Eligibility Criteria
This lab value is commonly used to determine eligibility in prostate cancer trials and must often be below a protocol-defined threshold.
PSA
This document serves as the “instruction manual” for conducting the clinical trial.
Protocol
This document must be IRB-approved and signed by the subject before any study-specific procedures occur.
ICF
This performance status scale is most commonly used in oncology trials to determine if a patient is fit for enrollment.
ECOG
This log tracks all subjects who were screened, including screen failures.
Screening Log
This document contains preclinical data, safety information, and known risks of the investigational product, and is used to assess whether an AE is expected.
IB
A patient’s baseline creatinine clearance is 48 mL/min. The protocol requires ≥50 mL/min. The PI thinks it’s “close enough.”
patient is ineligible
Midway through your GU oncology trial, the sponsor issues a protocol amendment to add a new dose cohort and update the eligibility criteria.
What steps must the CRC/site take before enrolling new patients under the amendment?
- Submit to IRB (IRB approval) - protocol, ICFs, etc
- Submit to PRMC
- Submit to OCTA
- Train all staff on IRB approved documents
You are opening a new GU oncology clinical trial under an IND. The sponsor submits a document to the FDA that includes the study protocol, investigator brochure, and overall investigational plan.
Meanwhile, your Principal Investigator signs a separate document agreeing to conduct the study, follow FDA regulations, and ensure proper oversight at the site.
Name BOTH forms.
1571 = Sponsor → FDA
1572 = Investigator → Sponsor/FDA