01 / SAP UPLOAD
Start from the SAP
Upload the SAP and its study design, analysis conventions, and output scope are structured.
CLINICAL STAT-QCEARLY BETA
Are SAP and TLF
written to the same
standard?
Analysis populations, endpoints, visit timing.
StrucTrial reviews the SAP for possible mismatches and gaps, then builds the TLF Shell and SAS code.
A CLOSER LOOK AT YOUR DOCUMENTSIllustrative example
StrucTrial / STAT-QC
EXAMPLE
Same analysis, different standard?
SAP_v1.2.pdf
TLF_Shell_v1.1.docx
Possible mismatchEXAMPLE 01 / 03
The population named for the primary analysis differs.
Comparing · primary efficacy analysis / Table 14.2.1
SAP §7.1
Primary population
FAS
Full Analysis Set
TLF 14.2.1
Primary population
PPS
Per-Protocol Set
A reviewer needs to confirm whether this is a supportive analysis or a labelling error.
Select a tab to compare.
01
Structure what the SAP says
Design, analysis conventions, output scope
02
Compare across documents
Mismatches, gaps, changes not carried through
03
Produce the deliverables
TLF Shell and SAS code
FROM SAP TO OUTPUT
Upload the SAP. We review it,
then build the outputs.
Core information scattered through the document is structured, then checked for mismatches and gaps. Once that is settled, the TLF Shell and SAS code are generated against the SAP. Anything that needs judgment is left to the reviewer.
02 / QC REVIEW
Review the issues
Possible mismatches and gaps in populations, endpoints, and visit structure are collected as QC issues. The judgment stays with you.
03 / OUTPUT
Get the deliverables
Once the review is settled, the TLF Shell and SAS code are generated against the SAP.
The current Beta covers SAP review and TLF Shell / SAS code generation. The values above are examples.
DESIGNED FOR REVIEW
We surface the candidates.
You make the call.
Not every difference is an error. StrucTrial organises what to compare and what to check, and leaves the judgment to the reviewer.
Populations, endpoints, visit structureCONSISTENCY
Possible mismatches and gapsQC REVIEW
Issues raised by a change in conventionCHANGE IMPACT
Current focusSAP review, TLF Shell and SAS code
THE BIGGER PICTURE
Statistical documents now,
clinical documentation next.
It starts with statistical documents. The same review widens outward, leading to Q-Trail — checking that the documents each SOP calls for were written the way that SOP requires.
-
NOW
StrucTrial · STAT-QC
Upload the SAP, review it against the document standard, and get the TLF Shell and SAS code.
In beta -
NEXT
Wider review scope
The same review extends to the protocol, CRF, data management documents, operational documents, and the CSR.
In progress -
THEN
Q-Trail (opens in a new window)
Growing into a product that checks whether the documents produced under each SOP were written the way that SOP requires.
Planned
BUILT FROM PRACTICE
From problems found in practice.
Repeated document checks —
this began in practice.
Writing the same information into one document after another, then checking each one by hand whenever it changes. StrucTrial started as an attempt to reduce that repetition, from work across clinical operations, data management, and statistical programming.
Hands-on CO · DM · STAT experienceM.S. Biostatistics · UC Davis · 2018
LET’S TALK
What would this look like
in your documents?
Product questions, demo requests, and collaboration proposals are all welcome.
Telling us which documents you keep re-checking is just as useful.