Free SOCRA SOCRA-CCRP Exam Questions

Become SOCRA Certified with updated SOCRA-CCRP exam questions and correct answers

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Total 131 Questions | Updated On: Oct 28, 2025

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Question 1

A sponsor is permitted to charge for an investigational drug but must provide what documentation?

A : CMS approval letter

B : Orphan product evidence

C : IRB attestation of institutional cost burden

D : Evidence of potential clinical benefit and significant advantage

Answer: D

Question 2

A subject has creatinine 1.6 mg/dL, slightly above eligibility (â‰¤1.5). Investigator believes this is normal for size. When can subject be enrolled?

A : After sponsor revises eligibility and IRB approves amendment

B : After repeat test confirms 1.6

C : After monitor approves deviation

D : After investigator documents explanation in chart

Answer: A

Question 3

In accordance with the CFR, for at least how many years after the completion of a study must the clinical investigator provide the sponsor with relevant changes to financial information?

A : One year

B : Two years

C : Three years

D : Five years

Answer: B

Question 4

A revised protocol added genomic testing to banked tissue samples. Before shipping samples, what must the site do?

A : Execute material transfer agreement

B : Ship under dangerous goods requirements

C : Obtain IRB/IEC approval for revised protocol and ICF

D : Notify enrolled subjects

Answer: C

Question 5

A clinical investigator terminated a Phase IV drug study. In accordance with the ICH GCP Guidelines, which of the following documents should the clinical investigator maintain?

A : The master randomization list

B : The completed subject identification code list

C : The final trial closeout monitoring report

D : The audit certificate

Answer: B

Page: 1 / 27

Total 131 Questions | Updated On: Oct 28, 2025

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