Package: edc
clinicedcHere 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
theHarvard T Chan School of Public Health, theBotswana-Harvard AIDS Institute Partnershipin Gaborone, Botswana and theLondon School of Hygiene and Tropical Medicine.
Almost all trials were originally related to HIV/AIDS research.More recent work with theRESPOND Africa Groupformerly at theLiverpool School of Tropical Medicineand now with theUniversity College London Institute for Global Healthhas 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 alsohttps://www.ucl.ac.uk/global-health/respond-africaThe implementations we have developed are mostly eSource systems rather than the traditional EDCs.Theclinicedcfor 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 useclinicedcRecent examples ofclinicedcapplications using this codebase:INTECOMMControlling chronic diseases in Africa: Development and evaluation of an integrated community-based management model for HIV, Diabetes and Hypertension in Tanzania and Ugandahttps://github.com/intecomm-trial/intecomm-edc(2022- )EFFECTFluconazole plus flucytosine vs. fluconazole alone for cryptococcal antigen-positive patients identified through screening:A phase III randomised controlled trialhttps://github.com/effect-trial/effect-edc(2021- )http://www.isrctn.com/ISRCTN30579828META 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/ISRCTN77382043MapitioRetrospective HIV/Diabetes/Hypertension Cohort (Tanzania)https://github.com/mapitio/mapitio-edc(2020-2022)MOCCAIntegrated 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/ISRCTN71437522INTE Africa TrialEvaluating 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.orghttp://www.isrctn.com/ISRCTN43896688META 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/ISRCTN76157257The Ambition TrialHigh 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/ISRCTN72509687Start with main repoambition-edcThe Botswana Combination Prevention Project(30 remote offline sites in Botswana)https://github.com/botswana-combination-prevention-project(2013-2018)https://clinicaltrials.gov/ct2/show/NCT01965470https://www.ncbi.nlm.nih.gov/pubmed/?term=NCT01965470https://aids.harvard.edu/tag/bcpp/Start with main repobcppContactsFor further information go tohttps://github.com/erikvw.edc-action-itemedc-adverse-eventedc-appconfigedc-appointmentedc-authedc-consentedc-constantsedc-crfedc-dashboardedc-data-manageredc-deviceedc-document-statusedc-egfredc-exportedc-facilityedc-fieldsetsedc-form-describeredc-form-labeledc-form-runnersedc-form-validatorsedc-identifieredc-labedc-lab-dashboardedc-lab-paneledc-lab-resultsedc-labeledc-list-dataedc-listboardedc-locatoredc-ltfuedc-metadataedc-modeledc-model-adminedc-model-fieldsedc-model-formedc-navbaredc-next-appointmentedc-notificationedc-offstudyedc-pdf-reportsedc-pdutilsedc-prnedc-protocoledc-protocol-incidentedc-randomizationedc-refusaledc-registrationedc-reportableedc-review-dashboardedc-screeningedc-searchedc-sitesedc-subject-dashboardedc-test-utilsedc-timepointedc-transferedc-unblindingedc-utilsedc-visit-scheduleedc-visit-trackingContribedc-adherenceedc-csfedc-dxedc-dx-reviewedc-glucoseedc-heedc-mnsiedc-microbiologyedc-microscopyedc-pharmacyedc-pharmacy-dashboardedc-qoledc-rxedc-vitalsThanks to JetBrains for support with an opensource PyCharm IDE license.