CRA review test questions & answers 2024/2025
RECIST (Response Evaluation Criteria in Solid Tumors) - ANSWERS"Measured via CT (or X-ray or MRI) the longest diameter of a tumor
• CR (complete response) = disappearance of all target lesions
• PR (partial response) = 30% decrease in the su...
RECIST (Response Evaluation Criteria in Solid Tumors) - ANSWERS"Measured via CT (or X-ray or MRI) the
longest diameter of a tumor
• CR (complete response) = disappearance of all target lesions
• PR (partial response) = 30% decrease in the sum of the longest diameter of target lesions
• PD (progressive disease) = 20% increase in the sum of the longest diameter of target lesions
• SD (stable disease) = small changes that do not meet above criteria
"
CTC (Common Toxicity Criteria) - ANSWERS"Adverse Event Grading System for cancer studies 0-4 (0 is
usually = None, 4 is life threatening or death)
"
Prior to any visit - ANSWERS"Confirmation Letter
Sign site visit log except at Pre-Study Visit
Follow up letter
"
Pre-Study Visit - ANSWERS"Evaluate Investigator, Staff, Facility (tour what type of storage/freezer type
space available), IRB (central or local), lab (local or central) and Protocol feasibility (experience w/ similar
studies, competing studies, availability of potential subjects etc.)
Review Investigator and Staff Qualifications
Gauge general interest and attitude
Review Licenses (Medical Licenses, Nurse etc)
"
Initiation Visit - ANSWERS"Confirm receipt of Supplies
, Review protocol
Review CRF completion/train on CRFs
Confirm all startup reg. docs are on file
Establish Monitor visit frequency
"
Monitoring Visit - ANSWERS"Review site status/ECRFs Prior to visit
Source document verification (compare source documents to CRFs)
Check for new AEs/SAEs
Review study drug accountability, storage, dispensing & any temperature excursions
Assure any safety update letters have been sent to the IRB - lots in Oncology trials
Review regulatory binder
Collect any new documents (original 1572 sent to Sponsor)
Complete Monitoring Report w/in 10 business days
"
Closeout Visit - ANSWERS"Ensure Regulatory documents on site match in house file
Ensure all CRFs are complete and submitted to sponsor
All queries are addressed
AE/SAE follow up is complete
All signed informed consent forms (ICFs) are filed
Ensure Study drug logs are complete & all study drug returned to sponsor per instructions
Ensure investigator brochure and study materials are filed together
Review long term storage
FINAL REPORT IS COMPLETED AND SUBMITTED TO IRB & SPONSOR (usually a form provided by IRB)
"
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 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 Bensuda. Stuvia facilitates payment to the seller.
Will I be stuck with a subscription?
No, you only buy these notes for £6.93. You're not tied to anything after your purchase.
