WP10 - Data management

Objectives

  • To develop validated (GAMP5) internet based online dedicated portal for trail data entry.
  • To set up the web-based clinical trial randomisation procedures.
  • To securely transfer data from paper based forms into the electronic database.
  • To check the quality of all data entered.
  • To ensure backup of all data files for the project.
  • To plan all statistical analysis for the randomised controlled trial.
  • To monitor data quality throughout the entire project.
  • To plan and publish the findings of the research study in high impact peer reviewed scientific journals.
  • To present the study results to relevant international audiences, policy makers and stakeholders.

Workpackage Description

Data from the clinical trial will abstracted and recorded in a standardized fashion, entered onto eCRF via a dedicated multilingual restricted access web portal and stored in a secure, traceable, backed up, cross-relational trial specific database. The database will automatically flag out-of range, clinically implausible or inconsistent data entries at the time of entry. Data will be monitored and audited in real time and data clarification requests emailed to study sites. The data manager and statistician will provide regular reports for use by study monitor, trial coordinator, TCC, ESRG and SAB.

The study CRFs, associated SOPs, training manual, manual of operations and teaching workshops will be developed by PI and coinvestigators in conjunction with the Trial Coordinating CentrePatrick Chevarier (ClinInfo) and Prof. Brendan Buckley, Director of the European Centre for Clinical Trials in Rare Disease, located at UCC, who has extensive experience in clinical trial conduct and data management. The web interface for data entry will be developed and maintained by Clininfo. Database will be backed up on an ongoing basis at the Boole Centre for Research Informatics (BSRI, established in 2001 under the HEA PRTLI-3 funding initiative) under direction of Professor John Morrison. The Boole Centre manages large scale computer and data facilities for the benefit of its UCC researchers and collaborators including the CRF and has undertaken similar role in conjunction with ClinInfo for current FP7 funded studies conducted at UCC (the HIP Trial and Nemo Study).

The study biostatistician based at UCC CRF will develop and validate the minimization algorithm, which will be provided to ClinInfo who will use them it to develop the trial randomization interface.

WP Leader

Philippe Foerster (Clininfo)
Dr. Denis O´Mahony (UCC)

Participating Partners

University College Cork (UCC)
Clininfo S.A. (CLIN)