Changes
+++++++

0.1.48
------
- updates to Subject Screening (#488-10, #503, #730, #731)
    - allow CD4 count to be up to and incl. 60 days old, and remain
      eligible (#503, #488-10)
    - allow CD4 count date older than 60 days to be saved, but as
      ineligible (#503, #488-10)
    - add 'unsuitable_reason', 'unsuitable_reason_other' questions,
      retire 'reasons_unsuitable' (#731)
    - add known (late exclusion) conditions to 'unsuitable_reason'
      choices (#730)
    - add 'safe_save_id' to prevent 'double-submission' of the same
      Subject Screening form (at a single point in time).
      - NOTE: will not protect against the same subject screening data
        being entered twice, on two separate screening forms
- add Consent Version 2 and Consent Version 2 (Update) models/forms
  with 'Substudy, Specimens and Data Sharing' questions (#755)
    - add "Submit Version 2 Consent" action item to those requiring it
- fix 'Unable to capture AE follow-up report, server error' (#781)
- use CrfCollection and RequisitionCollection, replacing FormsCollection
- Update consent_v1 to end 2024-04-22 13:59:59 (UTC)
  and consent_v2 to start 2024-04-22 14:00:00 (UTC)
- bump to edc 0.5.85
- bump to edc-microbiology 0.3.10
- bump to effect-form-validators 0.1.40

0.1.47
------
yanked as invalid (changes rolled into 0.1.48)

0.1.44
------
- disable form runners (temporary)
- bump to edc 0.5.66

0.1.43
------
- AE PDF reports for changes in edc_pdf_reports:
    - set `pdf_report_cls` on AE models (death report, AE initial)
    - update modeladmin changelist (death report, AE initial)
    - add urls from edc_pdf_reports
    - See edc_pdf_reports README
- user is now redirected to effect_ae changelists instead of AE
  listboards. Remove effect_ae from administration section.
  (changes from edc-adverse-event)
- migrations for indexes triggered from other modules e.g.
  edc-list-data, edc-model, etc
- remove redundant edc-sites post-migrate signal
- update edc_sites import paths
- fix inability to insert unscheduled visits in between existing
  unscheduled visits (#527, #528, #529, #632, #736, #744)
- fix '[Some] TMG death report forms not showing on TMG dashboard' (#642)
- fix 'Not all AEs showing up in 'Adverse Events: AE Initial and
  Follow-up Reports'' (#705)
- fix 'Server error when trying to delete a screening form' (#713)
- fix 'Study medication followup (and baseline) appearing at baseline
  visit' (#734)
- bump to edc 0.5.65
- bump to edc-microbiology 0.3.7
- bump to edc-csf 0.3.6
- bump to effect-form-validators 0.1.37

0.1.42
------
- bump to edc 0.5.43

0.1.41
------
- fix issue with overlapping CRFs/PRNs for a visit not showing as
  required (see #710)
- bump to edc 0.5.42

0.1.40
------
- updates to Death Report form (#706)
    - add 'blurred_vision' question to Death Report (#706)
    - increase trial specific form validation
- fix 'Keyed requisition forms showing as new/required, keyed PRNs not
  showing at all' (#710)
- fix Server error on clicking 'Add' Subject Visit in Subject admin (#531)
- update forms reference doc
- bump to edc 0.5.40
- bump to edc-microbiology 0.3.1
- bump to edc-csf 0.3.1
- bump to effect-form-validators 0.1.36

0.1.39
------
- fix Server error on saving StudyMedication and Adherence CRF proxy
  models (#711)
- fix 'CSF CRF culture requisition - field not required error' (#377)
- add Gunicorn and Nginx web config
- add project (static HTML) landing pages
- bump to effect-form-validators 0.1.35

