Known consent language patterns and their validated outcomes. The AI agent references this matrix for pattern matching before performing inference.
| ID | Pattern Name | Example Language | Opt-in Language | Expected Outcome | Source |
|---|---|---|---|---|---|
| 1 | Takeda Standard Broad Future Research | The coded information collected during this study may also be added to research databases and used in the future by the Sponsor, persons working with … | — | Allowed | TAK-788-3001 multiple countries |
| 2 | Takeda Optional Checkbox Broad Consent | The coded information collected during this study may also be added to research databases and used in the future by the Sponsor for the following reas… | □ YES, I agree to the use of my coded information for future research purposes as described above. □ | Allowed, subject to individual opt in | TAK-994-1501 Canada |
| 3 | Takeda Disease-Limited Consent | Your coded study data may be used for future research to develop a better understanding of the disease being studied in this clinical trial and to eva… | — | Allowed, limited to same disease | TAK-994-0001 US |
| 4 | Takeda Drug and Disease Limited with Opt-in | Your coded study information may be used for future research related to the study drug and the disease being studied. | □ YES □ NO — I consent to the use of my coded data for future research. | Allowed, limited to same drug and diseas | TAK-861-3002 multiple countries |
| 5 | EC Approval Required with Opt-in | Your coded data may be used for future research purposes. Any such future research will require approval from an Ethics Committee. You will be asked t… | Separate consent / signature required. | Allowed, subject to individual opt in, a | TAK-861-3002 Belgium |
| 6 | Separate Future Research ICF | [Consent for future research is contained in a separate Informed Consent Form / Personal Data Protection Form specifically for future research use of … | Separate ICF signature required. | Allowed, subject to individual opt in | TAK-861-2001 Germany, Italy, Norway |
| 7 | No Future Research Language Found | [ICF contains no language regarding future or secondary use of coded study data. Only discusses data use within the scope of the current study protoco… | — | Not Allowed | TAK-861-3001 Czechia, Finland |
| 8 | Anonymization Only | After the study is complete, your data may be made anonymous (all identifying information removed so that it can never be linked back to you) and comb… | — | Allowed to create anonymized datasets on | Training ICF Examples 14-15 |
| 9 | HIPAA Disclosure Only (Not Future Research) | A description of this clinical trial will be available on http://www.ClinicalTrials.gov. This website will not include information that can identify y… | — | Not Allowed | Training ICF Example 10 |
| 10 | IRB Override via As Permitted by Law | The Sponsor may use your coded study data for future research related to this study drug or disease area, subject to review and approval by an Institu… | — | Allowed | Training ICF Examples 8-9 |