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Modules for clinical trials research data collection and data management - overview

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clinicedc

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 have developed are mostly eSource systems rather than the traditional EDCs.

The clinicedc for each trial consists of a subset of trial-specific modules that reference this module.

(python 3.12, Django 4.2, MySQL 8+, see setup.cfg)

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

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- )

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)

http://www.isrctn.com/ISRCTN77382043

Mapitio

Retrospective HIV/Diabetes/Hypertension Cohort (Tanzania)

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

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)

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

Contacts

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

Made with Django JetBrains PyCharm

edc-action-item edc-action-item pypi-edc-action-item
edc-adverse-event edc-adverse-event pypi-edc-adverse-event
edc-appconfig edc-appconfig pypi-edc-appconfig
edc-appointment edc-appointment pypi-edc-appointment
edc-auth edc-auth pypi-edc-auth
edc-consent edc-consent pypi-edc-consent
edc-constants   pypi-edc-constants
edc-crf edc-crf pypi-edc-crf
edc-dashboard edc-dashboard pypi-edc-dashboard
edc-data-manager edc-data-manager pypi-edc-data-manager
edc-device edc-device pypi-edc-device
edc-document-status edc-document-status pypi-edc-document-status
edc-egfr edc-egfr pypi-edc-egfr
edc-export edc-export pypi-edc-export
edc-facility edc-facility pypi-edc-facility
edc-fieldsets edc-fieldsets pypi-edc-fieldsets
edc-form-describer edc-form-describer pypi-edc-form-describer
edc-form-label edc-form-label pypi-edc-form-label
edc-form-runners edc-form-runners pypi-edc-form-runners
edc-form-validators edc-form-validators pypi-edc-form-validators
edc-identifier edc-identifier pypi-edc-identifier
edc-lab edc-lab pypi-edc-lab
edc-lab-dashboard edc-lab-dashboard pypi-edc-lab-dashboard
edc-lab-panel edc-lab-panel pypi-edc-lab-panel
edc-lab-results edc-lab-results pypi-edc-lab-panel
edc-label edc-label pypi-edc-label
edc-list-data edc-list-data pypi-edc-list-data
edc-listboard edc-listboard pypi-edc-listboard
edc-locator edc-locator pypi-edc-locator
edc-ltfu edc-ltfu pypi-edc-ltfu
edc-metadata edc-metadata pypi-edc-metadata
edc-model edc-model pypi-edc-model
edc-model-admin edc-model-admin pypi-edc-model-admin
edc-model-fields edc-model-fields pypi-edc-model-fields
edc-model-form edc-model-form pypi-edc-model-form
edc-navbar edc-navbar pypi-edc-navbar
edc-next-appointment edc-next-appointment pypi-edc-next-appointment
edc-notification edc-notification pypi-edc-notification
edc-offstudy edc-offstudy pypi-edc-offstudy
edc-pdf-reports edc-pdf-reports pypi-edc-pdf-reports
edc-pdutils edc-pdutils pypi-edc-pdutils
edc-prn edc-prn pypi-edc-prn
edc-protocol edc-protocol pypi-edc-protocol
edc-protocol-incident edc-protocol-incident pypi-edc-protocol-incident
edc-qareports edc-qareports pypi-edc-qareports
edc-randomization edc-randomization pypi-edc-randomization
edc-refusal edc-refusal pypi-edc-refusal
edc-registration edc-registration pypi-edc-registration
edc-reportable edc-reportable pypi-edc-reportable
edc-review-dashboard edc-review-dashboard pypi-edc-review-dashboard
edc-screening edc-screening pypi-edc-screening
edc-search edc-search pypi-edc-search
edc-sites edc-sites pypi-edc-sites
edc-subject-dashboard edc-subject-dashboard pypi-edc-subject-dashboard
edc-test-utils edc-test-utils pypi-edc-test-utils
edc-timepoint edc-timepoint pypi-edc-timepoint
edc-transfer edc-transfer pypi-edc-transfer
edc-unblinding edc-unblinding pypi-edc-unblinding
edc-utils edc-utils pypi-edc-utils
edc-visit-schedule edc-visit-schedule pypi-edc-visit-schedule
edc-visit-tracking edc-visit-tracking pypi-edc-visit-tracking

Contrib

edc-adherence edc-adherence pypi-edc-adherence
edc-csf edc-csf pypi-edc-csf
edc-dx edc-dx pypi-edc-dx
edc-dx-review edc-dx-review pypi-edc-dx-review
edc-glucose edc-glucose pypi-edc-glucose
edc-he edc-he pypi-edc-he
edc-mnsi edc-mnsi pypi-edc-mnsi
edc-microbiology edc-microbiology pypi-edc-microbiology
edc-microscopy edc-microscopy pypi-edc-microscopy
edc-pharmacy edc-pharmacy pypi-edc-pharmacy
edc-pharmacy-dashboard edc-pharmacy-dashboard pypi-edc-pharmacy-dashboard
edc-qol edc-qol pypi-edc-qol
edc-rx edc-rx pypi-edc-rx
edc-vitals edc-vitals pypi-edc-vitals

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