Date	June 15, 2006
Location	CHIRON, Vergader en Congrescentrum Planetarium Gaasperplas, Kromwijkdreef 11, Amsterdam Zuidoost
Organisation	PSDM

Program

13:00 ÷ 13:40	Registration and coffee
13:40 ÷ 13:45	Welcome and introduction Maartjen Verdonk (PSDM board member portfolio Data Management), N.V. Organon, Oss
13:45 ÷ 14:30	Resource forecasting - Big Brother in Clinical Trials? Willem Klaassen, (project Data Manager) N.V. Organon, Oss
14:30 ÷ 15:15	CDISC - Explanation, Benefits and Implementation Pascal Groenen, (Data Manager) Factory CRO for Medical Devices, Bilthoven
15:15 ÷ 15:45	Coffee/Tea break
15:45 ÷ 17:00	Clinical Trial Directive - A Regulatory Perspective Dr. Laura Brown, (Course Director MSc Clinical Research, School of Pharmacy, University of Cardiff and QA and Training Consultant)
17:00 ÷ 18:00	Closure followed by an Informal Drink

Summaries

Resource forecasting - Big Brother in Clinical Trials?
Willem Klaassen, Clinical Data Management Organon, Oss, The Netherlands

Since in clinical trials enormous peaks in workload are a fact of life, it is extremely difficult to maintain a steady workflow without any loss of quality or sudden investments in CRO contracting. This, together with the fact that clinical data management is faced with more and more long-running trials, increasing numbers of patients and higher demand for efficiency, accuracy in resource forecasting has become of vital importance. Accurate forecasting of resources strengthens the position of clinical data management in her cost-effective strategy, both short- and long-term; either contract temporary or permanent personnel or outsource part of the workload.
Clinical Data Management at NV Organon recently developed an automated computer system that facilitates accurate resource planning. By combining several systems (e.g. Interactive Voice Response System, CRF-Track (CRF scanning), Oracle Clinical), we not only created a tool to calculate the short- and long-term resources, but also provide a clear overview of the current trial status in CRF collection and data cleaning. Only recently implemented, the system has already proven its contribution to efficient resource planning and resulted in a smoother and better fine-tuned cooperation between CRA and Data Manager.

CDISC - Explanation, Benefits and Implementation
Pascal Groenen, Factory CRO for Medical Devices, Bilthoven, The Netherlands

CDISC is a non-profit organization that is mostly sponsored by the pharmaceutical industry and that is dedicated to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare. CDISC currently consists of 4 models, i.e. data standards, directed at different aspects of data handling, transfer and analysis. The benefits of these global efforts are numerous; especially, since the FDA declared the CDISC derived Standard Tabulation Datasets Model (STDM) as a preferred way of submitting clinical data Q3 of last year.
At the beginning of Q2 of 2004, Factory CRO implemented STDM (version 3.0) in the first study that was run on the newly acquired fax-based database system. A brief overview of the implementation process and experience will be presented.

Clinical Trial Directive - A Regulatory Perspective
Laura Brown, Course Director MSc Clinical Research, School of Pharmacy, University of Cardiff and QA and Training Consultant

An overview of the Clinical Trial Directive and what effects it is having on the way Data Managers work.

Clinical trials in the EU should be following the Clinical Trial Directive (CTD) since 1st May 2004, when the legislation in the different Member States should have been in place. This is a major change in the way in which clinical trials are conducted, and it is imperative not only to pharmaceutical organisations and investigators running trials and relevant disciplines to comply, but also to do so effectively, efficiently and economically. This requires not only process change but a good deal of education and training - and project management of its implementation. In addition, the CTD is a legally enforceable framework which may result in major penalties for pharmaceutical companies or other organisations - and even individually.

The presentation will explain the main changes the CTD requires for running clinical trials. The key changes are:

• Each trial must be registered onto a central database - EudraCT
• Investigational medicinal products (IMPs) must be manufactured to good manufacturing practice (GMP) standards and the manufacturer must have a manufacturing license
• Each Member State must have a single national ethics committee system
• A standard regulatory authorisation application form (the CTA) is to be used for all phases of clinical trials
• Additional protection for minors and physically or mentally incapacitated adults who are candidates for clinical trials
• Additional safety reporting requirements including the reporting of SUSARs onto the PharmacoVigilance Clinical Trial module database
• To provide for inspection by the regulatory authority for GCP and GMP to help ensure compliance with the CTD.