PORTUGAL: Ethics Committee (CEIC) guidance on how to act towards COVID-19 in clinical trials
Although the Ministry of Health (INFARMED) did not provide any guidelines so far, we understand that CEIC guidelines have been developed with the INFARMED team.
Meditrial has direct connections with Investigators, hospitals and Portuguese Ethics Committees. Please feel free to contact us for advice and support.
Telephone visits or video calls should replace participants’ visits to trial sites, which should be reported to CEIC as a nonsubstantial amendment (NSA).
Monitoring activities may be carried out by alternative mechanisms, remotely and/or centralized, such as telephone connections, video calls, etc. Monitoring alternative routes and times shall be duly documented.
CRAs monitoring visits can be done remotely. However, remote monitoring does not include remote access to health records of the participants (unless the participant’s privacy is taken care of properly) or sending the source documents by fax (for remote review).
Any temporary interruption of the study, including for logistical reasons, such as the unavailability of the study team, should be considered as an urgent safety measure, and then notified to CEIC (NSA).
The infection of participants in clinical trials with the new coronavirus should be considered as an adverse effect and reported to CEIC (NSA); CEIC should be notified (NSA) of the decision to keep the patient in the study.
All requests for substantial amendment, as a result of a change in procedures in relation to Covid19, will be evaluated expeditiously by CEIC, and it is necessary for this, at the time of submission by the usual routes, communication via e-mail to ceic@ceic.pt.
All the amendments to the procedures of previously approved clinical studies, which do not require submission to CEIC as PSA, according to this information, should be duly documented, and notified to CEIC, for monitoring of the clinical trial by this Commission.
CEIC guidelines in the English language can be found here.
The original communication please see this website.
Meditrial can help – Contact us for immediate support
Meditrial has developed rapid workflows to conduct risk assessment, implement rescue plans and execute solutions for ongoing clinical trials:
- Identify patients requiring follow-up
- Conduct investigator and study nurse calls for training to address the situation
- Obtain authorizations for decentralized data collection
- Support to patients for alternative access to needed care
- Prepare procedures and worksheets for remote collection of patient clinical data
- Monitor work instructions and trainings for site support and remote monitoring
- EDC and ePRO solutions to enable study continuity
- Privacy protection measures
Contact Meditrial for immediate assistance in Europe or the US.
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This article provides general information and does not constitute regulatory or legal advice. Requirements should be confirmed for the specific study, applicable regulatory framework, and markets concerned.
