Application for clinical trials

Before the application can be submitted

The Clinical Trials Information System (CTIS) is a common online portal for submitting applications for clinical trials of medicinal products in humans in the EU and EEA. For information on system access, online training, and general information about processing in CTIS, visit our webpage: Clinical Trials Information System (CTIS). 

Application for a new clinical trial  

An application for a clinical trial consists of two parts. Part I contains documentation common to all participating member states in a multinational study, such as the protocol, Investigator's Brochure (IB), and product information. Part II includes documentation tailored for each member state, such as patient information, consent forms, and insurance certificates.

If the clinical trial is to be conducted in multiple member states, the sponsor must specify in the application which of these states will act as the Reporting Member State (RMS). The RMS leads and coordinates the validation and evaluation of the documentation in Part I of the application.

An application for a clinical trial must always include Part I. Part II can be submitted for one or more member states simultaneously with Part I. Alternatively, the sponsor may submit Part II to the various member states at a later date, but no later than two years after Part I is approved. If the sponsor does not submit Part II within two years after the conclusion of Part I, the application will lapse. In Norway, Part I is assessed by both DMP and the Regional Committee for Medical and Health Research Ethics (REK KULMU), while Part II is assessed solely by REK KULMU.

More information about:

• Requirements for application documentation
• Application for substantial modification

Processing of a clinical trial application 

Regulation (EU) No. 536/2014 determines the timelines for processing procedures in CTIS. Timelines may vary depending on the type of application being processed (initial, substantial modification, adding member states, etc.). For information on the various timelines, see the EMA's guidance document: CTIS Sponsor Handbook (PDF).

After an application is submitted, the estimated timeline for the procedure can be accessed under "timetable" in the application dossier in CTIS.

Deadlines in CTIS are based on calendar days. Note that CTIS only considers national holidays in the member state acting as the RMS. Deadlines are dynamic, meaning subsequent deadlines may change if the sponsor or authorities submit earlier than the deadline specified in CTIS. Email notifications are not sent, so it is important to check the system regularly.

It is not technically possible to extend deadlines in CTIS. If deadlines are not met, the application will lapse. It is not possible to reopen a lapsed application, and it must be resubmitted.

The processing of a clinical trial application is divided into three phases:

Validation phase

• Authorities have 10 days to review the application documentation. We check that the documentation is complete and correctly uploaded.
• If there are questions about the application, the sponsor will typically have 10 days to respond.
• The sponsor will receive a decision on whether the application is valid within 25 days of submission.

Evaluation phase

• The evaluation of a clinical trial application takes 38 to 45 days (depending on whether the study is mononational or multinational).
• If the authorities have questions about the application (Request for Information, RFI), this will extend the evaluation phase by a maximum of 31 days – 12 days for the sponsor to respond to questions and an additional 12–19 days for the evaluation of the sponsor's response.
• If the application involves the trial of a medicinal product defined as an Advanced Therapy Medicinal Product (ATMP), the RMS may extend the evaluation phase by up to 50 days.
• The sponsor will receive the conclusion of Part I of the application in CTIS.
• The evaluation of Part II will run parallel to Part I.

Decision phase

• The sponsor will receive a final national decision within 5 days after both Part I and Part II have been concluded. The decision will be issued in CTIS.
• A clinical trial application may be approved, approved with conditions, or rejected.

Publication rules in CTIS

Information about clinical studies is made available in the public CTIS portal in accordance with the revised CTIS transparency rules, effective from June 2024.

In general, the following applies to publication:

• Structured data (with some exceptions) will be published in full.
• The publication of application documents is limited to certain "key documents," primarily the protocol, protocol synopsis, patient information, consent declaration, and study report.
• Key documents must be redacted and submitted in two versions (for publication and not for publication) if they contain personal and/or sensitive information.

It is the sponsor's responsibility to ensure compliance with Regulation (EU) No. 2016/679 and Regulation (EU) No. 2018/1725 when uploading documents and processing personal data in CTIS.

The timing of document publication is determined by the category of the clinical trial:

• Category 1 trials - Pharmaceutical development
• Category 2 trials - Therapeutic exploratory and confirmatory clinical trials
• Category 3 trials - Therapeutic use clinical trials

The sponsor defines the study category when submitting the application.

Fees

Invoice information must be uploaded under "Proof of Payment of Fee" in the "Form" section of Part I of the application in CTIS. An invoice will be issued after the application is validated. The invoice will include the EU CT number and, if necessary, the Purchase Order number (PO).

More information about fees.  

Language requirements  

The application must be written in English. The protocol synopsis and information covered by points 24, 59–73 in Annex I to Regulation (EU) No. 536/2014 (patient information, consent forms, etc.) must be written in Norwegian.

An overview of language requirements for the various member states in the EU/EEA can be found in the Questions and Answers Document - Regulation (EU) 536/2014 (PDF), Annex II.