July 2004
ACDM Educational Supplement
The ACDM Training Committee provides a comprehensive suite of training courses designed to meet the needs of all ACDM members – from those very new to the professional discipline of Clinical Data Management (CDM) to our more experienced members who are able to share experiences and gain new ideas from our Senior CDM Forums.
Fundamentals of Clincal Data Management
This 2-day course is designed for those who are new to Clinical Data Management, having less than one year's experience in any aspect of Clinical Data processing. It is also an extremely useful course for those working in other functions who would benefit from a greater knowledge of the activities of CDM in the Drug Development process.
The objectives of the course are that through interactive presentations, discussion groups and exercises participants will:
Obtain an overview of the Pharmaceutical Industry and examine the place of Clinical Data Management within the clinical trial process
Examine the 'why's' as well as the 'hows' of CDM processes with particular reference to the ICH guidelines
Make contact with CDM professionals working in many different pharmaceutical companies and contract research organisations and thus gain an industry-wide perspective of CDM
This course replaced the Introduction to Clinical Data Management course, which had been running since 1990. The content is updated on a regular basis by a very experienced team of CDM professionals who provide the training on the course.
At the start of the course, we examine the pharmaceutical industry as a whole, looking at the history, markets, regulations and future of our rapidly changing industry.
In subsequent sessions, delegates focus on those topics that either form part of the CDM function or closely affect the work of the Data Manager.
Current topics include:
Importance of the protocol
CRF development – paper and electronic
Data entry, flow and tracking
Data Management systems and Database design
Coding dictionaries
Role of the Data Handling protocol
Data Validation
Safety
Quality Assurance and Quality Control
End of study procedures in CDM

Intermediate Clinical Data Management
This course is designed for CDM professionals with 1-3 year's experience in Clinical Data Management and is usually run twice per year.
The objectives of the course are that through interactive presentations, lectures and practical workshops participants will:
Develop an appreciation of the role of statistics in the design of clinical trials as well as an understanding of the results of statistical analyses
Increase understanding of design aspects of case record forms
Gain an appreciation of the different aspects of laboratory data handling with respect to clinical data management.
This three-day course was set up in 1996 to 'fill the gap' between the Introductory and Advanced courses, which had become well established and proved to be popular with ACDM members. The course focuses on three areas of clinical research which begin to take delegates 'out of the box' of pure clinical data management, those areas being:
Statistical aspects of clinical trials
CRF design
Laboratory data handling
These three topics are covered on the three days of the course, each topic being linked by a single study protocol that operates in the background for the duration of the course. Delegates are sent copies of this protocol in advance of attending the course to enable them to become familiar with the design of the trial, which will be a recurring theme throughout the course. They are also sent some background reading covering the therapeutic area of the trial

Advanced Clinical Data Management
ACDM Advanced CDM courses are designed for CDM professionals with at least two years' experience in Clinical Data Processing who are either in, or intending to pursue, a supervisory or management position. Two 2-day Advanced CDM courses are offered - Project Management in CDM and People Management Skills in CDM. Each course is run once per year.
Project Management - an Advanced Clinical Data Management Course
Objectives
The objective of this course is that through interactive presentations, discussion groups and exercises participants will:
Gain an overview of process improvement techniques in relation to clinical data management systems
Increase understanding of the principles of project management within clinical data management
Learn about tools available to maximise efficiency of project co-ordination within clinical data management
Content
The Project Management section of the Advanced Clinical Data Management course was first presented in 1993. In 2004 it was felt that this topic was a vital component of senior staff working in Clinical Data Management and warranted being separated into a standalone course. There are 2 presenters, experts in project management and process improvement within the Pharmaceutical Industry. Topics covered over the two days include:
Definition of process improvement and what it means for CDM
Using process improvement techniques to demonstrate measurable improvement
Overview of projects within CDM
Project management tools and techniques
People Management Skills – an Advanced Clinical Data Management Course
The objective and content of this course are currently being developed for the first run of this course in November 2004. Content will encompass popular people management components of the previous 3-day Advanced CDM course:
Interaction between the pharmaceutical company and the CRO, including:
Contract development, relationship building, determining resources required
Staff motivation, including:
Staff retention, relationship management, staff and team management
Training strategies

