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)
"
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