results glp
TRANSCRIPT
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RESULTS
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RESULTS Results include
Raw data
Study files
Data on environmental conditionsEtc.
These are DESCRIPTIVEdocuments
They give us the result of the experiment They tell us who did what,when,where
and how
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RESULTS
RESULTS
Raw data and data collection
Study report
Archives
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RESULTS
RAW DATA AND DATA COLLECTION
BEFORE the study starts:
Study Director assures that :
There are sufficient trained personnel
The protocol is understood and available
That SOPs are immediately available
That equipment/supplies are at hand
That the data collection forms are in the data file
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RESULTS
RAW DATA AND DATA COLLECTIONDURING the study :
Remember lost / inaccurate data mayinvalidate the study
Collect data on prepared forms / notebooksso that they indicate:
WHAT was done
HOW it was done
WHEN it was done
and
WHO collected the data
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RESULTS
RAW DATA AND DATA COLLECTION
DURING the study :
WHAT
Data should show:
that the protocol was followed
that the process complied with SOP instructions
the results of observation
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RESULTS
RAW DATA AND DATA COLLECTION
DURING the study :
HOW
Data should show that methods were carried out:
as indicated in the protocol and SOP
or that any deviations from protocol /SOPs were
recorded
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RESULTS
RAW DATA AND DATA COLLECTION
DURING the study :
WHEN
Data should show:
Timing as per protocol data/time
Any deviations from protocol schedule were recorded
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RESULTS
RAW DATA AND DATA COLLECTION
DURING the study :
WHO
Data should show:
Identity of operator
Identity of data recorder if different from operator
Identity of verifiers/correctors
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RESULTS
RAW DATA AND DATA COLLECTION
DURING the study :Data should be recorded:
Directly / not transcribed from a rough copy Promptly
Accurately
Legibly
IndeliblyThen:
Sign & date
Explain corrections
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RESULTS
RAW DATA AND DATA COLLECTION
AFTER the study :
Data should be :
Collected together in one place organized in local
order
Verified for completeness
Handed over to the Study Director
Kept in a safe place
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RESULTS
FINAL REPORT
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RESULTS
FINAL REPORT
GLP Requirements for Contents
Name & address of test facility/site
Dates of study (start and finish)
Name of study director
Study objectives
Test article details
Test system details
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RESULTS
FINAL REPORT
GLP Requirements for Contents
Dosing details route, duration
Results/statistics
Summary of findings
Discussion
References Study Director GLP compliance statement
Signed/ dated reports from scientists
QA statement
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RESULTS
FINAL REPORT
Once signed ..modifications by amendments only
(QA audit of amendments)
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RESULTS
ARCHIVES
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RESULTS
ARCHIVESThis is what is left when the study is over
Study plan
Raw data Specimens
Final report
QA document
Personnel records Facilities/equipment qualification records
Historical SOP file
Etc.
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RESULTS
ARCHIVES: Function
Long term, secure storage and fast
retrieval of data
Contains all original scientific data, master
documents and reports, etc.
Endpoint for regulated work
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RESULTS
ARCHIVES: Submission form
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ARCHIVES: History / Events Form
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ARCHIVES: Security
Only authorised entry permitted per SOP
Examination in situ of documents is
preferred
Photocopies made in place, if possible
Protection against fire, flood and vandalism if
possible
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RESULTS
ARCHIVES
Storage conditions should minimise deterrioration
Fire, flooding precautions?
Air conditioned general environment?
Copies made of heat sensitive papers?
Refrigeration used where necessary?
Blocks sealed in bags, tissues in preservative, slides?
Computer back ups maintained in security cabinet?
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RESULTS
ARCHIVES
Indexing parameters
Project
Test article / reference article and lot numbers for
test item and formulated material if appropriate
Protocol/study number
Testing facility Key word retrieval from comments section of
master schedule (e.g. regulatory information dates)
Department