Null Flavors are the values assigned to a field while entering the data for an AER in the ARISg. It is only applicable for E2B transmission of the cases, whereas the fields with Null Flavor value are not considered for printing in Report, but the database ID of the Null Flavor value associated with the field is considered for E2B transmission.
The Null Flavor values prevent printing of information in the Report, and support only the exchange of information through E2B Transmission. The reason for assigning a Null value for a field in the data entry for an AER is to omit data that is sensitive, unavailable, or unknown etc., and avoid incomplete information regarding an AER to be distributed.
For example, when an adverse event is reported and the Onset date (B.2.i.4b/E.i.4) is not captured by the reporter at the time of reporting, then in the data entry, select Not Asked from the Null Flavor drop-down list. This prevents incorrect or incomplete information about the Onset date being printed in the Report. However, when the case is sent for further analysis through E2B transmission, the event information is sent with the coded Null Flavor value (Not Asked) in the XML file for the next level of investigation.
The Null Flavor is supported in the following tabs in Full Data Entry:
Reporter
Patient
Product
Study
Event
Lab
Literature
The Null Flavor values corresponding to a field are displayed in a drop-down list. Depending on the scenarios select the appropriate value from the drop-down list.
The following Null Flavor values are displayed:
Asked but Unknown - Information was sought but not found (e.g., patient was asked but didn’t know)
No Information - No information is available.
Not Asked - No information is sought.
Unknown - A proper value is applicable, but not known.
Irrespective of the Null Flavor value selected for the fields, the application always prints blank in the Report corresponding to such field.
NOTE: When the Null Flavor and Lookup feature are associated to a field, the auto suggest feature displays only the Null Flavor values if the auto suggest feature is set.
Tag ID |
Tag Name |
Null flavor Values Allowed |
A.1.9 |
Does this Case Fulfill the Local Criteria for an Expedited Report? |
No Information |
A.1.11 |
Other Case Identifiers in Previous Transmissions |
No Information |
Reporter tab |
||
A.2.r.1.1a |
Reporter’s Title |
Asked but Unknown, Not Asked, Unknown |
A.2.r.1.1b |
Reporter’s Given Name |
Asked but Unknown, Not Asked |
A.2.r.1.1c |
Reporter’s Middle Name |
Asked but Unknown, Not Asked |
A.2.r.1.1d |
Reporter’s Family Name |
Asked but Unknown, Not Asked |
A.2.r.1.2a |
Reporter’s Organization |
Asked but Unknown, Not Asked |
A.2.r.1.2b |
Reporter’s Department |
Asked but Unknown, Not Asked |
A.2.r.1.2c |
Reporter’s Street |
Asked but Unknown, Not Asked |
A.2.r.1.2e |
Reporter’s State or Province |
Asked but Unknown, Not Asked |
A.2.r.1.3 |
Reporter’s Country Code |
Asked but Unknown, Not Asked |
A.2.r.1.4 |
Qualification |
Unknown |
FDA.C.2.r.2.5.1/ FDA.D.1i |
Reporter’s County |
Asked but Unknown, Not Asked, No Information |
|
Reporter’s email |
Asked but Unknown, Not Asked, No Information |
A.2.1.4/C.2.r.4 |
Reporter Type |
Other |
A.2.1.2a |
Hospital Name |
No Information |
| Person tab > Patient screen | ||
|
Reporter's Email |
Asked but Unknown, Not Asked, No Information |
|
Reporter Type |
Other |
|
Patient State or Foreign Province Name |
No Information |
FDA.C.2.r.2.5.1/ FDA.D.1i |
