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Molly Butler Auditor II Quality Associates, Inc.
Good Clinical Practice (GCP) through Good Documentation Practices (GDPs) Molly Butler Auditor II Quality Associates, Inc.
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Disclaimer The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Drug Information Association, Inc. (“DIA”), its directors, officers, employees, volunteers, members, chapters, councils, Special Interest Area Communities or affiliates, or any organization with which the presenter is employed or affiliated. These PowerPoint slides are the intellectual property of the individual presenter and are protected under the copyright laws of the United States of America and other countries. Used by permission. All rights reserved. Drug Information Association, Drug Information Association Inc., DIA and DIA logo are registered trademarks. All other trademarks are the property of their respective owners.
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Agenda Terms Requirements for Data Recording Sources of Data
Electronic Records Common Errors and Fixes How to Minimize Errors References
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Terms - Documentation Essential Documents – documents that individually and collectively permit evaluation of the conduct of a study and the quality of the data produced Case Report Form (CRF)- a printed, optical, or electronic document designed to record all of the protocol-required information to be reported to the sponsor on each trial subject
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Terms – Electronic Docs
eCFR – a central digital repository for electronic and paper based systems. Enables protocol required data to be “systematically reviewed and analyzed.” (See Reference Slide)
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Agenda Terms Requirements for Data Recording Sources of Data
Electronic Records Common Errors and Fixes How to Minimize Errors References
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Requirements for Data Recording
L Traceable To the person who recorded the data Readable Clear and legible Accurate Exact descriptions Immediate Contemporaneous and original Lasting Durable
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Agenda Terms Requirements for Data Recording Sources of Data
Electronic Records Common Errors and Fixes How to Minimize Errors References
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Supportive documentation
Data Directly Generated Protocol driven Indirectly Generated Supportive documentation
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Protocol, Investigator Brochure
Directly Generated By Sponsor/CRO Protocol, Investigator Brochure By Site ICFs, Study Data By Subject Diaries
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Sources of Data: Direct Data
Correspondence with CRO/Sponsor, IRB Generated on-site CRFs, ICFs, conmeds, clinical file, lab reports, drug/product accountability, chain of custody records Objective/subjective observations Generate by subject Diary, ePRO, subject documented data
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Sources of Data: Indirect Data
Facility data Equipment calibration/maintenance, temperature records (non study specific), Training files Archiving procedures/records
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Agenda Terms Requirements for Data Recording Sources of Data
Electronic Records Common Errors and Fixes How to Minimize Errors References
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Electronic Data
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Agenda Terms Requirements for Data Recording Sources of Data
Electronic Records Common Errors and Fixes How to Minimize Errors References
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Common Errors Missing/non existent data Write-overs
Unsigned/dated data Missing/improper units Recording in the wrong location Calculation error Misuse of form Improper/non contemporaneous dating Improper data corrections Most errors occur
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Error Corrections Timely description of the issue (Note to File)
Contemporaneous notes and information Transcription Periodic reviews of calculations
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Activity
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Agenda Terms Requirements for Data Recording Sources of Data
Electronic Records Common Errors and Fixes How to Minimize Errors References
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Minimizing Errors SOPs Form optimization
Periodic QC reviews (Invest. Brochure, Subject Files, ICFs) Training (Orientation and Annual) Metrics/Trending
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Activity regarding form optimization
Identifying misuse of forms Identifying deficiencies in reporting fields How to better prompt for accurate documentation
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Agenda Terms Requirements for Data Recording Sources of Data
Electronic Records Common Errors and Fixes How to Minimize Errors References
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References Electronic Source Documentation in Clinical Investigations (Draft Guidance) - Links - FDA parts Q&A pages related to documentation
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