To INFARMED, I.P.
Other notifications should be sent to Infarmed via RNEC, as provided in the "Technical and Functional Specifications", in accordance with article 10 of Ordinance No. 65/2015 of March 5.
To the CEIC - National Ethics Committee for Clinical Research
Other notifications should be sent to the CEIC via RNEC, as provided in the "Technical and Functional Specifications", in accordance with in article 10 of Ordinance No. 65/2015 of March 5.
The main types of notification to the CEIC are:
If the sponsor fails to submit the definitive and fully signed finantial contratc during the submission process, he must sent it as soon as he gathers all the signatures, respecting the version already submitted to and approved by the CEIC.
The investigation site/centre can only be initiated after issuance of the contract approval document.
Notification of the start of the study and notification of inclusion of the first subject
Given the powers conferred to this Committee mentioned in subparagraphs b) and f) of article 36 of Law No. 21/2014 of April 16, the CEIC must be notified of the start of the study by centre and/or inclusion of the first subject.
Therefore, it is requested the submission of an application with information about the initiated centre and date of the start and/or of the inclusion of the first subject. This information must be sent for each approved centre.
Notification of centre closure
A notification regarding the closure of the centres and its date must be sent to the CEIC. Therefore, it is requested the submission of an application with information about the closed centre and its closing date. This information must be sent for each approved centre.
If the center was not initiated it does not invalidate the need for information about the closure, so the CEIC must also be notified of the decision that led to not opening / not activating the centre.
Notification of non-substantial amendments
The sponsor does not need to notify non-substantial amendments. However, these non-substantial amendments should be recorded and later submitted together with documentation (e.g., in the submission of a substantial amendment).
If the sponsor wishes to individually send each non-substantial amendment, it should be sent an application with the amendment information as well as the documents that impact this amendment.
Because they do not require evaluation by the CEIC, non-substantial amendments may, in principle, be implemented in the centres after notification to this Committee. However, it is not possible to predict or allow the possibility of implementing all the notifications submitted to the CEIC, since every case is a single/different case. Some notifications can be considered by the expert as substantial amendments rather than non-substantial.
Thus, it would be desirable that all the amendments that have impact on subjects but are not urgent safety measures, are implemented after the reply of the CEIC.
According to article 15 of Law No. 21/2014 April 16, the sponsor must have an insurance to cover the liability for the property damage and personal injuries that the study can cause to the subjects, during the course of and in the year following its completion/conclusion, subject to the provisions of subparagraph i) of paragraph 6 of article 16.
The CEIC shall pronounce on insurance covering the liability of the investigator and promoter/sponsor. Thus, the sponsor must submit a certificate of insurance with valid coverage at the time of submission of the application for the clinical study, complying with the requirements and whenever changes and updates are applicable.
Updates of insurance certificates should be sent as notifications, presenting an application and the insurance certificate. Whenever a request for an opinion of a substantial amendment that has an impact on the insurance is submitted, the updated certificate should also be sent.
Continuation of the treatment after completion of the study
According to article 23 of Law No. 21/2014 of April 16 (points 2 and 3), it should be communicated to the CEIC the continuation of the treatment after completion of the clinical study. The CEIC provides a form for this purpose.
Annual progress reports
According to Law No. 21/2014 of April 16, it should be sent annually to the CEIC a progress report with the following information:
- Dates of approval of the study by the entities required by law;
- Dates of approval of major amendments by the entities required by law, the date of its implementation in the centre and the reasons for it;
- Started and closed centres and respective dates;
- Principal investigators;
- Number of included subjects, screening failures and subjects who discontinued the study at each centre and respective dates,
- May also be included minor deviations to the Protocol that may have occurred, among other relevant information.
The deadline for submission of the report is one year after gathering all the necessary authorizations required by law for the study.
Deviations from the Protocol
All major deviations from the Protocol must be notified to the CEIC for consideration by this committee.
Other deviations should be included in the annual progress report, if the sponsor wishes so.