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Research \u0026 Regulatory"],"sub_categories":["Clinical Trials \u0026 EDC"],"readme":"|pypi| |downloads| |black| |django-packages|\n\nclinicedc -  A clinical trials data management framework built on Django\n========================================================================\n\nA data management framework built on Django for multisite randomized longitudinal clinical trials.\n\n`Here are a set of python modules that extend Django \u003chttps://github.com/clinicedc/edc\u003e`__ to empower you to build an EDC / eSource system to handle data\ncollection and management for multi-site longitudinal clinical trials.\n\nRefer to the specific open projects listed below for example EDC systems built with these modules.\nThe more recent the trial the better the example.\n\nThe codebase continues to evolve over many years of conducting clinical trials for mostly NIH-funded clinical trials through\nthe `Harvard T Chan School of Public Health \u003chttps://aids.harvard.edu\u003e`__, the\n`Botswana-Harvard AIDS Institute Partnership \u003chttps://aids.harvard.edu/research/bhp\u003e`__\nin Gaborone, Botswana and the `London School of Hygiene and Tropical Medicine \u003chttps://lshtm.ac.uk\u003e`__.\nAlmost all trials were originally related to HIV/AIDS research.\n\nMore recent work with the `RESPOND Africa Group \u003chttps://www.ucl.ac.uk/global-health/respond-africa\u003e`__ formerly at the\n`Liverpool School of Tropical Medicine \u003chttps://lstm.ac.uk\u003e`__ and now with the `University College London Institute for Global Health \u003chttps://www.ucl.ac.uk/global-health/\u003e`__ has expanded into Diabetes (DM),\nHypertension (HTN) and models of integrating care in Africa (https://inteafrica.org) for the\nthree main chronic conditions -- HIV/DM/HTN.\n\nSee also https://www.ucl.ac.uk/global-health/respond-africa\n\nThe implementations we develop with this framework are mostly eSource systems rather than the traditional EDCs.\n\nThe ``clinicedc's`` listed below consist of a subset of trial-specific modules that make heavy use of modules in this framework.\n\n(python 3.12+, Django 5.2+, MySQL 8+, see setup.cfg)\n\n\nHow we describe the EDC in our protocol documents\n-------------------------------------------------\n\nHere is a simple example of a data management section for a study protocol document: `data_management_section`_\n\n.. _data_management_section: https://github.com/clinicedc/edc/blob/main/docs/protocol_data_management_section.rst\n\n\nProjects that use ``clinicedc``\n-------------------------------\nRecent examples of ``clinicedc`` applications using this codebase:\n\nINTECOMM\n--------\nControlling chronic diseases in Africa: Development and evaluation of an integrated community-based management model for HIV, Diabetes and Hypertension in Tanzania and Uganda\n\nhttps://github.com/intecomm-trial/intecomm-edc (2022- )\n\nEFFECT\n------\nFluconazole plus flucytosine vs. fluconazole alone for cryptococcal antigen-positive patients identified through screening:\n\nA phase III randomised controlled trial\n\nhttps://github.com/effect-trial/effect-edc (2021- )\n\nhttp://www.isrctn.com/ISRCTN30579828\n\nMETA Trial (Phase III)\n~~~~~~~~~~~~~~~~~~~~~~\nA 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.\n\nhttps://github.com/meta-trial/meta-edc (2021- )\n\n(The same codebase is used for META Phase 2 and META Phase 3)\n\nhttp://www.isrctn.com/ISRCTN77382043\n\nMapitio\n~~~~~~~\n\nRetrospective HIV/Diabetes/Hypertension Cohort (Tanzania)\n\nhttps://github.com/mapitio/mapitio-edc (2020-2022)\n\nMOCCA\n~~~~~\n\nIntegrated care for HIV and non-communicable diseases in Africa: a pilot study to inform a large-scale trial (MOCCA and MOCCA Extension Study)\n\nhttps://github.com/mocca-trail/mocca-edc (2020-2022)\n\nhttp://www.isrctn.com/ISRCTN71437522\n\nINTE Africa Trial\n~~~~~~~~~~~~~~~~~\nEvaluating the integration of health services for chronic diseases in Africa\n\n(32 sites in Uganda and Tanzania)\n\nhttps://github.com/inte-africa-trial/inte-edc (2020-2022)\n\nhttps://inteafrica.org\n\nhttp://www.isrctn.com/ISRCTN43896688\n\nMETA Trial (Phase II)\n~~~~~~~~~~~~~~~~~~~~~\nA 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.