clinicedc - A clinical trials data management framework
A data management framework for multisite randomized longitudinal clinical trials.
Here are a suite of python modules that extend Django to empower you to build an EDC / eSource system for multi-site (randomized) longitudinal clinical trials to handle informed consent, scheduled data collection, quality assurance, trial monitoring, reporting, adverse events, grading of clinical events, data export, auditing and more.
The codebase continues to evolve over many years of conducting clinical trials for mostly NIH-funded clinical trials through the Harvard T Chan School of Public Health, the Botswana-Harvard AIDS Institute Partnership in Gaborone, Botswana, the London School of Hygiene and Tropical Medicine and the Liverpool School of Tropical Medicine. Almost all trials have been related to HIV/AIDS research. Recent work with the Liverpool School of Tropical Medicine and now UCL Institute for Global Health expands our work into Diabetes (DM), Hypertension (HTN) and models of integrating diabetes, hypertension and HIV care in Africa.
We have a number of active clinical trials that use these modules for research data collection, monitoring, reporting and audit. All source code is published on GitHub available for your review. The more recent the trial the better the example. The META Trial has a demo that you can build and run on your local machine.
