Developing a study database with REDCap®
We offer two service packages to members of the Medical Faculty of the University of Basel and members of the Basel University Clinics.
LIGHT service
| free-of-charge |
|---|
| Access: We provide you with a REDCap® project and you create your database yourself. |
| Review: We review your database before moving to production. |
| User Management: We create new user accounts. |
| Support: We help with technical problems and basic questions. |
LIGHT PLUS service
| same as LIGHT service with following additional paid options |
|---|
| Support: We answer all questions about REDCap® use and suggest technical solutions. |
| Training: We show you how to implement advanced functions. |
| Teamwork: We develop and test your database in collaboration with you. |
When is it appropriate to develop a study database yourself?
- If the study team already has a good understanding of the data management of clinical studies.
- If basic knowledge of REDCap® is already available, for example by having attended the REDCap® workshop:How to develop your own database or equivalent courses.
- If the research project is not too complex.
We will be happy to counsel you.
How to reach us
The phases of a REDCap® database project
From the first contact to archiving
- Get in touch with us via our contact form
- If required, we will consult you on the best solutions for your project.
- We prepare a contract for the use of the REDCap® instance for the attention of and to be signed by the sponsor of your study.
- We create an empty REDCap® project for you and you can start with the development of your database.
- You develop and test your database. Please note that no real study data may be entered at this stage.
- You are welcome to attend our REDCap® workshop to learn the basics of this tool.
- If you would like more support, switch to the LIGHT PLUS service.
- Contact us when you have finished the development and testing of your database and it is ready to be activated for productive use.
- You receive a checklist from us that you use to review whether all important functions have been set up and tested.
- We perform a technical review that includes a check of basic functionalities and settings and its compliance with the requirements of Good Clinical Practice (GCP).
- You receive a template for a data management plan from us. This needs to be completed by you and signed by the sponsor of your study as well as the person responsible for the statistics.
- As of now, real study data can be collected.
- Please note: Plan changes carefully and evaluate what impact they will have on your current data. Be aware that the database remains productive during this phase.
- To make changes switch to "Draft mode".
- Submit the changes by clicking on "Submit for approval".
- We ckeck and commit your changes for productive use.
- The data will now be cleaned: As part of the monitoring process this can be done using queries.
- Please note: No new data can be entered in this phase but existing data can be edited.
- All data and metadata must be exported before archiving as the database can no longer be accessed afterwards.
- Export:
- Study data
- Logging information
- Comments & queries
- Data Dictionary
- Please inform us as soon as the database can be archived.
- Please note: The database can still be reactivated after archiving if required.
The following databases will be deleted after consultation:
- Databases that have never been started
- Databases that have been archived for four years or longer