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