Information Systems and Data Management

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"Committed to Data Integrity and Patient Safety"

The CRFG Data Management Department provide an integrated data management service for regulatory clinical and medical device trials, academic and observational studies across a wide range of clinical specialities in hospital and community settings.

We can work on single site small scale studies through to multinational clinical trials.

If you would like us to provide a quote for data management services, please email biometrics@nuigalway.ie and we will contact you to discuss options.

Our dynamic team currently comprises 10 staff with a wide range of industry, academic, technical and clinical backgrounds. We provide ongoing training and development for our staff.

  • Senior Data Manager
  • Data Managers
  • Database Developers
  • Clinical Research Data Coordinators
  • Masters students (on rotation)

We are committed to providing high quality data throughout the data management cycle:

 

We provide high quality data management services ensuring integrity of data that conforms to ICH Good Clinical Practice guidelines, Medical Device guidelines, CRFG Standard Operating Procedures and any other regulatory requirements pertaining to a study.

Data Management is the key to a successful project and therefore we integrate with the research team (PI, biostatistician, pharmacovigilance) from an early stage of the project through to completion.

Our team can provide bespoke data management support and expertise at every stage of the research project.

  • Data Management File set up and maintenance
  • Protocol review
  • eCRF or CRF design and development
  • Data Management Plan development
  • Data specifications and validations documentation
  • Clincial database creation and programming of validations/edit checks
  • Clinical database testing prior to release
  • CDMS system training
  • Study specific training with accompanying guidelines
  • CRF tracking for paper based CRF's
  • MedDRA Coding of Adverse Events
  • SAE reconciliation between the clinical and safety databases
  • Import of electronic data sources into CDMS
  • Continuous data cleaning plan and quality processes (query creation, quality checks)
  • EDC helpdesk
  • Development and provision of status reports
  • Database lock and Archive


Protocol Review

The team will review the protocol with you and advise the research team wtih regard to a data management plan for your study.

We will ensure that the relevant data mangement requirements are included in your protocol.

We will work with your team to answer any regulatory queries pertaining to data management.

Case Report  Form (CRF)

We will develop a new CRF from the final version of the research protocol in association with PI to ensure that all data (including critical data fields) are captured.

Electronic Case Report Form (eCRF) or paper versions (pCRF) developed according to your needs.

Development of CRF user documentation - e.g. data entry guidelines, CRF completion guidelines.

Provision of training on eCRF - e.g. training manuals.‌

Database Design and Build 

We have a number of validated CDMS options available for selection - depending on the needs of the study. These include Infermed MACRO and DataFax.

We can support electronic data capture and paper based CRF reporting as required.

Integration of MedDRA adverse event coding systems.

We can support integration with external databases (e.g. Mobile Applications, Labs).

Full database testing and training prior to release.

Maintenance of site user accounts.

User assignment for the relevant agreed roles upon satisfactory completion of system and study specific data entry training.

Assign permission at field, form and database level (read only, read/write and anonymised depending on role).

Adherence to Data Protection Act (2003) and EU Directive 95/46/EC.

Data Capture

Data can be entered at site level (eCRF) or by our experience data management team (pCRF).

Missing pages/visits report provided to ensure data entry and QC are on target.

Data queries raised, managed and tracked to resolution by the assigned data manager.

Audit trails tracking all deletions, updates or additions to data after initial entry.

Quality Control (QC) checks performed in line with the agreed Data Management Plan.

Data Validation

Data validations are agreed with the study team and are programmed into the database design.

Manual validations can be included as required.

Data can be extracted regularly for statistical and interim analyses.

We perform database lock upon completion of the study and our rigorous data cleaning QC checks prior to lock.

Data Reporting

CRF submission tracked to agreed schedule.

Accruals monitoring and reporting.

Data quality reports.

Data preparation for DSMB/Interim analysis reports.

Data exports provided to biostatisticians for analysis.

Data Archiving

Database lock QC checklist completed upon termination of study prior to lock.

Archive the database and associated files/documentation on study completion.