A clinical trial with an IMP aims to assess the safety and/or effectiveness of an investigational medicinal product (IMP). Possible examples of trials include:
- Evaluating a new medication
- Exploring a new application of an existing medication
- Investigating the pharmacokinetics of an existing drug in a different context from its phase 1 development, often conducted in academic settings
- Comparing the safety and/or effectiveness of existing medications
- Assessing combinations of existing or new medications
- Conducting a low-intervention study with an authorized medication
1. Study within the scope of the Clinical Trial Regulation (CTR) (initial application after January 31st 2023)
From January 31st, 2023, the Clinical Trial Regulation (CTR) is mandatory for all new submissions and from January 31st, 2025, all active trials need to be conducted under CTR. Hence, all new clinical trials have to be submitted under the new CTR and ongoing trials that were submitted under the old CTD, must be converted by January 2025 to follow the CTR. The submission goes via CTIS. More information can be found via the following link: https://www.ema.europa.eu/en/human-regulatory/research-development/clinical-trials/clinical-trials-regulation.
The review process in a multinational trial is coordinated by the Reporting Member State (RMS). The review from part I (core documents) is performed by the RMS and part II (national documents) is performed individually per Concerned Member State (CMS) and then consolidated.
A trial under CTR cannot be evaluated by the EC of a participating site. The study will be evaluated by an independent EC, selected by the CT College.
When UZ Leuven is a participating site in a clinical trial, the study must still be submitted to the Clinical Trial Center (CTC) but it will not be evaluated by EC Research. EC Research will not be involved in the review process anymore.
Compile the file
Part I
- Cover letter
- List of documents submitted
- EU application form
- Study protocol
- Synopsis of the study protocol (separate document, in English and the local language(s) of the participants)
- Participant facing documents: diary, questionnaire, interview topic list, etc.
- Documentation about the IMP(s) and AxMP(s):
- Investigator’s Brochure (IB)
- SmPC / IMPD
- Study label
- GMP documentation, if applicable
Part II
- Participant related documents:
- Informed Consent Form(s) (ICF(s))
- Recruitment materials: flyer, poster, etc.
- Description of the compensation for trial participants
- Suitability/ feasibility documentation:
- Suitability of the investigator(s):
- Declaration of interest of all participating PI’s
- CV of all participating PI’s
- GCP certificate of all participating PI’s
- Suitability of the facilities: written statement of each participating center
- Other documents:
- Data processing register
- Insurance certificate
- Agreements (if applicable – a draft version is sufficient)
- Statement data protection
- Copy of the summary of scientific advice, if applicable
More information about the timelines concerning the submission of the application, can be found at the website of CTC; https://gbiomed.kuleuven.be/english/ctc. When UZ Leuven is a participating site, the study needs to be registered at CTC.
Submit the study
You have to submit the study via CTIS via this link: https://euclinicaltrials.eu/ct-sponsor-services/login.
2. Study within the scope of the Clinical Trial Directive (CTD)
If the study is already running in Belgium and UZ Leuven is added as a participating site, the study can still be evaluated according to the “old legislation” (Clinical Trial Directive, CTD).