Purpose and Use of This Guideline Document

/ Handling and maintaining raw data
Guideline

Purpose and use of this guideline document

You are advised to ensure that a systematic and permanent record of experimental and analytical work is made, primarily for the purpose of research and patent protection. It is anticipated that raw data may be recorded and held either electronically and/or by the use of paper e.g. laboratory notebooks, print outs, worksheets. Any change to the data should be made so as not to obscure the previous entry and in line with GCP standards.

This document provides guidance for how raw data should be handled and maintained and can be used to develop trial-specific processes.

Guidelines

General points

¨ Raw data is defined as all original laboratory records and documentation and includes:

o Methodology.

o Preparation of appropriate reagents or materials.

o Original results, whether from machine print, manual interpretation, or directly entered into a computer through an instrument interface.

o Discussion and conclusions regarding any problems with the procedure.

¨ Always write using permanent ink or a dark ball-point pen and ensure recordings are clear and legible.

¨ If you are recording the details of an analytical procedure consider including the following:

o Date.

o Objective.

o List of materials.

o Reagent batches and/or lot numbers of key reagents.

o ID number of key equipment used e.g. air-displacement pipettes.

o Method or reference to method, ensuring that the correct version number of an experimental protocol or procedure is referenced.

o Results.

o Conclusion.

¨ It is recognised that some of the above information may be captured in trial-specific procedures and/or worksheets.

¨ If you make a mistake draw a single line through the error, record the correct information and initial and date the correction. If it is not clear why a correction is being made, please give a reason for correction. Do not use correction fluid, do not overwrite, and do not obliterate the incorrect entry

¨ Sign, date and reference any printouts of raw data back to the analysis or experimental procedure

¨ Store any files, folders or laboratory notebooks containing raw data safely and securely and store with the other trial documents when the trial closes.

Use of laboratory notebooks

¨ Permanently glue in any raw data of a format that is suitable for inclusion in a laboratory notebook.

¨ Complete all requests for recording information (e.g. headers) within the laboratory notebook at the earliest opportunity marking the section N/A if it is not applicable (do not leave it blank).

¨ Complete an index as the laboratory notebook is used.

¨ Use the pages in natural order.

¨ Fill in each page or score out unused pages to ensure that there are no blank pages left between recorded information.

¨ Ensure that each page is signed and dated by the author on completion and consider getting each completed page reviewed and signed off by the appropriate person within 6 weeks of completion.

¨ Ensure that no changes or insertions are made after the page has been reviewed

¨ Clearly reference the location of any raw data which is filed or stored separately from the laboratory notebook.

Electronic Raw Data

¨ Hold any electronic data on a secure area of the central server where it is protected by back-up and disaster recovery procedures.

¨ Data may be stored on non-rewritable CD-ROMs provided that they can be stored safely and securely.

¨ Memory sticks and floppy discs are not a suitable medium for storage of raw data.

Purpose and Use of This Guideline Document