SOCRA CCRP Site Management 2 — Questions and Answers
Question 1: What is investigational product (IP) accountability at a clinical trial site?
- Verifying that the IP is FDA-approved
- Documenting the receipt, storage, dispensing, use, and return/destruction of all investigational product (Correct answer)
- Tracking the cost of IP per subject
- Ensuring the IP is covered by the study insurance policy
Correct answer: Documenting the receipt, storage, dispensing, use, and return/destruction of all investigational product
IP accountability involves maintaining records of all investigational product received, stored, dispensed to each subject, and returned or destroyed, ensuring complete chain of custody.
Question 2: What is a 'protocol amendment' and what is required when one is issued?
- A change to the financial terms of the study contract
- A formal revision to the study protocol that requires IRB review and approval before implementation (Correct answer)
- An informal update communicated verbally to site staff
- A change that only requires the PI's signature to implement
Correct answer: A formal revision to the study protocol that requires IRB review and approval before implementation
A protocol amendment is a formal written change to the protocol that must be submitted to and approved by the IRB, and updated with regulatory authorities, before implementation.
Question 3: What is a 'pharmacy manual' and why is it used at clinical trial sites?
- A manual listing all approved medications in the hospital formulary
- A document providing site pharmacy staff with instructions for IP storage, dispensing, handling, and accountability procedures (Correct answer)
- A financial guide for billing investigational drugs to insurance
- A reference for subinvestigators on drug dosing calculations
Correct answer: A document providing site pharmacy staff with instructions for IP storage, dispensing, handling, and accountability procedures
A pharmacy manual provides study-specific instructions to pharmacists regarding IP storage conditions, reconstitution, dispensing procedures, and accountability requirements.
Question 4: What does 'subject screening' involve in clinical trial site management?
- Selecting subjects from a published database
- Evaluating potential participants against inclusion/exclusion criteria before enrolling them in the trial (Correct answer)
- Screening subjects for willingness to pay study costs
- Conducting a background check on potential participants
Correct answer: Evaluating potential participants against inclusion/exclusion criteria before enrolling them in the trial
Subject screening involves assessing candidates against the protocol's inclusion and exclusion criteria, typically including medical history review, physical exams, and lab tests.
Question 5: What is the purpose of a 'randomization log' at a clinical trial site?
- To record subjects' random assignment to treatment arms in blinded or open-label trials (Correct answer)
- To randomly assign tasks to site staff
- To document random audits conducted by the sponsor
- To track randomized protocol deviations
Correct answer: To record subjects' random assignment to treatment arms in blinded or open-label trials
A randomization log records each subject's randomization number and treatment assignment (or blind code), maintaining the integrity of the randomization process.
Question 6: What is a 'screening failure' in clinical research?
- A subject who withdraws before completing the study
- A potential participant who was screened but did not meet eligibility criteria and was not enrolled (Correct answer)
- A failure in the screening equipment at the site
- A protocol violation during the screening visit
Correct answer: A potential participant who was screened but did not meet eligibility criteria and was not enrolled
A screening failure is a subject who was consented and screened for a trial but did not qualify for enrollment based on inclusion/exclusion criteria.
SOCRA CCRP Site Management 2
What is investigational product (IP) accountability at a clinical trial site?