E2B Code Validation
The following table lists the E2B Code Validation items.
Tag Name | DTD Element | Case Form Field | LM Field |
---|---|---|---|
primarysourcecountry |
A.1.1 |
Case Form / General / Reporter Information / Country |
LM / Countries / Code (A2) |
occurcountry |
A.1.2 |
Case Form / General / General Information / Country |
LM / Countries / Code (A2) |
reporttype |
A.1.4 |
Case Form / General Information / Report Type |
LM / Report Type / E2B Code |
reportercountry |
A.2.1.3 |
Case Form / General / Reporter Information / Country |
LM / Countries / Code (A2) |
qualification |
A.2.1.4 |
Case Form / General / Reporter Information / Reporter Type |
LM / Reporter Type / E2B Code |
observestudytype |
A.2.3.3 |
Case Form / General / Study Information / Observe Study Type |
LM / Case Classification / E2B Code |
sendertype |
A.3.1.1 |
LM / Regulatory Authorities / Local Company Contact / Sender Type |
LM / Regulatory Authorities / Local Company Contact / Sender Type |
sendercountrycode |
A.3.1.4e |
LM / Regulatory Authorities / Local Company Contact / Country |
LM / Countries / Code (A2) |
receivertype |
A.3.2.1 |
LM / Regulatory Authorities / Agency Information / Agency Type |
LM / Regulatory Authorities / Agency Information / Agency Type |
receivercountrycode |
A.3.2.3e |
LM / Regulatory Authorities / Agency Information / Contact Information / Country |
LM / Countries / Code (A2) |
patientonsetageunit |
B.1.2.2b |
Case Form / Patient / Patient Information / Age Units |
LM / Age Units / E2B Code |
patientagegroup |
B.1.2.3 |
Case Form / Patient / Patient Information / Age Group |
LM / Age Group / E2B Code |
patientsex |
B.1.5 |
Case Form / Patient / Patient Information / Gender |
LM / Gender / E2B Code |
parentageunit |
B.1.10.2.2b |
Case Form / Patient / Parent / Age Unit |
LM / Age Units / E2B Code |
parentsex |
B.1.10.6 |
Case Form / Patient / Parent / Gender |
LM / Gender / E2B Code |
reactionoutcome |
B.2.i.8 |
Case Form / Events / Event Information / Outcome of Event |
LM / Event Outcome / E2B Code |
testunit |
B.3.1e |
Case Form / Patient / Lab Data / Lab Data / Units |
LM / Dossage Units / E2B Code |
obtaindrugcountry |
B.4.k.2.3 |
Case Form / Products / Product Information / Obtain Drug Country |
LM / Countries / Code (A2) |
drugauthorizationcountry |
B.4.k.4.2 |
LM / Licenses / License Information / Country |
LM / Countries / Code (A2) |
drugstructuredosageunit |
B.4.k.5.2 |
Case Form / Products / Dosage Regimens / Dose Units |
LM / Dosage Unit / E2B Code |
drugcumulativedosageunit |
B.4.k.5.7 |
Case Form / Products / Total Dose to Primary Event |
LM / Dosage Unit / E2B Code |
drugadministrationroute |
B.4.k.8 |
Case Form / Products / Dosage Regimens / Patient Route of Administration |
LM / Routes of Administration / E2B Code |
drugparadministration |
B.4.k.9 |
Case Form / Products / Dosage Regimens / Parent Route of Administration |
LM / Routes of Administration / E2B Code |
drugintervaldosagedefinition |
B.4.k.5.5 |
LM / Dosage Frequency / Unit |
LM / Dosage Frequency / Unit |
actiondrug |
B.4.k.16 |
Case Form / Products / Product Details / Action Taken |
LM / Action Taken / E2B Code |
mhlwadmicsrcasenumclass |
J.4a |
Case Form / Analysis / PMDA / General / Report Category |
LM / Reporting Category / E2B Code |
mhlwadmicsrnewdrugclass |
J.8 |
Case Form / Analysis / PMDA / Comments / Category of the new drug |
LM / License Category / E2B Code |
mhlwphaseofstudies |
J.12.i.2 |
Business Configuration / Studies / Study Development Phase |
LM / Study Development Phase / E2B Code |
Parent topic: Configure Code List Items