WP12 - Data management and dissemination

 

Workpackage lead and partners:

WP leader:
Dr Brendan Murphy, UCC

WP partners:
CHU
CLIN

Workpackage objectives: 

  • To set up and develop an internet based online database for managing clinical, laboratory, and outcome data acquired throughout the project.
  • 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 study and outcome study.
  • To provide data for 2 interim analyses during the clinical trial.
  • To monitor data quality throughout the entire project.
  • Analyse final data and summarise results.
  • 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:

This work package is essential for the day-to-day management and monitoring activities of this research study, which will by its very nature require a large amount of data management. Data from the clinical trial must be stored and archived, regular reports must be generated and in addition, data from the neurodevelopmental trial at two years must also be stored and reconciled with the clinical trial records. The data storage system required will be large and must have web-based functionality to allow study investigators from all the participating centres to interact with the system as seamlessly and efficiently as possible. The work package leader, Dr. Brendan Murphy has extensive experience with data management through his activities with regional and national neonatal benchmarking with Vermont Oxford Neonatal Network (VON) and the all-Ireland Neonatal Intensive Care Outcomes and Research Evaluation (NICORE) project and with the ongoing data management systems including BADGER Neonatal Clinical Data Management System currently in use in Cork University Maternity Hospital. He will work with Patrick Chevarier, ClinInfo, (WP 07) to set up and manage the clinical trials database. Professor John Morrison, Director of the Boole Centre for Research Informatics (BSRI, established in 2001 under the HEA PRTLI-3 funding initiative) will coordinate storage of the large data set in the Boole Centre in UCC. The centre houses and manages large scale computer and data facilities for the benefit of its researchers and collaborators.

Task 1: To set up and develop a secure internet based online data management system

In this work package, an online data management system will be set up that will allow all clinical centres to input data from both the clinical trial and the follow-up study at 2 years. This will require input from WP 04, 06, 07, 08, and WP 10.

  • The data from all paper based case report forms filled in by the local study investigators will be entered in duplicate into the electronic database.
  • A multilingual electronic case report form (eCRF) will be developed.
  • Electronic submission of SUSAR (Suspected Unexpected Serious Adverse Reactions) to the European Medicines Agency (EMEA), national ethics committees, national authorities and investigators on behalf of the sponsors.
  • Documentation of Serious Adverse Events (SAE) and Serious Adverse Reactions (SAR) in the validated database. Coding the SAE according to the Medical Dictionary for Regulatory Activities (MedRA)
  • Evaluation of SAE/SAR according to reference documentation. Clarification of SUSAR, coding of SUSAR according to MedRA
  • Electronic submission of SUSAR to the Eudravigliance Database of the EMEA and to the national authorities.
  • Submission of SUSAR to the study coordinator and the national ethics committees.
  • Preparation of annual safety reports for the data and safety monitoring board (DSMB).

Task 2: Randomization

Patients will be randomized according to a block design to ensure balanced treatment assignment for each treatment centre. Randomisation will be provided by ClinInfo using a web-based system. Each participating centre will have access to the web-based system, and as soon as an eligible baby has been identified and consent obtained, the details of the baby will be entered into the online system. Treatment allocation will then be assigned. Once randomised, each participant will be assigned a unique number and this will not be reallocated if a participant is prematurely withdrawn from the study. 

Task 3: Run Requested data reports

All reports requested by the ethics advisory board (EAB), the data and safety monitoring board (DSMB) and the external advisory board will be generated as requested. Functionality will be developed to export all data in Excel or SPSS format for the biostatistician who will conduct the interim analyses for the study and also the final analysis report. The biostatistician will require access to study data throughout the entire monitoring period. 

Task 4: Plan and disseminate the results of the study to the scientific community

The consortium is an experienced group who already disseminate the results of their research widely. The results will be submitted to peer reviewed scientific journals and national and international conferences in Paediatrics, Neonatology, Neurology ,Cardiology, Intensive care Medicine e.g. the conferences of the European Academy of Paediatrics, the American Pediatrics Society, and the Society for Pediatrics Research.