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 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 Operational Framework for further information.

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. CV template
  2. 'Declaration of Interest' 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

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. National statement of compliance template or study-specific Data Protection Impact Assessment

General Notes for Part II Dossier Submission to CTIS for all trials

Document Templates: NREC Templates are available on our website. All EMA and NREC document templates will be accepted, except for the Site Suitability Assessment Form. Only the NREC Template will be accepted for this document.

Document Accessibility: Please only submit original PDF documents for review; scanned copies of documents do not enable accessibility and if submitted, original PDF versions will be requested. If electronic signatures for the SSA documents cannot be facilitated, a scanned copy of the signed document can be accompanied by submission of the original PDF, which can be unsigned.

Signatures: The only document that the NREC requires a signature on is the SSA forms. Signatures on other documents are accepted, but not mandatory.

Personal Information: The only personal information that the NREC requires on documents are that of the signatory of the SSA (as per the template), and the name and job title of the DPO, who has provided input on the DPIA (for new submissions only; this is not applicable to transition trials unless already available as part of the CTD submission package. If no DPIA was originally approved for a CTD trial, a compliance statement is sufficient for a transition trial).

Documents required under the CTD; requirements for submission under the CTR:

There is no further requirement for submission of the NREC Application Form. The Radiation Appendix and Appendix for Combination Studies are also not mandatory under CTR; however, their submission is welcomed as part of the Part II Dossier, under Suitability of Facilities, in order to aid the NREC-CT in their assessment of the application.

Scroll to Top