Reporters County |
Asked but Unknown, Not Asked, No Information |
|
Patients County |
No Information |
|
Patients email |
Masked, Asked but Unknown, Not Asked, No Information |
| Person tab > Investigator screen | ||
(A.2.1.2e/C.2.r.2.5) |
Reporter’s State or Province |
No Information |
FDA.C.2.r.2.5.1/ FDA.D.1i |
Reporter’s County |
Asked but Unknown, Not Asked, No Information |
|
Reporter's Email |
Asked but Unknown, Not Asked, No Information |
|
Report Type |
Other |
| Person tab > Author screen | ||
(A.2.1.2e/C.2.r.2.5) |
Reporter’s State or Province |
No Information |
|
Reporter’s County |
Asked but Unknown, Not Asked, No Information |
|
Reporter's Email |
Asked but Unknown, Not Asked, No Information |
|
Report Type |
Other |
E2B tab |
||
A.3.3a |
Sender’s Department |
No Information |
A.3.3b |
Sender’s Title |
No Information |
A.3.3c |
Sender’s Given Name |
No Information |
A.3.3d |
Sender’s Middle Name |
No Information |
A.3.3e |
Sender’s Family Name |
No Information |
A.3.4a |
Sender’s Street Address |
No Information |
A.3.4b |
Sender’s City |
No Information |
A.3.4c |
Sender’s State or Province |
No Information |
A.3.4d |
Sender’s Postcode |
No Information |
A.3.4f |
Sender’s Telephone |
No Information |
A.3.4i |
Sender’s Fax |
No Information |
A.3.4l |
Sender’s E-mail Address |
No Information |
Literature tab |
||
A.4.r.1 |
Literature Reference(s) |
Asked but Unknown, Not Asked |
C.4.r.1 |
Literature Reference |
Asked but Unknown, Not Asked |
Study tab |
||
A.5.1.r.1 |
Study Registration Number |
Asked but Unknown, Not Asked |
A.5.1.r.2 |
Study Registration Country |
Asked but Unknown, Not Asked |
A.5.2 |
Study Name |
Asked but Unknown, Not Asked |
A.5.3 |
Sponsor Study Number |
Asked but Unknown, Not Asked |
Patient tab |
||
B.1.1 |
Patient (name or initials) |
Asked but Unknown, Not Asked, Unknown |
B.1.1.1a |
Patient Medical Record Number(s) and the Source(s) of the Record Number (GP Medical Record Number) |
Asked but Unknown, Not Asked |
B.1.1.1b |
Patient Medical Record Number(s) and the Source(s) of the Record Number (Specialist Record Number) |
Asked but Unknown, Not Asked |
B.1.1.1c |
Patient Medical Record Number(s) and Source(s) of the Record Number (Hospital Record Number) |
Asked but Unknown, Not Asked |
B.1.1.1d |
Patient Medical Record Number(s) and Source(s) of the Record Number (Investigation Number) |
Asked but Unknown, Not Asked |
B.1.5/D.5 |
Sex |
Unknown |
D.1 |
Patient ID |
Masked, Asked but Unknown, Not Asked, Unknown |
B.1.2.3/ D.2.3 |
Patient Age Group |
Masked, Asked but Unknown, Not Asked, Unknown |
FDA.D.12 |
Ethnic Origin |
Masked, Unknown, No Information (Vaccine) |
Patient > Disease tab |
||
B.1.7.1.r.c |
Start Date |
Asked but Unknown, Not Asked |
B.1.7.1.r.f |
End Date |
Asked but Unknown, Not Asked |
B.1.7.2 |
Text for Relevant Medical History and Concurrent Conditions (not including reaction /event) |
Asked but Unknown, Not Asked, Unknown |
B.1.8.r.c |
Start Date |
Asked but Unknown, Not Asked |
B.1.8.r.e |
End Date |
Asked but Unknown, Not Asked |
B.1.9.1 |
Date of Death |
Asked but Unknown, Not Asked |
B.1.9.3 |
Was Autopsy Done? |
Asked but Unknown, Not Asked, Unknown |
Patient > Parent tab |
||
B.1.10.1 |
Parent Identification |
Asked but Unknown, Not Asked, Unknown |
B.1.10.2.1 |
Date of Birth of Parent |
Asked but Unknown, Not Asked |
B.1.10.6 |
Sex Of Parent |
Asked but Unknown, Not Asked |
B.1.10.7.1.r.c |
Start Date |
Asked but Unknown, Not Asked |
B.1.10.8.r.c |
