18.03.2020
To the attention of interested persons
Supplementing NAMMDR notification of 12.03.2020 on submission of documents in the current epidemiological context requiring limitation to the utmost extent possible of Registry Service work, please be advised on specific details aimed to streamline admission of documents addressed to the Clinical Trials Directorate (CTD).
Therefore, please note:
Documents to CTD attention may be admitted as follows:
1. electronically, as follows:
– letters of intent, payment forms and various notifications are to be sent to registratura@anm.ro;
– documentation related to important amendments or clinical trial are to be sent directly to the CTD, using the Upload platform, to aurora.nicula@anm.ro, with specification of the registration number provided in the confirmation of payment;
– documentation related to authorisation of healthcare facilities as clinical trial sites are to be submitted directly to the CTD, using the Upload platform to aida.goran@anm.ro, with specification of the full name of the healthcare facility and the valid contact email address;
– documentation accompanying notifications is to be submitted directly to the CTD, using the Upload platform, to aurora.nicula@anm.ro, with the specification Notification + brief summary, e.g. DSUR, non-important amendment etc.
2. by regular mail or courier (if the above is not feasible)
Please note that submission using CESP or PCUe is not applicable for the Clinical Trials Directorate.