Quality expectations and tolerance limits of trial master files (TMF) - Developing a risk-based approach for quality assessments of TMFs
This article addresses the question of when a trial master file (TMF) can be considered sufficiently accurate and complete: What attributes does the TMF need to have so that a clinical trial can be adequately reconstructed from documented data and procedures? Clinical trial sponsors face significant...
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Published in | German medical science Vol. 13; p. Doc23 |
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Main Authors | , , , , , , |
Format | Journal Article |
Language | English German |
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Germany
German Medical Science GMS Publishing House
2015
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Abstract | This article addresses the question of when a trial master file (TMF) can be considered sufficiently accurate and complete: What attributes does the TMF need to have so that a clinical trial can be adequately reconstructed from documented data and procedures? Clinical trial sponsors face significant challenges in assembling the TMF, especially when dealing with large, international, multicenter studies; despite all newly introduced archiving techniques it is becoming more and more difficult to ensure that the TMF is complete. This is directly reflected in the number of inspection findings reported and published by the EMA in 2014. Based on quality risk management principles in clinical trials the authors defined the quality expectations for the different document types in a TMF and furthermore defined tolerance limits for missing documents. This publication provides guidance on what type of documents and processes are most important, and in consequence, indicates on which documents and processes trial team staff should focus in order to achieve a high-quality TMF. The members of this working group belong to the CQAG Group (Clinical Quality Assurance Germany) and are QA (quality assurance) experts (auditors or compliance functions) with long-term experience in the practical handling of TMFs. |
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AbstractList | This article addresses the question of when a trial master file (TMF) can be considered sufficiently accurate and complete: What attributes does the TMF need to have so that a clinical trial can be adequately reconstructed from documented data and procedures? Clinical trial sponsors face significant challenges in assembling the TMF, especially when dealing with large, international, multicenter studies; despite all newly introduced archiving techniques it is becoming more and more difficult to ensure that the TMF is complete. This is directly reflected in the number of inspection findings reported and published by the EMA in 2014. Based on quality risk management principles in clinical trials the authors defined the quality expectations for the different document types in a TMF and furthermore defined tolerance limits for missing documents. This publication provides guidance on what type of documents and processes are most important, and in consequence, indicates on which documents and processes trial team staff should focus in order to achieve a high-quality TMF.The members of this working group belong to the CQAG Group (Clinical Quality Assurance Germany) and are QA (quality assurance) experts (auditors or compliance functions) with long-term experience in the practical handling of TMFs. This article addresses the question of when a trial master file (TMF) can be considered sufficiently accurate and complete: What attributes does the TMF need to have so that a clinical trial can be adequately reconstructed from documented data and procedures? Clinical trial sponsors face significant challenges in assembling the TMF, especially when dealing with large, international, multicenter studies; despite all newly introduced archiving techniques it is becoming more and more difficult to ensure that the TMF is complete. This is directly reflected in the number of inspection findings reported and published by the EMA in 2014. Based on quality risk management principles in clinical trials the authors defined the quality expectations for the different document types in a TMF and furthermore defined tolerance limits for missing documents. This publication provides guidance on what type of documents and processes are most important, and in consequence, indicates on which documents and processes trial team staff should focus in order to achieve a high-quality TMF. The members of this working group belong to the CQAG Group (Clinical Quality Assurance Germany) and are QA (quality assurance) experts (auditors or compliance functions) with long-term experience in the practical handling of TMFs. |
Author | Schmidt, Gabriele B Hecht, Arthur Busch-Heidger, Barbara Sanden, Per-Holger Ruhfus, Birgit Gertzen, Heiner Pfister, Heike |
AuthorAffiliation | 1 Global Quality Medicine, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany 4 Clinical Project Management Specialty Medicine, Bayer Pharma AG, Berlin, Germany 6 Global Clinical Trial Operations, MSD SHARP & DOHME GMBH, München, Germany 2 Quality Medicine Germany, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany 3 R&D Clinical & Medical Quality Operations, Sanofi, Chilly-Mazarin, France 5 Global Inspection Management, Merck Serono, Darmstadt, Germany |
AuthorAffiliation_xml | – name: 6 Global Clinical Trial Operations, MSD SHARP & DOHME GMBH, München, Germany – name: 3 R&D Clinical & Medical Quality Operations, Sanofi, Chilly-Mazarin, France – name: 5 Global Inspection Management, Merck Serono, Darmstadt, Germany – name: 1 Global Quality Medicine, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany – name: 2 Quality Medicine Germany, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany – name: 4 Clinical Project Management Specialty Medicine, Bayer Pharma AG, Berlin, Germany |
Author_xml | – sequence: 1 givenname: Arthur surname: Hecht fullname: Hecht, Arthur organization: Global Quality Medicine, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany – sequence: 2 givenname: Barbara surname: Busch-Heidger fullname: Busch-Heidger, Barbara organization: Quality Medicine Germany, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany – sequence: 3 givenname: Heiner surname: Gertzen fullname: Gertzen, Heiner organization: R&D Clinical & Medical Quality Operations, Sanofi, Chilly-Mazarin, France – sequence: 4 givenname: Heike surname: Pfister fullname: Pfister, Heike organization: Quality Medicine Germany, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany – sequence: 5 givenname: Birgit surname: Ruhfus fullname: Ruhfus, Birgit organization: Clinical Project Management Specialty Medicine, Bayer Pharma AG, Berlin, Germany – sequence: 6 givenname: Per-Holger surname: Sanden fullname: Sanden, Per-Holger organization: Global Inspection Management, Merck Serono, Darmstadt, Germany – sequence: 7 givenname: Gabriele B surname: Schmidt fullname: Schmidt, Gabriele B organization: Global Clinical Trial Operations, MSD SHARP & DOHME GMBH, München, Germany |
BackLink | https://www.ncbi.nlm.nih.gov/pubmed/26693218$$D View this record in MEDLINE/PubMed |
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SubjectTerms | clinical trial Clinical Trials as Topic - methods Data Accuracy Data Curation Filing - methods Filing - standards Guidelines as Topic Humans Quality Improvement - organization & administration quality risk management Records - standards Risk Management - organization & administration trial master file |
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Title | Quality expectations and tolerance limits of trial master files (TMF) - Developing a risk-based approach for quality assessments of TMFs |
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