| Order | Question Text | Prompt | Case Report Form Completion Instructions | Type | Collection Variable | Tabulation Target | Mapping Instructions | Controlled Terminology CodeList Name | Permissible Values | Pre-Populated Value |
|---|
| 2 | What is the category of the adverse experience? | Adverse Experiences Category Category | Record the adverse experience category, if not pre-printed on the CRF. | Text | AECAT | AECAT |
|
|
| Applicant Defined |
| 3 | What is the subcategory of the adverse experience? | Adverse Experience Subcategory | Record the adverse experience subcategory, if not pre-printed on the CRF. | Text | AESCAT | AESCAT |
|
|
| Applicant Defined |
| 4 | What is the adverse experience identifier? | AE Number | If collected on the CRF, the applicant may insert instructions to ensure each record has a unique identifier. | Integer | AESPID | AESPID |
|
|
|
|
| 5 | What is the adverse experience term? | Adverse Experiences | 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 |
|
|
|
|
| 6 | What is the adverse experience start date? | Start Date | Record the start date of the AE Adverse Experience using this format (DD-MON-YYYY). | Date | AESTDAT | AESTDTC |
|
|
|
|
| 7 | Is the adverse experience ongoing? | Ongoing | Indicate if the adverse experience has not resolved at the time of data collection; leave the End Date blank. | Text | AEONGO | AEENRTPT; AEENRF | AEENRTPT/ AEENRF | (NY) | Yes |
|
| 8 | What was the adverse experience 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 |
|
|
|
|
| 9 | What is the severity of the adverse experience? | Severity | The reporting physician/healthcare professional will assess the severity of the experience using applicant-defined categories. This assessment is subjective, and the reporting physician/healthcare professional should use medical judgment to compare the reported AE to similar type experiences observed in clinical practice. Severity is not equivalent to seriousness. | Text | AESEV | AESEV |
| (AESEV) | MILD; MODERATE; SEVERE |
|
| 10 | Was the adverse experience serious? | Serious | Assess if an adverse experience should be classified as serious based on the criteria defined in the protocol. | Text | AESER | AESER |
| (NY) | Yes; No |
|
| 11 | Did the adverse experience result in death? | Death | Record whether the serious adverse experience resulted in death. | Text | AESDTH | AESDTH |
| (NY) | Yes; No |
|
| 12 | What[was the subject’s date of death? | Death Date | Record the date of death. | date | DTHDAT | DM.DTHDTC | 13 | Was the adverse experience life-threatening? | Life Threatening | Record whether the serious adverse experience is life-threatening. | Text | AESLIFE | AESLIFE |
| (NY) | Yes; No |
|
| 1413 | Did the adverse experience result in initial or prolonged hospitalization for the subject? | Hospitalization (initial or prolonged) | Record whether the serious adverse experience resulted in an initial or prolonged hospitalization. | Text | AESHOSP | AESHOSP |
| (NY) | Yes; No |
|
| 1514 | Did the adverse experience result in disability or permanent damage? | Disability or Permanent Damage | Record whether the serious adverse experience resulted in a persistent or significant disability or incapacity. | Text | AESDISAB | AESDISAB |
| (NY) | Yes; No |
|
| 1615 | Was the adverse experience associated with a congenital anomaly or birth defect? | Congenital Anomaly or Birth Defect | Record whether the serious adverse experience was associated with congenital anomaly or birth defect. | Text | AESCONG | AESCONG |
| (NY) | Yes; No |
|
| 1716 | Did the adverse experience 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 experience required intervention to prevent permanent impairment or damage due to the use of a medical product. | Text | AESINTV | SUPPAE.QVAL |
| (NY) | Yes; No |
|
| 1817 | Was the adverse experience a medically important event not covered by other "serious" criteria? | Other Serious (Important Medical Events) | Record whether the serious adverse experience is an important medical event, which may be defined in the protocol or in the investigator brochure. | Text | AESMIE | AESMIE |
| (NY) | Yes; No |
|
| 1918 | Was this adverse experience related to study product? | Relationship to Study Product | Indicate if the cause of the adverse experience was related to the study product and cannot be reasonably explained by other factors (e.g., subject's clinical state, concomitant therapy, other interventions). | Text | AEREL | AEREL |
|
| NOT RELATED; UNLIKELY RELATED; POSSIBLY RELATED; RELATED |
|
| 2019 | What action was taken with the study product? | Action Taken with Study Product | Record changes made to the study intervention product resulting from the adverse experience. | Text | AEACN | AEACN |
| (ACNTPACN) | DRUG WITHDRAWN; DOSE REDUCED; DOSE INCREASED; DOSE NOT CHANGED; UNKNOWN; NOT APPLICABLE |
|
| 2120 | What is the outcome of this adverse experience? | Outcome | other action was taken? | Other Action Taken | Record all other action(s) taken resulting from the adverse experience that are unrelated to study product given because of this adverse experienceRecord the appropriate outcome of the experience in relation to the subject's status. | Text | AEOUTAEACNOTH | AEOUT | (OUT) | RECOVERING / RESOLVING; NOT RECOVERED / NOT RESOLVED; RECOVERED / RESOLVED; RECOVERED / RESOLVED WITH SEQUELAE; FATAL | AEACNOTH |
|
|
|
|
| 21 | 22 | What is the action taken with a device? | Action Taken with Device | Record any action taken with a device as the result of the adverse experience. The device may or may not be a device under study. | Text | AEACNDEV | AEACNDEV |
| (DEACNDEV) | DEVICE REPLACED: BATTERY REPLACED:CALIBRATION; REMOVAL; REPROGRAMMING ; REPROGRAMMING
|
|
22
| What is the outcome of this adverse experience? | Outcome | Record the appropriate outcome of the experience in relation to the subject's status. | Text | AEOUT | AEOUT |
| (OUT) | FATAL;NOT RECOVERED/ NOT RESOLVED;RECOVERED/RESOLVED; RECOVERED/RESOLVED WITH SEQUELAE; RECOVERING/RESOLVING; UNKNOWN |
|
| 23 | Was this adverse experience related to a device? | Relationship of Experience to Device | Record the relationship of the adverse experience to Devicedevice | Text | AERLDEV | AERLDEV |
|
| NOT RELATED; UNLIKELY RELATED; POSSIBLY RELATED; RELATED |
|
