Serious Adverse Event (SAE) Notification
Study Information
| Study Title |
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| Protocol Number |
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| Sponsor |
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| Principal Investigator |
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| Site |
|
Patient Information
| Screening/Subject ID |
|
| Initials |
|
| Date of Birth |
|
| Sex |
|
SAE Details
| Event Term / Diagnosis |
|
| Date of Onset |
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| Date of Reporting |
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| Seriousness Criteria |
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| Outcome |
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| Date of Outcome |
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Treatment / Action Taken
| Study Drug/Intervention Withdrawn? |
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| Concomitant Medication(s) |
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| Relevant Medical History |
|
Investigator's Assessment
| Causality (related/unrelated) |
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| Comments |
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Reporter Details
| Name |
|
| Role |
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| Contact Information |
|
| Date |
|