This document provides information about an upcoming masterclass on mastering clinical trial documents. The masterclass will outline regulations related to the Trial Master File and explain how documents can be created and managed to ensure an inspection-ready file. Attendees will learn about documentation requirements, effective document management strategies, using records to enhance information sharing and facilitate operations, and improving inspection readiness to avoid burdensome preparations for audits. The full-day event will include presentations, discussions and activities on topics such as the Trial Master File reference model, electronic record requirements, inspection expectations, and archiving requirements and options.

1. Overview:
Once a clinical trial ends, the trial
documents are the only remaining
artifacts that permit evaluation of the
conduct of the trial and the quality of the
data produced. They are critical to
demonstrating compliance with GcP and
other applicable regulations. This
masterclass will outline the regulations that
relate to the Trial Master File – including the
latest thinking from the european
Medicines Agency - and will explain how
documents can be created and
managed in a way that should ensure an
inspection-ready TMF is available.
Why attend this masterclass:
Attendance at this workshop will enable
participants to:
• Understand the requirements for clinical
study documents;
• comprehend how documents can be
managed more effectively;
• Learn how to make best use of clinical
trial records to enhance information
sharing and facilitate more efficient
operations; and
• Improve inspection–readiness to avoid
resource-intensive preparations when
notified of impending audits and
inspections
SMi MASTERCLASS SERIES 2014
www.smi-online.co.uk/2014clinical-documents.asp
Register online and receive full information on all of SMi’s conferences
Alternatively fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711
GROUP DISCOUNTS AVAILABLE
MC388
2014
9th
central London
Hosted by: Russel Joyce, Director, Heath Barrowcliff Consulting Ltd.
Mastering clinical
Trial Documents
Dec
SMi presents its masterclass on

2. www.smi-online.co.uk/2014clinical-documents.asp
Register online and receive full information on all of SMi’s conferences
Alternatively fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711
GROUP DISCOUNTS AVAILABLE
Mastering Clinical Trial Documents
9.00 Registration & Coffee
9.15 Welcome & Introduction
9.30 Overview of documentation requirements
This session will define the characteristics of the “Trial
Master File” and challenge the concept of
“essential documents”.
10.45 Morning Refreshments
11.00 The TMF reference model
An exploration of efforts to standardise TMF content
and structure across the life-sciences sector.
12.15 Networking Lunch
13.15 Electronic Record Requirements
This session will consider the minimum requirements
for electronic systems and examine how electronic
records can be used to optimise their effectiveness.
14.00 Inspection requirements and expectations
An exploration of regulatory authorities expectations
in relation to (electronic) signatures and quality
control as well as a review of common TMF
inspection findings.
14.45 Afternoon Refreshments
15.00 Archiving
This session will consider the retention requirements
for clinical study records and the options available
for archiving them in paper and electronic format.
16.00 Group discussion
16.30 Close of workshop
MASTERCLASS AGENDA
About the masterclass leader:
Russell Joyce has over 20 years’ experience in records management across a wide variety of industries
(including pharmaceuticals) both as a practitioner and consultant. He is a Director of the Scientific
Archivists Group and executive committee Member of the Good clinical Practice Records Managers
Association, promoting latest developments, trends, industry best practices and standards in the life
sciences sector. Russell has spoken extensively on records management issues for both these groups as
well as for the Drug Information Association and the Institute of clinical Research.
About Heath Barrowcliff Consulting Limited
Heath Barrowcliff Consulting Limited is an independent records & information management consultancy offering over 20
years’ experience in archive, document, records and information management as well as advice on commercial
records storage. The consultancy aims to deliver practical, user-friendly solutions that enable its clients to create,
maintain, retrieve and (re-)use information in a financially and operationally cost efficient manner that best meets their
needs whilst also ensuring compliance with statutory and regulatory requirements.
Overview:
Good records management not only has an impact on how effectively an organization manages its records during
the conduct of a clinical study; well-managed clinical study records are critical to demonstrating compliance with
GcP and other applicable regulations and to supporting regulatory inspections.
Once a clinical study has ended, the clinical study records are the primary -and often only- evidence of the clinical
study activities and so are critical to permitting evaluation of the conduct of the study and the quality of the data
produced.
This full-day masterclass (comprising interactive seminars, discussions, and group activities) will outline the regulations
that relate to Trial Master Files (including best practice guidance and the latest thinking from the european Medicines
Agency) and explain how clinical study records can be created and managed to ensure the timely availability of an
inspection-ready TMF.

3. MASTERING CLINICAL TRIAL DOCUMENTS
9th December 2014, Central London
4 WAYS TO REGISTER
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PHONE on +44 (0) 870 9090 711
ONLINE www.smi-online.co.uk/2014clinical-documents.asp
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