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Does the device have a unique identifier

Is the intra-operable data entered into the EHR or a third party product and then the data exchanged via an integration

Is there a way to differentiate what phase of care (pre-op, intra-op, post-op) the data is associated with

How much of the necessary data is in structured data versus unstructured data

Are necessary data elements captured electronically i.e. vent settings


Identified challenges with data flow and integration:

  • Patient may seek care outside of the trial, which would not be directly communicated back to the investigator.  Could there be an adverse event to report?  How could this data and any events be communicated back to the site/investigator?
    • e.g., patient is on a clinical trial and develops a cold.  they seek treatment at an urgent care center for cold symptoms.  could this be an allergy to the treatment?  an adverse event?  
  • Primary care physician does not have access to clinical trial data for the patient.
  • What happens with the unscheduled items?
  • How do adverse events flow?
  • Does the other non-study site have visibility that the patient is enrolled in a study?
  • Is there a data agreement in place between sites (required by FDA)
  • Is that data integrated as discrete data or as a pdf
  • Is there medidata? i.e. reference ranges for labs
  • How is the patient identified in both systems? i.e. UI 

Sample Data - Schedule of Activities (Device Implant)

This is based on a real schedule of activities but anonymised.  Items on a green background can be used as a minimal set for proof of concept.

The trial is a comparison of a Insufix, a new (and imaginary) form of insulin and a conventional form (referred to as "Standard").  Patients record their insulin dosage and blood glucose levels and keep a diary.  Each patient spends 24 weeks on the trial.  

Period

Baseline

ImplantVisit Schedule3 Month FUP6 Month FUP12 Month FUP18 Month FUP24 Month FUPExitAdverse EventSystem ModDevice DeficiencyDeviationMRI
Inclusion & Clinical Eval













Informed ConsentX












Inclusion/Exclusion CriteriaX












Patient DemographyX












Med/Surg HistoryX












Social HistoryX












MedicationsX












Physical ExamX












RandomizationX












VitalsXXXXXXXX





Testing













LabsX

XXXXX





ElectrocardiogramX

XXXXX





EchocardiogramX

XXXXX





MRIX











X




















































































































































































Activity details

Activity

What it means

Informed consentThe subject should sign an appropriate Informed consent form (or forms). Without this nothing further can happen
Baseline & Medical HistoryCollect demographics, medical history, physical examination, device specific testing (Echocardiogram, )
Pre-Procedure
RandomizationSubject is allocated to a particular path through the trial (treatment arm)
ProcedureCollect procedure details, unsuccessful implant attempts, final system configuration, electrical data, event assessment
Follow-up AssessmentsCollect type of visit/review, re-assessment of conditions and interventions, event assessments, testing results, MRI, electrical data, therapy response assessment
Event
??Device interrogation??


Other details



Study full nameComparison of Insufix against standard delivery method for adults with long term diabetes
Study short nameInsufix Comparison
Study IDINS001
Study short descriptionA comparison of a micro-dermal administration of insulin (Insufix) against conventional subcutaneous injection. Subjects record their insulin dosage and blood glucose levels and keep a diary.  Each of 500 subjects spends 24 weeks on the trial.   
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