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A Complete Guide to Designing, Writing, Implementing, Revising and Updating

SOPs for
Clinical Data Management

 

Chair

Barbara Kay-Farrow
Head, Quality Business Improvement
Quintiles


Speakers

Kaye H. Fendt
Independent Consultant
Former FDA Regulatory Health Information Specialist
Former Trustee of the Society for Clinical Data Management (SCDM), USA

Jan Henderson
Director, Clinical Data Management
Quintiles, UK

Graeme Ladds
Consultant
Pharsafer Ltd

Dr Piera Lukes
Consultant
IT’sQA

Malene Munch-Andersen
GCP Auditor and GCP
Co-ordinator, GCP QA
H. Lundbeck, Denmark

Sue Perks
Manager DM Process Management and Training Group
PAREXEL Data Management

Margarete Rudloff
Assistant Director/Clinical Data Management
Kendle International, Germany

Dr Olaf Schoepke
European Business Manager
CDC Solutions

Ellen Sweet-Escott
Solicitor
Eversheds Commercial Department

John Varley
Global Training Manager, Medical Development
Bayer

Kate Wallace
Data Manager
Ingenix

Louise Wood
Operations Standards Manager
Roche Products Ltd

 

What the Regulators want
Sites involved in clinical trials and especially data management are very likely to be inspected by regulators. In this presentation Kate Wallace, Data Manager from Ingenix will explain how to prepare for an investigation, what the regulators commonly look for and find and how to ensure your SOPs meet their requirements.

  • What do the regulators want?
  • The questions they are likely to ask
    - do you understand the process?
    - do you follow the SOP?
    - are the SOPs well written and without ambiguity?
  • Examples of problems commonly encountered
  • How to prepare for an inspection - what to do and what not to do

Kate Wallace
Data Manager
Ingenix

 

Implications of the NEW Society for Clinical Data Management (SCDM) Guidelines on SOPs
SOP information is interwoven throughout the NEW 2002 GCDMP document. Every GCDMP section lists recommended SOPs. In addition, the Assuring Data Quality section of the GCDMP guidelines discusses SOPs from a Quality Systems perspective. The document also references other known CDM SOP resources. In this presentation Kaye Fendt, formerly with the FDA and former Trustee of the SCDM will highlight the recommended SOPs, best practices and minimum standards identified in the NEW GCDMP guidelines.

  • 17 Sections of the GCDMP and their recommended SOPs for CDM
  • Quality System Approach
  • Best practices
  • Minimum standards

Kaye H. Fendt
Independent Consultant
Former FDA Regulatory Health Information Specialist
Former Trustee of the Society for Clinical Data Management (SCDM), USA

 

How to Write SOPs and the Level of Detail to Include
Sue Perks, Manager DM Process Management and Training Group at PAREXEL will explain how to decide what level of detail is appropriate and what she found works best when writing Data Management SOPs.

  • Where do you start - you must fully understand the process
  • Including the users in SOP creation/revision, approval and the implementation process
  • Appropriate level of detail in the SOP
  • Impact of new technology and new systems on Data Management SOPs
  • Data Management SOPs for a CRO

Sue Perks
Manager DM Process Management and Training Group
PAREXEL Data Management

 

CASE STUDY: The Evaluation and Revision of Global Data Management SOPs
The revision of global SOPs creates a challenge for all involved in the review, rollout and application of new procedures. Jan Henderson will share Quintiles’ experience from their recent revision of Global Data Management SOPs and report on progress with the current implementation. In this presentation the speaker will cover:

  • The rationale for change
  • The evaluation and review of existing procedures
  • Problems encountered and how they were overcome
  • The role of the Training Team in implementation
  • Assessing the effectiveness of the rollout

Jan Henderson
Director, Clinical Data Management
Quintiles, UK

 

Avoiding Mistakes when Designing, Implementing and Using Electronic SOPs for Clinical Data Management: A Practical Approach to the Electronic SOP Life Cycle
Using a ‘live’ example of an electronic SOP, Dr Olaf Schoepke from CDC Solutions will demonstrate some practical solutions for solving some of the most common problems associated with electronic SOP life cycles. This presentation explains in detail how to design, draft and review the document prior to approval and publishing in pdf format. How MS Word is transformed into a pdf format in a satisfactory regulatory manner will also be demonstrated. This presentation will cover:

  • How to reach all those who need to be included in the document process all at the same time
  • The creation and use of audit trails
  • Rules based access
  • The importance of meta-data and water marking in the electronic SOP life cycle
  • Handling group responsibilities
  • Web access
  • Process and technology validation
  • Managing automated release dates
  • Controlling electronic SOPs outside of the Electronic Document Management System (EDMS) e.g. controlled printing

Dr Olaf Schoepke
European Business Manager
CDC Solutions

 

CASE STUDY from International Clinical Research at H. Lundbeck on the Design, Development and Implementation of the New SOPs Related to CDM
Malene Munch-Henderson, GCP Auditor and GCP Co-ordinator with H. Lundbeck will share her company’s experience as it took two years to develop a new SOP system. The new SOP system maps out the entire clinical trial process with its chain of activities and associated documents. It allows quick on-line navigation between interlinked activities. The speaker will explain how the system works, the problems they encountered and the solutions they adopted.

