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Module 1: Lesson 1
Completing feasibility questionnaires and confidential disclosure agreements
Complete feasibility questionnaires with honest, data-supported answers and understand the purpose and obligations of confidential disclosure agreements.
The questionnaire asks. Your data answers.
The sponsor's feasibility questionnaire arrives. Question 7 reads: "How many patients with Type 2 diabetes does your site see annually?" The investigator's clinic sees roughly 1,200 patients with Type 2 diabetes every year. The number who meet the protocol's 17 inclusion and 23 exclusion criteria -- based on the EMR analysis you completed in Lesson 1 -- is closer to 85. The number who survive the enrollment funnel after consent rates, screening attrition, and competing study overlap is approximately 12 to 18 per year.
Three numbers. Three very different answers. And what you write on that questionnaire determines two things: whether the sponsor selects your site, and whether your site can deliver what it promised.
This is where the analytical work of the previous three lessons becomes consequential. The patient population assessment from Lesson 1, the resource and infrastructure evaluation from Lesson 2, and the competitive landscape analysis from Lesson 3 -- all of it was preparation for this moment. The feasibility questionnaire is the document where those analyses are translated into commitments. Not impressions. Not aspirations. Commitments that the sponsor will hold you to, that the monitor will track, and that your site's reputation will be measured against 12 months from now.
I have reviewed hundreds of feasibility questionnaire responses over my career, and the gap between the best and the worst is not sophistication. It is honesty supported by data. The best responses cite their methodology. They present ranges, not single numbers. They disclose constraints. They say "12 to 18 participants over 18 months, based on EMR analysis of 85 eligible patients reduced by a 40% consent rate, 70% screening pass rate, and 20% competing study overlap." The worst responses say "25 patients, no problem." And both types of sites sometimes get selected -- but only one type consistently delivers.
This lesson teaches you how to complete a feasibility questionnaire with data-supported, verifiable responses, how to navigate the confidential disclosure agreement that precedes the questionnaire, and how sponsors evaluate the answers you provide.
What you will learn
By the end of this lesson, you will be able to: