| Order | Question Text | Prompt | CRF Completion Instructions | Type | CDASH Variable | SDTMIG Target Variable | SDTMIG Target Mapping | Controlled Terminology CodeList Name | Permissible Values | Pre-Populated Value | Query Display | List Style | Hidden |
|---|
| 1 | Were any adverse events experienced? | Any Adverse Events | Indicate if the subject experienced any adverse events. If Yes, include the appropriate details where indicated on the CRF. | Text | AEYN | N/A |
| (NY) | Yes; No |
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| 2 | What is the category of the adverse event? | Adverse Event Category | Record the adverse event category, if not pre-printed on the CRF. | Text | AECAT | AECAT |
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| Sponsor Defined |
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| Yes |
| 3 | What is the subcategory of the adverse event? | Adverse Event Subcategory | Record the adverse event subcategory, if not pre-printed on the CRF. | Text | AESCAT | AESCAT |
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| Sponsor Defined |
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| Yes |
| 4 | What is the adverse event identifier? | AE Number | If collected on the CRF, the sponsor may insert instructions to ensure each record has a unique identifier. | Integer | AESPID | AESPID |
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| prompt |
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| 5 | What is the adverse event term? | Adverse Event | Record only 1 diagnosis, sign, or symptom per line (e.g., nausea and vomiting should not be recorded in the same entry, but as 2 separate entries). Using accepted medical terminology, enter the diagnosis (if known); otherwise, enter a sign or symptom. | Text | AETERM | AETERM |
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| 6 | What is the adverse event start date? | Start Date | Record the start date of the AE using this format (DD-MON-YYYY). | Date | AESTDAT | AESTDTC |
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| prompt |
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| 7 | Is the adverse event ongoing? | Ongoing | Indicate if the adverse event has not resolved at the time of data collection; leave the End Date blank. | Text | AEONGO | AEENRTPT; AEENRF | AEENRTPT; AEENRF | (NY) | Yes |
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| checkbox |
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| 8 | What was the adverse event end date? | End Date | Record the date that the AE resolved using this format (DD-MON-YYYY). If the AE is ongoing, leave the field blank. | date | AEENDAT | AEENDTC |
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| prompt |
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| 9 | What is the severity of the adverse event? | Severity | The reporting physician/healthcare professional will assess the severity of the event using sponsor-defined categories. This assessment is subjective and the reporting physician/ healthcare professional should use medical judgment to compare the reported AE to similar type events observed in clinical practice. Severity is not equivalent to seriousness. | Text | AESEV | AESEV |
| (AESEV) | MILD; MODERATE; SEVERE |
| prompt |
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| 10 | Was the adverse event serious? | Serious | Assess if an adverse event should be classified as serious based on the criteria defined in the protocol. | Text | AESER | AESER |
| (NY) | Yes; No |
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| 11 | Did the adverse event result in death? | Death | Record whether the serious adverse event resulted in death. | Text | AESDTH | AESDTH |
| (NY) | Yes; No |
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| 12 | What [is/was] the subject’s date of death? | Death Date | Record the date of death. | date | DTHDAT | DM.DTHDTC |
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| prompt |
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| 13 | Was the adverse event life-threatening? | Life Threatening | Record whether the serious adverse event is life-threatening. | Text | AESLIFE | AESLIFE |
| (NY) | Yes; No |
| prompt |
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| 14 | Did the adverse event result in initial or prolonged hospitalization for the subject? | Hospitalization (initial or prolonged) | Record whether the serious adverse event resulted in an initial or prolonged hospitalization. | Text | AESHOSP | AESHOSP |
| (NY) | Yes; No |
| prompt |
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| 15 | Did the adverse event result in disability or permanent damage? | Disability or Permanent Damage | Record whether the serious adverse event resulted in a persistent or significant disability or incapacity. | Text | AESDISAB | AESDISAB |
| (NY) | Yes; No |
| prompt |
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| 16 | Was the adverse event associated with a congenital anomaly or birth defect? | Congenital Anomaly or Birth Defect | Record whether the serious adverse event was associated with congenital anomaly or birth defect. | Text | AESCONG | AESCONG |
| (NY) | Yes; No |
| prompt |
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| 17 | Did the adverse event require intervention to prevent permanent impairment or damage resulting from the use of a medical product? | Needs Intervention to Prevent Impairment | Record whether the serious adverse event required intervention to prevent permanent impairment or damage due to the use of a medical product. | Text | AESINTV | SUPPAE.QVAL |
| (NY) | Yes; No |
| prompt |
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| 18 | Was the adverse event a medically important event not covered by other "serious" criteria? | Other Serious (Important Medical Events) | Record whether the serious adverse event is an important medical event, which may be defined in the protocol or in the investigator brochure. | Text | AESMIE | AESMIE |
| (NY) | Yes; No |
| prompt |
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| 19 | Was this adverse event related to study treatment? | Relationship to Study Treatment | Indicate if the cause of the adverse event was related to the study treatment and cannot be reasonably explained by other factors (e.g., subject's clinical state, concomitant therapy, other interventions). | Text | AEREL | AEREL |
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| NOT RELATED; UNLIKELY RELATED; POSSIBLY RELATED; RELATED |
| prompt |
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| 20 | What action was taken with the study treatment? | Action Taken with Study Treatment | Record changes made to the study treatment resulting from the adverse event. | Text | AEACN | AEACN |
| (ACN) | DRUG WITHDRAWN; DOSE REDUCED; DOSE INCREASED; DOSE NOT CHANGED; UNKNOWN; NOT APPLICABLE |
| prompt |
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| 21 | What is the outcome of this adverse event? | Outcome | Record the appropriate outcome of the event in relation to the subject's status. | Text | AEOUT | AEOUT |
| (OUT) | RECOVERING / RESOLVING; NOT RECOVERED / NOT RESOLVED; RECOVERED / RESOLVED; RECOVERED / RESOLVED WITH SEQUELAE; FATAL |
| prompt |
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