Since January 28, 2019, the Ministry of Health is the single point of contact to submit the request for authorization of the conduct of a study or clinical research project involving healthy volunteers or patients in Luxembourg.
To assist the application procedure, the CIEC is responsible for reviewing and sending all the documents to be included in the submission file (incl. information sheet, informed consent form for participants, study protocol, insurance, etc...).
Laetitia Garcia joined the CIEC team last April. As Clinical Research Coordinator, Quality and Regulatory, she took over regulatory and quality activities (previously from Charlotte Lieunard) since November 1, 2020.
With the support of the team of Clinical Research Associates, she is in charge of reviewing and submitting your application to the Authorities.
This procedure aims at harmonizing submissions to the Ministry and ensuring compliance of the files with the regulatory requirements expected in terms of ethics and respect of patients/participants’ privacy and confidentiality of personal data.
Please kindly address your files for review to LIH_Regulatory@lih.lu
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Investigators and study staff who wish to be part of a unique network, in order to stay abreast of clinical trials taking place in Luxembourg and who are willing to further develop their competencies.
