- 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.
|Week||-2||0||1||2||3||4||5||6||8||10||12||16||20||24||Within week 25||Vital signs and Body Weight||X||X||X||X|
|Visit||1||2||3||4||5||6||7||8||9||10||11||12||13||14||15||Type of contact||Visit||Treatment satisfaction||continuous through trial|
|Previous and concomitant medication||X||X||X||X||X||X||X||X||X||X||X||X||X||X||X||Pregnancy test||Plasma glucose values for 3 days before visit||X|
|Visit Schedule||3 Month FUP||6 Month FUP||12 Month FUP||18 Month FUP||24 Month FUP||Exit||Adverse Event||System Mod||Device Deficiency||Deviation||MRI|
|Inclusion & Clinical Eval|
|Vitals||X||X||X||XPlasma Glucose Self Monitoring||Physical examination||X||X||Patient demography||X||Medical and Surgical history||X|
|TestingInsulin dose day before visit|
|Electrocardiogram||X||X||X||X||X||Informed consent||X||Inclusion and exclusion criteria|
Inclusion and Clinical Evaluation
Efficacy and Safety
|Dispensation of plasma glucose meter||X||Dispensation of Insufix or Standard and training||X|
|Echocardiogram||X||X||X||X||X||X||Dispensation and collection of diaries||X||X||X||X||X||X||X||Biochemistry|
|AE/SAE||continuous through trial||Accountability of investigational products||X||X||XX||MRI||X||X|
What it means
|Informed consent||The subject should sign an appropriate Informed consent form (or forms). Without this nothing further can happen|
|Baseline & Medical History||Collect demographics, medical history, physical examination, device specific testing (Echocardiogram, )|
|Randomization||Subject is allocated to a particular path through the trial (treatment arm)|
|Procedure||Collect procedure details, unsuccessful implant attempts, final system configuration, electrical data, event assessment|
|Follow-up Assessments||Collect type of visit/review, re-assessment of conditions and interventions, event assessments, testing results, MRI, electrical data, therapy response assessment|