CTA Study Startup & Feasibility 2 — Questions and Answers
Question 1: Which document formally authorizes a site to begin enrolling subjects in a clinical trial?
- Investigational New Drug Application
- Site Initiation Visit report
- IRB/IEC approval letter (Correct answer)
- Feasibility questionnaire
Correct answer: IRB/IEC approval letter
IRB/IEC approval is a mandatory regulatory prerequisite before any site may enroll study subjects.
Question 2: During site feasibility assessment, which metric is MOST predictive of a site's ability to meet enrollment targets?
- Number of exam rooms available
- Historical enrollment rate for similar studies (Correct answer)
- Investigator's publication count
- Laboratory accreditation date
Correct answer: Historical enrollment rate for similar studies
Past enrollment performance on comparable protocols is the strongest predictor of future enrollment success.
Question 3: A CTA discovers that the site's pharmacy lacks adequate cold-storage capacity for the investigational product. What is the IMMEDIATE next step?
- Begin enrollment and resolve storage issues later
- Notify the sponsor and place the site on clinical hold
- Document the finding and escalate to the sponsor before site activation (Correct answer)
- Ask the PI to store the drug in a personal refrigerator
Correct answer: Document the finding and escalate to the sponsor before site activation
Critical infrastructure deficiencies must be documented and escalated to the sponsor prior to site activation to protect product integrity and subject safety.
Question 4: What is the primary purpose of a Pre-Study Site Visit (PSV)?
- To train site staff on electronic data capture
- To evaluate the site's suitability and capabilities before trial initiation (Correct answer)
- To conduct the first patient screening visit
- To deliver investigational product to the pharmacy
Correct answer: To evaluate the site's suitability and capabilities before trial initiation
A PSV assesses whether a site has the facilities, staff, and patient population to successfully conduct the trial.
Question 5: Which of the following is NOT typically included in a site feasibility questionnaire?
- Estimated number of eligible patients per year
- Staff availability and experience with GCP
- Subject randomization allocation ratios (Correct answer)
- Availability of required diagnostic equipment
Correct answer: Subject randomization allocation ratios
Randomization allocation ratios are defined in the protocol, not assessed through feasibility questionnaires.
Question 6: A sponsor requires that all site staff involved in the study complete GCP training before the SIV. Which document provides the most widely accepted GCP standard?
- 21 CFR Part 312
- ICH E6(R2) (Correct answer)
- FDA Guidance for Industry: E8
- ISO 14155
Correct answer: ICH E6(R2)
ICH E6(R2) is the internationally recognized Good Clinical Practice guideline that defines GCP standards for clinical trials.
Question 7: When reviewing a site's essential documents binder at study startup, the CTA notes the CVs of two sub-investigators are missing. The BEST action is to:
- Proceed with the SIV and collect CVs within 30 days
- Obtain the CVs before concluding the SIV or document as an outstanding item with a due date (Correct answer)
- Remove the sub-investigators from the delegation log
- Notify the IRB immediately of the missing documents
Correct answer: Obtain the CVs before concluding the SIV or document as an outstanding item with a due date
Missing essential documents should be collected or formally tracked with a resolution deadline before the site is declared initiation-ready.
CTA Study Startup & Feasibility 2
Which document formally authorizes a site to begin enrolling subjects in a clinical trial?