We are updating the validaton rules in connection with the implementation of the Danish Medicines Agency's new adverse reaction database. The changes, which entered into force on 6 December 2010, are:
|
E2B element |
E2B field name |
Validation |
|
A1.1 |
Primarysourcecountry |
Mandatory field for all cases |
|
A.2.1.4 |
qualification |
At least one 'qualification' is required per report |
|
B1.2.2a |
Patientonsetage |
Age cannot be above 120 years |
|
B.1.3 |
Patientweight |
Weight cannot be above 500 kg |
|
B.1.4 |
Patientheight |
Height cannot be above 300 cm |
|
B.1.7.1c |
Patientmedicalstartdate |
Date cannot be superior to the current database date/ report date |
|
B.1.7.1f |
Patientmedicalenddate |
Date cannot be superior to the current database date/ report date |
|
B.1.8c |
Patientdrugstartdate |
Date cannot be superior to the current database date/ report date |
|
B.1.8e |
Patientdrugenddate |
Date cannot be superior to the current database date/ report date |
|
B.1.9.1b |
Patientdeathdate |
Date cannot be superior to the current database date/ report date or inferior to the date when treatment started |
|
B.1.10.7.1c |
Parentmedicalstartdate |
Date cannot be superior to the current database date/ report date |
|
B.1.10.7.1f |
parentmedicalenddate |
Date cannot be superior to the current database date/ report date |
|
B.1.10.8c |
parentdrugstartdate |
Date cannot be superior to the current database date/ report date |
|
B.1.10.8e |
parentdrugenddate |
Date cannot be superior to the current database date/ report date |
|
B.2.i.8 |
reactionoutcome |
All outcomes should be specified. If the outcome is unknown, "unknown" should be specified. |
|
B.3.1b |
testdate |
Date cannot be superior to the current database date/ report date |
|
N/A |
All dates |
All dates should be inferior to or equal to the current database date and cannot be in the future. |
|
B.2.i.4b |
reactionstartdate |
The reaction start date should be superior to the start date of treatment with the suspected medicine |
|
B.4.k.7 |
drugdosageform |
The drug dosage form can be specified with text or code. The text / code should be selected from the list available in the factbox to the right. |
|
B.4.k.18.1b |
drugreactionassess |
This MedDRA code should be the same as the one used in the field "reactionmeddrallt" |
|
All numerical fields |
|
A unit should be specified for all completed numeric fields. The only exception is test fields, for which the associated unit field does not have to be filled out (however, it is advised to do so when possible) |
For further information, please contact the Danish Medicines Agency on +45 4488 9595 or email: E2B@dkma.dk.
Danish Medicines Agency, 8 December 2010
