Clinical Protocol Deviation Reporter
3.00 in major clinical trial protocol deviations identified across across 3 items.
Drug administered without required baseline liver panel. Classified as Critical Safety Violation under Protocol Rule 2.
Method1Audited patient visit dates and drug administration logs against protocol tolerance windows.
2Formatted regulatory deviation dossier ready for IRB and FDA annual safety reporting.
| Reference | Description | Deviation_Count |
|---|---|---|
| SUBJ-102 | Baseline Liver Panel Omission Critical Violation | 1.00 |
| SUBJ-103 | Double Investigational Dosage Administered | 1.00 |
| SUBJ-101 | Out of Window Efficacy Assessment | 1.00 |
EDC clinical trial visit tracking logs and subject inclusion records, plus FDA Good Clinical Practice (GCP) protocol specifications
FDA Form 1572 major deviation summary and Institutional Review Board (IRB) reporting dossier (Resolution Dossier, Findings Schedule)
Open Clinical Protocol Deviation Reporter on sample data now with no sign-up, then run your own files free for 14 days. $3,500 a month after that, cancel any time. 30% goes to the referring partner.
Read in memory for the session, never stored, never used to train a model.
Outputs are computed from your inputs and the tool's rules. Check them before you rely on them.
14 days on your own files, then $3,500 a month.
Open Clinical Protocol Deviation Reporter on sample data now with no sign-up, then run your own files free for 14 days. $3,500 a month after that, cancel any time.
On a sample file: 3.00 in major clinical trial protocol deviations identified across across 3 items.
Why not just use ChatGPT?
Rules that stay current: the rate cards, tariffs, code sets and regulations it checks against are kept up to date for you; a one-off prompt starts from nothing each time. Evidence that stands up: every finding cites the line, the file and the rule, so it holds up with a vendor, a payer or an auditor. The same answer every time: the checks are written rules, not a fresh guess, so this month's result can be compared with last month's. Nobody has to own it: no one inside has to build, test and maintain a home-made tool, and files are not pasted into a public chatbot.
Start on your own files
If you would rather talk it through, write to dev.sathya@baseloom.app; that reaches Dev Sathya, founder.