Newcastle Clinical Trials Unit

Data Management

Data Management

NCTU has an experienced data management team who enable the design, development, testing and validation of databases, data capture systems and randomisation systems used for clinical trials and research studies. The data management team work closely with Chief Investigators, trial teams, database providers and other, as appropriate, to ensure the smooth running of all data aspects of NCTU trials.

Data Management

NCTU have experience of using several different clinical data management systems, with current trials using Ennov’s MACRO, Sealed Envelope’s Red Pill and REDCap. These systems are web-based systems which are available 24 hours a day and are accessible directly by research sites, facilitating efficient and timely data acquisition.  

The data management team support the full trial life cycle from design, through to data collection and cleaning to archiving of the dataset.

The NCTU data management team perform the following activities:

  • eCRF Design - designed based on the study protocol.
  • Creation of Data Management Plan.
  • Database testing and validation.
  • Creation of Data Validation Plans.
  • Managing database changes (including risk assessment, testing and validation).
  • Data downloads/uploads.
  • Data capture system training.
  • Data validation, cleaning and data quality checking.
  • MedDRA coding
  • Production of Trial Management Group Data Quality and Progress reports.
  • Controlling database access
  • Providing support for participating sites
  • Database lock process including pre lock QC checks.
  • Data archiving - long term storage and management of electronic study data.
  • Anonymisation of trial datasets to facilitated data sharing.

Randomisation Services

Where randomisation is required per trial design, NTCU offers access to regulatory compliant web-based systems which are accessible 24 hours per day, 7 days per week. These systems can allow trial teams to log in, enter key information about the participant and the randomisation allocation occurs instantly. Using the web-based systems allows researchers to remain blinded to treatment allocations.

We are happy to discuss the specific randomisation requirements for your trial with you.

The NCTU data management team perform the following randomisation activities:

  • Randomisation system design based on trial protocol.
  • Randomisation system testing and validation.
  • Randomisation system updates.
  • Creation of randomisation system user manuals.
  • Randomisation system training for study teams.
  • Controlling randomization system access
  • Providing support for participating sites
  • Central randomization/unblinding services (as delegated)
  • Randomisation data archiving

If you are currently experiencing any problems, using a trial system, a helpline is available Monday - Friday 0900 to 1700 hours (excluding bank holidays)

Please e-mail or telephone 0191 208 8211.