Help

Table of contents

1. How to log in and use the site

1.1 Logging into this website  

1.2 Browser compatibility

2. Accessing clinical data

2.1 Searching clinical data

2.1.1 Advanced search

2.2 Browse by category

2.3 Most viewed clinical data

2.4 Using the search results table

3. Downloading clinical data

4. Clinical data dossier structure

5. Reporting patient re-identification

1. How to log in and use the site

1.1 Logging into this website

You need to have an EMA account to log into this website.

If you have access to any of the following EMA-hosted websites or online applications, you already have an EMA account and you should use the same credentials:

Eudralink, EudraCT Secure, service desk portal, European union telematics controlled terms (EUTCT), meeting management system (MMSe), managing meeting document system (MMD), EudraVigilance data analysis system (EVDAS), EudraPORTAL, European Union good manufacturing and distribution practices database (EUDRAGMDP), paediatrics records application (PedRA), SIAMED business intelligence dashboard (BI DASHBOARD), corporate GxP database (CORPGXP), European pharmacovigilance issues tracking tool (EPITT) or periodic safety update repository (PSUR repository).

 

If you do not already have an EMA account, you need to create an EMA account.

Once you have an EMA account, you need to log into this website to access the published clinical data.

There are two levels of access you can choose from, depending on your intended use of the clinical data. You must accept the specific terms of use for the level of access you wish to have.

  • General information purposes: the intended use of the clinical data is for general and non-commercial purposes. You can view on screen any report.
  • Academic and other non-commercial research purposes: the intended use of the clinical data is for academic and other non-commercial research purposes. You can view on screen and download any report.

    The second level of access requires you to provide additional personal information at the login stage. You need to provide an identity document reference number and expiry date, and you must enter an address in the European Union (EU). If you do not have an address in the EU, you can use the address of a third party that is resident, or domiciled, in the EU. This third party is then considered to be the user and has to comply with all the terms of use. For further information please see annex 2, point 2.2 of the Policy.

For details of how personal data are processed and retained by EMA, see the data protection notice.

1.2 Browser compatibility 

This website has been tested on Windows 7 to be compatible with the latest versions of the most commonly used web browsers, including Internet Explorer 11 and Google Chrome 52.

2. Accessing clinical data

You must be logged in to access the clinical data. You should then use the search or the browse by category page under Find clinical data

2.1 Searching clinical data

You can enter any search term in the main search bar, such as the name of a medicinal product, an adverse drug reaction or a medical condition.

2.1.1 Advanced search

You also have the option of using the advanced search. You can search by:

  • product name;
  • active substance name/international non-proprietary name (INN);
  • anatomical therapeutic chemical (ATC) code: this is a unique code assigned to a medicine according to the organ or system it works on and how it works. [Of note, the ATC code of a medicine can change and a single medicine can have several ATC codes];
  • marketing authorisation holder (MAH)/Applicant: this is the natural or legal person(s) or organisation(s) that submitted the clinical reports to EMA, as well as any person(s) or organisation(s) who own(s) copyright or other intellectual property rights in the clinical reports;
  • date of publication of the data: from October 2016.

You must enter at least 3 characters to return results.

You can choose to filter the search in the following ways:

  • 'Include': this category includes authorised medicines, medicines that have been refused a marketing authorisation or whose marketing authorisation application has been withdrawn, and medicines intended exclusively for markets outside of the EU approved in cooperation with the World Health Organisation under article 58 of Regulation (EC) 726/2004;
  • 'type of procedure': you can filter the regulatory procedure for which the clinical data were submitted. Procedure types include marketing authorisation applications, line extensions and extensions of indication. For details on procedure types, please see the glossary of the EMA website;
  • 'type': you can filter the type of product (generic, biosimilar or orphan) or type of marketing authorisation (conditional approval or exceptional circumstances). These types are not mutually exclusive e.g. an orphan medicine can have a marketing authorisation under exceptional circumstances.

'Help' boxes on the left-hand side of the web page provide useful tips on using the search function.

2.2 Browse by category

This option allows you to browse alphabetically by product or by MAH/applicant. You can also browse based on “Type” by selecting a category of product (generic, biosimilar or orphan) or of marketing authorisation (conditional approval or exceptional circumstances). You can also filter the results by product status - see "Include" category under 2.1.1. Advanced search.

2.3 Most viewed clinical data

This page allows you to search for the 15 most viewed clinical dossiers by general or academic users.

2.4 Using the search results table

The results are displayed in the search results table. You can use the six categories in the table header to sort your results. Each row of results has up/down arrow icons. Click on the down arrow icon to view more information, such as the ATC code, category of product (generic, biosimilar or orphan) or of marketing authorisation (conditional approval or exceptional circumstances), article 58 status and whether the marketing authorisation application was withdrawn.

Click on a medicinal product name to view its clinical data dossier page, including the procedure type and number. Clicking on the different sections of the dossier will reveal the individual documents, which you can view by clicking on the title. The documents are in PDF format and are text searchable.

You can download the search results table as a CSV-file and open it in MS Excel.

3. Downloading clinical data

You can select the documents you wish to download by clicking the relevant box(es) on the left of the list of documents on the dossier page.

Only users registered to use the site for academic and other non-commercial research purposes can download clinical reports. You can upgrade your account to academic and other non-commercial research purposes by logging into your account and selecting 'Upgrade your access'.

4. Clinical data dossier structure

The following types of clinical documents are available in the data dossier:

  • Clinical overview
  • Clinical summary
  • Clinical study report (CSR)
  • Protocol and protocol amendments
  • Sample case report form
  • Documentation of statistical methods
  • Anonymisation report

For more information see Clinical data available.

Please note that the applicant/MAH can choose to submit a clinical study report and its 3 appendices as a single document, or as 4 separate documents.

5. Reporting patient re-identification

The Agency has taken steps to ensure that the risk of identification of patients involved in clinical trials is as low as possible.

Marketing authorisation holders are expected to upload only fully anonymised versions of clinical study reports for publication, in accordance with 'External guidance on the anonymisation of clinical reports for the purpose of publication in accordance with EMA Policy 0070'. Users accessing published clinical reports undertake, by accepting the terms of use, not to seek to re-identify the trial subjects or other individuals from the clinical reports.

Re-identification alert mechanism

If you are aware of any instance of possible re-identification of a patient, please report it using the online form on the EMA website and provide all the information available to you, including:

  • product name;
  • EMA procedure number (visible on the clinical data dossier page - see section 2.4);
  • title of the relevant document(s);
  • page number(s);
  • URL of the page(s).

The Agency will promptly examine your complaint, review the corresponding published data and take appropriate action. The Agency will also notify the marketing authorisation holder (MAH).