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CRA review test questions & answers 2024/2025
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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...

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  • September 18, 2024
  • 9
  • 2024/2025
  • Exam (elaborations)
  • Questions & answers

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  • cra review test questions answers

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  • CRA
  • CRA

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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 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

Review protocol compliance - primarily inclusion/exclusion criteria

Review ICFs (informed consent forms)

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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