Layout Part I application in CTIS

In CTIS, there are three sections (Form, MSCs and Part I) to complete for an initial application of Part I.

Form

Initial application details

  • Cover letter: Placeholder to upload cover letter;
  • Proof of payment of fee: No proof of payment of fee has to submitted. In the Netherlands fee will be collected after the clinical trial application has been received;
  • Compliance with Regulation (EU) 2016/679: Placeholder to upload statement;
  • Deferral publication date: Trial category 1,2 or 3 has to selected for the publication date of trial information, including a justification for the selected category (see transparency rules). Deferral of publication date is possible by indicating a new publication date.

MSCs

  • Overview of the member states concerned including the proposed reporting member state. Also an overview of the participating countries outside the European Economic Area.

Part I

Trial details

  • Trial identifiers: Full and public title, protocol code, secondary identifying number registries;
  • 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;
  • Protocol information: Placeholder to upload clinical trial protocol, synopsis of the protocol, data safety monitoring committee charter (if applicable), study design description including the different treatment groups (“study arms”, including placebo group if applicable);
  • Scientific advice and Paediatric Investigation Plan (PIP): Placeholder to upload scientific advice (if applicable) and/or PIP (if applicable);
  • Associate clinical trials: Trial number of associate clinical trial (EU CT number or EudraCT number) (if applicable);
  • References: references to online publications (if applicable);
  • Countries outside the EEA: to identify third countries where CT is will be conducted (if applicable).

Sponsors: Sponsor identifier, contact point for EU and scientific and public contact point.

Products: Description of investigational medicinal products (test and/or comparator), auxiliary medicinal products (if applicable) and placebo (if applicable). Placeholder to submit product-related documents, like Investigator’s Brochure, IMPD-Quality, IMPD-Safety&Efficacy, GMP certificates (manufacturing and import, QP) and sample label text.