How do you get an EudraCT number?

Researchers should apply via the EudraCT website by clicking ‘Login to EudraCT’ and then ‘Create’ and ‘EudraCT number’ before completing the registration form. The unique EudraCT number generated has the format YYYY-NNNNNN-CC, where: YYYY is the year in which the number is issued.

How do I post results on EudraCT?

Tutorials on posting results in EudraCT Request assignment to become the primary user for your trial: download the form, and fill it in, inserting your results user email as Requestor’s email, then log in, click on “your page” and “request assignment”, insert your trial’s details and upload the filled in form.

What is the EudraCT form?

EudraCT form (concerns only the EU) The EudraCT form contains information on the clinical trial, the investigational medicinal product, the study design and the different actors involved (sponsor, applicant, CROs, central laboratories, investigators, etc.).

What does EudraCT stand for?

European Union Drug Regulating Authorities Clinical Trials Database
EudraCT (European Union Drug Regulating Authorities Clinical Trials Database) is the European database for all interventional clinical trials on medicinal products authorized in the European Union (EEA) and outside the EU/EEA if they are part of a Paediatric Investigation Plan (PIP) from 1 May 2004 onwards.

How do I create a EudraCT account?

To register as a first time results user select Register, from the main login page:

  1. The following screen is displayed:
  2. Click Create a new EMA account .
  3. Fields with a red asterisk are mandatory and must be input.
  4. If you agree with the terms, click Register.
  5. .

What is an EV substance code?

EV CODE (EudraVigilance code) is a unique code assigned to any entity (e.g. substance, product etc.) entered in the XEVMPD. An EV Code is generated after the substance has been inserted successfully in the XEVMPD; the EV Code is included in the XEVPRM_ACK.

What is required for an IND?

Filing an IND requires completion of 3 sets of forms: 1 detailing the study (FDA Form 1571), 1 providing information about the investigator and study site (FDA Form 1572), and 1 certifying that the study is registered in the national database of clinical trials (FDA Form 3674).