Is your study a clinical trial, a clinical investigation, or both?

Question 1.12 of the Q&A answers this by looking at what the study investigates:

  • One integral drug-device product: its principal mode of action decides its status.
    • If it is a medicinal product (for example, a prefilled syringe), the CTR applies.
    • If it is a medical device, the CTR does not apply.
  • A medicinal product under study, with devices used only as tools: the CTR applies, and the devices must comply with the EU rules for placing on the market.
  • Two separate products, both under study: the CTR covers the medicine, and the MDR or IVDR covers the device.

The third case costs the most. It creates two dossiers, two safety reporting flows and two sets of results deadlines.

Chapter 6 now explains what “no results” really means

The core rule has not changed. Within one year of the end of the trial, the sponsor must upload two documents to the Clinical Trials Information System (CTIS): a summary of results and a summary for laypersons. This applies whatever the outcome. Paediatric trials have six months.

The technical summary must cover at least the primary and secondary endpoints. The lay summary must give the overall results, the primary endpoints and the secondary endpoints that matter to patients.

The revised chapter is much clearer about trials that end early. If no EU/EEA subject was ever enrolled, the sponsor uploads a short statement saying so in both CTIS spaces. If an authorised trial expired after two years without any EU/EEA subjects, no summaries are expected.

“The summary of results and the layperson summary are expected to be submitted whenever a trial that included EU/EEA subjects is early terminated, even when a sound statistical analysis cannot be performed.”

Q&A 6.1

If the data are too thin to analyse, the sponsor leaves out the primary endpoint data points and both summaries explain why. The reason for closing the trial early, such as poor recruitment or a safety event, goes in sections 3.2 and 3.3 of the lay summary.

Comparison of CTR & MDR

Scenario CTR (medicinal product) MDR Article 77(5) (device)
Normal end of study 12 months (6 for paediatric trials) 1 year
Early termination 12 months, counted from the termination date 3 months (also after a temporary halt)
Plain-language summary Layperson summary (Annex V) Summary easily understandable to the intended user

Safety reporting overlaps too. Q&A 7.52 asks sponsors to cover two things in the “evaluation of risks” or “benefit-risk considerations” section of the Annual Safety Report: SAEs related to investigational devices or IVDs, and device deficiencies that could lead to such SAEs.

The Q&A is not legally binding, but the national contact points who sit on CTAG endorsed it. Sponsors of combined studies benefit most by agreeing early on one statistical analysis plan and one communication timeline for both arms. If the study then stops early, the sponsor sends one coordinated response instead of two unrelated reports months apart.

Link to the document: CTR Q&A version 7.4