Scott C. Grimstead, CRC, EMT
A Clinical Explanation into My Uniquity & My Clinical Research Background
15+ Years Experience in the Design & Creation of Source Documents, QA Chart Review, & EDC!
How Can I Help Your Institution?
The days of Sponsors or CRO's supplying study source documents are a thing of the past!
The Average Coordinator spends > 20 hours per Study to create source documents (And inevitably something always gets missed!)
That 20 hours could be used for:
- Data Entry
- Enrollment Logs
- Master IP Logs
- Patient Visits
- Recruitment
- Lab Samples & Frozen Shipments
and MUCH MUCH MORE...
Let Me Help!
While creating source documents, I integrate data from all 3 of the below to ensure 100% of the required Protocol data is COMPLETE & ACCURATE !
Close Review of the Protocol
Complete review of the Clinical Trial Protocol! When creating Source
Documents, it is IMPERATIVE that EVERY page of the Protocol is read page
by page to ensure 100% protocol adherence!
Schedule of Events
a.k.a.
"The Flow Sheet"
I utilize the "Schedule of Events" page to compare
missing information not documented in the Protocol.
(including the footnotes)
Providing this information ensures ALL Protocol data is included.
Electronic Data Capture
By reviewing the EDC Screenshots AND EDC Guidelines,
any additional information can be captured!
To allow for timely data entry,
ALL source documents are created to mimic the EDC pages
(unless otherwise noted in the protocol).
