Automated Protocol Amendment IRB Notification Drafts
Every morning, WebRun opens RealTime-CTMS, checks for protocol amendments logged since the last run, drafts a standardized IRB notification letter and a staff communication email for each amendment in Gmail for regulatory coordinator review, and stages the IRB letter in DocuSign for electronic signature once approved.
How do I automatically draft IRB notification letters when a protocol amendment arrives?
WebRun checks RealTime-CTMS every morning for newly logged protocol amendments, drafts an IRB notification letter and a staff communication email in Gmail for regulatory coordinator review, and stages the IRB letter in DocuSign for signature. No letter is submitted or sent without coordinator approval.
- IRB notification drafts ready within hours of an amendment being logged, not days
- Staff communication email drafted at the same time so no separate manual step is needed
- DocuSign envelope staged and waiting, removing the last manual friction before submission
Built for regulatory coordinators · research site managers · principal investigators · clinical research sites
What does WebRun do on every run?
The exact actions WebRun takes, in order - in plain language, so you can adjust anything.
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WebRun signs in and gets to work
Opens
realtime-ctms.com/loginin a real browser with your saved login - no setup, no API keys. -
1
RealTime-CTMS - detect newly logged protocol amendments
realtime-ctms.com
WebRun opens RealTime-CTMS to detect newly logged protocol amendments. - Open RealTime-CTMS and check the Protocol or Documents section for amendments logged since the last run
- Capture the study name, amendment number, date received, and a summary of the changes noted
- Identify which staff roles are affected by the amendment
Done when Every new protocol amendment is identified with its study details and scope of change.
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2
Gmail - draft IRB notification and staff communication for coordinator review
gmail.com
WebRun opens Gmail to draft IRB notification and staff communication for coordinator review. - Draft a standardized IRB protocol amendment notification letter for each new amendment
- Draft a staff communication email summarizing the key changes for affected team members
- Leave both drafts unsent for regulatory coordinator review and approval before submission or distribution
Done when An IRB notification draft and a staff communication draft are ready in Gmail for every new amendment, awaiting coordinator approval.
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3
DocuSign - stage the IRB letter for electronic signature after approval
docusign.com
WebRun opens DocuSign to stage the IRB letter for electronic signature after approval. - Stage the IRB notification letter as a DocuSign envelope once the coordinator confirms the draft is ready
- Add the PI and regulatory coordinator as required signers
- Leave the envelope in draft status until the coordinator sends it for signature after approval
Done when A DocuSign envelope for the IRB letter is staged and ready, awaiting coordinator-triggered send.
How is each run configured?
Secure by default
Connect once, stays signed in
WebRun signs in once and keeps each session in a persistent environment, so every run picks up right where it left off.
Every action is checked against this policy before it runs.
Questions, answered
Will it submit the IRB notification automatically?
No. Submitting to the IRB is an irreversible regulatory action. WebRun drafts the letter and stages the DocuSign envelope, but your regulatory coordinator reviews, approves, and triggers the send.
Where does it get the amendment details to populate the letter?
It reads the amendment record logged in RealTime-CTMS, including the study name, amendment number, date received, and summary of changes recorded by your team.
What if an amendment was already processed and the notification sent?
Amendments already marked as processed or notified in RealTime-CTMS are skipped in each daily run so coordinators do not receive duplicate drafts.
Related templates
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