Supervision

Trial application and modifications

Trial application and modifications

Access to the CTIS system

In order for a trial application to be stored in the CTIS system, the applicant must have a valid EMA user account. The account can be applied for on a self-service basis from EMA Account Management. With the account the user has access to the CTIS system where, according to the policies of your organisation, the user can either apply for rights to manage a trial or to create a trial by her/himself.

If an EMA user account (or, previously, Eudralink credentials) has been active in other EMA systems (such as Eudravigilance or submission of results to EudraCT), there is no need to open a new account. 

The EMA user account will be closed if it is not used for six months or if you attempt use a wrong password for multiple times. The account holder will be able to re-open the account through EMA Account Management.

Invoicing details

Only one fee will be charged in Finland for the processing of a trial application. Fimea will invoice the sponsor once Part I has been accepted for processing and divide the free with the National Committee on Medical Research Ethics (Tukija) in accordance with the Decree of the Ministry of Social Affairs and health on fees chargeable by the Finnish Medicines Agency. Each EU and EEA country has its own procedures in place regarding the fee.

The trial and modification applications’ invoicing details are included in the CTIS system’s item Proof of payment (section Q ‘Proof of payment of fee’ of Annex I to the Regulation). The invoicing details must contain the same information as in the Customer data reporting form which can be found in the Fimea website, section Fees. Invoicing details the customer wants to be printed in the invoice, for example PO and / or project number, must be enclosed.

Exemption from the processing fee may be requested from Fimea in respect of the processing of an application relating to a clinical trial conducted by an individual investigator, a team of investigators, a university department, a university hospital clinic or the Finnish Institute for Health and Welfare without outside financing or with financing from a non-profit organisation. In these cases, the trial application must be accompanied by a free-form statement attesting that the trial will not receive any outside financing. Medicinal products received free of charge for the purpose of the trial are not considered as outside financing.

The processing fees for the trial application are set out in the Decree 103/2022 of the Ministry of Social Affairs and Health (in Finnish, applicable from 02.02.2022).

Regulatory processing of a new trial notification and responding to questions

Even if Parts I and II were submitted at the same time, under the EU Regulation, they will be assessed independently according to their own timetables.

Part I:
If the trial application is submitted in more than one country at the same time, one country will become the reporting Member State responsible for assessing the study, taking into account the views of the concerned Member States. The sponsor submits its own proposal for a reporting Member State. The Reporting Member State will remain the same throughout the trial. 

Prior to the assessment, the authorities will validate (pre-examine) the application. The sponsor will receive any requests for additional information in the CTIS system within ten days of the submission of the trial application.

The sponsor shall submit any additions in response to the request to complete the application within 10 days in the CTIS system. If the response time is exceeded, the trial application will lapse.

The additions will be reviewed within five days and, if the trial application is found to be appropriate, the authorities will start the assessment of the application under the direction of the reporting Member State. If necessary, additional information will be requested from the sponsor via the CTIS system within 45 days of the commencement of the assessment of the trial application. The sponsor is allowed 12 days to submit the additional information. If the response time is exceeded, the trial application will lapse.

The authorities will assess the submitted additional information within 19 days. 

The participating Member States will draw a joint conclusion on Part I. Under certain conditions, an individual Member State may also derogate from the position of other Member States and draw its own negative conclusion.

In addition to the conclusion on Part I, the authorities’ assessment report will also be displayed in the CTIS system.

Trial processing Part I application times, maximum days

Part II:

The primarily responsibility for the assessment of the national part of the trial application, i.e., Part II, rests with Tukija. Fimea may provide Tukija with opinions in support of the assessment and the preparation of the assessment report.

Decision on the trial application

In Finland, the final decision on the trial will be made by Fimea within five days of the completion of both Part I and Part II conclusions. When making the decision, Fimea will be bound by Tukija's potentially negative opinion. The decision will be recorded in the CTIS system, where it will also be available to the sponsor.

Other entries to the CTIS system 

The sponsor of the trial is required to enter information on the status of the trial in the CTIS system country by country. Examples of such information include:

The sponsor of the trial is required to enter information on the status of the trial in the CTIS system country by country. Examples of such information include:

  • commencement of the recruitment of trial subjects 
  • first visit of the first subject
  • end of the recruitment of subjects
  • last visit of the last subject
  • potential temporary suspension and re-starting of the trial

Under the EU Regulation, the sponsor is also required to report via the CTIS system any serious breaches, urgent safety measures and other reporting obligations relevant for subject safety, concerning which the authority may request additional information via the system.

Substantial modifications

A notification of a modification or addition of a new Member State can be submitted to the CTIS system once the trial and all the previous modifications have been approved. 

Modifications other than substantial

Modifications may be linked to a trial in the CTIS system if there is no pending processing in the trial.