Implementation of Italian CTU/CROs Network

Advice and Information for CTU/CROs

Self Assessment Sheet, SAS

One of ItaCRIN main objectives is to provide services for conducting International and multicentre clinical studies in accordance with the GCP procedures, as foreseen by ICH E6 R2 guidelines. To be included in the Italian Network, ECRIN requires that CTU/CROs complete the self-assessment questionnaire (SAS). The questionnaire provides an opportunity for CTU/CROs to self-certify on its own experience, quality, resources and skills. This questionnaire is valid for three years and is confidential.

Data Centre Certification

ECRIN offers the opportunity to the CTU/CROs who are part of the Networks of Member Countries to apply in order to obtain the Certification as Data Centre. This quality Certification can be obtained following a successful audit procedure conducted by internal and external experts and it is based on ECRIN published standard requirements in the following areas: IT, data management and general.

The selection of Data Centres for the Certification process is made by the National Coordination (ItaCRIN) and forwarded to the ECRIN Independent Certification Board, in response to the launch of the annual call (www.ecrin.org/data-centre-certification-Validate).

The ECRIN Data Centre Certification program identifies non-commercial clinical trials units in Europe that have demonstrated they can provide safe, secure, compliant and efficient management of clinical research data. 

Within its Data Centre Certification programme, ECRIN launches a call mostly every year. No fees are foreseen for the CTUs included in the Nationa networks of ECRIN members countries.

For more information, please visit the following link:

https://www.ecrin.org/activities/data-centre-certification.

 

Both of these procedures do not request any cost from the CTU/CROs

 


 

The following Italian Centres have received ECRIN Data Certification

  • Data Centre of the Institute of Pharmacological Research "Mario Negri" (IRCCS)

Location: Milan

  • Group for Haematological Diseases in Adults (GIMEMA)

Location: Rome

  • Ospedale Pediatrico Bambino Gesù

Location: Rome

 

Istituto Superiore di Sanità

Viale Regina Elena, 299 - 00161 - Roma

1