Join us in London this December

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
FAX your booking form to +44 (0) 870 9090 712
PHONE on +44 (0) 870 9090 711
ONLINE www.smi-online.co.uk/2014clinical-documents.asp
If you have any further queries please call the Events Team on tel +44 (0) 870 9090 711 or you can email them at events@smi-online.co.uk
POST your booking form to: Events Team, SMi Group Ltd, 2nd Floor
South, Harling House, 47-51 Great Suffolk Street, London, SE1 0BS
Payment: If payment is not made at the time of booking, then an invoice will be
issued and must be paid immediately and prior to the start of the event. If
payment has not been received then credit card details will be requested and
payment taken before entry to the event. Bookings made within 7 days of the
event require payment on booking.
Substitutions/Name Changes: If you are unable to attend you may nominate, in
writing, another delegate to take your place at any time prior to the start of the
event. Two or more delegates may not ‘share’ a place at an event. Please make
separate bookings for each delegate.
Cancellation: If you wish to cancel your attendance at an event and you are
unable to send a substitute, then we will refund/credit 50% of the due fee less a
£50 administration charge, providing that cancellation is made in writing and
received at least 28 days prior to the start of the event. Regretfully cancellation
after this time cannot be accepted.
Alterations: It may become necessary for us to make alterations to the content,
speakers, timing, venue or date of the event compared to the advertised
programme.
Data Protection: The SMi Group gathers personal data in accordance with the UK
Data Protection Act 1998 and we may use this to contact you by telephone, fax,
post or email to tell you about other products and services. Unless you tick here □
we may also share your data with third parties offering complementary products
or services. If you have any queries or want to update any of the data that we
hold then please contact our Database Manager databasemanager@smi-
online.co.uk or visit our website www.smi-online.co.uk/updates quoting the URN as
detailed above your address on the attached letter.
Unique Reference Number
Our Reference MC388
Terms and Conditions of Booking
DELEGATE DETAILS
Please complete fully and clearly in capital letters. Please photocopy for additional delegates.
Title: Forename:
Surname:
Job Title:
Department/Division:
Company/Organisation:
Email:
Company VAT Number:
Address:
Town/City:
Post/Zip Code: Country:
Direct Tel: Direct Fax:
Mobile:
Switchboard:
Signature: Date:
I agree to be bound by SMi's Terms and conditions of Booking.
ACCOUNTS DEPT
Title: Forename:
Surname:
Email:
Address (if different from above):
Town/City:
Post/Zip Code: Country:
Direct Tel: Direct Fax:
CONFERENCE PRICES
VENUE
□ Please contact me to book my hotel
Alternatively call us on +44 (0) 870 9090 711,
email: hotels@smi-online.co.uk or fax +44 (0) 870 9090 712
VAT
VAT at 20% is charged on the attendance fees for all delegates.
Payment must be made to SMi Group Ltd, and received before the event,
by one of the following methods quoting reference MC388 and the
delegate’s name. Bookings made within 7 days of the event require
payment on booking, methods of payment are below. Please indicate
method of payment:
□ UK BACS Sort code 300009, Account 00936418
□ Wire Transfer Lloyds TSB Bank Plc, 39 Threadneedle Street,
London, ec2R 8AU
Swift (BIc): LOYDGB21013, Account 00936418
IBAN GB48 LOYD 3000 0900 9364 18
□ Cheque We can only accept Sterling cheques drawn on a UK
bank.
□ Credit Card □ Visa □ Mastercard □ American express
All credit card payments will be subject to standard credit card charges.
card No: □□□□ □□□□ □□□□ □□□
□
Valid From □□/□□ expiry Date □□/□□
cVV Number □□□□ 3 digit security on reverse of card, 4 digits for AMeX card
Cardholder’s Name:
Signature: Date:
I agree to be bound by SMi's Terms and conditions of Booking.
Card Billing Address (If different from above):
MASTERCLASS PRICE
PAYMENT
FUTURE MASTERCLASSES
I would like to attend: Fee Total
□ Masterclass: £599.00 +VAT £718.80
I would be interested in attending a Masterclass on the following topic or
area: