Overview:
Once a clinical trial ends, the trial
documents are the only remaining
artifacts that permit evaluation of the
c...
www.smi-online.co.uk/2014clinical-documents.asp
Register online and receive full information on all of SMi’s conferences
A...
MASTERING CLINICAL TRIAL DOCUMENTS
9th December 2014, Central London
4 WAYS TO REGISTER
FAX your booking form to +44 (0) 8...
Upcoming SlideShare
Loading in...5
×

Mastering clinical trial documents

93

Published on

Join us in London this December

Published in: Education
0 Comments
0 Likes
Statistics
Notes
  • Be the first to comment

  • Be the first to like this

No Downloads
Views
Total Views
93
On Slideshare
0
From Embeds
0
Number of Embeds
0
Actions
Shares
0
Downloads
1
Comments
0
Likes
0
Embeds 0
No embeds

No notes for slide

Transcript of "Mastering clinical trial documents"

  1. 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. 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. 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:

×