Application
Applying for a clinical trial
A EudraCT number must be applied for.
EudraCT is a database for all clinical trials within the European Economic Area (EEA), in which applications to all the European medicines agencies are filed. The database is made in accordance with Directive 2001/20/EC. Applicants/sponsors can access the database through the internet in order to:
· Apply for a EudraCT number – http://eudract.emea.europa.eu
- Fill in, save and print an electronic version of the filled-in application form for clinical trials
Access to the database proper is restricted and only the European medicines agencies within EEA, EMEA and the Council of Europe can access it.
Detailed guidance on filling in the EudraCT for applying for a clinical trial in Iceland can be found on the EMEA website, www.emea.europa.eu
Guidance on applying for a EudraCT number
EudraCT number – the ID of the clinical trial
In order to have a specific reference to the clinical trial with at least one centre within the EEA, each trial receives a specific number – EudraCT number. That number must feature in all applications for clinical trials within the EEA as well in other documents related to the trial (e.g. SUSARs). Getting a EudraCT number is a two-step process comprising the items described below.
The structure of the EudraCT number is YYYY-NNNNNN-CC, where
YYYY is the year when the number was published
NNNNNN is a six digit sequential number
CC is a validation number
Step 1 – Applying for a safety code
The first step involves receiving a confirmed safety code. This code is sent to the email address, which the applicant denotes in the application and is essential in order to finalise the application fro a EudraCT number. The safety code is only valid for one EudraCT number and expires 24 hours after application.
Step 2 – Applying for a EudraCT number
This step is the application proper for a EudraCT number. In this step the safety code from Step 1 must be utilised. The EudraCT number is sent to the email address, which the applicant denotes in his application.
The following data shall be attached to the clinical trial application (CTA):
1. Covering letter
A covering letter must accompany the CTA, which includes the title of the trial, EudraCT number, and the protocol number of the sponsor. Specific issues and concerns related to the trial should be highlighted, e.g. if a scientific advice is associated with the trial.
The letter must also state the importer of the investigational medicinal product and which pharmacy will store it. If the applicant has requested to be exempted from storing the investigational medicinal product in the custody and supervision of a pharmacy or hospital pharmacy, standard operating procedures regarding reception, handling, delivery, storage and disposal should be included in the application.
2. A print-out of the application from the EudraCT system
The CTA shall be submitted in a printed form and the EudraCT application in an .xml format on a CD.
3. A copy of the allocation of the EudraCT number
A copy of the allocation of the EudraCT number must accompany the CTA.
4. Signature form
A signature form must be attached to the CTA, signed by the principal investigator (PI). If the trial is conducted in a hospital or other health organisation, then a senior physician, head of department or organisation must also sign the form. It the trial is conducted in cooperation with a sponsor, his representative must also sign the form. In the absence of a sponsor the PI takes on the role of the sponsor.
Multi-centre trials are regarded as one trial. In such cases only one application shall be submitted to IMCA along with the signature form signed by the coordinating investigator/ supervisor of the trial. Signature forms signed by the PIs at each investigator site (centre) in Iceland must also accompany the letter.
5. Copy of an application to the respective ethics committee
Copy of an application to the respective ethics committee shall also accompany the application.
6. Protocol
A protocol must be submitted, stating inter alia the objective, set-up, methodology, statistical methods and the design of the trial.
It should be stated whether the trial is a part of a multinational clinical trial.
The trial must be conducted in accordance with Regulation No 443/2004 and rules on good clinical practice (GCP).
7. Investigator’s Brochure
The application must be accompanied by a summary of clinical and pre-clinical data on the investigational medicinal product(s) which is relevant fro a clinical trial on the medicine(s) in humans. The brochure must include a risk-benefit assessment.
8. Investigational Medicinal Product Dossier (IMPD)
Summary of the chemistry, pharmaceutics, pharmacology in animals, toxicology, pharmacology in humans and clinical properties of the medicinal products must be submitted.
9. Manufacturing licence, GMP certificate or a corresponding inspection report/letter from respective regulatory authorities
A certificate from all manufacturing units, including packaging, labelling and batch release must be submitted
If the investigational medicinal product is not manufactured within the EEA and does not have a marketing authorisation in EEA, a statement is needed from the Qualified Person (QP) of the importer into the EEA, stating that the medicine is manufactured in accordance with GMP rules and that research has confirmed the quality of the product. The QP can come from whichever country within the EEA.
10. A copy of information to participants and their informed consent
A copy of information to participants and their informed consent must also be submitted.
11. A copy of a confirmation of insurance
A copy of a confirmation of insurance must be submitted. The clinical trial insurance should accommodate health impairments of patients participating in the certified clinical trial including death.
12. A list of other medicines agencies to which the application has been sent
A list of other medicines agencies to which the application has been sent must also accompany the application.
13. Labelling on packaging
Labelling on packaging must be in accordance with provisions in article 28 of Regulation No 443/2004 on clinical trials of medicinal products in humans.
14. Import licence application for IMP
For import of the IMP a special import licence application has to be completed. The form is available at IMCA.
The CTA should be submitted in triplicate (1 original and 2 copies).
Please use the applicable checklist for the preparation of the CTA. Attach the completed list to the application.
Checklist IMP with marketing authorisation in EEA (March 2010)
Checklist IMP without marketing authorisation in EEA (March 2010)
Before the CTA can be validated by IMCA the documents according to the checklist have to be enclosed. In addition the application fee has to be payed, an invoice will be sent.
If the application fee has not been paid by deadline the application will be considered invalid.