Start Date |
Asked but Unknown, Not Asked |
D.10.6 |
Sex |
Unknown |
Patient > Parent tab > Disease link page |
||
D.10.7.1.r.3 |
Continuing? |
Unknown |
| Patient > Parent tab > Parent Address link page | ||
First Name |
Masked, Asked but Unknown, Not Asked |
|
Last Name |
Masked, Asked but Unknown, Not Asked |
|
Middle Name |
Masked, Asked but Unknown, Not Asked |
|
Event tab |
||
B.2.i.3 |
Date of Start of Reaction / Event |
Asked but Unknown, Not Asked |
B.2.i.4 |
Date of End of Reaction on / Event |
Asked but Unknown, Not Asked |
| FDA.E.i.3.3a | Emergency Room |
No Information |
|
Physician Office |
No Information |
FDA.E.i.3.2c. |
Hospitalization required-Historic |
No Information |
|
None of the above |
No Information |
Lab tab |
||
B.3.r.b |
Test Date |
Unknown |
Product tab > Dosing Regimen section |
||
G.k.4.r.7 |
Batch/Lot No. |
Asked but Unknown, Unknown |
B.4.k.4.r.7 |
Date and Time of Last Administration |
Asked but Unknown, Not Asked |
Product tab > Indication section |
||
G.k.7.r.1 |
Indication term |
Asked but Unknown, Not Asked, Unknown |
Product tab > Pharmaceutical Dose Form section |
||
B.4.k.4.r.11.1 |
Pharmaceutical Dose Form (free text) |
Asked but Unknown, Not Asked, Unknown |
Product tab > Route of Admin section |
||
B.4.k.4.r.12.1 |
Route of Administration (free text) |
Asked but Unknown, Not Asked, Unknown |
Product tab > Parent Route of Admin section |
||
B.4.k.4.r.13.1 |
Parent Route of Administration (free text) |
Asked but Unknown, Not Asked, Unknown |
B.4.k.7.r.1 |
Indication as Reported by the Primary Source |
Asked but Unknown, Not Asked, Unknown |
Product tab > Vaccine section |
||
FDA.G.k.4.r.14.9 |
Military Status |
Other |
|
vaccination site |
Asked but Unknown, Not Asked, No Information |
| Assessment > General Info | ||
B.1.5/D.5 |
Sex |
The Information entered in FDE appears in assessment screen. |
B.1.9.3/D.9.3 |
Autopsy performed |
The Information entered in FDE appears in assessment screen. |
B.1.9.1b/D.9.1 |
Date of death |
The Information entered in FDE appears in assessment screen. |
B.1.2.3/ D.2.3 |
Age group |
The Information entered in FDE appears in assessment screen. |
Assessment > Product |
||
|
Therapy start date |
The Information entered in FDE appears in assessment screen. |
|
Therapy End date |
The Information entered in FDE appears in assessment screen. |
| Assessment > Event | ||
|
Onset date |
The Information entered in FDE appears in assessment screen. |
|
Cessation Date |
The Information entered in FDE appears in assessment screen. |
| Assessment >Medical History | ||
|
Start Date |
The Information entered in FDE appears in assessment screen. |
|
End Date |
The Information entered in FDE appears in assessment screen. |
| Assessment > Case level Assessment | ||
A.1.9/C.1.7 |
Local expedited |
No Information |
| Assessment > Reaction Assessment | ||
|
Onset date |
Asked but Unknown Not Asked |
|
Cessation Date |
Asked but Unknown Not Asked |
E.i.3.2a |
Death? |
No information |
E.i.3.2b |
Life threatening? |
No information |
E.i.3.2c |
Hospitalization prolonged? |
No Information |
|
Other medically important condition |
No Information |
E.i.3.2d |
Disability? |
No Information |
Easy View Assessment > Drug |
||
B.4.k.12b/D.8.r |
Therapy Start date |
The Information entered in FDE appears in assessment screen. |
B.4.k.14b/D.8.r.5 |
Therapy End date |
The Information entered in FDE appears in assessment screen. |
| Easy View Assessment >Event | ||
|