0.1.38
------
- default model manager changed from `on_site` to `objects`
- renamed 'Edc Metadata' to 'Data Collection Status'
- updates to better support internationalization
- add SiteModelAdminMixin to various model admin classes (to restrict
  to viewing entries only from current site)
- override AppointmentAdmin to keep appt_reason choices
- update mysqlclient dependency to be handled by core edc package
  instead of explicitly pinning to mysqlclient 2.1.1
- notes for migrations:
  - drop edc-visit-tracking tables and reset migrations before migrate:
        `drop table edc_visit_tracking_subjectvisitmissedreasons;`
        `drop table edc_visit_tracking_visitreasons;`
        `delete from django_migrations where app='edc_visit_tracking';`
  - migrate:
        `manage.py migrate`
  - reset metadata and references, and update:
        `manage.py update_metadata --delete_metadata --delete_references`
- drop Python 3.10 support
- drop Django 4.1 support
- bump to edc 0.5.36
- bump to edc-microbiology 0.1.15
- bump to edc-csf 0.1.20
- bump to effect-form-validators 0.1.34

0.1.37
------
- re-add Python 3.10 support
- bump to effect-form-validators 0.1.33

0.1.36
------
- updates to Mental Status form (#455, #482)
    - remove 'Not done' choice for Modified Rankin (as per #455-7)
- update and standardise reporting questions, used by: Significant Diagnoses, Mental Status,
  Signs and Symptoms, Subject Visit and Vital Signs forms  (#536)
- restrict Vital Signs form field choices for 'reportable_as_ae' and 'patient_admitted'
  to YES_NO (#418)
- require Vital Signs form only for in person visits (#412, #496)
- convert 'diagnoses_other' to TextField in Significant Diagnoses form
  increasing max_length to 150 chars (#390)
- add Vital Signs and Clinical Note to list of available PRNs (#520)
- fix Blood Result: Chemistry eGFR calculation not finding most recent weight
  if no Vital Signs recorded at current visit (#518)
- retire ReportingFieldsetBaselineTestCaseMixin
- update forms reference doc
- drop Python 3.10 support
- bump to effect-form-validators 0.1.32

0.1.35
------
- fix requisitions not filtering correctly in TB Diagnostics and LP/CSF forms (#659)
- add additional help text to ARV History, ARV Treatment, Participant History,
  Participant Treatment forms (#656)
- validate on_tb_tx is not YES at both D1 Participant History, and D14 Patient Treatment (#656)
- update forms reference doc

0.1.34
------
- add 'diarrhoea' to Signs and Symptoms form (#365, #637)
- require Lumbar Puncture/CSF form at baseline if screening LP done (#639)
- update forms reference doc
- bump to edc 0.4.99

0.1.33
------
- add 'inpatient' and 'admission_indication' fields to Participant History form (#540)
- bump to edc 0.4.96
- bump to edc-microbiology 0.1.12
- bump to edc-csf 0.1.16
- remove explicitly defined edc-egfr dependency (part of edc)
- bump to effect-form-validators 0.1.31

0.1.32
------
- update AE Classifiers list (#524)
- fix AE initial validation (relationship to study drugs/involvement in study, #465, #537)
- bump to edc-microbiology 0.1.11
- bump to edc 0.4.92

0.1.31
------
- fix 'Server error on ARV history form' (missing subject_screening property, #535)
- bump to effect-form-validators 0.1.30

0.1.30
------
- add missed days/doses missed (for flucon and flucyt) to Adherence Day 14 form (towards #422)
- fix 'Blood results: FBC lymphocyte and neutrophil validation error' (#486, #507)
- fix 'Refused status on Subject Screening not auto-updating after subject refusal' (#532)
- drop Django 4.0 support
- bump to edc 0.4.72
- bump to effect-form-validators 0.1.29

0.1.29
------
- fix report datetime validation issues on FBC and Chem blood results forms (#485)

0.1.28
------
- update visit schedule windows (towards #480)
- add migration (introduced in 0.1.27)
- bump to edc 0.4.69

0.1.27
------
- fix 'Server error loading AE TMG Report' (#519)
- fix 'Server error on participant history form (with previous opportunistic infection)' (#515)
- update forms reference doc
- bump to edc 0.4.61
- bump to effect-form-validators 0.1.28


