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  • 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.  

Plasma Glucose Self MonitoringLaboratory Insulin dose day before visitXX

Period

ScreeningBaselineFollow up

Implant
Week-2012345681012162024Within week 25
Vital signs and Body WeightXXXX
Visit123456789101112131415
Type of contactVisitTreatment satisfactioncontinuous through trial

Treatment

Training patientXXRandomisationX
Previous and concomitant medicationXXXXXXXXXXXXXXX
Pregnancy testPlasma glucose values for 3 days before visitX
Visit 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












VitalsXXXXPhysical examinationXXPatient demographyXMedical and Surgical historyX





Testing













LabsX

XXXXX





ElectrocardiogramX

XXXXInformed consentXInclusion and exclusion criteria

X

X

Inclusion and Clinical Evaluation

HbA1c

Efficacy and Safety

Dispensation of plasma glucose meterXDispensation of Insufix or Standard and trainingX





EchocardiogramX

XXXXXDispensation and collection of diariesXXXXXXXBiochemistry





AE/SAEcontinuous through trialAccountability of investigational productsXXXMRIX











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??


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