product? - ANSWER- No, and this is confusing to me.

Do investigational new drugs need to be clearly labeled as such? -

ANSWER- Yes

Can sponsors charge for an investigational drug? - ANSWER- Yes, but

it has to be regulated and approved by the FDA. And they need to show

proof that its efficacious. Also, the cost of the drug must be burdensome

on the sponsor in order for them to charge for it.

What are the three phases of investigational drug studies? Describe and

provide average # of subjects. - ANSWER- Phase 1 - initial introduction

of IND into humans. Determine metabolism and pharmacologic actions,

pharmacokinetics. 20-80 subjects.

Phase 2 - Controlled clinical study to evaluate effectiveness for a

particular indication. Determine short term side effects and risks. Several

hundred subjects.

Phase 3 - Gather additional information about safety and efficacy,

needed to evaluate overall benefit-risk ratio. Hundreds to thousands of

subjects.

What does an Investigator's Brochure contain? - ANSWER- Drug

substance, formula, structural formula. summary of animal data,

summary of any human data. Pharmacokinetics in animals/humans.

Summary of safety and efficacy, risks and side effects (to the extent

known)

Is an IND application brief? - ANSWER- No it needs a billion and one

things, like a grant but way worse. Summarizing the state of the union

on this drug across time and nations

How does an SAE differ from an AE? - ANSWER- SAE contains death,

life-threatening state, inpatient hospitalization (or prolongation thereof),

incapacity, birth defect.

Do researchers need to submit annual reports updating the FDA on their

IND? - ANSWER- YES! lots of details needed.

How soon after an IND is submitted can investigators begin their

studies? - ANSWER- 30 days

What is a "clinical hold" in regard to an IND? - ANSWER- Issued by

the FDA to delay a proposed clinical investigation or to suspend an

ongoing investigation. This means no new subjects can be recruited.

Why might a clinical hold be issued? - ANSWER- unreasonable risk is

posed to human subjects, investigators are not qualified, brochure is

misleading, IND is not sufficient, reproductive toxicity, etc. OR

approved for marketing by another study. OR shown to be ineffective.

Can the FDA terminate an IND? - ANSWER- Yes, for mostly the same

reasons why they would impose a clinical hold

Can an IND be deemed "inactive" but not "terminated"? - ANSWERYes. if no subjects are entered for 2 years or more, or if on clinical hold

for 1 year, the IND can be placed on inactive status.

Does the FDA spell out suggested meetings as well as dispute resolution

for sponsors and investigators? - ANSWER- Yes

Who is ultimately responsible for the proper conduct of a study? -

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? - ANSWER- Yes

Who receives the investigator's brochure? - ANSWER- Every

participating clinical investigator

How long does a sponsor need to keep records after a marketing

application for a drug is approved? - ANSWER- 2 years

Can FDA inspect whenever they want? - ANSWER- Yes i think so