This document provides guidance on using ClinSpark for clinical trial design and data collection. It discusses setting up form libraries, defining objectives for different roles, and tips for creating studies, events, items, and code lists. Challenges addressed include transferring subjects between studies and designing adverse event forms. Lessons learned include needing static dates on forms and the usefulness of repeating forms. The document aims to help new users of ClinSpark understand how to structure studies and optimize the software.

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?