EDC core modules for clinicedc/edc projects.
Project description
Clinic EDC
Clinic EDC contains complete code for a set of core modules for clinical trial data management to build a trial EDC. 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 have been related to HIV/AIDS research. Recent work with the Liverpool School of Tropical Medicine 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.lstmed.ac.uk/RespondAfrica
The implementations we have developed are mostly eSource systems rather than the traditional EDCs.
The Clinic EDC for each trial consists of a subset of trial-specific modules that reference this module.
(python 3.9+ and Django 3.2, see setup.cfg)
Projects that use the EDC
Recent examples of EDC’s using this codebase:
INTECOMM
https://github.com/intecomm-trial/intecomm-edc (under-development (2022- )
EFFECT
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)
Mapitio
Retrospective HIV/Diabetes/Hypertension Cohort (Tanzania)
MOCCA
Integrated care for HIV and non-communicable diseases in Africa: a pilot study to inform a large-scale trial (MOCCA and MOCCA Extension Study)
INTE Africa Trial
(32 sites in Uganda and Tanzania)
META Trial (Phase II)
(3 sites in Tanzania)
https://github.com/meta-trial/meta-edc (2019-2021)
The Ambition Trial
(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
Contacts
For further information go to https://github.com/erikvw.
Contrib
Thanks to JetBrains for support with an opensource PyCharm IDE license.
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