name: AtomicAI IRB Human Subjects Assistant on: issue_comment: types: [created] issues: types: [opened, assigned] pull_request: types: [opened, synchronize, assigned] pull_request_review_comment: types: [created] jobs: claude-assistant: runs-on: ubuntu-latest if: | github.actor != 'atomicqms-service' && ( (github.event_name == 'issue_comment' && contains(github.event.comment.body, '@atomicai') && github.event.comment.user.login != 'atomicqms-service') || (github.event_name == 'issues' && github.event.action == 'opened' && contains(github.event.issue.body, '@atomicai')) || (github.event_name == 'pull_request' && github.event.action == 'opened' && contains(github.event.pull_request.body, '@atomicai')) || (github.event_name == 'pull_request_review_comment' && contains(github.event.comment.body, '@atomicai') && github.event.comment.user.login != 'atomicqms-service') || (github.event.action == 'assigned' && github.event.assignee.login == 'atomicai') ) permissions: contents: write issues: write pull-requests: write steps: - uses: actions/checkout@v4 with: fetch-depth: 0 - name: Run AtomicAI IRB Human Subjects Assistant uses: https://beta.atomicqms.com/atomicqms-service/actions/claude-code-gitea-action-slim@main with: trigger_phrase: '@atomicai' assignee_trigger: 'atomicai' claude_git_name: 'AtomicAI' claude_git_email: 'atomicai@atomicqms.local' custom_instructions: | You are AtomicAI, an AI assistant specialized in IRB and Human Subjects Research Quality Management. ## Your Expertise - 45 CFR 46 (Common Rule) requirements - FDA regulations for clinical investigations (21 CFR 50, 56) - ICH-GCP (Good Clinical Practice) guidelines - AAHRPP accreditation standards - IRB submission and review processes - Informed consent requirements - Vulnerable populations protections - Continuing review and reporting - Protocol deviations and violations - Adverse event reporting - Data safety monitoring - Research billing compliance ## Document Creation Guidelines - Place IRB SOPs in SOPs/IRB/ - Place Consent Templates in Templates/Consent/ - Place Submission Forms in Forms/Submission/ - Place Reporting Forms in Forms/Reporting/ - Place Training Records in Forms/Training/ - Place Policies in Policies/ ## Numbering Convention - SOP-IRB-XXX for IRB SOPs - SOP-CON-XXX for Consent SOPs - SOP-RPT-XXX for Reporting SOPs - TPL-XXX for Templates - POL-XXX for Policies - FRM-XXX for Forms Always create branches and submit changes as Pull Requests for review. Prioritize participant protection, regulatory compliance, and ethical conduct. allowed_tools: 'Read,Edit,Grep,Glob,Write' disallowed_tools: 'Bash,WebSearch'