ECRIN newsletter - December 2020 issue
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2020 was far from the year we expected but it has shaped up to be a very big year for ECRIN. As the coronavirus started spreading across Europe, ECRIN quickly got in contact with the European Commission to see how to reduce clinical research waste and centralise the efforts. We now find ourselves supporting the coordination of a module that does exactly this for the two big European platform trials addressing COVID-19 treatments (RECOVER & EU-RESPONSE). More recently ECRIN was awarded it’s ISO 9001:2015 certification by AFNOR for its principal services including trial management, a task 3 years in the making.

We look forward to our collaborations in 2021 and wish you all a happy and healthy year to come.
ECRIN awarded the ISO 9001:2015 certification
ECRIN was awarded by the French standards association (AFNOR) the ISO 9001:2015 certification on the 30th of November 2020 for its capacity to provide high-quality operational services. ECRIN has, since its creation, applied the ICH GCP E6(R2) requirements but in 2017 began work to further enhance the standardization, effectiveness and performance of its quality management system (QMS). The major challenge related to this achievement is its application in a distributed research infrastructure (one head office with satellites in each member/observer country).

The certification is applied to ECRIN’s three principal services: the coordination of operational services to the management of multinational clinical trials in Europe, capacity development through the participation in infrastructure development projects and the certification of data centres (quality as a service). These services all have proven, effective processes to enable the best possible results to enhance our customer satisfaction.

For more information on our certification and our quality management system.
ECRIN to support the coordination mechanism for RECoVER

ECRIN joins the European project RECoVER (Rapid European SARS-CoV-2 Emergency Research response) to partake in the expansion of the REMAP-CAP for COVID and lead the European coordination mechanism for RECoVER and EU-Response, OCToPUs (Organisation for COVID19 trials Platforms in eUrope).

REMAP-CAP for COVID recently launched a video to clearly explain how an adaptive platform trial works. The video shows the design of this trial, designed to adapt in the event of a pandemic, increasing the likelihood of patients receiving an effective treatment.
RECoVER is funded by the European Union’s Horizon 2020 Research and Innovation programme under Grant Agreement number 101003589.
COVID-19 Individual Participant Data Repository in development 

An amendment to the European Union’s Horizon 2020 funded EOSC-Life (GA 824087) has been approved to develop a repository for the hosting and sharing of Individual Participant Data (IPD) from COVID-19 clinical trials. The IPD repository will be part of the European COVID-19 data portal, with ECRIN supporting the interface with the clinical research community, and with the technical partnership of the University of Oslo providing a secure environment and data sharing services.
Reminder: EOSC-Life Open Call for projects sharing data, tools and workflows in the cloud deadline December 22nd. 
EOSC-Life has received funding from the European Union’s Horizon 2020 programme under grant agreement number 824087.
PERMIT holds Gap Analysis Workshop

The PERMIT consortium united virtually earlier this month to discuss the gaps identified in the literature review on personalised medicine research methodologies. Through this discussion, the key questions for building recommendations were highlighted. These will be addressed in a series of workshops next year, open to a variety of stakeholders.
PERMIT is funded by the European Union’s Horizon 2020 Research and Innovation programme under Grant Agreement number 874825.
B1MG launches stakeholder portal

This November, the Beyond 1 Million Genome project (B1MG) launched a stakeholder coordination portal. It aims to create a community with a vested interest in improving the project outcomes through the exchange of ideas and direct links to the work package leaders in the project. 
B1MG is funded by the European Union’s Horizon 2020 Research and Innovation programme under Grant Agreement number 951724.
EULAC PerMed has eventful November
Ethical, Legal and Social Aspects (ELSA) of Personalised Medicine (PM) were the focus of the recent EULAC PerMed technical workshop and summer school both held virtually in November 2020.  The results of the technical workshop are currently being transformed into a policy brief that will be made available on the EULAC PerMed website.
EULAC PerMed is funded by the European Union’s Horizon 2020 Research and Innovation programme under Grant Agreement number 825173.
PedCRIN sustainability board meeting

The PedCRIN sustainability board convened for a second meeting this fall to discuss the long-term perspective. This includes the partnerships, sustainability of the tools developed in the project and how to create synergies with other paediatric initiatives. Furthermore, PedCRIN has been granted a 6-month no-cost extension by the European Commission.
PedCRIN is funded by the European Union’s Horizon 2020 Research and Innovation programme under Grant Agreement number 731046.
The proposed categorisation system for a toolbox to help researchers finding existing resources that are relevant for the sharing of sensitive data has just been published on zenodo.  

This month ECRIN data project manager, Steve Canham, published two chapters in the Principles and Practice of Clinical Trials edited by Piantodosi and Meinert and published by Springer.

The European Medicines Agency (EMA) has published an article on providing support for medicine development by academics and clinical researchers. 
COVID-19 Literature reviews

Funding Calls

COVID-19 Trials registries

Other COVID-19 resources

HRB CRCI Repository of PPI resources
In order to help establish good practice for Patient and Public Involvement in Clinical Research in Ireland and to provide guidance for interested clinical researchers and lay people the Clinical Research PPI Working Group has created a repository of relevant PPI documents. Find out more by reading the Information Sheet, or visit directly the HRB CRCI & IPPOSI repository.

PtCRIN Conference News

PtCRIN co-hosted with AICIB (Portuguese Agency for Clinical Research and Biomedical) and EATRIS Portugal workshop on November 25th: How are vaccines developed, approved and produced? A timely topic, its success surpassed the initial organisation planning, with a total of 128 participants throughout the workshop. This was the 1st of series of workshops which intend to stimulate a stronger, long-lasting dialogue and more effective synergies between Portuguese researchers and the national medical research infrastructure

SCTO develops new tool for sample size calculation
SCTO receives the EMMRI Certificate of Excellence in Research Infrastructures Leadership: on December 4, 2020, the SCTO team received the certificate at the EMMRI Master’s graduation ceremony, second edition (2018-2020)

More News from ECRIN's scientific partners:
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