Society for Clinical Data Management 2012 Annual Conference
The SCDM Annual Conference is the world's largest education event for clinical data managers and related professionals, attracting over 600 attendees from across North America and around the world.
The 2012 Annual Conference runs September 22-25 in Los Angeles, California.
Topics
Adaptive Trials: What are they, and how are they different for Data Managers?
What does it mean to be an adaptive trial? What exactly gets adapted? How does that happen?
What does the FDA think about this? The industry?
How does an Adaptive Trial differ for Data Management?
Working Together for Success – CDMs and CRAs in the 21st Century
Partnership lessons from the perspective of the CRA
Analytical tools for the DM and the CRA
Areas of synergy – where the CRA and CDM should work more closely
How can we, collectively, affect overall study quality?
Understanding each other's perspectives, while still achieving clinical study success
Who's on First, What's on Second – Who's Going to Resolve that Query!!
Enhancing Research Through Metadata-driven Processes
Case Studies from implementers who have implemented metadata-driven processes
Metrics on how implementing standards ""up front"" has improved timelines and reduced costs
Case studies on how having your clinical data repository in a standard format enhanced your research
Case studies from implementers of eSource or EHR for clinical research
Case studies of collaborating with partners (CROs, vendors,other research partners) in a metadata driven process
Data Management: Core Functions Under the Spotlight
Efficacy in Serious Adverse Event (SAE) Reconciliation
The Role of the CRF Designer – Present and Future
Dictionary Coding – Is Certification Necessary?
Other important Data Management specialty roles/functions
Medical Devices Session
Are a Data Manager's skills transferable between the drug and device industries?
What are the main challenges for a data manager in the device industry?
How is the changing regulatory landscape affecting our deliverables?
Review and discussion of the newly released CDISC SDTM Device domains
The Benefits of Informatics to Data Managers
Infrastructure changes needed to accommodate the new technology which will impact and facilitate data collection, management and electronic exchange… Electronic Health Records, Data Standards, Health Information Exchange (HIE)
Skills required in the future environment of data collection, data sharing and electronic data exchange between organizations.
Opportunities for gaining knowledge and experience that will facilitate new skills and advance career goals in the new technology age
The look at data management in the future what does it look like and who are catalyst (CDISC, HL7, EHR vendors, HIEs, Pharma, Regulatory Agencies…)
Managing Data (and more) at the Program Level
Ensuring application and usage of standards across the program
Planning, resourcing and timeline management
Challenges/Benefits of working from the first Phase 1 to the first Phase IV
eSource: It's more than Data
Clarify differences between Source and CRF (Regulatory, Data Standards, Site Impact)
eSource impact on data management expectations, infrastructure, and workflow
Define operational and financial benefits of eSource relative to EDC
Clinical Endpoint Adjudication: A clinical trial within a clinical trial?
What is Endpoint Adjudication and when is it necessary
What Regulators want to know about Endpoint Adjudication
Issues and Opportunities for efficiencies
How to be a Leader in Data Management
Project Management Techniques for the Data Manager
How to Successfully Collaborate with Cross Functional Team members for optimal results
Finding or Becoming a Mentor in Data Management
An outline of the most effective ways of mentoring and training CDMs for leadership roles
How to take control of your own development and find a mentor to help you grow in your career
Not everyone is a natural born mentor, what are important qualities to look for when choosing a mentor?
Experience is the best teacher, whether positive or negative - what personal experience can you share in assisting a CDM in finding a mentor? Or what tips do you have for mentoring someone?
Outsourcing DM: How to Get the Most Value out of a Partnership
CRO oversight by sponsor - balance between control and micro-managing
Sharing tools: Vendor Oversight Plan, Transition Plan, QC Plan
If only one service is outsourced (e.g. coding), how to work with DM team?
Risk-based Approach to Monitoring: The Way of the Future
Variety of alternative approaches to assess data quality and patient safety
Centralized monitoring of data quality, site characteristics and performance metrics that can trigger on-site monitoring
Guidelines for risk based monitoring plans.
Key challenges of integrating this approach into your trials.
CDM role in the FDA guidance of Risk-Based Approach to Monitoring
Will this approach compromise data quality and integrity?
What kind of challenges will pose to data managers?
What new role, responsibilities and skill sets will be needed for data managers to provide value in this approach?
Technology Drivers as Motivators for Change
A perspective on how Electronic Health Records, the push for Centralized Monitoring, analytical tools, Mobility and Portals drive toward a change in roles and activities to be performed by CDM now and in the future.
What might the landscape look like in technology and how this will result in a shift in priority for CDM in alignment with shifting roles in monitoring and the needs of statistics.
Rock, Paper, Scissors, Technology: The Impact of Technological Advances on the DM Landscape
The risk of layers of more complex process instead of overall improvement in process when introducing new technology. Are we as bogged down as when we used paper data collection.
Ways in which advances in technology have increased productivity, provided greater or more varied access to data, and improved the efficiency with which Clinical Data Managers are able to perform their jobs.
The many pitfalls associated with adopting new technology and methods that we can use to address these issues.