0.1.26
------
- add "Adverse event report withdrawn after TMG review" option to AE follow up
- add custom language choices to Subject Consent form based on country of site
  currently logged into
- limit requisition choices for lab results to only include relevant requisitions
- fix 'Server error on End of Study form' (#516)
- fix 'Server error on submission of reportable blood chemistry result' (#425)
- fix 'Unknown error on TMG death report form' (#517)
- update forms reference doc
- bump to edc 0.4.60
- bump to edc-csf 0.1.15

0.1.25
------
- updates to Subject Screening form (#488, #498, #499)
    - allow form to save 'serum_crag_date' > 14 days (though patient to be ineligible) (#488)
    - increase 'cm_in_csf_method_other' char limit to 50 (#498)
    - add 'Not done' choice to 'csf_crag_result' question (#499)
- updates to ARV History form (#375, #479, #490, #506)
    - improve validation for applicability of 'art_decision' question (#375)
    - change cd4_value' help text (units) to 'cells/μL' (#490)
    - fix validation preventing 'is_adherent' from being answered when applicable (#479, #506)
    - other validation improvements/fixes
- bump to edc 0.4.52
- bump to effect-form-validators 0.1.27
- expand test matrix to include Py: 3.11
- update forms reference doc

0.1.24
------
- add migrations introduced in 0.1.23

0.1.23
------
- add question for current 'site' to Subject Screening form
- bump to edc 0.4.49
- bump to edc-microbiology==0.1.10
- bump to edc-csf==0.1.14
- bump to edc-egfr==0.1.10
- bump to effect-form-validators==0.1.25

0.1.22
------
- update form validator mixins, fixes 'Server Error on submission of FBC and chemistry results' (#477)
- update subject-visit modelform mixins
- add INCOMPLETE status to eligibility
- color screen listboard eligibility button according to eligibility status
- updates to Subject Screening form (#468, towards #478)
    - update (validation and help text) to allow 'lp_date' to be at most 3 days before 'serum_crag_date' (#468, #478)
    - update 'serum_crag_date' and 'prior_cm_episode' and question wording (#478)
    - update 'cm_in_csf' help text (#478)
- bump to edc 0.4.48
- bump to effect-form-validators 0.1.24
- drop Python 3.9 support
- drop Django 3.2 support
- add edc-egfr as dependency; modify admin to display eGFR as read only in
  BloodResultChem; validate in form to expect weight before calculating eGFR.

0.1.21
------
- fix error raised when running update_forms_reference
- bump to edc 0.4.46

0.1.20
------
- rename Patient History CRF to Participant History (#446)
- rename Patient Treatment CRF to Participant Treatment (#446)
- rename 'gender' to 'sex' in Subject Screening forms, Subject Consent form,
  and Screening Listboard (#443)
- updates to Subject Screening form (#440, #458)
    - add 'Not evaluated' choices to a number of screening questions (#440)
    - remove help text from 'csf_crag_value'(#458)
    - fix patient remains eligible even if deemed unsuitable for study
    - improvements to coverage of eligibility checks
    - increase test coverage
- bump to edc 0.4.44
- bump to edc-csf 0.1.13
- bump to effect-form-validators 0.1.23
- add edc_protocol middleware

