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General Comments

MedDRA Vocabulary load source files

The design and implementation of the LexEVS 6.1 MedDRA Vocabulary Loader assumes the user has access to MedDRA ASCII source files which can be purchased from: MedDRA MSSO

Overview

The current implementation of the LexEVS 6.1 MedDRA Vocabulary Loader will load all information contained within the ASCII load source files.  Two root nodes are created, one for the SMQ root node and one for the SOC root node.

LexGrid Objects Created

The following describes LexGrid Objects created. Values extracted from MedDRA tables are in bold using the syntax: <tablename>.<fieldname>

Root Nodes

  • SOC
  • SMQ

Coding Scheme

CodingSchemeName

“MedDRA”

FormalName:

“MedDRA-16.0”

CodingSchemeURI

"http://id.nlm.nih.gov/sab/MDR"

DefaultLanguage

“en”

RepresentsVersion

medra_release.version

LocalNameAsReference

“MedDRA”

EntityDescription

“Medical Dictionary for Regulatory Activities”

Copyright

“THIS DATA IS COVERED BY A COPYRIGHT”

Hierarchy

 

Hierarchy.LocalID

“is_a”

Hierarchy.AssociationName

“hasSubtype”

Hierarchy.RootCode

“@”

Hierarchy.ForwardNavigable

True

Entities – System Organ Class (SOC)

EntityCode:

soc.soc_code

EntityDescription:

soc.soc_name

isActive:

true

Presentation

 

Presentation.PropertyName

“T-1”

Presentation.Value

soc.soc_name

Presentation.RepresentationalForm

“OS”

Presentation.IsPreferred

True

Property

 

Property.PropertyName

“P-1”

Property.Value

intl_ord.intl_ord

Property

 

Property.PropertyName

“P-2”

Property.Value

soc.soc_abbrev

Entities - High Level Group Term (HLGT)

EntityCode:

hlgt.hlgt_code

EntityDescription:

hlgt.hlgt_name

isActive:

true

Presentation

 

Presentation.PropertyName

“T-1”

Presentation.Value

hlgt.hlgt_name

Presentation.RepresentationalForm

“HG”

Presentation.IsPreferred

true

Entities - High Level Term (HLT)

EntityCode

hlt.hlt_code

EntityDescription

hlt.hlt_name

isActive

true

Presentation

 

Presentation.PropertyName

“T-1”

Presentation.Value

hlt.hlt_name

Presentation.RepresentationalForm

“HT”

Presentation.IsPreferred

true

Entities - Preferred Term (PT)

EntityCode

pt.pt_code

EntityDescription

pt.pt_name

isActive

true

Presentation

 

Presentation.PropertyName

“T-1”

Presentation.Value

pt.pt_name

Presentation.RepresentationalForm

“PT”

Presentation.IsPreferred

true

Presentation (exists if an LLT with duplicate ID exists)

 

Presentation.PropertyName

“T-2”

Presentation.Value

llt.llt_name

Presentation.RepresentationalForm

“LT”

Presentation.IsPreferred

false

Property

 

Property.PropertyName

“PSOC”

Property.Value

pt.pt_soc_code

Following properties exist if PT is listed in table smq_content

Property

 

Property.PropertyName

“SMQ:term level”

Property.Value

smq_content.term_level

Property

 

Property.PropertyName

“SMQ:term scope”

Property.Value

smq_content.term_scope

Property

 

Property.PropertyName

“SMQ:term category”

Property.Value

smq_content.term_category

Property

 

Property.PropertyName

“SMQ:term weight”

Property.Value

smq_content.term_weight

Property

 

Property.PropertyName

“SMQ:term status”

Property.Value

smq_content.term_status

Property

 

Property.PropertyName

“SMQ:term addition version”

Property.Value

smq_content.term_addition_version

Property

 

Property.PropertyName

“SMQ:term last modified version”

Property.Value

smq_content.term_last_modified_version

Entities - Lower Level Term (LLT)

EntityCode

llt.llt_code

EntityDescription

llt.llt_name

isActive

true

Presentation

 

Presentation.PropertyName

“T-1”

Presentation.Value

llt.llt_name

Presentation.RepresentationalForm

“LT”

Presentation.IsPreferred

true

Following properties exist if LLT is listed in table smq_content

Property

 

Property.PropertyName

“SMQ:term level”

Property.Value

smq_content.term_level

Property

 

Property.PropertyName

“SMQ:term scope”

Property.Value

smq_content.term_scope

Property

 

Property.PropertyName

“SMQ:term category”

Property.Value

smq_content.term_category

Property

 

Property.PropertyName

“SMQ:term weight”

Property.Value

smq_content.term_weight

Property

 

Property.PropertyName

“SMQ:term status”

Property.Value

smq_content.term_status

Property

 

Property.PropertyName

“SMQ:term addition version”

Property.Value

smq_content.term_addition_version

Property

 

Property.PropertyName

“SMQ:term last modified version”

Property.Value

smq_content.term_last_modified_version

Entities - Standard MedDRA Query (SMQ)