Senior Clinical Data Managers' Forum
The Senior Clinical Data Managers' Forum (SCDM) is a discussion forum, which takes place three times per year. The membership for the forum is comprised of individuals in Clinical Data Management (CDM) who have 5 years or more experience within CDM plus some line management or project management experience. The current membership total to date is 170 members. To join the SCDM mailing list individuals meeting the membership criteria forward their email addresses to the SCDM coordinator via training@acdm.org.uk. Mailing list members are then notified by email each time a new forum is scheduled.
The format for each forum consists of a Keynote speaker who guides the meeting and acts as a facilitator, accompanied by 2 or 3 presenters who present case studies or scenarios which the attendees discuss in a workshop situation. So far the ACDM Training Committee has organised 10 Senior Clinical Data Managers' Forums which have been attended by approximately 130 delegates in total.
Previous Senior Clinical Data Managers' Forums have covered the topics:
Motivating a Composite Workforce
Cultural Awareness in International Teams
Developing and Assessing Personal Skills in Data Managers
Cost Effective Data Management - Strategies for the Future
The Flexible Workforce
Managing Change - Mergers and Acquisitions
Data Quality - What's it worth?
The Flexible Workforce
CDM Resource Strategies
Motivation and Retention of Quality Data Management staff

Clinical Data - The Guidelines for Today
This one-day workshop is aimed at CDM professionals with at least three year's experience and is usually run twice per year. The objectives of the workshop are that through interactive presentations and discussions participants will:
Consider the impact of the latest legislation and regulations affecting Clinical Data Management
Explore key aspects of the EU Data Privacy Directive from a Clinical Data Management perspective
Review the legislation on e-business
Discuss the ground rules on which data management is based
Set up in 1995, this one-day workshop offers a participative review of current quality and regulatory legislation that affects the discipline of CDM. Presented by three widely respected lecturers from both the pharmaceutical company and CRO sectors of the industry, it offers delegates the opportunity to develop their own interpretation of guidelines, whilst basing such interpretations on the experience and knowledge of not only the lecturers but also the other delegates attending the workshop. The workshop content changes on a continuous basis to ensure that it consistently reflects topics that are currently relevant to those working within CDM.
Current topics include:
Clinical Data Interchange Standards Consortium (CDISC)
MedDRA
CFR 21 part 11
Data Privacy
Clinical Trials Directive
Electronic submissions

Computer Systems Validation in Clinical Research
This two-day practical workshop is run in collaboration with the multi-disciplinary Computer System Validation in Clinical Research Working Party and is designed for those using or introducing computer systems in Clinical Research to process data for regulatory submission.
This workshop was first presented in 1999 to coincide with the publication of the 1st edition of the well renowned 'Computer Systems Validation in Clinical Research, A Practical Guide'. It continues to be run in conjunction with the working party that developed the Guideline and has been updated to complement and expand on the content of the 2nd edition of the Guideline, published in February 2004.
This two-day workshop consists of a series of highly interactive exercises, supported by informed presentations given by members of the working party experienced in the practical application of the Guideline's approach. The workshop not only facilitates a clear understanding of the methodologies and tools described in the Guideline, but also stresses the importance of developing the right business driven quality culture within the organisation.
To do this, the workshop builds on the information in the Guideline by addressing a number of key topics:
How validation fits into and adds value to the business.
The relationship between validation and system development.
The importance and benefits of a risk managed approach.
Practical application of validation tools.
Making validation work in practice, e.g. getting management buy-in.
Current industry and regulatory perspective.

Our list of ACDM training courses for 2004/5 is provided below:
Senior Clinical Data Managers' Forum
23 September Novartis Foundation, London
Intermediate Clinical Data Management
5-7 October Oxford Belfry Hotel, Thame, Oxfordshire
Fundamentals of Clinical Data Management
13-14 October Oxford Belfry Hotel, Thame, Oxfordshire
Computer Systems Validation in Clinical Research
3-4 November Oxford Belfry Hotel, Thame, Oxfordshire
People Management Skills - an Advanced CDM Course
17-18 November Oxford Belfry Hotel, Thame, Oxfordshire
Clinical Data - The Guidelines for Today
1 December Novartis Foundation, London
Senior Clinical Data Managers' Forum
2 March 2005 Novartis Foundation, London
Fundamentals of Clinical Data Management
9-10 March 2005 TBD
Intermediate Clinical Data Management
15-17 March 2005 TBD