clinicedc 2.0.6

A clinical trials data management framework built on Django

clinicedc - A clinical trials data management framework built on Django

A data management framework built on Django for multisite randomized longitudinal clinical trials.

Documentation: clinicedc.readthedocs.io

Here are a set of python modules that extend Django to empower you to build an EDC / eSource system to handle data collection and management for multi-site longitudinal clinical trials.

Refer to the specific open projects listed below for example EDC systems built with these modules. The more recent the trial the better the example.

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 and the London School of Hygiene and Tropical Medicine. Almost all trials were originally related to HIV/AIDS research.

More recent work with the RESPOND Africa Group formerly at the Liverpool School of Tropical Medicine and now with the University College London Institute for Global Health has expanded into Diabetes (DM), Hypertension (HTN) and models of integrating care in Africa (https://inteafrica.org) for the three main chronic conditions – HIV/DM/HTN.

See also https://www.ucl.ac.uk/global-health/respond-africa

The implementations we develop with this framework are mostly eSource systems rather than the traditional EDCs.

The clinicedc's listed below consist of a subset of trial-specific modules that make heavy use of modules in this framework.

Contacts

For further information go to https://github.com/erikvw.

Thanks to JetBrains for support with an opensource PyCharm IDE license.

Framework stack

python	Django	mysql
python 3.12+	Django 5.2+	mysql 8+

How we describe the EDC in our protocol documents

Here is a simple example of a data management section for a study protocol document: data_management_section

Projects that use clinicedc

Recent examples of clinicedc applications using this codebase:

INTECOMM Trial

Controlling chronic diseases in Africa: Development and evaluation of an integrated community-based management model for HIV, Diabetes and Hypertension in Tanzania and Uganda

https://github.com/intecomm-trial/intecomm-edc (2022-2025)

EFFECT Trial

Fluconazole plus flucytosine vs. fluconazole alone for cryptococcal antigen-positive patients identified through screening:

A phase III randomised controlled trial

https://github.com/effect-trial/effect-edc (2021- )

http://www.isrctn.com/ISRCTN30579828

META Trial (Phase III)

A randomised placebo-controlled double-blind phase III trial to determine the effects of metformin versus placebo on the incidence of diabetes in HIV-infected persons with pre-diabetes in Tanzania.

https://github.com/meta-trial/meta-edc (2021- )

(The same codebase is used for META Phase 2 and META Phase 3)

http://www.isrctn.com/ISRCTN77382043

Mapitio

Retrospective HIV/Diabetes/Hypertension Cohort (Tanzania)

https://github.com/mapitio/mapitio-edc (2020-2022)

MOCCA Trial

Integrated care for HIV and non-communicable diseases in Africa: a pilot study to inform a large-scale trial (MOCCA and MOCCA Extension Study)

https://github.com/mocca-trail/mocca-edc (2020-2022)

http://www.isrctn.com/ISRCTN71437522

INTE Africa Trial

Evaluating the integration of health services for chronic diseases in Africa

(32 sites in Uganda and Tanzania)

https://github.com/inte-africa-trial/inte-edc (2020-2022)

https://inteafrica.org

http://www.isrctn.com/ISRCTN43896688

META Trial (Phase II)

A randomised placebo-controlled double-blind phase II trial to determine the effects of metformin versus placebo on the incidence of diabetes in HIV-infected persons with pre-diabetes in Tanzania.

(3 sites in Tanzania)

https://github.com/meta-trial/meta-edc (2019-2021)

http://www.isrctn.com/ISRCTN76157257

The Ambition Trial

High dose AMBISOME on a fluconazole backbone for cryptococcal meningitis induction therapy in sub-Saharan Africa

(7 sites in Botswana, Malawi, South Africa, Uganda, Zimbabwe)

https://github.com/ambition-trial/ambition-edc (2018-2021)

http://www.isrctn.com/ISRCTN72509687

Start with main repo ambition-edc

The Botswana Combination Prevention Project

(30 remote offline sites in Botswana)

https://github.com/botswana-combination-prevention-project (2013-2018)

https://clinicaltrials.gov/ct2/show/NCT01965470

https://www.ncbi.nlm.nih.gov/pubmed/?term=NCT01965470

https://aids.harvard.edu/tag/bcpp/

Start with main repo bcpp

Optional modules

edc-csf
edc-dx
edc-dx-review
edc-he
edc-icecap-a
edc-microbiology
edc-microscopy
edc-mnsi
edc-phq9
edc-qol

Testing modules

clinicedc-tests
edc-test-settings

Env

uv venv
source .venv/bin/activate
uv sync --no-sources

Tests

uv run --group test runtests.py

Lint and format

uvx ruff check