Exam (elaborations)
CCRP SOCRA Exam – Miscellaneous test questions and answers 2024.
- Course
- Institution
CCRP SOCRA Exam – Miscellaneous test questions and answers 2024.
[Show more]
Content preview
CCRP SOCRAExam –
Miscellaneous
test questions
and answers
2024
How long does IRB keep records for?
3 Years 21 CFR 50.24 (c)
How long does site keep records for?
2 Years Sub Part D 312.62
When would you require an amendment?
A sponsor shall submit a protocol amendment describing any change in a
Phase 1 protocol that significantly affects the safety of subjects or any
change in a Phase 2 or 3 protocol that significantly affects the safety of
subjects
Examples: Dose change, cohort additions, new test or procedure
Which countries are included in the ICH GCP?
European Union, Japan, United States, Canada and Switzerland
, True or False:
GCP applies to research in human subjects and animals.
False; human subject only
Who is responsible for maintaining the close out report?
Sponsor
If a patient fills out questionnaire on sponsor EDC system, what is the
source document?
Who is making sure there are enough devices at the site if patient is using
ePRO (electronic Patient Reported Outcomes) - electronic device capturing
questionnaires?
Who is responsible for device accountability?
Sponsor and Investigator
According to ICH E6, an inspection is defined as:
An official review of documents, facilities, records, and any other
resources related to a clinical trial.
According to ICH guidelines UAE needs to be reported by investigator
within how many days?
If site is working on a phase II trial, then they started phase III, how long
is the site required to keep their records?
What is the monitor not responsible for?
A) Patient information
B) Sponsor SOP
C) Protocol/ICF
D) Reporting to IRB
What is included in the investigator brochure?
An investigator wants to use cardiac device for another indication (off-
label). What applications/approvals does he need to start?
A patient received an initial dose and had no initial reaction. The protocol
says the patient needs to increase it by 20%. The initial dose was
370mg^3/m; what is the next treatment?
The benefits of buying summaries with Stuvia:
Guaranteed quality through customer reviews
Stuvia customers have reviewed more than 700,000 summaries. This how you know that you are buying the best documents.
Quick and easy check-out
You can quickly pay through credit card or Stuvia-credit for the summaries. There is no membership needed.
Focus on what matters
Your fellow students write the study notes themselves, which is why the documents are always reliable and up-to-date. This ensures you quickly get to the core!
Frequently asked questions
What do I get when I buy this document?
You get a PDF, available immediately after your purchase. The purchased document is accessible anytime, anywhere and indefinitely through your profile.
Satisfaction guarantee: how does it work?
Our satisfaction guarantee ensures that you always find a study document that suits you well. You fill out a form, and our customer service team takes care of the rest.
Who am I buying these notes from?
Stuvia is a marketplace, so you are not buying this document from us, but from seller GUARANTEEDSUCCESS. Stuvia facilitates payment to the seller.
Will I be stuck with a subscription?
No, you only buy these notes for $14.99. You're not tied to anything after your purchase.
Can Stuvia be trusted?
4.6 stars on Google & Trustpilot (+1000 reviews)
75323 documents were sold in the last 30 days
Founded in 2010, the go-to place to buy study notes for 14 years now