Our experienced data management team can assist you in advising on or providing the following for your study:
- Data management plan
This plan outlines the way in which all data will be handled and processed throughout the life of the clinical trial.
- Case report form and worksheet design
Case report form (CRF) and worksheets are designed to collect all relevant participant data which is then entered into the study database.
- Database design, validation and testing
The database specification and data validation plan specify the structure and validation checks to be built. User acceptance testing ensures the database is fit for purpose prior to database release.
- Data entry
Depending on whether the study is paper-based or electronic, data can either be transcribed from CRFs/worksheets (paper-based) or entered in real-time into the database (electronic).
- Data cleaning and query management
Queries from the data validation plan (DVP) can be built into the system (automated system checks) to fire in real time for site staff to respond to. Manual queries arising from data management oversight and/or monitoring can be raised and answered as part of the cleaning process.
- Coding (MedDRA)
Terms for adverse events can be classified by a medical dictionary in order to standardise reporting. Our electronic data capture (EDC) system has a module for coding.
- Database lock procedures
The activities which take place as part of database lock include: coding, serious adverse event (SAE) reconciliation (ensuring that SAEs in the database match site/investigator-held logs), and electronic investigator’s sign-off.
- Data quality assessment
A series of quality control checks which verify that the data is of sufficient quality for analysis.
- Data reports
Customisable reports including any data recorded in the EDC system and outstanding queries can be created regularly or ad-hoc.
Please get in touch with us as soon as you have a research idea so as to get the appropriate support.
Derby Clinical Trials Support Unit
Medical School, Office 5033
Royal Derby Hospital