SOPs for EDC

A Henry Stewart 2-Day Briefing

Designing, Writing and Implementing

SOPs for EDC

Managing the Change

Chair:
Anthony J. Costello
VP, Product Development and Data Services
Nextrials, Inc.
Current Board of Trustees Member of the SCDM
Member of the DQRI (Data Quality Research Institute)

Speakers:
Gregg Dearhammer
Director of Biometrics
Kendle International

Susan Klimek
Associate Director, Global Clinical Data Services: Customer Service
Pfizer

Thomas Martin
Documentation Manager
LifeTree Technology, LLC

Jules T. Mitchel
President
Target Health, Inc.

Robert Pearsall
President
AXON Research

Alan W. Pollack
Senior Manager, Quality & Regulatory Compliance
Phase Forward

Diane P. Ryan
Director, Global Clinical Data Services: Customer Service
Pfizer

Karen S. Sargent
Global Project Manager &
Director, Training & Audits
Research Dynamics Consulting Group

Laura Suciu
Director Quality Assurance and Regulatory Affairs
Target Health, Inc.

Kelly R. Vaillant
Global Head, Clinical Data Management
Global Development Operations
Amgen

Where we are now, the Problems and Solutions
• Major components and types of SOPs for clinical trials
• Do the same apply to EDC SOPs?
• What needs to change in your SOPs when systems change?
Gregg Dearhammer
Director of Biometrics
Kendle International

Understanding EDC
• The role of EDC in clinical trials
• The benefits of changing to an EDC system
- reduced clinical trial costs
- faster completion times
- improved patient safety
• The challenges of moving to an EDC system
- adaptation to new technologies
- re-engineering procedures
- re-defining roles and re-training personnel
• Types of EDC
- web-based data entry
- patient diaries
- Interactive Voice Response (IVR)
- investigator portals
• Industry trends in EDC
- technology has come of age
- increasing rate of new pilot programs
- moving from pilots to enterprise-wide adoption
Alan W. Pollack
Senior Manager, Quality & Regulatory Compliance
Phase Forward

SOP Considerations for EDC Based Clinical Trials
Many of the basic SOPs needed to manage an EDC based clinical trial may already exist in your company’s library. Examples of these procedures include:
• CRF generation
• Data entry
• Data management
• Training
• Document control
• Change control
• Corrective action plans
• Validation
• Testing
• Vendor audits
While it may be necessary to modify some of your procedures, it should not be a major effort. The one procedure which must be created de novo, relates to Work Flow. This SOP addresses all of the steps needed to create an Internet-based clinical trial. The speaker will discuss how existing SOPs can be edited to meet EDC requirements and defines the essential components of the Work Flow SOP.
Jules T. Mitchel
President
Target Health, Inc.

Re-engineering the Clinical Trial Process to Realize the Value of EDC
As the EDC market develops, it is increasingly recognized that procedures need to change with the implementation of technology for maximal value to be realized. With EDC, data assessments can be accomplished remotely using secure technology platforms with incumbent audit trails that provide greater reliability, legibility and archival traceability than traditional paper methods. However, since SOPs govern organizational behavior, especially in a regulated field such as clinical trials, upgrading of SOPs is necessary to establish procedures that are efficient and compliant.
The clinical site does not experience a major functional change in their clinical research SOPs except for utilizing a different method of reporting data requiring computer skills and proper access to the Internet. On the other hand, Sponsors and CROs must make dramatic changes in their clinical trial process and developing study timelines. This requires major SOP changes. The goal of this presentation is to assist Sponsors, CROs and clinical sites in re-engineering the clinical trial process and identifying the appropriate SOPs requiring revision to properly implement the technology and to fully realize the value of EDC.
Karen S. Sargent
Global Project Manager &
Director, Training & Audits
Research Dynamics Consulting Group

Integrating EDC into the Business
Implementing EDC systems is often seen as a radical departure from traditional clinical study and data management. For EDC systems to be truly successful, however, they need to become fully integrated into existing business processes. This presentation focuses on the challenges of moving beyond the EDC “pilot” stage and gaining acceptance of EDC systems as a mainstream business tool.
Diane P. Ryan
Director, Global Clinical Data Services: Customer Service
Pfizer
Susan Klimek
Associate Director, Global Clinical Data Services: Customer Service
Pfizer

Interactive Workshop
What SOPs should be in Place for an EDC Based Clinical Trial?
Delegates will split into small groups and, with the help of an expert group leader, will compare listings of SOPs designed for paper-based clinical trials and decide which SOPs are still applicable in an EDC environment and which need to be amended in order to support the different workflow.

Training Aspects for EDC Based Clinical Trials
This presentation will highlight the elements of an effective EDC training program in the framework of quality assurance systems and SOPs. The questions that the presentation will answer include:
• Why training is important (regulatory reasons, scientific reasons, business reasons)
• Who needs to be trained (site personnel, sponsor staff, EDC developers)
• What training is required for each category of personnel?
• How to deliver effective EDC training (instructor-led programs, electronic training)
• Lessons learned from EDC training
Laura Suciu
Director Quality Assurance and Regulatory Affairs
Target Health, Inc.

Interactive Workshop
Write a SOP for the Data Flow Process using EDC
Delegates will map the EDC workflow, identify critical processes which require SOPs and develop the content of relevant SOPs. Templates for designing SOPs will be given to all attendees to take away with them for future guidance.

SOPs for Designing eCRFs
Moving from paper-based CRFs to electronic CRFs (eCRFs) encompasses more than just creating a new study or implementing a new information system or web site. The use of eCRFs requires consideration of the implications of introducing an EDC system. Technical issues, process changes, and regulatory implications have significant impact on SOPs for the operation of any EDC system. This presentation will address the following:
• Process changes for using eCRFs
• Cultural shifts: internal and clinical site roles
• Key regulatory considerations
• Quality assurance issues
• Changes in training requirements
Robert Pearsall
President
AXON Research

SOPs for the Management and Oversight of Technical Vendors (including EDC) – A Sponsors Perspective
• Why are technical vendor oversight SOPs needed?
• Qualification and selection of vendors
• Managing vendor activities
• Managing quality
• Eliminating “black box” perception
• Regulatory considerations
Kelly R. Vaillant
Global Head, Clinical Data Management
Global Development Operations
Amgen

IT SOPs for EDC Based Systems – what SOPs are Necessary from a Security/System Perspective?
• What is IT security and why is it needed?
• What are some of the common problem areas of IT EDC security?
• Why is it important to have an EDC system that is secure?
• Identifying and writing security SOPs
- what is physical and logical security and what do they encompass?
- how to identify security SOPs to target and remediate problem areas
- how to design and write security SOPs
- the importance of having a knowledgeable team (subject matter experts) to work on identifying and writing security SOPs
• The importance of being informed (up-to-date) of potential security hazards
• Always be ready to withstand potential attacks
Thomas Martin
Documentation Manager
LifeTree Technology, LLC

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