Guide to submitting an additional Member State concerned application for EMPRESS in the CTIS sponsor workspace

Each of the sections below represent how the Clinical Trials Information System (CTIS) application system is structured. Below you will find documents used to applying for approval in Denmark.

1.0 Form

1.1 Cover letter: Find the document used in the original CTA in CTIS for the Cover letter here.

1.2 Proof of payment of fee: In Denmark no proof of payment of fee must be submitted. You must check whether this is required by your national authorities. However, you may be required to upload the invoice details, which you can find here.

1.3 Compliance with regulation: See completed statement here.

1.4 Deferral of publication dates: Trial category 1,2 or 3 must be selected for the publication date of trial information, including a justification for the selected category. Deferral of publication date is possible by indicating a new publication date.

2.0 Part I

2.1 Trial identifiers: Full and public title, protocol code, secondary identifying number registries can be found here.

2.2 Trial information: Justification low-intervention clinical trial (if applicable), medical condition, primary and secondary objectives, principal in- and exclusion criteria, primary and secondary endpoints, trial duration, source of monetary support, identifiers study population can be found here.

2.3 Protocol information: Current protocol can be found here. Synopsis of the protocol in English can be found here, be aware that a version of the synopsis in the native language must be drafted as well. The patient facing documents for EQ-5D-5L and EQ-VAS can be found here. Data safety and monitoring charter can be found here.

2.4 Scientific advice and Paediatric Investigation (PIP): Not applicable. Since EMPRESS does not include minors.

2.5 Associate clinical trials: Not applicable.

2.6 References: Not applicable.

2.7 Countries outside the European Economic Area: Not applicable.

2.8 Sponsors: Sponsor identifier, contact point for EU and scientific and public contact point can be found here.

2.9 Products: Summary of product characteristics (test = meropenem and comparator = piperacillin/tazobactam) in both English and your native language versions.