0.1.19
------
- fix 'Screening' and 'Subjects' links missing from navbar

0.1.18
------
- bump to edc 0.4.34
- bump to edc-csf 0.1.12
- bump to edc-microbiology 0.1.8
- bump to effect-form-validators 0.1.21
- set themes for live and test
- update urls for changes in edc-auth
- replace usages of 'patient' with 'participant' (#446) on:
    - AE form
    - ARV History form
    - ARV Treatment form
    - Adherence form
    - Adherence D1 form
    - Adherence D14 form
    - Adherence D14+ form
    - Mental Status form
    - Patient History form
    - Patient Treatment form
    - Significant Diagnoses form
    - Signs and Symptoms form
    - Study Medication Baseline form
    - Study Medication Follow-up form
    - Subject Visit form
    - Vital Signs form
- fix Day 1 forms prompting "This field is required" for Action identifier (#470)
- remove `tracking_identifier` field from models and admin
- replace `visit_model_attr` with `related_visit_model_attr`
- add new context_processors and middleware to default settings
- updates to Subject Screening form question choices for 'cm_in_csf' and 'cm_in_csf_method' (towards #440)
- updates to Study Medication Baseline/Follow-up forms (towards #395, fixes #433)
    - add 'flucon_next_dose' and 'flucyt_next_dose' fields
    - add 'flucyt_dose_expected', 'flucyt_dose_0400/1000/1600/2200' fields
    - add 'modifications_reason' and 'modifications_reason_other' fields (follow-up)
    - allow 'flucyt_modified' to be NA, or flucytosine dose to be dropped to 0 at Day 14
    - additional validation checks

0.1.17
------
- add edc-egfr, update imports
- add treatment arm/summary to subject dashboard
- add (via edc-auth 0.3.45) 'last_login' and 'is_active' (account enabled) status to user admin list
- make Subject Identifier, and Action Identifier fields read only, in:
    - AE Initial Form, AE Follow-up Form, AE TMG Form
    - Death Report Form, Death Report TMG (2nd), Death Report TMG Form
    - End of Study Form
    - Hospitalisation Form
    - Loss to Follow-up
    - Protocol Deviation/Violation Form
- fix Subject Screening Admin server error on load, reasons not displayed, typo (#332)
- fix (via bump to edc>=0.4.1) permissions error when attempting to add an unscheduled appointment (#466)
- bump to edc 0.4.12
- bump to edc-csf 0.1.10

0.1.16
------
- updates to Health Economics Event CRF (#451):
    - add 'admitted' question
    - move 'routine_activities_disrupted_days' into "Loss of productivity and earnings" section
    - add "Not applicable" option, and updated choice text to be less ambiguous
      to 'lost_income', 'admitted_time_off', and 'admitted_kith_kin_time_off' questions
- updated Forms Reference documentation: https://github.com/effect-trial/effect-edc/blob/develop/docs/forms_reference.md
- bump to edc 0.4.0

0.1.15
------
- updates to End of Study CRF:
    - update 'offschedule_reason' list to reflect (#404#note-3, #380)
    - add link to End of Study form to "Add Action linked PRN" pop-up (#388)
    - reword from "Patient" to "Participant" (#442, #446)
    - update validation to validate against Death Report and LTFU
    - add 'consent_withdrawal_reason', 'late_exclusion_reasons', 'transferred_consent' and 'invalid_enrol_reason' questions
- add Health Economics CRF for review
- add Health Economics Event CRF for review
- changes to Visit Schedule:
    - Study Medication (Baseline/Follow Up) CRF only required: Baseline, Day 14, Week 10.  Also available as PRN (#448)
    - Health Economics CRF only required: Baseline, Week 24
    - Health Economics Event CRF only required: Unscheduled visits.  Also available as PRN
- remove sentry and sauce from settings (#449)
- bump to edc 0.3.98
- bump to effect-form-validators 0.1.18
- bump to edc-microbiology 0.1.5
- bump to edc-csf 0.1.9

0.1.14
------
- updates to Mental Status CRF:
    - add 'require_help' and 'any_other_problems' questions (#423)
    - validate all symptoms must now be negative at baseline visit (#439)
- update Vital Signs CRF to validate g3 or higher fever/blood pressure requires 'reportable_as_ae' to be YES
- update Patient History CRF 'on_tb_tx' question wording to direct at clinician not participant (#444)
- bump to edc 0.3.89

0.1.13
------
- change chest_xray_results_other from char to text field on Chest X-ray CRF (#430)
- update TB section on Patient History CRF (#437):
    - add 'tb_dx_date', 'tb_dx_date_estimated', 'tb_tx_type', 'active_tb_tx'
    - remove 'tb_dx_ago', 'on_rifampicin', 'rifampicin_start_date'
- bump to effect-form-validators 0.1.16

