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.

What is an EudraCT number?

A EudraCT number is a unique identifier of the trial and once. issued, it never expires. It identifies a specific trial.

How do you find the EudraCT number?

The e-mail containing the EudraCT number should be printed and filed. As the trial progresses, the EudraCT number will be the main identifier for that trial and should be included on all correspondence (for example when reporting substantial amendments and safety reports).

When should EudraCT number be applied for?

A EudraCT number is required in order to apply to the Medicines and Healthcare products Regulatory Agency (MHRA) for a Clinical Trial Authorisation (CTA) and to apply for REC approval of your clinical trial. CTIMPS which began before 2021 will still need to register and report results on EudraCT.

Who Ictrp database?

The ICTRP Search Portal aims to provide a single point of access to information about ongoing and completed clinical trials. It provides a searchable database containing the trial registration data sets made available by data providers around the world meeting criteria for content and quality control.

What is IND number in clinical trials?

An Investigational New Drug Application (IND) is a request from a clinical study sponsor to obtain authorization from the Food and Drug Administration (FDA) to administer an investigational drug or biological product to humans.

What does NCT stand for in clinical trials?

National Clinical Trial
Mandatory Reporting of National Clinical Trial (NCT) Identifier.

How do I find Ictrp?

The WHO ICTRP database follows specific rules when constructing a standard search or an advanced search: Do not enclose phrases in double quotes (e.g., “pain management”). Two or more words in consecutive order will be searched as a phrase. Searches automatically include synonyms.

What is who Ictrp?

The International Clinical Trials Registry Platform (ICTRP) is a platform for the registration of clinical trials operated by the World Health Organization.

What is NDA and IND?

The Investigational New Drug (IND) application falls into the first category, while the New Drug Application (NDA), Abbreviated New Drug Application (ANDA), and Biologics License Application (BLA) fall into the second category.

Do you need IND before Phase 1?

CLARIFICATIONS OF PRESENT IND REGULATIONS An IND submission for Phase 1 studies is required by regulation to contain the sections enumerated below. Clarifications are described when appropriate beneath each section heading.

What is NCT number in clinical trials?

National Clinical Trial number
NCT Number: The National Clinical Trial number is an identification that ClinicalTrials.gov assigns a study when it is registered. The NCT number is in the format “NCTXXXXXXXX”. Until an NCT number is assigned, the study is not registered.