TAK-861-2003_Main ICF V2.0_06Jul2023.docx · main_icf · 2026-03-15T17:07:16
STEP 1: SCAN FOR TRIGGER TERMS - Conducted comprehensive scan of entire ICF document for all trigger terms including 'future research', 'future use', 'future studies', 'other research', 'secondary research', 'secondary use', 're-use', 're-disclose', 'research repository', 'research database', 'added to research databases', 'used in the future by the Sponsor', 'anonymized', 'de-identified', 'identifiers removed', 'personal information removed', 'stripped of your participant number', 'cannot be linked back to you', 'limited data set', 'data use agreement', 'DUA', 'as permitted by law', 'as allowed by law', 'as required by law', 'IRB', 'Institutional Review Board', 'Ethics Committee', 'EC approval', 'GDPR', 'Article 89', 'scientific research purpose', 'HIPAA authorization', 'privacy authorization', 'if you agree', 'if you consent', 'your choice', 'optional', 'Yes □ / No □', 'I agree that', 'mark your choices', 'On the consent form you indicate whether you agree', 'related to the condition', 'related to the disease', 'related to the study drug', 'same disease', 'same drug', 'same indication', 'for the purpose of this study only', 'limited to'. NO TRIGGER TERMS FOUND anywhere in the document. STEP 2: EVALUATE BASE AUTHORIZATION - No verbatim text found in the ICF that explicitly permits future/secondary use of coded study data. The ICF contains standard language about data confidentiality, regulatory authority access, and publication of anonymized results, but no language authorizing secondary use of coded data for future research purposes beyond the current study protocol. STEP 3: EVALUATE RESEARCH AREA LIMITATIONS - Not applicable as no base authorization exists. STEP 4: SCAN FOR OPT-IN MECHANISMS - No opt-in language, checkboxes, Yes/No selections, or separate consent sections for future research found anywhere in the document including signature pages. STEP 5: EVALUATE EC/IRB REQUIREMENTS - Not applicable as no secondary use authorization exists. STEP 6: RESOLVE CONFLICTS - No conflicting language present. STEP 7: REGULATORY CITATIONS - Applied FDA 21 CFR 50.25(a) which requires disclosure of secondary use if applicable; absence of such disclosure means no authorization obtained.
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90a35a541cb64451Independent verification that the AI's classification is grounded in the ICF text, free of fabricated content, and correctly scoped. Run at 2026-03-15T17:07:49 UTC.
One or more quality checks failed. This classification should be carefully reviewed before any data use decisions are made. Pay particular attention to the Supporting Excerpts above — verify each quote exists verbatim in the uploaded ICF.