CATrialAuthorisation object

Regulatory and ethics bodies involved in approval process

Competent Authority/-ies (CA)
Ethics committee(s)

Regulatory and ethics bodies involved in approval process for trials including patients

Institutional CA

Regulatory and ethics bodies involved in approval process for trials including including healthy participants

Institutional EC

Regulatory and ethics bodies involved in approval process for trials including vulnerable population

Medicines Agency
Competent Authority/-ies (CA)
Ethics committee(s)

Regulatory and ethics bodies involved - Additional information

Medicines Agency could be required if nutritional intervention was categorised as ‘treating’ a disease
National or only institutional EC and CA approval depends on the participants i.e. whether they are ‘patients’ or recruited from the community

Registration requirements - Additional information

Although not ‘mandatory’ for UK governance authorities, registration of nutritional studies (observational and interventional studies) is recommended due to publication requirements.

CA - Submission required to

Institutional CA

Studies including patients - submission required to

National CA

Studies including vulnerable population - submission required to

whether national or only institutional approval is required, depends on the participants i.e. whether they are ‘patients’ or recruited from the community

Additional Information

Studies including vulnerable population - submission required to: whether national or only institutional approval is required, depends on the participants i.e. whether they are ‘patients’ or recruited from the community

This project (ECRIN Integrating Activity/ECRIN-IA) has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 284395