Where a clinical trial is intended to be used for obtaining a marketing authorization for an investigational medicinal product, the sponsor must submit a Marketing Authorization Application (MAA).
The European Regulatory Authorities are responsible for evaluating those applications in the European Union (EU).
Once granted, the authorization allows sponsor to commercialize a medicine and make it available to patients and healthcare professionals across the European Economic Area.
The process for evaluation of the MAA is not performed in CTIS and therefore it will not be the focus of this module.
The marketing authorization applicants/holders must submit a ‘Clinical Study Report’ (CSR) to CTIS, within 30 days after the day the marketing authorization has been granted, the procedure for granting the marketing authorization has been completed, or the applicant for the marketing authorization has withdrawn the application.
A CSR is a report of an individual study of an investigational medicinal product, in which the clinical and statistical description, presentations, and analyses are integrated.
- The CSR includes a title page;
- a synopsis;
- a table of contents for the individual clinical study report;
- a list of abbreviations and definitions of terms;
- the ethics of the clinical study;
- the investigators and study administrative structure;
- the study objectives;
- the investigational plan;
- the study patients;
- the efficacy evaluation;
- and the safety evaluation.
At the moment of the submission, the information contained in the CSR will become public. In Clinical Trial Information System (CTIS), the users responsible for this action are the Marketing Authorization Holder users (MAH) within the sponsor workspace.
Article 37of the CT Regulation also describes that irrespective of the outcome of a clinical trial, the sponsor must submit to CTIS a summary of the results of the trial, within one year from the end of a clinical trial in all Member States concerned or within six months for a trial in pediatric population.
The summary of results shall be accompanied by a summary written in a manner that is understandable to laypersons.
It should be noted that while the summary of results and the layperson summary are to be provided by the sponsor users after the end of each clinical trial in the EU, the CSRs are to be submitted by the MAH users only, in the case that a clinical trial is intended to be used for obtaining a marketing authorization for the investigational medicinal product.
As these processes are independent and performed by different users, they are explained in dedicated modules.