\n\n(3 sites in Tanzania)\n\nhttps://github.com/meta-trial/meta-edc (2019-2021)\n\nhttp://www.isrctn.com/ISRCTN76157257\n\n\nThe Ambition Trial\n~~~~~~~~~~~~~~~~~~\n\nHigh dose AMBISOME on a fluconazole backbone for cryptococcal meningitis induction therapy in sub-Saharan Africa\n\n(7 sites in Botswana, Malawi, South Africa, Uganda, Zimbabwe)\n\nhttps://github.com/ambition-trial/ambition-edc (2018-2021)\n\nhttp://www.isrctn.com/ISRCTN72509687\n\nStart with main repo `ambition-edc`\n\nThe Botswana Combination Prevention Project\n~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~\n\n(30 remote offline sites in Botswana)\n\nhttps://github.com/botswana-combination-prevention-project (2013-2018)\n\nhttps://clinicaltrials.gov/ct2/show/NCT01965470\n\nhttps://www.ncbi.nlm.nih.gov/pubmed/?term=NCT01965470\n\nhttps://aids.harvard.edu/tag/bcpp/\n\nStart with main repo `bcpp`\n\nContacts\n--------\n\nFor further information go to https://github.com/erikvw.\n\n|django| |jet-brains|\n\n\n\n=========================== ============================= ==================================\nedc-action-item_            |edc-action-item|             |pypi-edc-action-item|\nedc-adherence_              |edc-adherence|               |pypi-edc-adherence|\nedc-adverse-event_          |edc-adverse-event|           |pypi-edc-adverse-event|\nedc-analytics_                                            |pypi-edc-analytics|\nedc-appconfig_              |edc-appconfig|               |pypi-edc-appconfig|\nedc-appointment_            |edc-appointment|             |pypi-edc-appointment|\nedc-auth_                   |edc-auth|                    |pypi-edc-auth|\nedc-consent_                |edc-consent|                 |pypi-edc-consent|\nedc-constants_                                            |pypi-edc-constants|\nedc-crf_                    |edc-crf|                     |pypi-edc-crf|\nedc-dashboard_              |edc-dashboard|               |pypi-edc-dashboard|\nedc-data-manager_           |edc-data-manager|            |pypi-edc-data-manager|\nedc-device_                 |edc-device|                  |pypi-edc-device|\nedc-document-status_        |edc-document-status|         |pypi-edc-document-status|\nedc-dx_                     |edc-dx|                      |pypi-edc-dx|\nedc-dx-review_              |edc-dx-review|               |pypi-edc-dx-review|\nedc-egfr_                   |edc-egfr|                    |pypi-edc-egfr|\nedc-export_                 |edc-export|                  |pypi-edc-export|\nedc-facility_               |edc-facility|                |pypi-edc-facility|\nedc-fieldsets_              |edc-fieldsets|               |pypi-edc-fieldsets|\nedc-form-describer_         |edc-form-describer|          |pypi-edc-form-describer|\nedc-form-label_             |edc-form-label|              |pypi-edc-form-label|\nedc-form-runners_           |edc-form-runners|            |pypi-edc-form-runners|\nedc-form-validators_        |edc-form-validators|         |pypi-edc-form-validators|\nedc-glucose_                |edc-glucose|                 |pypi-edc-glucose|\nedc-he_                     |edc-he|                      |pypi-edc-he|\nedc-identifier_             |edc-identifier|              |pypi-edc-identifier|\nedc-lab_                    |edc-lab|                     |pypi-edc-lab|\nedc-lab-dashboard_          |edc-lab-dashboard|           |pypi-edc-lab-dashboard|\nedc-lab-panel_              |edc-lab-panel|               |pypi-edc-lab-panel|\nedc-lab-results_            |edc-lab-results|             |pypi-edc-lab-results|\nedc-label_                  |edc-label|                   |pypi-edc-label|\nedc-list-data_              |edc-list-data|               |pypi-edc-list-data|\nedc-listboard_              |edc-listboard|               |pypi-edc-listboard|\nedc-locator_                |edc-locator|                 |pypi-edc-locator|\nedc-ltfu_                   |edc-ltfu|                    |pypi-edc-ltfu|\nedc-metadata_               |edc-metadata|                |pypi-edc-metadata|\nedc-mnsi_                   |edc-mnsi|                    |pypi-edc-mnsi|\nedc-model_                  |edc-model|                   |pypi-edc-model|\nedc-model-admin_            |edc-model-admin|             |pypi-edc-model-admin|\nedc-model-fields_           |edc-model-fields|            |pypi-edc-model-fields|\nedc-model-form_             |edc-model-form|              |pypi-edc-model-form|\nedc-model-to-dataframe_     |edc-model-to-dataframe|      |pypi-edc-model-to-dataframe|\nedc-navbar_                 |edc-navbar|                  |pypi-edc-navbar|\nedc-next-appointment_       |edc-next-appointment|        |pypi-edc-next-appointment|\nedc-notification_           |edc-notification|            |pypi-edc-notification|\nedc-offstudy_               |edc-offstudy|                |pypi-edc-offstudy|\nedc-pdf-reports_            |edc-pdf-reports|             |pypi-edc-pdf-reports|\nedc-pdutils_                |edc-pdutils|                 |pypi-edc-pdutils|\nedc-pharmacy_               |edc-pharmacy|                |pypi-edc-pharmacy|\nedc-prn_                    |edc-prn|                     |pypi-edc-prn|\nedc-protocol_               |edc-protocol|                |pypi-edc-protocol|\nedc-protocol-incident_      |edc-protocol-incident|       |pypi-edc-protocol-incident|\nedc-pylabels_               |edc-pylabels|                |pypi-edc-pylabels|\nedc-qareports_              |edc-qareports|               |pypi-edc-qareports|\nedc-qol_                    |edc-qol|                     |pypi-edc-qol|\nedc-randomization_          |edc-randomization|           |pypi-edc-randomization|\nedc-refusal_                |edc-refusal|                 |pypi-edc-refusal|\nedc-registration_           |edc-registration|            |pypi-edc-registration|\nedc-reportable_             |edc-reportable|              |pypi-edc-reportable|\nedc-review-dashboard_       |edc-review-dashboard|        |pypi-edc-review-dashboard|\nedc-rx_                     |edc-rx|                      |pypi-edc-rx|\nedc-screening_              |edc-screening|               |pypi-edc-screening|\nedc-search_                 |edc-search|                  |pypi-edc-search|\nedc-sites_                  |edc-sites|                   |pypi-edc-sites|\nedc-subject-dashboard_      |edc-subject-dashboard|       |pypi-edc-subject-dashboard|\nedc-test-utils_             |edc-test-utils|              |pypi-edc-test-utils|\nedc-timepoint_              |edc-timepoint|               |pypi-edc-timepoint|\nedc-transfer_               |edc-transfer|                |pypi-edc-transfer|\nedc-unblinding_             |edc-unblinding|              |pypi-edc-unblinding|\nedc-utils_                  |edc-utils|                   |pypi-edc-utils|\nedc-view-utils_             |edc-view-utils|              |pypi-edc-view-utils|\nedc-visit-schedule_         |edc-visit-schedule|          |pypi-edc-visit-schedule|\nedc-visit-tracking_         |edc-visit-tracking|          |pypi-edc-visit-tracking|\nedc-vitals_                 |edc-vitals|                  |pypi-edc-vitals|\n=========================== ============================= ==================================\n\n\nContrib\n-------\n\n========================== ============================== ==================================\nedc-csf_                    |edc-csf|                     |pypi-edc-csf|\nedc-microbiology_           |edc-microbiology|            |pypi-edc-microbiology|\nedc-microscopy_             |edc-microscopy|              |pypi-edc-microscopy|\n========================== ============================== ==================================\n\nThanks to JetBrains for support with an opensource PyCharm IDE license. |jet-brains|\n\n.. |pypi| image:: https://img.shields.io/pypi/v/edc.svg\n    :target: https://pypi.python.org/pypi/edc\n\n.. |downloads| image:: https://pepy.tech/badge/edc\n   :target: https://pepy.tech/project/edc\n\n.. |django| image:: https://www.djangoproject.com/m/img/badges/djangomade124x25.gif\n   :target: http://www.djangoproject.com/\n   :alt: Made with Django\n\n\n.. _edc-action-item: https://github.com/clinicedc/edc-action-item\n.. _edc-adherence: https://github.com/clinicedc/edc-adherence\n.. _edc-adverse-event: https://github.com/clinicedc/edc-adverse-event\n.. _edc-analytics: https://github.com/clinicedc/edc-analytics\n.. _edc-appointment: https://github.com/clinicedc/edc-appointment\n.. _edc-appconfig: https://github.com/clinicedc/edc-appconfig\n.. _edc-auth: https://github.com/clinicedc/edc-auth\n.. _edc-consent: https://github.com/clinicedc/edc-consent\n.. _edc-constants: https://github.com/clinicedc/edc-constants\n.. _edc-crf: https://github.com/clinicedc/edc-crf\n.. _edc-csf: https://github.com/clinicedc/edc-csf\n.. _edc-dashboard: https://github.com/clinicedc/edc-dashboard\n.. _edc-data-manager: https://github.com/clinicedc/edc-data-manager\n.. _edc-device: https://github.com/clinicedc/edc-device\n.. _edc-document-status: https://github.com/clinicedc/edc-document-status\n.. _edc-dx: https://github.com/clinicedc/edc-dx\n.. _edc-dx-review: https://github.com/clinicedc/edc-dx-review\n.. _edc-egfr: https://github.com/clinicedc/edc-egfr\n.. _edc-export: https://github.com/clinicedc/edc-export\n.. _edc-facility: https://github.com/clinicedc/edc-facility\n.. _edc-fieldsets: https://github.com/clinicedc/edc-fieldsets\n.. _edc-form-describer: https://github.com/clinicedc/edc-form-describer\n.. _edc-form-label: https://github.com/clinicedc/edc-form-label\n.. _edc-form-runners: https://github.com/clinicedc/edc-form-runners\n.. _edc-form-validators: https://github.com/clinicedc/edc-form-validators\n.. _edc-glucose: https://github.com/clinicedc/edc-glucose\n.. _edc-he: https://github.com/clinicedc/edc-he\n.. _edc-identifier: https://github.com/clinicedc/edc-identifier\n.. _edc-lab: https://github.com/clinicedc/edc-lab\n.. _edc-lab-dashboard: https://github.com/clinicedc/edc-lab-dashboard\n.. _edc-lab-panel: https://github.com/clinicedc/edc-lab-panel\n.. _edc-lab-results: https://github.com/clinicedc/edc-lab-results\n.. _edc-label: https://github.com/clinicedc/edc-label\n.. _edc-list-data: https://github.com/clinicedc/edc-list-data\n.. _edc-listboard: https://github.com/clinicedc/edc-listboard\n.. _edc-locator: https://github.com/clinicedc/edc-locator\n.. _edc-ltfu: https://github.com/clinicedc/edc-ltfu\n.. _edc-metadata: https://github.com/clinicedc/edc-metadata\n.. _edc-mnsi: https://github.com/clinicedc/edc-mnsi\n.. _edc-microbiology: https://github.com/clinicedc/edc-microbiology\n.. _edc-microscopy: https://github.com/clinicedc/edc-microscopy\n.. _edc-model: https://github.com/clinicedc/edc-model\n.. _edc-model-admin: https://github.com/clinicedc/edc-model-admin\n.. _edc-model-fields: https://github.com/clinicedc/edc-model-fields\n.. _edc-model-form: https://github.com/clinicedc/edc-model-form\n.. _edc-model-to-dataframe: https://github.com/clinicedc/edc-model-to-dataframe\n.. _edc-navbar: https://github.com/clinicedc/edc-navbar\n.. _edc-next-appointment: https://github.com/clinicedc/edc-next-appointment\n.. _edc-notification: https://github.com/clinicedc/edc-notification\n.. _edc-offstudy: https://github.com/clinicedc/edc-offstudy\n.. _edc-pdutils: https://github.com/clinicedc/edc-pdutils\n.. _edc-pharmacy: https://github.com/clinicedc/edc-pharmacy\n.. _edc-prn: https://github.com/clinicedc/edc-prn\n.. _edc-protocol: https://github.com/clinicedc/edc-protocol\n.. _edc-protocol-incident: https://github.com/clinicedc/edc-protocol-incident\n.. _edc-pylabels: https://github.com/clinicedc/edc-pylabels\n.. _edc-qareports: https://github.com/clinicedc/edc-qareports\n.. _edc-qol: https://github.com/clinicedc/edc-qol\n.. _edc-randomization: https://github.com/clinicedc/edc-randomization\n.. _edc-refusal: https://github.com/clinicedc/edc-refusal\n.. _edc-registration: https://github.com/clinicedc/edc-registration\n.. _edc-reportable: https://github.com/clinicedc/edc-reportable\n.. _edc-pdf-reports: https://github.com/clinicedc/edc-reports\n.. _edc-review-dashboard: https://github.com/clinicedc/edc-review-dashboard\n.. _edc-rx: https://github.com/clinicedc/edc-rx\n.. _edc-screening: https://github.com/clinicedc/edc-screening\n.. _edc-search: https://github.com/clinicedc/edc-search\n.. _edc-sites: https://github.com/clinicedc/edc-sites\n.. _edc-subject-dashboard: https://github.com/clinicedc/edc-subject-dashboard\n.. _edc-test-utils: https://github.com/clinicedc/edc-test-utils\n.. _edc-timepoint: https://github.com/clinicedc/edc-timepoint\n.. _edc-transfer: https://github.com/clinicedc/edc-transfer\n.. _edc-unblinding: https://github.com/clinicedc/edc-unblinding\n.. _edc-utils: https://github.com/clinicedc/edc-utils\n.. _edc-view-utils: https://github.com/clinicedc/edc-view-utils\n.. _edc-visit-schedule: https://github.com/clinicedc/edc-visit-schedule\n.. _edc-visit-tracking: https://github.com/clinicedc/edc-visit-tracking\n.. _edc-vitals: https://github.com/clinicedc/edc-vitals\n\n.. |edc-action-item| image:: https://github.com/clinicedc/edc-action-item/actions/workflows/build.yml/badge.svg\n  :target: https://github.com/clinicedc/edc-action-item/actions/workflows/build.yml\n.. |edc-adherence| image:: https://github.com/clinicedc/edc-adherence/actions/workflows/build.yml/badge.svg\n  :target: 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