Onset date |
The Information entered in FDE appears in assessment screen. |
|
Cessation Date |
The Information entered in FDE appears in assessment screen. |
| Triage and Assessment >Case Info | ||
B.1.5/D.5 |
Sex |
The Information entered in FDE appears in assessment screen. Unknown. |
| Triage and Assessment > Other AE characteristics at case level | ||
|
Hospitalization required? |
No Information |
| Triage and Assessment > Drug | ||
B.4.k.12b/D.8.r. |
Therapy Start date |
|
B.4.k.14b/D.8.r.5 |
Therapy End date |
|
| Triage and Assessment > Event | ||
B.2.i.5b/E.i.5 |
Cessation Date |
|
| Affiliate Reporting > General | ||
B.1.5/D.5 |
Sex | The Information entered in FDE appears here. |
B.1.9.3/D.9.3 |
Autopsy performed |
The Information entered in FDE appears here. |
B.1.9.1b/D.9.1 |
Date of death |
The Information entered in FDE appears here. |
B.1.2.3/ D.2.3 |
Age group |
The Information entered in FDE appears here. |
| Affiliate Reporting > General > Products | ||
B.4.k.12b/D.8.r |
Therapy Start date |
The Information entered in FDE appears here. |
B.4.k.14b/D.8.r.5 |
Therapy End date |
|
| Affiliate Reporting >Events | ||
|
Onset date |
The Information entered in FDE appears here. |
|
Cessation Date |
The Information entered in FDE appears here. |
| Affiliate Reporting >Risk Factors >Products | ||
B.4.k.12b/D.8. |
Therapy Start date |
The Information entered in FDE appears here. |
B.4.k.14b/D.8.r.5 |
Therapy End date |
The Information entered in FDE appears here. |
| Affiliate Reporting >Risk Factors >Expectedness | ||
|
Onset date |
The Information entered in FDE appears here. |
|
End Date |
The Information entered in FDE appears here. |
| Affiliate Reporting >Disease | ||
|
Start Date |
The Information entered in FDE appears here. |
|
End Date |
The Information entered in FDE appears here. |
| Affiliate Reporting >Disease >Products | ||
B.4.k.12b/D.8.r |
Therapy Start date |
The Information entered in FDE appears here. |
B.4.k.14b/D.8.r.5 |
Therapy End date |
The Information entered in FDE appears here. |
| Affiliate Reporting >ParentDisease >Expectedness | ||
|
Onset date |
The Information entered in FDE appears here. |
|
End Date |
The Information entered in FDE appears here. |
| Affiliate Reporting >Causality >Products | ||
B.4.k.12b/D.8.r |
Therapy Start date |
The Information entered in FDE appears here. |
B.4.k.14b/D.8.r.5 |
Therapy End date |
The Information entered in FDE appears here. |
| Affiliate Reporting > Causality >Expectedness | ||
|
Onset date |
|
|
End Date |
|
| Affiliate Reporting >Japanese reporting >JP Evaluation2 >Dosage Regimen | ||
B.4.k.12b/D.8.r |
Therapy Start date |
The Information entered in FDE appears here. |
B.4.k.14b/D.8.r.5 |
Therapy End date |
The Information entered in FDE appears here. |
| Affiliate Reporting > Case Description | ||
B.4.k.12b/D.8.r |
Therapy Start date |
The Information entered in FDE appears here. |
B.4.k.14b/D.8.r.5 |
Therapy End date |
The Information entered in FDE appears here. |
| Product Complaints >Customer Details | ||
B.2.i.4b/E.i.4 |
Onset date |
The Information entered in FDE appears here. |
| Product Complaints >Event Details | ||
B.2.i.4b/E.i.4 |
Onset date |
The Information entered in FDE appears here. |
B.2.i.5b/E.i.5 |
Cessation date |
The Information entered in FDE appears here. |
| FDE> Case Intake | ||
B.2.i.4b/E.i.4 |
Onset date |
The Information entered in FDE appears here. |
|
End Date |
The Information entered in FDE appears here. |