09.04.2020
To the attention of interested persons
In addition to the NAMMDR important notification published on 18.03.2020 on submission of documents, requiring limitation of the Registry Service’s activity, to the utmost extent possible, here are some clarifications about streamlining the document reception activity of the Clinical Trials Directorate (DSC).
These refer to the following:
The submission of documents to the attention of the DSC shall be done as follows:
1. electronically, as follows:
– letters of intent, payment forms and various notifications shall be sent to registratura@anm.ro;
– the documentation related to substantial amendments or clinical trials shall be sent directly to the DSC, using the Upload platform, selecting the Clinical Trials Directorate as the recipient, mentioning the registration number written in the payment confirmation; the documentation shall be sent by archive.
– the documentation related to authorisation of healthcare facilities as clinical trial sites shall be submitted directly to the DSC, using the Upload platform, mentioning the full name of the healthcare facility and the valid contact e-mail address;
– the documentation accompanying notifications shall be submitted directly to the DSC, using the Upload platform, selecting the Clinical Trials Directorate as the recipient, with the specification Notification + brief summary, e.g. DSUR, unimportant amendment etc.
2. By regular mail or courier (in case large documentation is transmitted, exceeding the loading capacity on the platform or if the above is not feasible)
Please note that submission through the CESP or PCUe is not applicable for the Clinical Trials Directorate.