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Publication duties
A recruitment microsite is marketing. The legal record is the registry entry. In the US, an applicable trial must be registered within 21 calendar days of the first participant enrolling. In the EU, sponsors submit through CTIS. An IRB reviews and approves recruitment advertising. FDA guidance exempts a listing that carries only basic trial information.
A reference note from Dan Malone, who builds software products.
The rule
“not later than December 26, 2007, or 21 calendar days after the first human subject is enrolled, whichever date is later.”
The facts
| Field | Value |
|---|---|
| US registration deadline | The responsible party must submit registration information within 21 calendar days after the first human subject is enrolled. Source |
| US results deadline | Results information is due no later than 1 year after the primary completion date of the trial. Source |
| US failure to file | Failure to submit required trial information is a prohibited act. It carries civil monetary penalties and withheld grant funds. Source |
| US consent form posting | For a trial a federal agency conducts or supports, one IRB-approved consent form goes on a public federal website. Posting happens after the trial closes to recruitment, and no later than 60 days after the last study visit. Source |
| Who approves the recruitment copy | The IRB reviews and approves the methods and material that investigators propose to use to recruit subjects. Source |
| What the copy may say | An advertisement is limited to what a person needs to judge eligibility and interest. Payment may be stated, not emphasised. Source |
| Banned wording | FDA guidance says advertising must not call the article new medication or new treatment without saying it is investigational. It must not promise free medical treatment. Source |
| EU results summary and lay summary | The sponsor submits a results summary to the EU database within one year of trial end. A layperson summary must accompany it. Its content is set out in Annex V. Source |
| EU lay summary timing bands | 12 months from the protocol-defined end for adults, 6 months for paediatric studies. Non-therapeutic Phase 1 trials get up to 30 months. Source |
| EU end-of-trial notice | The sponsor notifies each Member State of the end of the trial within 15 days, through the EU portal. Source |
| Where EU trial information is published | CTIS became the single entry point on 31 January 2023. Revised CTIS transparency rules apply from 18 June 2024. Source |
| Screening form data | The controller gives its identity and contact details when it collects personal data from the person. Source |
The artefact
What goes wrong
/01
Registration is filed after day 21 of first enrolment, so the record is late from the start.
/02
Results appear on the microsite but never reach the registry inside the one-year window.
/03
Marketing edits the live copy after IRB approval, so the public wording is unapproved.
/04
The page promises a new or better treatment, which the guidance treats as a promotional claim.
/05
The lay summary is written at a clinical reading level, or misses the 12, 6 or 30 month band.
/06
The consent form is not posted to the federal repository within 60 days of the last study visit.
/07
The screening form collects health data with no privacy notice and no named controller.
/08
The site stays live and still says recruiting long after the trial closed to enrolment.
/09
The microsite and the registry record disagree on eligibility or site list, so a reader gets two answers.
Who supplies this
Patient recruitment service that matches people to trials and runs sponsor-facing recruitment media.
https://www.antidote.me/
Clinical trial platform with participant recruitment, eConsent and screening flows built in.
https://www.curebase.ai/
Trial disclosure and transparency software for registry submissions and lay summary workflow.
https://www.citeline.com/en/products-services/regulatory-and-compliance
Patient recruitment company that builds study landing pages and runs enrolment campaigns.
https://www.studykik.com/
Send the duty, the deadline and where it has to sit. What comes back is a written scope for the page, or a straight answer that you do not need one.
Send the briefLast checked 2026-09-01 · Published 2026-09-01
This page is reference material, not legal advice. Your advisor owns what applies to you.