Quality assurance

The Quality Assurance and Control Unit (QA&C) unit promotes and encourages quality awareness throughout the organization and provides expertise in the development and maintenance of the quality management system pertaining to clinical study activities.

The QA&C team contributes to minimizing the risk of non-compliance, coordinates internal and external audit programs, performs on-site monitoring visits, and provides the necessary training and assistance to achieve these goals.

Site monitoring

The EORTC strategy is to perform on-site monitoring in studies having a high or medium level of risk and/or when required by pharmaceutical industry partners. At the study level, the frequency and distribution of site visits across participating institutions depends on the accrual and the observations reported by the clinical research assistant(s) (CRA) during site visits and/or by the EORTC data managers during data cleaning.

The aim of site monitoring is to assess data quality and compliance with ICH-GCP and protocol. This is achieved through direct source data verification by the CRAs.

Monitoring Visits 2004-2013 2014
Trials 45 18
EORTC groups 14 13
Institutions 219 97
Total site visits 4010 284

Site audits

A yearly audit program allows routine audits in a selection of EORTC sites based on risk criteria: quality issues, delay in data submission, big recruiting sites participating in non-monitored studies.

Additional audits are also conducted for the institutions flagged as ‘quality exclusion’ for which a qualification visit by QA&C is needed to be re-integrated into new EORTC trials.

From January 2012 until December 2013, the QA&C performed 29 audits in participating institutions and CROs involved in the conduct of clinical trials.

Audits 2004-2013 2014
Trials 53 4
EORTC groups 15 4
Institutions 101 10
Contract Research Organization (CRO) 5 1
Total audits 182 11

Data Timeliness

The QA&C unit is responsible for identifying and tracking sites with persistent missing forms by means of a central Data Timeliness (DTL) procedure conducted on an annual basis.

This process is handled in addition to the regular form request performed by the Data Management Department.

Quality management system

The QA&C unit coordinates the development and review of EORTC Headquarters procedures and policies and the organization of related training sessions.

Training

The QA&C unit provides help to the various EORTC units and departments in order to harmonize trainings and documentation.

The training plan for new employees at EORTC Headquarters is centralized at QA&C.

A GCP course for investigators organized every 2 years by EORTC in collaboration with EFGCP (European Forum for Good Clinical Practice).   In September 2015, a one-day GCP course will take place at EORTC HQs for EORTC network (investigators, research nurses, and data managers).

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