Drug Clinical Trials Portal: ECM
Target persons
The ECM Portal allows the promoters of clinical trials with medicinal products to carry out telematically to the AEMPS and the CEIm applications for authorisation of substantial modifications of clinical trials regulated by Directive, as well as any type of application relating to an authorised clinical trial that has not yet transited to the Regulation. It is recalled that the authorization of new clinical trials with medicines must be requested through the CTIS Portal.
To make any type of telematic application with a digital signature through this system, the promoter must have an eDNI or digital certificate accepted by the electronic headquarters of the Ministry of Health, Social Policy and Equality.
The administrative procedures that can be carried out through this application are the following:
| Code: | Name of the Procedure | Object |
|---|---|---|
| 080240 | Authorisation for relevant modification of an authorised clinical trial | Modifying the previously authorized clinical trial protocol |
| 085058 | Autorización de importación de medicamentos para utilizar en ensayos clínicos autorizados en España | Obtain authorization for the import of medicines for use in clinical trials authorized in Spain |
Documentation
Regulations
Presentations:
- Presentation 1: Types of CE requests
- Presentation 2: Fill out the initial application form
- Presentation 3: Letter of presentation
- Presentation 4: Clinical trial applications in progress
- Presentation 5: Applications for Approved Clinical Trials
- Presentation 6: Applications to the CEIC
Manuals:
- Introduction to the ECM portal(Version January 13, 2014)
- Manual of help ECM initial request(Version January 13, 2014)
- Manual of sending requests in process by the ECM Portal(Version January 13, 2014)
- EC Request Submission Manual Authorized by the ECM Portal(Version January 13, 2014)
- Manual of participating centers in clinical trials(Version 5 of June 2014)
Characteristics of the client equipment
What authentication methods will be needed?
- Digital certificate
- Electronic DNI
- Cl@ve PIN
- In some cases it will not be necessary to have any method of authentication
What characteristics do the client teams have to have?
- Next generation browser: Edge, Chrome, Firefox, Safari or similar.
- The use of Internet Explorer is not recommended.
- Any PDF document viewer. You can download the Adobe Acrobat Reader at the address http://www.adobe.com/.
- User authorization and password of RPS.
- Application security: activate the Java Script option in the browser if it is not active (this option comes by default).
Since it is a Web application, there are no operating system or memory or disk requirements beyond those necessary for the operating system, browser and PDF viewer chosen.
What are the security elements that the applications incorporate?
- 128-bit SSL communications encryption.
- User authentication using USER and password.
- Autenticación de usuario de segundo nivel, mediante TOKEN UNICO por solicitud que el usuario debe introducir para el envío de las mismas.
- Each external user can only access the data of the entity it represents.
- Log of accesses and audit of modifications (it is known who modifies and what).
- Time out of connection.
Notification of errors
If you experience technical errors or difficulties with the application, please contact us at the address below.incidensayos@aemps.es. Include as much information as possible about the incident, including detailed steps, screenshots, error messages, etc. To make it easier for our technicians to detect and resolve the problem.
For questions related to business logic, the operation of the application or any query you wish to make, contact us at the addressincidensayos@aemps.es.
In any case, prior consultation of the documents and presentations included in the previous section Documentation is recommended.