How do you currently capture images for your studies?
Acquired and shipped on CD for upload to an analysis system
Acquired, uploaded and then transferred to other software systems for evaluation
Acquired and locally evaluated for clinical trial criteria
Acquired, encrypted, uploaded and tracked in a single system through analysis and data output
Do you use one imaging solution for both early and late phase studies?
Yes, it is the same solution from my imaging partner for all my trials
Yes, but there are different solutions provided by my imaging partner
No, we are working with different vendors for early and late phase studies
What process do you follow to quarantine and remove protected health information (PHI) from images submitted by study sites?
Manually review every image and obscure header tags, audio or visual (pixel) PHI
DICOM tags are automatically cleaned, but audio, video or PHI “burned” into the image have to be manually inspected and cleaned
PHI across a variety of mediums (e.g., header tags, audio, visual) and image formats (e.g., DICOM and non-DICOM) are automatically processed and cleaned within an integrated imaging management technology
Check all that apply in your imaging trial:
Readers use different image viewing tools
Readers use different imaging measurement tools
Readers struggle to meet turnaround times
Data is not easily available or accessible throughout the trial
How often would you estimate that readers deviate from the reading protocol that has been approved for your trial?
75%-100% of the time
50%-74% of the time
25%-49% of the time
Less than 25% of the time
Do you have visibility into study operational data as the clinical trial progresses? For example, the number of uploads, image passing/failing QC, reads completed, exams per image management workflow step.
Yes, I have access to study operational data/metrics through an online self-serve dashboard within my imaging vendor's platform
Yes, I get regular study operational reports (e.g., PDF) from my imaging vendor
Yes, I track down my imaging vendor project manager and have them gather the information whenever I want it
No, I only see and review study operational data when I'm closing out the trial
Are your images only qualitatively evaluated by trained readers?
No. We use a combination of quantitative image processing and analysis software tools.
I'm not sure
How do you determine outlier data points, and how quickly can you correct the data?
We manually review the data and images on a regular basis. When we detect an outlier, we take action.
We do not assess imaging outliers. We reconcile the data and any enrollment implications during trial close-out.
We use an automated system with imaging data and workflow edit/logic checks to quickly detect, assess and reconcile imaging data outliers -- sometimes while the patient is still in the office/clinic/study site
Do you have access to a visual audit trail connecting reader annotations and measurements made on the image to the data captured within the eCRF?
I'm not sure
How and where is your trial imaging data currently being stored?
Stored locally (CDs or server), spread across multiple study sites
Stored locally (CDs or server), spread across multiple imaging vendor platforms
Stored locally, within a single imaging vendor platform
Stored securely in the cloud, within a single imaging vendor platform
I'm not sure
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