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EDC core modules for clinicedc/edc projects.

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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 3.11, Django 4.2, MySQL 8+, see setup.cfg)

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-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

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