What is an Annex 1 form?
Annex 1: Clinical trial Application Form. REQUEST FOR AUTHORISATION OF A CLINICAL TRIAL ON A MEDICINAL PRODUCT FOR. HUMAN USE TO THE COMPETENT AUTHORITIES AND FOR OPINION OF THE ETHICS. COMMITTEES IN THE COMMUNITY.
What is the European equivalent of Clinicaltrials gov?
EudraCT
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.
What is Annex 1 clinical trial?
Annex 1: A[pplication form. REQUEST FOR AUTHORISATION OF A CLINICAL TRIAL ON A MEDICINAL PRODUCT FOR HUMAN USE TO THE COMPETENT AUTHORITIES AND FOR OPINION OF THE ETHICS COMMITTEES IN THE COMMUNITY.
What does it mean to annex someone?
(Entry 1 of 2) transitive verb. 1 : to attach as a quality, consequence, or condition Many privileges were annexed exclusively to royalty. 2 archaic : to join together materially : unite.
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.).
How long does it take to get a EudraCT number?
It is mandatory for clinical trial summary results to be posted in EudraCT within six to twelve months following the end of the trial (depending on the type of trial). It is the sponsor’s responsibility to ensure that this is done. Non-CTIMP research does not require a EudraCT number.
What is 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 CTA in regulatory affairs?
A Clinical Trial Application (CTA) is a submission to the competent National Regulatory Authority(ies) for obtaining authorization to conduct a clinical trial in a specific country.
What are some examples of Annex?
Annex is defined as an additional part of a building or a nearby building which is used as part of the main building. An example of an annex is a building in the parking lot which is used as additional office space to supplement the office space in the main building.
How to send clinical trial packages by eudralink?
Please send clinical trial packages electronically by Eudralink or email to [email protected] and ccing [email protected]. Do not send storage disks (CDs/DVDs) by post during this time.
When did the EudraCT clinical trials database start?
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.
What are the EU clinical trials guidelines Volume 10?
Volume 10 of the publication “The rules governing medicinal products in the European Union” contains guidance documents applying to clinical trials. A number of documents in Volume 10 are being revised and updated to bring them in line with the changes required by the Clinical Trials Regulation (EU) No 536/2014.
How to apply for clinical trials in Denmark?
Clinical trial applications via Eudralink Updated 09 April 2021 The Danish Medicines Agency prefers to receive clinical trial applications electronically. For example, applicants can submit the application online via Eudralink or by e-mail to our clinical trial inbox.