When should EudraCT number be applied for?

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 needed for a CTA submission?

For a CTA, the four main documents are the protocol, informed consent form, IB, and Investigational Medicinal Product Dossier (IMPD), which contains CMC data. In addition to these, other documents such as EU-specific forms, questionnaires and insurance certificates must be included.

What is a Ctimp?

A Clinical Trial of an Investigational Medicinal Product (CTIMP) is a clinical trial or study that is evaluating the safety or efficacy of a drug (Investigational Medicinal Product) or obtaining any other information about the drug e.g. how it is absorbed, distributed, metabolised or excreted.

What is a CTA document?

CTAs are one of several key documents that govern the conduct of clinical trials. They serve as a legally binding contract between a sponsor, site, and researcher, and outline each party’s responsibilities and obligations for the clinical trial.

What is a non Ctimp?

Non-CTIMPS are studies which do not use Investigational Medicinal Products (IMPs) as. defined by the Medicines and Healthcare products Regulatory Agency (MHRA)

What is the difference between PSUR and DSUR?

The Development Safety Update Report (DSUR) is used for drugs still under development to assess risk to the subjects enrolled in the study, while the Periodic Safety Update Report (PSUR) is used for drugs already on the market to assess long-term safety.

Is clinical trials Authorisation required?

In the UK, a Clinical Trial Authorisation (CTA) from Medicine and Healthcare Products Regulatory Agency (MHRA) is required for a Clinical Trial of an Investigational Medicinal Product (CTIMP).

What kinds of trials require a EudraCT number?

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.

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. .

Who is responsible for CTA?

The governing arm of CTA is the Chicago Transit Board. Lester L. Barclay serves as Chairman. The board consists of seven members, four appointed by the Mayor of Chicago and three by the Governor of Illinois.

How much do IND enabling studies cost?

Being Patience and Persistent! The only problem: it will cost $2-3 millions for IND-enabling studies and another $5-10M for a phase I trial.

What is CTA USA?

The mission of the Consumer Technology Association (CTA)® is to help innovators of all sizes grow their business. Technology is about changing people’s lives for the better. It’s about ideas, large and small, that keep us connected, that help us move and that spark even bigger ideas.