COVID-19 Space: IiSGM Internal Procedure
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_______________________________________________________________________________ Recommendations and guidelines published by the EMA (European Medicines Agency) in relation to COVID-19 studies- EU PAS (post-authorisation studies) Register for 'COVID-19' studies
Researchers are encouraged to register their pharmacoepidemiological studies related to the COVID-19 pandemic in the EU PAS Register (http://www.encepp.eu/encepp/studiesDatabase.jsp ), including a study protocol and a description of the data collected.
The reference "COVID-19" must be included in the title to allow others to retrieve it easily.
- Guidance on the management of clinical trials during COVID-19
The EMA guidance on the management of clinical trials during the COVID-19 pandemic (pdf) has been updated and now also includes:
- safety reports
- distribution of in vitro diagnostics
- medical devices
- auditing
- informed consent
- Guidance on the methodological aspects of ongoing clinical trials during COVID-19
The EMA has published guidance to help ensure the integrity of its studies and the interpretation of their results, while safeguarding the safety of trial participants as the top priority.
ISCIII Extraordinary Call
FUNDING OF RESEARCH PROJECTS ON SARS-COV-2 AND COVID-19
The deadline for submitting proposals opens on 19 March 2020 and will remain open until the COVID-19 fund is exhausted, which will be announced through the indicated media.
The link provides access to the call and the expression of interest template, and the full information can also be consulted at the following link:
https://www.isciii.es/QueHacemos/Financiacion/Paginas/SolicitudExpresionesInteresCoVid19.aspx
INTERNAL PROCEDURE:
Proposals must have the approval of the relevant Committees (Research Ethics Committee for Medicinal Products (CEIm), Research Committee (CI), Animal Experimentation Ethics Committee (CEEA), etc.).
In order to expedite the management of proposals submitted by our institution as much as possible, the Scientific Director of IiSGM personally centralises the receipt and processing of proposals, which must be sent directly to ismaelbuno(ELIMINAR)@iisgm.es with a copy to the relevant Project Manager.
An extraordinary procedure has been established in the various Committees (CEIm, CI, CEEA), which will proceed to the urgent evaluation of proposals within 24–48 hours.
Once the internal procedure has been completed and the Favourable Report from the Committees has been obtained, the proposals will be submitted to the ISCIII institutionally through each research group’s project manager by email to: covid19(ELIMINAR)@isciii.es. Under no circumstances should researchers submit them in their own name.