1. User Guide
  2. Working with your records
  3. Working with the data in your documents
  4. Know the fields in the Review Form

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.

The validation criteria reflect the format of data the respective fields accept. The system automatically marks any data that cannot be validated with a status of Needs review.

Table 7-3 General

Field name Validation criteria
Receipt Date Valid date format: DD-MON-YYYY
Country N/A
Report Type N/A

Table 7-4 Study

Field name Validation criteria
Study Name 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:

  • (0, No, N, False, F) to No

  • (Yes, Y, True, T, 1) to Yes
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, “one” will be converted to “1”.
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:

  • (0, No, N, False, F) is converted to No

  • (Yes, Y, True, T, 1) is converted to Yes
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 LLT N/A
Death
Valid Yes or No Conversion:

  • (0, No, N, False, F) is converted to No

  • (Yes, Y, True, T, 1) is converted to Yes
Life Threatening
Valid Yes or No Conversion:

  • (0, No, N, False, F) is converted to No

  • (Yes, Y, True, T, 1) is converted to Yes
Hospitalization
Valid Yes or No Conversion:

  • (0, No, N, False, F) is converted to No

  • (Yes, Y, True, T, 1) is converted to Yes
Disability
Valid Yes or No Conversion:

  • (0, No, N, False, F) is converted to No

  • (Yes, Y, True, T, 1) is converted to Yes
Congenital Anomaly
Valid Yes or No Conversion:

  • (0, No, N, False, F) is converted to No

  • (Yes, Y, True, T, 1) is converted to Yes
Other
Valid Yes or No Conversion:

  • (0, No, N, False, F) is converted to No

  • (Yes, Y, True, T, 1) is converted to Yes
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
Generic Name N/A
Product Type This field only has two values:
  1. Suspect
  2. Concomitant Default - Suspect
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