These forms provide a standards-based method of reporting Adverse Event and Concommitant Medications on a clinical trial. They use REDCap's text auto- completion and the MEDDRA, ATC, and RxNorm ontologies to provided assisted text entry and validation of data entry. These features simplify the aggregation and sharing of medication and adverse event data in clinical trials.
Many of the questions on the Adverse Event form are tailored to mirror changes currently in draft at the University of Florida Institutional Review Board. Some changes to those questions should be expected when those changes are released.
TODO: Add a field description in the each variable's annotation field to describe the variable in a machine-parsable way.
These forms require the REDCap biomedical ontology features first released in REDCap 6.7.0. The forms were developed using REDCap 6.8.1. Each of the forms references ontologies served by http://data.bioontology.org Access to that service requires an API key from http://bioportal.bioontology.org/ No special REDCap extensions are required.
These forms are distributed as REDCap instruments. Each form is packaged in its own zip file and has to be imported separately to get the full functionality of the forms. To download the latest instruments see https://github.com/ctsit/ae_and_conmeds/releases/latest
After downloading the instruments you require from the above location, follow these instructions to upload them into your REDCap instance
- Open your project
- Open 'Project Setup'
- Open 'Online Designer'
- Under 'Add new instrument', click on 'Upload'
- Choose one of the zip files containing the new instruments you just downloaded
- Click 'Upload Instrument ZIP'
- Repeat for other instruments if desired, otherwise you are done!!
These forms are based in part on work by Ken Bergquist done for the HCV Target project. The forms were adapted for use at the University of Florida by Philip Chase pbc@ufl.edu, Ruchi V. Desai ruchivdesai@gmail.com, Roy Keyes keyse@ufl.edu and Christopher P. Barnes senrabc@gmail.com. Many thanks to David Nelson, MD, Director of UF's Clinical Translational Science Institute and Principal Investigator on the HCV Target project for his support of this work.
We welcome contributions to these instruments. The authoritative copy is on Github at https://github.com/ctsit/ae_and_conmeds. Please fork the repo at Github, modify files as needed and submit a pull request. For more details on making contributions, please see the Developers Notes
See LICENSE.txt