Agenda
1
Overview
Types of Laboratories
Standards
Key Messages
1. Overview
The vast majority of clinical studies use
laboratory to provide:
Safety Data
Hematology, Chemistry, Urinalysis
Efficacy Data
Cholesterol level for Hyperlipidemia patient
Plasma Glucose, for diabetes patient
Special Data
PK / PD data
Genomic data
Biomarkers
1. Overview
There are many challenges in the data
management task, but the ultimate challenge
is managing the Lab Data.
Laboratory data derived from tests of both drug safety
and efficacy have been estimated to be as much as
60-80% of the data generated during the conduct of
clinical trials
Lab results tell the physician significant information
about the body that are directly related to the safety
and well-being of the subject
Lab data are more difficult to interpret if one does not
have clinical training, and what is appropriate to query
is less clear
If involving central lab, data transfer and loading, it
requires data manager having more understanding in
database structure and data transfer technical and
processes
4
Agenda
1
Overview
Types of Laboratories
Standards
Key Messages
Central Lab
Local Lab
Virtual Central
Lab
Core Labs
Specialty Lab
Pros
Cons
Pros
Cons
Pros
Cons
10
Pros
Cons
11
Pros
Cons
12
Local Lab
Sample
Handling
Cost
Results
availability
Reference
Range and
Units
Expensive
Need extra time due to sample
shipping
Relatively inexpensive
Data handling
Data Quality
Data Analysis
13
Quick
Agenda
1
Overview
Types of Laboratories
Standards
Key Messages
14
DM Flow
Data
KeyIn
Protocol
Development
CRF
Development
Develop
Database
ExternalData
LoadingIn
DataQuality
Review
Coding
Medical
Review
SAE
Reconciliation
Data
Management
Plan
Yes
DMsend
QueryReport
No
Any
Query?
SiteRespond
Queries
Update
Database
StudyStartUp
QAstaff
QualityControl
DatabaseQuality
ControlReport
Database
Lock
Data
Extraction
Data
analysis
Clinical
Study
Report
Conduct
15
Closeout
Start Up Phase
Protocol Development
What tests is required and when (Schedule of
Assessment
Central lab or local lab
17
Start Up Phase
Determine if data should be loaded into the
clinical database
Identify and involve lab vendor as early in the
process as possible
Identify key individuals for communication and
follow through
Collect the reference range and units from the
central lab
18
Start Up Phase
Establish the procedures for collecting,
transferring, loading, validating and editing
external data and document.
Data Transfer Agreement (DTA)
File Format Specifications (FFS)
Data Cleaning Plan
19
23
25
26
Start Up Phase
Protocol Development
What tests is required and when (Schedule of
Assessment
Central lab or local lab
28
Start Up Phase
Collect the reference range and units from the
individual local labs
Verify the reference ranges and units
DTA and FFS are not needed but data
cleaning plan is still required
29
Close-down Phase
Review and clean all the lab data
Resolve all data discrepancies
31
Agenda
1
Overview
Types of Laboratories
Standards
Key Messages
32
Test Name
& Units
CRF
design
33
Data
Structure
Data
Interchange
34
CDISC PT
(LBTESTCD)
BILI
BILIND
BUN
Long Name
/Descripti
on
(LBTEST)
Bilirubin
Indirect
Bilirubin
Blood Urea
Nitrogen
Definition
Synonyms
Total Bilirubin
Compo
nent
14631-6 BILIRU
BIN
Propert
y
Time
Aspect
System
Scale
SCNC
PT
SER/PL QN
AS
1974-5
BILIRU
BIN
MCNC
PT
FLU
QN
1977-8
BILIRU
BIN
ACNC
PT
UR
ORD
Method
LOINC
Short
name
Bilirub
SerPlsCnc
Bilirub
FldmCnc
Bilirub
Ur Ql
Property observed
System specimen
Method where applicable
Test Units
Reported Units
Conventional Units (typically based on US
measuring methods)
SI Units (le Systeme International dUnites)
For example, reference and units for Potassium
(
3.5 - 5.0 mmol/L
3.5 - 5.0 mEq/L
13.7 - 19.5 mg/dL
37
40
Variable
Name
Varia
ble
Label
STUDYID
Study
Identif Char
ier
Type
DOMAIN
Doma
in
Abbre
viatio
n
USUBJID
Uniqu
e
Subje
Char
ct
Identif
ier
Char
Controlled
Terms,
Codelist or
Format
LB
Rol
e
CDISC Notes
Iden
tifier
SDTMIG
2.4.4
Iden
tifier
Two-character
abbreviation for the
domain.
Req
SDTMIG
2.4.4,
SDTMIG
4.1.2.2,
SDTMIG
Appendix
C2
Iden
tifier
Identifier used to
uniquely identify a
subject across all
Req
studies for all
applications or
submissions
involving the product.
SDTMIG
2.4.4,
SDTMIG
4.1.2.3
41
Core
Referenc
es
Variable
Name
LBSEQ
LBGRPID
Controlled
Variable
Terms,
Type
Label
Codelist
or Format
Sequen
ce
Number
Group
ID
Result
or
Finding
LBORRES
in
Original
Units
Num
Iden
tifier
Char
Iden
tifier
Char
Res
ult
Qua
lifier
42
Sequence Number
given to ensure
uniqueness of
subject records
within a domain. May
be any valid number.
Used to tie together
a block of related
records in a single
domain for a subject.
Result of the
measurement or
finding as originally
received or collected.
Core
Referen
ces
Req
SDTMIG
2.4.4
Perm
SDTMIG
2.4.4,
SDTMIG
4.1.2.6
Exp
SDTMIG
2.4.3,
SDTMIG
4.1.5.1
ASTM International
Health Level 7 (HL7)
ACDM (the Associate for Clinical Data Management)
X12
43
45
Click
to
edit
company
slogan
Variable
Description
Model Version
Subject
Variable
Screen ID or Number
Subject ID or Number
Description
The ID of the subject before randomization
The ID of the subject after randomization
Subject Initials
Subject Sex
Subject Race