EntityCode

smq_list.smq_code

EntityDescription

smq_list.smq_name

isActive

True

Presentation

 

Presentation.PropertyName

“T-1”

Presentation.Value

smq_list.smq_name

Presentation.RepresentationalForm

“SMQ”

Presentation.IsPreferred

true

Comment

 

Comment.PropertyName

“Name”

Comment.Value

smq_list.smq_name

Comment

 

Comment.PropertyName

“Code”

Comment.Value

smq_list.smq_code

Comment

 

Comment.PropertyName

“Level”

Comment.Value

smq_list.smq_level

Comment

 

Comment.PropertyName

“Description”

Comment.Value

smq_list.smq_description

Comment

 

Comment.PropertyName

“Source”

Comment.Value

smq_list.smq_source

Comment

 

Comment.PropertyName

“Note”

Comment.Value

smq_list.smq_note

Comment

 

Comment.PropertyName

“MedDRA Dictionary Version”

Comment.Value

smq_list.MedDRA_version

Comment

 

Comment.PropertyName

“Status”

Comment.Value

smq_list.status

Comment

 

Comment.PropertyName

“Algorithm”

Comment.Value

smq_list.smq_algorithm

Relations

---

Association

Source

Target

Soc_hlgt

“hasSubtype”

soc_hlgt.soc_code

soc_hlgt.hlgt_code

Hlgt_hlt

“hasSubtype”

hlgt_hlt.hlgt_code

hlgt_hlt.hlt_code

Hlt_pt

“hasSubtype”

hlt_pt.hlt_code

hlt_pt.pt_code

Llt1

“hasSubtype”

llt.pt_code

llt.llt_code

Smq_content

“hasSubtype”

smq_content.smq_code

term_code2

  1. Created only if llt_code does not duplicate a pt_code
  2. May be a pt_code or an llt_code

Mapping of MedDRA tables to LexGrid Coding Scheme

Meddra_release

MedDRA Table

MedDRA field

LexEVS Object

LexEVS field

meddra_release

version

CodingScheme

RepresentsVersion

Meddra_release

Language

---

---

Meddra_history_english

MedDRA Table

MedDRA field

LexEVS Object

LexEVS field

Meddra_history_english

Term_code

---

---

Meddra_history_english

Term_name

---

---

Meddra_history_english

Term_addition_version

---

---

Meddra_history_english

Term_type

---

---

Meddra_history_english

Action

---

---

Mdhier

MedDRA Table

MedDRA field

LexEVS Object

LexEVS field

Mdhier

Pt_code

---

---

Mdhier

Hlt_code

---

---

Mdhier

Hlgt_code

---

---

Mdhier

Soc_code

---

---

Mdhier

Pt_name

---

---

Mdhier

Hlt_name

---

---

Mdhier

Hlgt_name

---

---

Mdhier

Soc_name

---

---

Mdhier

Soc_abbrev

---

---

Mdhier

Pt_soc_code

---

---

Mdhier

Primary_soc_fg

---

---

Intl_ord

MedDRA Table

MedDRA field

LexEVS Object

LexEVS field

Intl_ord

Intl_ord_code

Entity

Property.Value

Intl_ord

Soc_code

 

 

