New clinical investigations/
Performance studies

If you wish to apply to the NREC-MD for a new clinical investigation or performance study, please use the templates below for the Application Form, Documentation Checklist and the Site Suitability template. For more information on the application and review process, please visit the NREC-MD FAQs.

Please note that all applications submitted should be accompanied by V4 of the NREC-MD Documentation Checklist.

Please note that applicable applications should be accompanied by V4 of the NREC-MD Application Form.

Please follow the NREC-MD Documentation Checklist when compiling your application dossier.

All application documents should be numbered and file names should include version number and date.

Applications that do not include the relevant documentation or information will be deemed invalid and will require resubmission.

All applications should be sent as a zipped folder to

You can find the NREC-MD meeting and cut off dates here.

You can find more information about fees here.

You can find more information about submission processes in our Operational Framework.

Please also consider the information below when preparing your application for submission:


Accessibility of documentation

Any documentation submitted for NREC review must be presented in an accessible and searchable format (Word or original PDF). We are unable to accept scanned documents as these documents are composed of images, rather than searchable text, and cannot be optimised for use with assistive software. If it’s not possible to submit an accessible document due to a scanned wet ink signature, an unsigned accessible version must also be included as part of the submission. Submissions that are not in an accessible format may be deemed invalid or may delay the assessment process.


Aligning your study with the Health Research Regulations 2018 

All applications submitted to the NRECs for ethics assessment must demonstrate compliance with the requirements under the Health Research Regulations 2018, as well as any other national or European legislation relevant to the study. Below are some examples of the key safeguards from the HRR 2018 that all studies must comply with:

  1. Ethics review

Any processing or further processing of personal data for the purposes of health research requires ethics approval by a research ethics committee. This includes the re-use of study data for secondary research purposes when identifiable or pseudonymised data is used.

  1. ‘Broad’ or ‘explicit’ consent for future use

The legislation allows for the use of ‘broad’ or ‘explicit’ consent in the processing or further processing of personal data for the purposes of health research. This legislation does not allow for blanket consent. Consent for future use of data must be limited to a particular disease area or more generally in that area or a related area of health research and must be clearly described in the Participant Information Leaflet. An example would be limiting future use of study data to the disease and / or medicinal product / device being studied.

  1. Consent declarations

If your study involves participants that may lack decision making capacity, or you are unable to obtain explicit consent for the personal data being processed in the study, then an application for a consent declaration may be necessary.  The NRECs must be notified if a study requires a consent declaration as part of the application. This can be included in the Cover Letter or the Recruitment and Informed Consent Procedure. It is advisable to engage with the Secretariat of the HRCDC with any queries on this as early as possible in your project, in order to prevent potential delays.,


Involvement of participants without proficient English language

In the interest of equitable access to research participation, all reasonable efforts should made to allow access to the study participation for participants without proficient English, or who do not speak English. Such participants should be provided with a copy of a translated Participant Information Leaflet and Informed Consent Form and the translations must be completed by a certified translation provider. Copy of translation certificates should be provided to the National Office as non-substantial amendment. In addition, when interacting with the study team, the services of interpreter should be made available to such participants.

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