0.1.12
------
- updates to Mental Status CRF:
    - fix unable to specify "Not applicable" if no symptoms to report on D3 (#402, #370)
- add "Coamoxiclav (amoxicillin/clavulanate)" to antibiotics list on Patient Treatment CRF (#431)
- fix typo (split "LamotriginePyridoxine" into two entries) in 'specify_medication' list in Patient History CRF
- merge contents of Medical History CRF into Patient History CRF (#334, #360)
- updates to ARV History CRF:
    - remove 'has_cd4_result' question (#359)
    - rename 'cd4_result' to 'cd4_value' and set max value to 105 (#381)
- add 'calculated_headache_duration' to Signs and Symptoms CRF
- bump to edc 0.3.89
- bump to effect-form-validators 0.1.15

0.1.11
------
- updates to ARV History CRF:
    - add 'hiv_dx_date' and 'hiv_dx_date_estimated' questions to top of ARV History CRF (#337)
    - make 'cd4_result' and 'cd4_date' required (#359), and validate against screening (#381)
- updates to Subject Screening CRF (#337)
    - remove 'hiv_dx_date', 'hiv_dx_ago' and 'hiv_dx_date' questions
    - add 'hiv_confirmed_date' and 'hiv_confirmed_method' questions
- updates to Death Report CRF cause of death choices (#421):
    - add "PCP" and "Toxoplasmosis" choices
    - consolidate "Bacteraemia" and "Sepsis" choices to "Bacteraemia/sepsis"
    - consolidate "Cryptococcal meningitis relapse" and "CM-IRIS" choices to "Cryptococcal meningitis relapse/IRIS"
- updates to AE Initial Report CRF AE classification choices
    - consolidate "Bacteraemia" and "Sepsis" choices to "Bacteraemia/sepsis"
    - consolidate "Cryptococcal meningitis relapse" and "CM-IRIS" choices to "Cryptococcal meningitis relapse/IRIS"
- bump to edc 0.3.88
- bump to effect-form-validators >= 0.1.12

0.1.10
------
- add 'hiv_dx_new' question to Subject Screening CRF (#337)
- fix listboard search
- update consent form
- bump to edc 0.3.87

0.1.7
-----
- move HIV diagnosis questions from Medical History to Subject Screening CRF (#337)
- move 'abnormal_lung_exam' from Patient History to Vital Signs CRF (#382)

0.1.5
-----
- add 'csf_positive_cm' and 'csf_positive_cm_date' fields to Hospitalization form
- add 'hospitalization_date', 'hospitalization_date_estimate', 'clinical_notes_available', 'cm_sx' to Death Report
- changes to drug field names to make consistent (prefer 'flucon_', 'flucyt_')

0.1.3
-----
- add initial Hospitalization form
- align CM choices in Death and AE forms
- update 'specify_medications' choices list to include common medications
- changes to Signs and Symptoms form:
    - reorder:
        - move 'cm_sx' (Are any of the signs or symptoms related to cryptococcal meningitis (CM)?) higher up form
        - move reporting fields: 'reportable_as_ae' and 'patient_admitted' to bottom of form
    - remove fields: 'cm_sx_lp_done' , 'cm_sx_bloods_taken', 'cm_sx_bloods_taken_other'
    - remove '--No symptoms to report' symptom choice (to be replaced by use of '--Not applicable')
    - minor updates to question text/help text
- changes to Visit Schedule:
    - D1:
        - require only FBC and Chemistry requisitions at baseline (all others still available as PRNs)
    - Unscheduled:
        - Add Vital Signs CRF to be included for all unscheduled visits

