Books Available from the Association for Clinical Data Management


The following publications are available from the Association for Clinical Data Management (ACDM). To purchase these books please follow the link to the ACDM Online Ordering and Purchasing Area by clicking here

Twists & Turns in Laboratory Data by John Petley

Price: 

  • ACDM Members: £16.50
  • Non-Members: £19.50
  • (prices include P&P UK/EU)

Description

For data managers, laboratory data can prove to be a frustrating, if not bewildering, subject with unrivalled subtleties and pitfalls. This book sets out to document many of these problems and give the reader a better understanding of his/her data.  This book is about laboratory data as data. It seeks to give an explanation for what is going on and why the laboratories supply the information in the way they do. It also tries to highlight the questions that data managers should look for and to point out what is not as erroneous as might be expected. It is intended for the non-expert in laboratory data. The hope is that she/he will find within the book answers to the questions that arise during handling of the data such as "Is this unit possible?", "could this result be right?" or "Should there be a normal range for this test?". Such a book as this can not hope to make its reader into a clinical expert. There is little coverage of the clinical significance of the tests. As far as possible laboratory terminology is explained. There are also· definitions to units and to a number of calculated values but no attempt to supply a list of normal range values. These vary greatly between labs and any single list will at best only be a guide. The book is set out in a number of sections to try and give a pattern to the issues involved. There is an extensive index to enable the user to identify specific problems or specific tests. Hopefully this will add greatly to the book's usefulness as a source of reference. There is not a section on data cleaning as such. There are many different ways of checking laboratory data and the method selected will depend upon the systems used and the flow of data. This booklet will provide useful reference for data managers trying to interpret the checks that they have done. Likewise reporting receives only scant mention. The design of reports depends very much on the message you want to convey. There are thousands of tests that can be performed. Many are very esoteric and useful only in highly specialised situations. There is no intention this for booklet to mention them all. We will focus on the tests that are used most commonly but in many cases the points discussed will be of general relevance to all tests.

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Validation and Management of e-Clinical Systems in Collaborative Clinical Trials

Price: 

  • ACDM Members: £16.50
  • Non-Members: £26.50
  • (prices include P&P UK/EU)

Description

Academic researchers are increasingly supporting their clinical research through the development of novel electronic technologies. These can take many forms such as tools, devices, systems, tests, methodologies and processes. Researchers sometimes engage with potential industry partners, either directly or through a commercial or semi-commercial organisation. Pharmaceutical companies are increasingly open to exploring these types of relations. As this type of collaboration becomes more common, significant challenges exist on both sides in terms of managing expectations and achieving acceptable levels of compliance with regulatory requirements governing the use of e-clinical technologies, referred to herein as e-clinical systems. To help meet these challenges, the authors of this document have applied their own experience to address frequent concerns and recurring risks related to the use of e-clinical systems in the context of academia - industry collaborations. The systems that are used range from single 'simple' programs for specific trials to multi­module, complex data management systems. Through the use of worked examples, this publication aims to help both research organisations and industry sponsors to understand how to successfully deploy e-clinical systems for use in clinical trials in a regulated environment. The authors reference the detailed guidance on computerised systems validation (CSV) provided in their earlier publication Computerised Systems Used in Clinical Research (2nd edition) to provide a consistent, risk-based approach for determining whether an e-clinical system is ready, or can be made ready, to adhere to international gold standards, national Jaws and/or regulations applicable to good clinical practice (GCP).

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Computer Systems Validation in Clinical Research - A Practical Guide Edition 2

Price: 

  • ACDM Members: £16.50
  • Non-Members: £26.50
  • (prices include P&P UK/EU)

Description

Validation encompasses the entire system development life-cycle from initiation through development, testing and production use, to decommissioning. The purpose of validation is to demonstrate that a system is developed, used, maintained, evolved and eventually decommissioned, in a controlled, documented manner that is consistent with it' intended business use. A broad, holistic, view of computerised systems is taken to cover software, hardware, processes and people. Validation of clinical research computer systems is required by ICH regulatory guidelines on Good Clinical Practice and Statistical Principles for Clinical Trials as well as national regulations such as Title 21 of the US Code of Federal Regulations. However, the over­riding rationale for validation is that it makes good business sense by ensuring quality, timeliness and efficiency, and by effectively addressing business risks.  The purpose of the 1st Edition of the Guideline was to suggest approaches by which validation might be achieved. The 2nd Edition updates these approaches in light of changes to the technology and regulatory landscape and provides additional guidance on the tools necessary to achieve validation, such as risk management and requirements analysis.  This Guideline is structured as an aid to both the novice and the experienced practitioner. It describes how to incorporate validation within the culture of an organisation via a high-level strategy, SOPs and clearly identified accountability. While corporate management has ultimate responsibility for systems validation, specific responsibility for the implementation rests with user management. The generalities of reaching and maintaining the validated state, and the appropriate tools to use, are covered for any system from any source, from a one-off analysis program to a large multi-functional, multi-site installation, and from inception to decommissioning.  Aspects of different types of clinical research computerised systems which require special attention during validation arc highlighted. Such systems include administration, randomisation, drug supplies, web-based data capture and transfer, databases and associated review tools, statistical analysis, document management, publishing and regulatory submission, and pharmacovigilance.  Throughout the Guideline, emphasis is placed on the importance of good processes and procedures, training, adequate documentation and approval signatures to provide evidence that a system has been, and remains, properly validated. The Guideline is intended to provide guidance to all those with an interest in the validation of computerised systems in clinical research. The intended audience will range from the individual user of a small stand-alone system or one-off program, through groups with multi-level access, to senior managers who need guidance on the requirements for a corporate validation strategy and the validation requirements for their systems. 

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Guidelines for Writing Standard Operating Procedures

Price: 

  • ACDM Members: £6.50
  • Non-Members: £11.50
  • (prices include P&P UK/EU)

Description

Standard Operating Procedures (SOPs) are guidelines which are instaIJed by an organisation to ensure the consistent approach by those involved to that organisation's activities. Within Clinical Data Management, such SOPs are an essential foundation for ensuring that current guidelines, e.g. Good Clinical Practice (GCP) are adhered to in producing reliable clinical data. They may be highly detailed working documents which direct specific personnel through specific tasks, or may be less well defined, covering the essential principles of Clinical Data Management. SOPs are dynamic documents which require regular review in order to meet the requirements of new regulations, company policy, or new technologies. The SOP Working Party was set up in October 1993 to develop some initial ideas put forward by the Data Quality Control Special Interest Group. The group consisted of representatives of Clinical Data Management groups from various pharmaceutical companies and clinical research organisations, and regular meetings were held in order to produce and finalise the documents.  The aim of the group was to produce guidelines for the preparation of SOPs for Clinical Data Management. These guidelines, which conform to a recommended format and provide example information for content, could serve to form a possible basis from which Clinical Data Management groups across the industry could develop their own company-specific procedures. SOPs need to cover every Clinical Data Management activity from the preparatory stages such as clinical protocol review, through to the production of data for the final study report. 

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Special Purchase - Computer Systems Validation in Clinical Research - A Practical Guide and Validation and Management of e-clinical Systems in Collaborative Clinical Trials

Price: 

  • ACDM Members: £26.50
  • Non-Members: £41.50
  • (prices include P&P UK/EU)

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