ICSR Length Check

When you select ICSR Length Check, the system generates a report that prints the code list item length check and M2 validation warnings. This menu item has been added under Oracle Argus Safety Console > Tools > ICSR Length Check.

ICSR Report Output screen

The following table lists the Code List items the length check is run on.

Data Element LM Field Argus Field Length DTD Allowed Length

A.2.1.1d

LM / Clinical Studies / Study Information / Study Description.

The application needs to consider the EUDRA-CT length (35) while displaying the message.

2000

100

A.3.1.3b

LM / Regulatory Authorities / Local Company Contact / Title

40

10

A.3.1.4a

LM / Regulatory Authorities / Local Company Contact / Address

120

100

A.3.1.4f

LM / Regulatory Authorities / Local Company Contact / Phone

20

10

A.3.1.4g

LM / Regulatory Authorities / Local Company Contact / Phone / Ext.

10

5

A.3.1.4i

LM / Regulatory Authorities / Local Company Contact / Fax

50

10

A.3.1.4j

LM / Regulatory Authorities / Local Company Contact / Fax / Ext.

10

5

A.3.2.2c

LM / Regulatory Authorities / Agency Information / Contact Information / Title

40

10

A.3.2.2f

LM / Regulatory Authorities / Agency Information / Contact Information / Last Name

40

35

A.3.2.3a

LM / Regulatory Authorities / Agency Information / Contact Information / Address

120

100

A.3.2.3f

LM / Regulatory Authorities / Agency Information / Contact Information / Phone

20

10

A.3.2.3g

LM / Regulatory Authorities / Agency Information / Contact Information / Phone / Ext.

10

5

A.3.2.3i

LM / Regulatory Authorities / Agency Information / Contact Information / Fax

50

10

A.3.2.3j

LM / Regulatory Authorities / Agency Information / Contact Information / Fax / Ext.

10

5

A.2.1.2c

LM / Reporter Information / Address

120

100

B.4.k.2.2

LM / Products / Key Ingredient

120

100

B.4.k.4.1

LM / Licenses / License Information / Number

40

35