CTA Study Startup & Feasibility 3 — Questions and Answers
Question 1: What is the role of a Clinical Trial Agreement (CTA) between a sponsor and an institution during study startup?
- It defines the investigational product dosing schedule
- It establishes legal and financial terms governing the conduct of the trial at the site (Correct answer)
- It replaces the need for an IRB-approved protocol
- It certifies that the investigator has completed GCP training
Correct answer: It establishes legal and financial terms governing the conduct of the trial at the site
The Clinical Trial Agreement is a legal contract outlining financial, intellectual property, publication rights, and liability terms between the sponsor and site.
Question 2: During feasibility, a site reports 200 patients with the target diagnosis seen annually, but 80% are managed by physicians not involved in the study. How many potentially eligible patients per year should be estimated?
- 200
- 160
- 40 (Correct answer)
- 120
Correct answer: 40
Only 20% of the 200 patients (40) are managed by participating physicians and therefore realistically accessible for the study.
Question 3: Which regulatory submission is required before a Phase I investigational drug trial may begin in the United States?
- New Drug Application (NDA)
- Biologics License Application (BLA)
- Investigational New Drug Application (IND) (Correct answer)
- Abbreviated New Drug Application (ANDA)
Correct answer: Investigational New Drug Application (IND)
An IND must be filed with and accepted by the FDA before human trials of an investigational drug can commence in the US.
Question 4: A site initiation visit (SIV) checklist item states that the delegation of authority log must be completed. Who is responsible for signing this log?
- The CTA/CRA on behalf of the sponsor
- The IRB chairperson
- The Principal Investigator (Correct answer)
- The institutional compliance officer
Correct answer: The Principal Investigator
The Principal Investigator must sign the delegation log to formally delegate tasks to qualified study team members.
Question 5: A sponsor's feasibility team identifies two candidate sites with similar patient populations. Site A has a dedicated research nurse; Site B does not. Which factor does this MOST directly affect?
- Protocol complexity tolerance
- Site's regulatory submission timeline
- Operational capacity and subject management quality (Correct answer)
- Investigator's conflict-of-interest disclosure
Correct answer: Operational capacity and subject management quality
A dedicated research nurse directly improves subject recruitment, scheduling, data collection, and overall operational capacity.
Question 6: At what point during study startup should laboratory normal ranges for the central laboratory be filed in the site's Investigator Site File (ISF)?
- After the first subject is enrolled
- Before the first subject is screened (Correct answer)
- At the end of the study
- Only if local labs are also being used
Correct answer: Before the first subject is screened
Lab normal ranges must be available before screening so that lab results can be interpreted correctly at baseline.
Question 7: Which of the following BEST describes a 'protocol feasibility review' conducted by an investigator?
- A formal IRB submission to approve subject enrollment
- An investigator's assessment of whether the protocol can be executed safely and realistically at their site (Correct answer)
- A sponsor audit of the investigator's prior research conduct
- A regulatory agency inspection of the investigational site
Correct answer: An investigator's assessment of whether the protocol can be executed safely and realistically at their site
Protocol feasibility review is the investigator's internal evaluation of whether the study design, procedures, and requirements are achievable at their specific site.
CTA Study Startup & Feasibility 3
What is the role of a Clinical Trial Agreement (CTA) between a sponsor and an institution during study startup?