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- separate Phase 2 and Phase 3 screening: inclusion
criteria, randomizer, table, etc (meta_screening)
- add table randomizationlist (accessible in Phase 3) (meta_rando)
- rename fields in model SubjectScreening` -- `stay_nearby`
to `stay_nearby_6` (meta_screening)
- add fields to model SubjectScreening -- `has_dm`, `on_dm_medication`, `severe_htn`
(accessible in Phase 3) (meta_screening)
- add fields to model SubjectScreening for BP 2X readings/avg
(accessible in Phase 3) (meta_screening)
- add separate Phase 3 visit schedule / data collection schedule
(meta_visit_schedule)
- add bloodresult utest_ids for MCH, MCHC, MCV. Migrate fields
into existing BloodResultsFbc (meta_subject)
- add bloodresult utestids for CHOL. Migrate fields
into existing BloodResultsLipids (meta_subject)
- add HepatitisTest model, add dyslipidaemia_rx to PatientHistory
model (accessible in Phase 3) (meta_subject)
- require `edc_vitals` for field classes used in models PhysicalExam
and FollowupVitals (meta_subject)
- add model StudyDrugRefill, AdditionalScreening
(accessible in Phase 3) (meta_subject)
- add ComplicationsGlycemia (accessible for Phase 3 / pending)
(meta_subject)
- require `edc-mnsi`. MNSI / (accessible in Phase 3) (meta_subject)
- add OtherArvRegimens model (accessible in Phase 3) (meta_subject)
- add nullable fields to PatientHistory:
concomitant_medications, other_dyslipidaemia_rx
(accessible in Phase 3) (meta_subject)
- add inline model OtherArvRegimensDetail to capture history of ARVs
(accessible in Phase 3) (meta_subject)
- add fields to model FollowupVitals for BP 2X readings/avg
(accessible in Phase 3) (meta_subject)
- leave 1X BP reading fields in FollowupVitals for Phase 2, make
nullable but required if in Admin (meta_subject)
- create model BloodResultsIns (accessible in Phase 3) (meta_subject)
- rename fields in model PatientHistory (0075):
diabetes_in_family->dm_in_family
diabetes_symptoms->dm_symptoms
hypertension_treatment->htn_treatment
on_hypertension_treatment->on_htn_treatment
other_diabetes_symptoms->other_dm_symptoms
other_hypertension_treatment->other_htn_treatment
(meta_subject)
- add model HealthEconomicsSimple. Require on or after W2
(accessible in Phase 3) (meta_subject)
- move Unblinding models from meta_prn to edc_unblinding (meta_prn)
- rename field in model ProtocolDeviationViolation `violation_type` to `violation`.
Also change datatype from CharField to ForeignKey. Update data to match existing.
(meta_prn)
- rename field in model ProtocolDeviationViolation `violation_type_other`
to `violation_other` (meta_prn)
- Change datatype of field in model ProtocolDeviationViolation `actions_required`
from CharField to ForeignKey. Update data to match existing (meta_prn)