Know the fields in the Review Form
Whenever records are associated with the Create New Records task, you may be required to manually add data to fields belonging to several categories.
Table 7-3 General
| Field name | Validation criteria |
|---|---|
| Initial Receipt Date | Valid date format: DD-MON-YYYY |
| Country | N/A |
| Report Type | N/A |
Table 7-4 Study
| Field name | Validation criteria |
|---|---|
| Study ID | N/A |
Table 7-5 Reporter
| Field name | Validation criteria |
|---|---|
| Title | N/A |
| First Name | N/A |
| Middle Name | N/A |
| Last Name | N/A |
| Email Address | N/A |
| Country | N/A |
| Address | N/A |
| Healthcare Professional |
Non-E2b Valid Yes or No Conversion:
|
| Reporter Type | N/A |
Table 7-6 Literature
| Field name | Validation criteria |
|---|---|
| Literature Reference | N/A |
Table 7-7 Patient
| Field name | Validation criteria |
|---|---|
| Patient Initial | N/A |
| Patient ID | Non E2B field |
| DOB | Valid date format: DD-MON-YYYY |
| Age | Valid numeric value. For example, βoneβ will be converted to β1β. |
| Unit | N/A |
| Age Group | N/A |
| Gender | N/A |
| Height | N/A |
| Unit | Non E2B field |
| Death Date | Valid date format: DD-MON-YYYY HH:MM |
Table 7-8 Patient - Other Relevant History
| Field name | Validation criteria |
|---|---|
| Category | Non E2B field |
| Description Condition Reported | N/A |
| Start Date | Valid date format: DD-MON-YYYY |
| End Date | Valid date format: DD-MON-YYYY |
| Ongoing |
Valid Yes or No Conversion:
|
| Notes | N/A |
Table 7-9 Patient - Other Relevant Past Drug History
| Field name | Validation criteria |
|---|---|
| Category | Non E2B field |
| Drug Name | N/A |
| Start Date | Valid date format: DD-MON-YYYY HH:MM |
| End Date | Valid date format: DD-MON-YYYY HH:MM |
| Notes | Non E2B field |
Table 7-10 Lab Data
| Field name | Validation criteria |
|---|---|
| Test Name | N/A |
| Date | Validation date format: DD-MON-YYYY HH:MM |
| Result | N/A |
| Unit | N/A |
| Low | N/A |
| High | N/A |
| Comments | N/A |
Table 7-11 Events
| Field name | Validation criteria |
|---|---|
| Event as Reported | N/A |
| Event as Coded | N/A |
| Death |
Valid Yes or No Conversion:
|
| Life Threatening |
Valid Yes or No Conversion:
|
| Hospitalization |
Valid Yes or No Conversion:
|
| Disability |
Valid Yes or No Conversion:
|
| Congenital Anomaly |
Valid Yes or No Conversion:
|
| Other |
Valid Yes or No Conversion:
|
| Onset Date | Valid date format: DD-MON-YYYY HH:MM |
| Stop Date | Valid date format: DD-MON-YYYY HH:MM |
| Duration | N/A |
| Duration Unit | N/A |
| Outcome | N/A |
| Occur Country | N/A |
| Intensity | Non E2B field |
Table 7-12 Product
| Field name | Validation criteria |
|---|---|
| Product Name | N/A |
| Product Type | This field only has two values:
|
| Obtain Drug Country | N/A |
| Manufacturer | N/A |
| Authorization Number | N/A |
| Action Taken | N/A |
| Indication | N/A |
Table 7-13 Product - Dosage
| Field name | Validation criteria |
|---|---|
| Dose | N/A |
| Unit | N/A |
| Start Date | Valid date format: DD-MON-YYYY HH:MM |
| End Date | Valid date format: DD-MON-YYYY HH:MM |
| Duration | N/A |
| Duration Unit | N/A |
| Frequency | Non E2B field |
| Batch/Lot # | N/A |
| Formulation | N/A |
| Dose Description | N/A |
| Route of Administration | N/A |
Table 7-14 Narrative
| Field name | Validation criteria |
|---|---|
| Narrative | N/A |
| Reporter Comment | N/A |
Table 7-15 References
| Field name | Validation criteria |
|---|---|
| References Type | Non E2B field |
| ID | N/A |
Parent topic: Working with the data in your documents