SOCRA Certification Exam Questions
and Answers
The IRB will determine if a study is morally justified and demonstrates what key 4 items? -
Answer-1. Adequate design
2. a favorable risk/benefit ratio
3. equitable selection of subjects
4. informed consent by subjects
What all does the 1572 con...
7.Adequate protection of privacy and confidentiality of data -> additional safeguards for
vulnerable populations.
How many days must the IRB revise its registration information? - Answer✔✔-90 Days
What should sponsor obtain from investigator regarding IRB? - Answer✔✔-1. Name/Address of
IRB
2. Statement from IRB that it is organized and complies with GCP
3. Documented approval of ICS and Protocol
Record Keeping - Answer✔✔-Investigators: 2 years after marketing applications approval or 2
years after investigation is discontinued and FDA is notified.
Sponsor: Should maintain all sponsor specific docs for at least 2 years after they discontinue
development.
IRB: 3 years after completion of research.
If a sponsor discontinues the clinical development of an investigational product (i.e.) for any or
all indications, routes of admin, dosage forms) the sponsor should maintain all sponsor specific
essential documents for at least how many years? - Answer✔✔-2 years.
Can a clinical investigator submit an IDE? - Answer✔✔-Yes. They can sponsor their own study.
They are considered a sponsor-investigator and must comply with all responsibilities of both
sponsor and investigator.
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