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GLP TrainingRaw Data and Records

Wayne Jiang, PhD IR-4, Michigan State University, jiangwa@msu.edu

Michael Braverman, PhDIR-4 headquarters, Rutgers University

Contents Sample Receipt

Sample Handling and Processing

Sample Storage

R f S d d d S l i Reference Standards and Solutions

Reference Method and Working Method

Method Validation and Sample Analysis

Storage Stability

Raw Data

Analytical Summary Report

Raw DataAny laboratory worksheets, records, memoranda, notes or exact copies thereof, that are the result of original , gobservations and activities of a study and are necessary for the reconstruction and evaluation of the report of that study.

GLP definition from 21 CFR 58, 40 CFR 160, 40 CFR 792

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Raw Data Formats

Raw Data may include photographs, microfilm or microfiche copies, computer printouts, magnetic media, p p , g ,including dictated observations, and recorded data from automated instruments.

GLP definition from 21 CFR 58, 40 CFR 160, 40 CFR 792

“Raw Data” Proof All data generated during the conduct of a study, except

those that are generated by automated data collection systems, shall be recorded directly, promptly and legibly in ink.

All data entries shall be dated on the date of entry and signed or initialed by the person entering the data.

Any change in entries shall be made so as not to obscure the original entry, shall indicate the reasonfor such change, and shall be dated and signed or identified at the time of the change.

GLP definition from 21 CFR 58, 40 CFR 160, 40 CFR 792

“Raw Data” Proof In automated data collection systems, the

individual responsible for direct data inputshall be identified at the time of data input.

Any change in automated data entries shall be made so as not to obscure the original entry, shall indicate the reason for change, shall be dated, and the responsible individual shall be identified.

GLP definition from 21 CFR 58, 40 CFR 160, 40 CFR 792

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“Raw Data” Raw data shall be sufficiently detailed to

allow reconstruction of the study, so that such reconstruction is capable of pgenerating SIMILAR RESULTS and CONCLUSIONS.

You still need to document what you did - even if the protocol spells out the requirement

“Raw Data”

All experimental data, including

b ti f ti i t dobservations of unanticipated

responses, shall be ACCURATELY

recorded and VERIFIED.

Rules for Good Documentation

Make original hand-written entries directly into

notebook/logbook or appropriate study record

Record legibly using indelible ink

Use a ball-point pen or permanent ink pen

Do not use pencil

Do not use water soluble or erasable inks

Affix “loose papers” into notebooks or binders

Label data with Trial/Sample Information

Sign/date lab records daily as work progresses

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Do’s and Dont’s Draw a large diagonal line through unused or

blank pages

Do not erase/obliterate an entry

To correct errors

Line through an incorrect entry

Add the correct entry

Document the reason for the change or correction

Initial/Date

Do’s and Dont’s Do NOT scribble out mistakes (obscures entry) Do NOT write correct entries over top of

incorrect entries (writeovers obscure original entries)

Do NOT forget to enter all required information Do NOT forget to initial and date the entry Do NOT use colored ink/pencil/white-out Do NOT leave mistakes uncorrected (check

your entries)

Do’s and Dont’s Do take time, commitment and attention to

detail by all employees

The time spent on doing the work correctly the

first time will prevent, or at least minimize, time-

consuming and costly reviews, corrections, and

time/money involved in repeating work

conducted incorrectly.

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Example: Entry Corrections

Date corrections 6/15/2012 (incorrect date)

Corrections: line through the wrong entry Corrections: line through the wrong entry 6 / 15 / 2012 16-Jun-12 (Good)

6 / 15 / 2012 6/16/2012 (OK)

6/ 15 / 2012 6/16/12 (ok)

footnote the reason for change

initial and date

Example: Error CodesCode

ExplanationNo Letter1 WE Wrong entry due to typographic error2 Human error (similar to EC 1)2 Human error (similar to EC 1)3 Mathematical error, calculation mistake4 Unnecessary entry5 IE Illegible entry6 LE Late entry

NA Not applicable or no data necessaryNE No entry (left blank on purpose)

Record Keeping

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Golden Rules Document everything related to the study

Keep everything (used and unused data)

Clearly mark with necessary information Clearly mark with necessary information (such study # and sample ID, etc)

Provide reasons why data were not used

Initial and date raw data to show who collected data or who performed each operation

Important Points

Traceability

Reproducibilityp y

Re-constructability

Late Documentation

FDA Warning Letter In the absence of contemporaneous

documentation, FDA does not have confidence that the final report can accurately and completely describe these operations more than 18 months after the study was conducted.

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Late Documentation

FDA Warning Letter The Study Director has not noted

unforeseen circumstances or deviations that may affect the quality and integrity of nonclinical studies when they occurred and failed to document what corrective actions, if any, were taken at that time. In several cases, deviations that occurred were noted six months to more than one year later.

Electronics data

Separate Powerpoint slides

Archives All raw data, documentation, records,

protocols, specimens and final reports shall be retained in the archives

Orderly, secure storage and expedient retrieval of all items

Conditions of storage shall minimize deterioration

An individual shall be identified as responsible for the archives

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Retention of Records

Length of retention is dependent upon regulation

Some items are not stable and may not yneed to be retained for the entire retention period

Master schedule, copies of protocols, records of QA inspections, training records, equipment records need to be retained for the retention period