0.1.2
-----
- remove 'Unblinding request' action linked PRN
- changes to Lumbar Puncture/CSF CRF:
    - remove Q16: QC Requisition
    - remove Q17: QC Result Report Date and Time
    - remove Q18: Quantitative culture
    - remove Q32: CSF CrAg done by IMMY CrAg LFA
- changes to Chest X-ray CRF:
    - add 'Normal' option to results list
    - add 'chest_xray_results_other' field
- remove MCV, MCH, MCHC and HCT from Full Blood Count CRF
- changes to Patient Treatment CRF:
    - merge Patient Treatment and Patient Treatment Day 14 into single CRF
    - remove Fluconazole dose question
- changes to Visit Schedule:
    - D1
        - Re-order baseline forms
        - Move X-ray, LP CSF & Microbiology (TB Diagnostics) to PRN forms
        - If yes to "Was an Xray/lumbar puncture/urinary LAM performed" on Signs and Symptoms, present relevant CRF
        - Make renal function and liver function required at baseline
    - Unscheduled:
        - Add Health Economics CRF to be included for all unscheduled visits
    - Schedule Significant Diagnoses CRF for all visits post baseline
- rename Microbiology CRF to TB Diagnostics
- changes to Consent form:
    - remove "Guardian name" field (#346)
- changes to Screening:
    - move "willing to participate?" and "capacity to provide informed consent?" towards bottom of form (#339, #340)
    - remove all "Not answered" responses (#341, #342)
    - validate/prevent saving if CD4 count not < 100 (#345)
    - update verbose_name to ‘Is the patient CONFIRMED HIV sero-positive’
    - Serum CrAg
        - validate/prevent saving if serum CrAg result not positive (#341)
        - remove IND as option for CrAg results
        - validate/prevent saving if serum CrAg date not within last 14 days (#344)
    - change to 'Was CM confirmed in CSF by any other method? etc' and add list of methods
    - explicitly ask about/exclude protocol listed clinical symptoms/signs of symptomatic meningitis (#343)
      (i.e. a progressively severe headache, a headache and marked nuchal rigidity,
      a headache and vomiting, seizures, a Glasgow Coma Scale (GCS) score of <15)
    - separate pregnancy / breastfeeding questions to be like ambition, add preg date
- changes to Follow-up (formerly Clinical Assessment) form:
    - rename/standardise 'Clinical Assessment' to be 'Follow-up' throughout
    - add "Other" choice/"Other, please specify..." field to Q3 (Was this a telephone follow up or an in person visit?)
    - add survival status help text, for 'Deceased' and 'Alive, but unwell' choices
    - modify adherence_counselling to only be applicable if not 'Deceased'
    - add AE_INITIAL_ACTION action item if yes answer to 'hospitalized'
    - validate 'assessment_type' and 'info_source' against 'info_source' answer provided on Subject Visit CRF
- changes to Signs and Symptoms form:
    - reorder fields based on feedback
    - convert headache_duration to edc_models.DurationDHField
    - use _sx in field names to be consistent ('current_sx', cm_sx')
    - add new model fields: 'any_sx', 'current_sx_other', 'current_sx_gte_g3', 'current_sx_gte_g3_other', 'headache_duration_microseconds', 'xray_performed', 'lp_performed', 'urinary_lam_performed', 'cm_sx_lp_done', 'cm_sx_bloods_taken', 'cm_sx_bloods_taken_other'
    - add N/A options for if no/unknown answer to 'any_sx'
    - add validation
    - add AE_INITIAL_ACTION action item if yes answer to any of: 'reportable_as_ae' or 'patient_admitted'
    - merge in Neurological form fields
- changes to Mental Status form:
    - expand Modified Rankin Score choices to include 0 and 6, and add descriptions
    - make 'reportable_as_ae' and 'patient_admitted' not applicable at baseline
- changes to AE Initial Form:
    - add new model fields: 'fluconazole_relation', 'flucytosine_relation', 'patient_admitted', 'date_admitted', 'inpatient_status' and 'date_discharged'
    - added 'Hospitalization' section to form/admin
    - reordered 'Cause and relationship to study' form/admin section
- rename Study Treatment form to Patient Treatment
    - replace 'admission' with 'enrolment' in 'current_arv_decision' question
- remove:
    - Neurological Symptoms form
    - FocalNeurologicDeficits list model
- fix server error when trying to save “mental status” form

0.1.1
-----
- add migrations

0.1.0
-----
- initial release
