Part II National Requirements

In order to obtain authorisation for a clinical trial for a mono-national or multi-country trial, a sponsor must submit a harmonised set of documentation to Member States through the Clinical Trials Information System. Where the Clinical Trial Application (CTA) is multinational, the sponsor must nominate a single Reporting Member State (RMS) whose role is to lead and support the coordination of the assessment of the clinical trial. This represents a significant departure from the previous requirement that a separate CTA needed to be submitted to various independent bodies in different Member States.

The authorisation procedure will is split into two stages:

  1. Part I: a coordinated scientific assessment of the CTA by the RMS and all Member States Concerned (MSCs).
  2. Part II: an ethical assessment of country-specific and site-specific documents by each MSC according to its own national requirements.
    Following this procedure, each Member State will reach its own outcome and notify the sponsor through CTIS as to whether the clinical trial is authorised, authorised subject to conditions, or refused.

Please see the NREC-CT Operational Framework under CTR for further information.

Above: timeline of assessment by the National Research Ethics Committee for Clinical Trials (NREC-CT)

What documentation is needed?

Recruitment arrangements

  1. Recruitment and informed consent procedure template
  2. All other relevant materials

Subject information and informed consent

  1. Recruitment and informed consent procedure template
  2. Consent / assent forms
  3. Participant information materials
  4. Additional relevant materials

Suitability of investigator

  1. Signed CV template

Suitability of facilities

  1. Signed site suitability template for each individual site

Proof for insurance and indemnification

  1. Evidence of policy cover

Financial and other arrangements

  1. Statement confirming source of funding
  2. Compensation for trial participants template
  3. Signed 'Declaration of Interest' template

Collection, storage and use of biological samples

  1. Compliance with use of human biological samples template
  2. Additional materials where relevant

Evidence of compliance with data protection laws

  1. Statement outlining measures in place to comply with national and EU legislation
  2. Study-specific Data Protection Impact Assessment with evidence of input from Data Protection Officer (or where relevant, statement outlining why a study-specific DPIA is not necessary)
Scroll to Top
Skip to content