The IRB questionnaire

Ready-made answers for ethics-committee questions, built from your protocol.

Before a study can start, an ethics committee — in the United States, an IRB (Institutional Review Board) — reviews it and asks a long, predictable list of questions: What is the purpose? Who can join? What are the risks? How is consent obtained? You have already answered all of this in the protocol. The IRB questionnaire collects those answers into one ready-made document, so nobody retypes them into a submission form.

Opening the questionnaire#

1. Open your protocol in the editor and click the Documents button at the top-right.
2. On the Document Generation page, click the card named IRB Q&A.
3. What you'll see: a spinner with "Generating IRB questionnaire…", then the finished page. Generation happens fresh each time, so the answers always reflect the protocol as it is right now.

Reading the page#

At the top is a white card headed IRB Submission Q&A, with the note "Auto-generated from protocol structured data" and the date and time it was generated. Below that, four boxes show the protocol title, its version, the study number, and the phase.

Under those is a colored progress bar with three counts:

• Green — questions marked complete: fully answered from the protocol.
• Amber — partial: an answer was found, but only in free text, so it deserves a careful read.
• Gray — not found: the protocol does not yet contain this information.

Categories and questions#

The questions are grouped by topic into collapsible cards — each headed with the category name and the regulation it comes from, plus a count like "6/8 complete" on the right. All categories start open. Click a category's header to fold it away; click again to reopen it. The Expand all and Collapse all buttons in the toolbar at the top do it for the whole page at once.

Inside a category, each question is numbered (Q1, Q2, …) and shows:

• A status badge: green Complete, amber Partial, or gray Not found.
• The answer, written out in full, drawn from your protocol's structured data.
• A Source: line with one or more small blue chips naming the protocol sections the answer came from. Rest your mouse on a chip to see exactly which field was used. These citations are the same idea as golden threads: every claim traces back to its source.

When an answer is missing#

A question marked Not found shows an italic line naming the section to fill in — for example, "Complete the Study Design section to populate this answer." Open the protocol editor, complete that structured section, and return to the questionnaire; the answer fills in on the next visit to the page.

Copying an answer#

Ethics committees usually have their own portal or form. To move an answer across:

1. Find the question you need.
2. Click the small copy icon at the top-right of the question card (its tooltip reads Copy answer).
3. What you'll see: the icon briefly turns into a green check. The full answer text is now on your clipboard — paste it into the committee's form.

Printing#

Click the blue Print button in the toolbar. Your browser's print window opens; from there you can print on paper or save the whole questionnaire as a PDF. The printout expands every category, so nothing is hidden.

To return to your protocol, click Back to editor at the top-left.

Before you submit#

The footer of the page says it plainly: "Generated from protocol structured data. Review all answers before submission. Answers marked Partial or Not Found require manual completion by the medical writer."

Note: The questionnaire is a preparation tool, not the submission itself. It is only as good as the protocol behind it — an answer generated from an unreviewed draft section is a draft answer. Read everything before it leaves your hands.

Troubleshooting: If the page shows "Failed to generate IRB questionnaire", the protocol could not be read — most often because it is very new and has no structured content yet. Use the link back to the editor, fill in the key sections, and try again.