TraIT CRF Building Blocks made available
One of the main goals of TraIT is to improve the quality of data collected within translational research. In the clinical data domain, the tool OpenClinica has been used since 2011 for this purpose. TraIT is introducing the "TraIT Building Blocks" (BBs for short) to further improve the quality and consistency of collected data in OpenClinica.
Using the BBs will save time when setting up a study in OpenClinica and promote a more uniform setup. The BBs are meant as a starting point. Fields can be removed and added where needed.
The BBs are freely available in Excel format on our new forum on the TraIT website (http://www.ctmm-trait.nl/forums). The forum can be used by all OpenClinica users to discuss the BBs and suggest improvements or changes.
The creation of the BBs has been a collaboration between the following organizations: VUMC, Erasmus MC, AMC, NKI, Trial Data Solutions, Mook projects, The Hyve and Philips Research. Those involved came from different fields of expertise: oncology, cardiology and pathology.
Currently 13 BBs are online on the forum:
- Adverse Events
- Concomitant Medications
- General ECG
- Cardiology ECG
- Cardiology Echo (ultrasound)
- General Comments
- Inclusion and Exclusion Criteria
- Laboratory Test Results
- Medical History
- Physical Examination
- Vital Signs
In the future another series of BBs will follow: "Drug Accountability", "Addictive substance use", "Prior Therapy", "Oncology Prior Therapy", "Pathology", "Death Report" and "End of Study".
The BBs are set up according to a number of conventions, to make the BBs as uniform as possible. A short summary of the most important conventions are available on the forum with each BB. Specific emphasis has been put on the use of "null values" instead of just leaving a field empty. A field can be empty for many reasons and it is worthwhile to register the reason.
Standards, such as CDASH and CTCAE, were used for some of the BBs. Documentation on the standards used are published with the BB on the forum.
The corresponding CRFs can also be viewed in OpenClinica on the TraIT Sandbox environment. However, an account is required to access these CRFs.
Visit our forum if you are interested in OpenClinica or if you are setting up your study.