Eudralex - Templates CTIS Application Part I and Part II CTA
EudraLex Volume 10 is the European Commission’s collection of clinical trials guidelines and related documents. Within this collection, Chapter I “Application and application documents” focuses on clinical trial applications under Regulation (EU) No 536/2014 and provides a set of standardised templates for use in CTIS.
The page lists “Templates documents for FORM section of the CTIS”, including a template statement on compliance with Regulation (EU) 2016/679 on the protection of natural persons with regard to the processing of personal data, available in both PDF and Word formats. It then provides “Part II application document templates” in the same formats, covering key elements of Part II of a clinical trial application dossier:
- compensation for trial participants
- investigator curriculum vitae
- declaration of interest
- site suitability form
- informed consent and patient recruitment procedure
- compliance with applicable rules for biological samples.
Together, these documents form a coherent set of tools and guidelines for sponsors preparing and maintaining clinical trial applications in CTIS. The templates are intended to support harmonised content and structure for Part II documentation across member states, while allowing countries and ethics committees to request additional information where needed. The templates are based on the wording in the Clinical Trials Regulation, endorsed by member states, and designed to help both ethics committees assess applications and sponsors prepare submissions. Using these templates can reduce avoidable queries, support compliance with data‑protection and ethical requirements, and facilitate parallel submissions in several countries through CTIS.
The EudraLex Volume 10 page also links to six chapters relevant to CTR 536/2014 applications:
Chapter I – Application documents; CTIS form template; Part II templates for compensation, investigator CV, declaration of interest, site suitability, informed consent and recruitment, biological samples
Chapter II – Safety reporting; ICH E2F safety update guideline
Chapter III – Quality; Guidance on handling investigational products, GMP, batch release, quality documentation, auxiliary products
Chapter IV – Inspections; GCP inspection guidance for sponsors, sites, laboratories, systems, Phase I units
Chapter V – Additional documents; CTR Q&As, complex trials, device interface, data protection, risk‑proportionate approaches, lay summaries, decentralised elements, ICH E6, ACT EU, contact points
Chapter VI – Legislation; Clinical Trials Regulation (EU) No 536/2014 and related delegated and implementing acts.