results glp

8/3/2019 Results Glp

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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


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


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


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


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


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


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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RESULTS

ARCHIVES: History / Events Form


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RESULTS

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

results glp

Documents