  • Why develop a new system?
  • Considerations before starting development
  • The development process
  • System highlights
  • Rollout
  • Problems encountered and how they were overcome

Malene Munch-Andersen
GCP Auditor and GCP Co-ordinator, GCP QA
H. Lundbeck, Denmark

 

CASE STUDY: Aligning Practices within the Scope of SOPs across the Drug Development Process
Even with a comprehensive infrastructure for SOPs and other documents in place, there is scope in a global organisation for compromise of standardisation across studies, projects and therapeutic areas. This presentation will discuss how Roche are currently addressing standards management.

  • Background to the initiation of the Operations Standards Management department
  • Structure and functions of the department
  • The role of the Operations Standards Manager
  • The story so far
  • The future

Louise Wood
Operations Standards Manager
Roche Products Ltd

 

CASE STUDY: A Kendle International Experience: Designing, Implementing and Developing New SOPs for CDM
As an organisation grows in size or in the number of geographic locations it operates, the way it handles its SOPs may change. Margarete Rudloff, Assistant Director, Clinical Data Management at Kendle International, will share information on how her company developed a new SOP system and the principal components of that system, the problems they encountered and how it works.

  • Why develop a new system?
  • Considerations before starting development
  • The development process
  • System highlights
  • Rollout

Margarete Rudloff
Assistant Director/Clinical Data Management
Kendle International, Germany

 

SOP Training - As Essential as the SOP
If an auditor or inspector asked you to print all of the listed user IDs from a study database, and show that every employee was qualified by education, training and experience to perform their functions, could you do it? How would you do this? Documenting which SOPs are relevant to which jobs and aligning SOPs, processes and training is essential. John Varley, Global Training Manager, Medical Development will explain how Bayer are tackling this specific issue.

  • The training cycle
  • Training methods
  • Responsibility for SOP Training
  • Training the trainer - using Data Managers as trainers
  • SOP for training

John Varley
Global Training Manager, Medical Development
Bayer

 

Preparing for a FDA Inspection
Pharmaceuticals, CROs and Vendors are all partnering with an increasing number of other organisations and doing a greater variety of work in ever more complex systems. Often this requires a trial specific level of documentation. In this presentation Kaye Fendt, formerly with the FDA will explain what you need to do to prepare for the FDA inspector and review some of the changes currently underway at the FDA that may affect the way inspections are carried out in the future.

Kaye H. Fendt
Independent Consultant
Former FDA Regulatory Health Information Specialist
Former Trustee of the Society for Clinical Data Management (SCDM), USA

 

Implications of EU and US Data Protection Legislation for the Development and Revision of SOPs
The implementation of the 1995 European Data Protection Directive adopted in all European member states affects many areas of pharmaceutical healthcare including CDM. In this presentation Ellen Sweet-Escott, data protection lawyer at Eversheds, will discuss:

  • The practical implications of Data Protection legislation
  • How data protection legislation will impact on CDM and development of SOPs
  • Issues frequently encountered:
    - multi-centre trials
    - differences in enforcement in different countries
    - the need to share data
  • How to move towards compliance
  • Best strategies to reduce risk of non-compliance
  • The possible effects of the upcoming U.S. HIPAA Privacy Regulation
  • What are the problems?
  • What are the solutions?

Ellen Sweet-Escott
Solicitor
Eversheds Commercial Department

 

A Process Based Approach to Data Management SOPs
In this presentation Dr Piera Lukes will review the data flow in clinical research, create a process map and analyse the data to ensure that the requirements of ICH are embedded in the SOPs and that data integrity is maintained throughout the process (including the interfaces).

Dr Piera Lukes
Consultant
IT’sQA

 

Global SOPs, Local SOPs and Working Practice Documents. A Safety Perspective for Regulatory Audits

  • Global SOPs for Safety - content, agreement, signature, training
  • Local (National) SOPs - purpose, signature, implementation, training, maintenance
  • Working Practice Documents - function, signature, implementation, training
  • Centralised SOP repository and training records
  • SOPs linking separate company functions - influence on implementation, training, maintenance and audits
  • SOPs and audits - expectations, training, maintenance and audits

Graeme Ladds
Consultant
Pharsafer Ltd


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