Presented at Foundry Health's eSource meeting in Chicago, 03-Oct-2017

2. Where I’m coming from…
• ClinSpark v.1.0.5 (coming from paper source)
• Phase 1 CRO
• Vasoconstriction (dermatology) and PK studies that
are relatively standardized within our organization

3. Where to start?
• Create your form libraries
• * Approved forms (with a date)
• * In Progress (with a date)
• Research / Define the Objectives of each form from the
different perspectives
• Clinical Data Collection
• Quality Assurance
• Report Writers
• Other Key Players

4. Tips & Tricks
Discovered Along the Way

5. Create new study with Epochs

6. Study Events
• Lists the order that information is printed in the CRF
• Can use multiple Unscheduled types

7. Item Groups & Items
• We have opted to give most of the Item Groups and
Items unique names.
• This gives us flexibility in making changes
between CRF and Protocol items.
• It also gives us flexibility in SDTM coding for our
Report Writers

8. Code Lists
• Keep a copy of your Code List Items in a word document

9. Measurements
• To produce symbols, I used ASCII keyboard shortcuts
• For example, this is the website I used to find the shortcut for the
superscript 2 -- https://tools.oratory.com/altcodes.html

10. Methods
• Currently, we have used Methods for our BMI
calculation and Total Score for our Fitzpatrick form

11. Forms
• Add them from the existing “Approved” library

12. Keeping the Libraries Clean
• Keep only the fully approved forms in the “* Approved forms”
library
• Create and make changes in the “* In Progress” library
• If you make form changes in a specific study that will also affect
future studies, then take notes so that these changes can be
applied to the “Approved” library
• Old Item Groups, Items and Code Lists start to take over after
many changes. As needed, create a new “In Progress” library to
start from a clean slate.

13. Reports used for Study Design
• Study>Report>Study Design
1. Activity Plan Excel
• Study Event
• Form Name
• Hidden
• Mandatory
• Timepoint
• Pre Window
• Post Window
2. Hyperlinked PDF

14. Testing and Approval
• Major form changes / Changes that affect business
processes – approved by a group of key stakeholders
• Day-to-day study design – approved by Clinical managers
• Run through the study design in the test
environment
• Review the “Activity Plan Excel” reports

15. What’s still paper source
• Dosing – Multiple subjects dosing at the same time
• PK Blood Samples – Not comfortable with the short time
frame for the part-time phlebotomists to be able to do their
job well in one-minute draws, and also concentrate on
documenting the exact timepoints.
• Chromameter Readings – Due to the lack of a physical cable

16. Biggest Challenges
• Transferring subjects from one study to another
• Adverse Event form

17. Lessons Learned
• We needed static dates for many of our forms.
• We liked the functionality of repeating forms.
• Used for device repeats such as vitals
• Used for medical histories such as medications

18. Questions / Comments?