WG5 Project 02
4/13/2015
FDA scripts.
Validation of script/programs.
Heavy and light validation
Check list FDA scripts
Basis for discussion
FDA: WG5 Project 02
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• Programming and validation of script/programs.
13/04/2015
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• I image that everyone can submit a script to FDA.
• They just have to fill in the check list and use Data Fit - FDA product(check for CDISC) !!,
but it is important that FDA is safe with the process we find.
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Things to consider:
Script must be divided in: small, medium, large and software
Script must be divided in: to produce derived data, (SDTM or ADaM).
to produce TFL.
Script validations type:
Heavy validation Light validation
-------------------------------------------------------------------------------------------Test data
:
SDTM description of version (should FDA have there own
repository) . Establish min. SDTM/ADaM test data.
Requirement for minimum data to test script
Check test data
:
Check for CDISC. Use Software Data Fit.?
Should all contributors use Data Fit before they submit a
standard script. Data Fit checks data model, but not
necessary a standard script connections to data model.
Or should a standard script be developed that check for
SDTM/ADaM.
Study design
:
A script must run on all kinds of designs(parallel, crossover
etc.) It could also just be stated in specification which
design is applicable.
Parameter to a script :
How to describe. Should it be a small dataset holding all
parameters.
Template
:
We must have a template for program header. Coordinate
GPP group.
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4/13/2015
WG5 Project 02
Heavy validation:
Specific
ation
Establish
min.
SDTM/ADaM
test data
Documentat
ion or
document
in header
Standard
program
(Beta)
Use of
Data
Fit ?
Use of
Data Fit ?
Branch test
(test all If
statements
in source
User test
Peer
review
Standard
program
Draft
Plan
Create
validation
plan, test
program
and Test
data(STDM
/ADaM).
GPP. God
Program
ming
Practise
Report
Peer
review
Create
Validation
report
Test final Standard
program
for CDISC
Compliance
Submit to
FDA as script
Test log
from all
test
cases
Test
Output
from all
test cases
Peer
review
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WG5 Project 02
4/13/2015
Light validation
Existing
Standard
program
Draft
Establish
min.
SDTM/ADaM
test data
Note: Must
Must
Must
Must
Must
be GPP in Source.
use SDTM/ADaM data/test data
be documented
be tested by End Users
be a user Guide
1-2 years of
production without
ERROR
Use Data
Fit (FDA
program) !
Test
for CDISC
Compliance
Submit to
FDA as
script
Note: Must use SDTM/ADaM in input
and output.
Note: Use Check List.
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Check list FDA script
Heavy
13/04/2015
Light
Robust
without
errors
in companies’
production
environment.
Able to run
on allred
Trial
design(parallel,
crossover,
extension..)
x x
x x
User Guide
Robust
andexist
used in FDA scripts repository, ranked ******.
x
x
x
Has program
Fit been
program
for data
model check)
Open
CDISCData
validator
or used
Data(FDA
Fit used
to check
input/output.
x x
x
x
SDTM/ADaM used in input/output.
x
x
GPP in source.
x
x
Documented or perhaps only documented in header.
x
User Guide.
x
x
Requirement specification.
x
?
Run according to Requirement specification.
x
?
Tested by validation plan, test program all Peer reviewed
x
?
Tested by Endusers
x
?
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13/04/2015
WG5 Project 02
Moving a script to “production”:
Use folder ./src for non validated scripts
Use folder ./valid for validated scrips.
Discuss by whom and how
Goggle Code Repository:
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13/04/2015
WG5 Project 02
The process to move the scrip could be:
• 1. A BOARD that meets 4 times a year and decide whether a script
can be called validated and move it from folder <.src> to <.valid>
folder.
• 2. Establish the checklist electronic. Committers must tick mark
witch items on the list the script fulfil and are then allowed to move
a script from folder <.src> to <.valid> folder.
A Naming convention could be an advantage
E.g. Prefix:
Not validated scripts:
(nothing)
Validated scripts:
_production
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