FDA Guidance Quiz

How much do you know about the FDA Draft PRO Guidance?

Are you familiar with the FDA’s draft guidance on Patient Reported Outcomes (PRO) in clinical research? How well do you know the elements of the guidance that may affect your PRO strategies?

Test your knowledge of the draft guidance by taking the quiz below. After submitting you'll get a brief summary of the answer for each question. The full answers and a summary of participant responses were provided during an exclusive Web Seminar. Hosted by the scientific and regulatory expects of PRO Consulting®/invivodata, inc., this interactive Webinar was designed to help you understand the implications of the draft guidance as you make key decisions about the PRO strategy and instruments for your clinical programs and individual trials.

Hit ‘Submit’ to view the correct responses, and to register to download the webinar.


(* Required)
1. Does the PRO Guidance apply to instruments developed and used prior to the release of the PRO Guidance? *
a. Yes
b. No
2. According to the guidance, should you conduct validation activities as part of your phase III study? *
a. Yes
b. No
3. Changing the order of PRO instrument items or deleting portions of the questionnaire can alter the way a patient responds to a questionnaire *
a. True
b. False
4. Why is PRO data important *
a. For many outcomes, patient reports are the best available method for obtaining information on unobservable events
b. Even when an event is observable (e.g., voiding, dietary intake), the patient is often in the best position to assess and report these outcomes
c. PRO measures may be more reliable and valid than measures completed by a clinician via an interview with the patient
d. PRO data can uniquely provide information on a patient's perception of both a disorder and the treatment for the disorder
e. All of the above
5. Which strategies should be used to ensure that patients are using an electronic measure appropriately? *
a. Cognitive debriefing
b. Usability testing
c. Psychometric testing
d. A and B
e. A and C
6. How can a sponsor receive feedback from FDA on a strategy for administering PROs in a clinical development program? *
a. Requesting a Type C meeting
b. Requesting written feedback on a briefing book
c. Submitting the PRO strategy as part of a scheduled meeting
d. All of the above
7. Is it a requirement that development, modification and validation of a PRO instrument occur in a linear manner? *
a. Yes
b. No
8. Which of the following is NOT contained in a Cognitive Debriefing Report to the FDA? *
a. Readibility test
b. Script used in patient cognitive debriefing interviews
c. Audio recording of the interviews
9. If an instrument is modified, evidence supporting the psychometric properties of the modified measure is required. *
a. True
b. False
10. How do you currently calculate a minimum important difference (MID)? *
a. Use change of .5 standard deviation units as a threshold
b. Compare change in PRO to change in clinical measure
c. Compare change in PRO to global impression of change measure
d. There is no single correct way to calculate an MID
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