Soc

MedDRA Table

MedDRA field

LexEVS Object

LexEVS field

Soc

Soc_code

Entity

EntityCode

Soc

Soc_name

Entity

Entity

EntityDescription

Presentation.Value

Soc

Soc_abbrev

Entity

Presentation.Value

Soc_hlgt

MedDRA Table

MedDRA field

LexEVS Object

LexEVS field

Soc_hlgt

Soc_code

AssociationPredicate

AssociationSource

Soc_hlgt

Hlgt_code

AssociationPredicate

AssociationTarget

Hlgt

MedDRA Table

MedDRA field

LexEVS Object

LexEVS field

Hlgt

Hlgt_code

Entity

EntityCode

Hlgt

Hlgt_name

Entity

Entity

EntityDescription

Presentation.Value

Hlgt_hlt

MedDRA Table

MedDRA field

LexEVS Object

LexEVS field

Hlgt_hlt

Hlgt_code

AssociationPredicate

AssociationSource

Hlgt_hlt

Hlt_code

AssociationPredicate

AssociationTarget

Hlt

MedDRA Table

MedDRA field

LexEVS Object

LexEVS field

Hlt

Hlt_code

Entity

EntityCode

Hlt

Hlt_name

Entity

Entity

EntityDescription

Presentation.Value

Hlt_pt 

MedDRA Table

MedDRA field

LexEVS Object

LexEVS field

Hlt_pt

Hlt_code

AssociationPredicate

AssociationSource

Hlt_pt

Pt_code

AssociationPredicate

AssociationTarget

Pt

MedDRA Table

MedDRA field

LexEVS Object

LexEVS field

Pt

Pt_code

Entity

EntityCode

Pt

Pt_name

Entity

Entity

EntityDescription

Presentation.Value

Pt

Pt_soc_code

Entity

Property.Value

Llt

MedDRA Table

MedDRA field

LexEVS Object

LexEVS field

Llt

Llt_code

Entity

AssociationPredicate

EntityCode

AssociationTarget

Llt

Llt_name

Entity

Entity

EntityDescription

Presentation.Value

Llt

Pt_code

AssociationPredicate

AssociationSource

Llt

Llt_currency

---

---

Smq_list

MedDRA Table

MedDRA field

LexEVS Object

LexEVS field

Smq_list

Smq_code

Entity

Entity

EntityCode

Comment.Value

Smq_list

Smq_name

Entity

Entity

Entity

EntityDescription

Presentation.Value

Comment.Value

Smq_list

Smq_level

Entity

Comment.Value

Smq_list

Smq_description

Entity

Comment.Value

Smq_list

Smq_source

Entity

Comment.Value

Smq_list

Smq_note

Entity

Comment.Value

Smq_list

MedDRA_version

Entity

Comment.Value

Smq_list

Status

Entity

Comment.Value

Smq_list

Smq_algorithm

Entity

Comment.Value

Smq_content

MedDRA Table

MedDRA field

LexEVS Object

LexEVS field

Smq_content

Smq_code

AssociationPredicate

AssociationSource

smq_content

Term_code

AssociationPredicate

AssociationTarget

Smq_content

Term_level

Entity

Property.Value

Smq_content

Term_scope

Entity

Property.Value

Smq_content

Term_category

Entity

Property.Value

Sqm_content

Term_weight

Entity

Property.Value

Smq_content

Term_status

Entity

Property.Value

Smq_content

Term_addition_version

Entity

Property.Value

Smq_content

Term_last_modified_version

Entity

Property.Value

Error Messages

File expected is missing

0 - error - Thu May 23 13:10:26 CDT 2013 - Following files are MISSING in directory provided:
/C:/Users/m113216/Desktop/MedDRA/TestData/Missing PT File/pt.asc
-
1 - fatal - Thu May 23 13:10:26 CDT 2013 - Failed while running the conversion - null
Load process finished - Thu May 23 13:10:26 CDT 2013
Errors Logged: true
Warnings Logged: false
End State: failed

Multiple files expected is missing

0 - error - Thu May 23 13:11:29 CDT 2013 - Following files are MISSING in directory provided:
/C:/Users/m113216/Desktop/MedDRA/TestData/Missing Mult Files/meddra_release.asc
/C:/Users/m113216/Desktop/MedDRA/TestData/Missing Mult Files/mdhier.asc
/C:/Users/m113216/Desktop/MedDRA/TestData/Missing Mult Files/smq_list.asc
/C:/Users/m113216/Desktop/MedDRA/TestData/Missing Mult Files/soc.asc
/C:/Users/m113216/Desktop/MedDRA/TestData/Missing Mult Files/pt.asc
/C:/Users/m113216/Desktop/MedDRA/TestData/Missing Mult Files/soc_hlgt.asc
/C:/Users/m113216/Desktop/MedDRA/TestData/Missing Mult Files/smq_content.asc
-
1 - fatal - Thu May 23 13:11:29 CDT 2013 - Failed while running the conversion - null
Load process finished - Thu May 23 13:11:29 CDT 2013
Errors Logged: true
Warnings Logged: false
End State: failed

File is empty

0 - error - Thu May 23 13:12:14 CDT 2013 - Following files are EMPTY in directory provided:
/C:/Users/m113216/Desktop/MedDRA/TestData/Empty HLT File/hlt.asc
-
1 - fatal - Thu May 23 13:12:14 CDT 2013 - Failed while running the conversion - null
Load process finished - Thu May 23 13:12:14 CDT 2013
Errors Logged: true
Warnings Logged: false
End State: failed

File missing a data field

0 - info - Thu May 23 13:14:40 CDT 2013 - Checking validity of data imported. -
1 - error - Thu May 23 13:14:40 CDT 2013 - ERROR in data imported from file (row 0): hlgt.asc -
2 - error - Thu May 23 13:14:40 CDT 2013 - <REQUIRED>: hlgt_code: null
<REQUIRED>: hlgt_name: null
<IGNORED>: htgt_whoart_code: null
<IGNORED>: hlgt_harts_code: null
<IGNORED>: hlgt_costart_sym: null
<IGNORED>: hlgt_icd9_code: null
<IGNORED>: hlgt_icd9cm_code: null
<IGNORED>: hlgt_icd10_code: null
<IGNORED>: hlgt_jart_code: null
-
3 - info - Thu May 23 13:14:40 CDT 2013 - Completed mapping.  Now saving to database -
4 - fatal - Thu May 23 13:14:41 CDT 2013 - Failed while running the conversion - org.LexGrid.LexBIG.Exceptions.LBParameterException: The URN and the version must be populated.
Load process finished - Thu May 23 13:14:41 CDT 2013
Errors Logged: true
Warnings Logged: false
End State: failed
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