Layout Part I application in CTIS

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: Study design description including the different treatment groups (“study arms”, including placebo group if applicable), placeholder to upload clinical trial protocol, synopsis of the protocol, data safety monitoring committee charter (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-Efficacy&Safety, GMP certificates (manufacturing and import, QP) and sample label text.