INVESTIGATOR SITE FILES SUMMIT

Transcription

1 From the creators of the TMF series INVESTIGATOR SITE FILES SUMMIT Best Practices for Ensuring Compliant, Timely and Quality ISF Management for CROs, Sponsors and Sites SEPTEMBER 19-20, 2016 WYNDHAM BOSTON BEACON HILL BOSTON, MA Conference Co-Chair: Betsy Fallen, Global Head of Program and Business Development, SAFE-BIOPHARMA ASSOCIATION Conference Co-Chair: Terry Stubbs, President and CEO, ACTIVMED PRACTICES & RESEARCH, INC. Jonathan Helfgott, Former Associate Director for Risk Science, OSI, CDER, FDA and Coordinator for Regulatory Science Graduate Program, JOHNS HOPKINS UNIVERSITY Carolyn Lucas, Regulatory Documentation Systems Specialist, AKEBIA THERAPEUTICS Frances Abeton, Vice President, FIRECREST NEW TECHNOLOGIES AND THE eisf/etmf WORLD STAFF TRAINING PROCEDURES SEAMLESS RECONCILIATION WITH THE TMF DOCUMENT MANAGEMENT STRATEGIES SOP AND PROTOCOL IMPLEMENTATION ISF COMPLETION FEATURED SESSIONS INCLUDE: Panel Discussion: ISF/eISF Process Optimization and Technology Innovation Case Study: ISF Management When Switching from a Paper TMF to an etmf PRE-CONFERENCE WORKSHOP: The Investigator Site File Management Plan Addressing the Challenges Created by the Need for Active Management Through Its Entire Life Cycle Considering Different Perspectives and Document Formats Methods of Preparation for a Regulatory Inspection SPONSORS: KEY TAKEAWAYS FROM THIS EVENT Learn from sponsors, technology vendors, sites and CROs about their dealings with ISFs for an all-encompassing view Network with industry leaders from different clinical and medical device landscapes Ensure your ISF is complete and your SOPs are ready in case of inspection Develop a comprehensive document management strategy through our intensive, hands-on workshop Address best practices for seamless reconciliation with the TMF/eTMF

2 INVESTIGATOR SITE FILES SUMMIT WHO SHOULD ATTEND This conference is designed for professionals from pharmaceutical, biotechnology and medical device companies with responsibilities in the following areas: Dear Colleague, Inspections of clinical trial site documents by regulatory authorities can happen at any time. Both clinical trial sponsors and sites need to be prepared there can be severe penalties for failing an inspection. In preparation for audits at clinical sites, clinical monitors and study coordinators usually manually assess trial documentation for completeness and quality within the ISF. Data Management Clinical Operations/Research/ Documentation Site Partnerships Investigator Site Files Clinical Compliance Trial Master Files The investigator site file contains all the documents pertaining to site staff, patient information and consent forms, protocols, SOPs, data management, financial disclosures, and more. Sites are responsible for keeping this file current and in working order because they are required to provide the ISF to the clinical trial sponsor. All of these documents need to be kept up to date and maintained by the site/investigator in real time so they can be put within the Trial Master File (TMF) for a clinical inspection. There has also been a recent push to move physical files over to electronic systems (eisfs) to enable easier transfer of information to the etmf. But the move from paper to electronic systems comes with its own obstacles. The challenge is that regulatory authorities including the MHRA, FDA and EMA have increased the number of inspections, and sites must deal with the resulting consequences. As they face written warnings, loss of reputation, potential data exclusions or fines, clinical sites must create stronger ISF filing plans that can be integrated and organized with greater ease. Join us at the Investigator Site Files Summit, where industry leaders from sponsors, CROs, clinical sites and other stakeholders will come together to discuss the issues facing the industry today. Sincerely, Dio Lichiardopol Conference Production Director ExL Events Scott Grossman Division Head, Conference Production ExL Events Clinical Data Clinical Quality Trial Documentation Auditing GCP Records Management This conference also ideal for professionals from clinical trial sites who are: Study Managers Investigators Study Coordinators Clinical Research Associates VENUE INFORMATION WYNDHAM BOSTON BEACON HILL 5 Blossom St. Boston, MA If you require overnight accommodations please contact the hotel to book your room. ExL has reserved a block of rooms at a group rate for participants. To make reservations guests can call and request the negotiated rate for ExL s Investigator Site Files Summit. You may also make reservations online by visiting The group rate is available until August 29, Please book your room early as rooms available at this rate are limited. *ExL Events, Inc. is not affiliated with Exhibition Housing Management (EHM)/Exhibitors Housing Services (EHS) or any third-party booking agencies, housing bureaus, or travel and events companies. In the event that an outside party contacts you for any type of hotel or travel arrangements, please disregard these solicitations and kindly us at info@exlevents.com. ExL has not authorized these companies to contact you and we do not verify the legitimacy of the services or rates offered. Please book your guest rooms through ExL s reserved guest room block using the details provided.

3 WORKSHOP MONDAY, SEPTEMBER 19, :00 REGISTRATION AND CONTINENTAL BREAKFAST FOR WORKSHOP PARTICIPANTS 9:00 PRE-CONFERENCE WORKSHOP: The Investigator Site File Management Plan Addressing the Challenges Created by the Need for Active Management Through Its Entire Life Cycle Considering Different Perspectives and Document Formats A Trial Master File (TMF) is a collection of content created to support a clinical trial. A TMF is made up of a sponsor file and the file at the investigator sites. The investigator site file, ISF, has the same responsibilities for maintenance, specifically for quality, timeliness and completeness, as the sponsor TMF. The TMF and the ISF get reconciled against each other by a sponsor representative. Study-specific TMF management plans are created by the sponsors to outline the details associated with how the sponsor s TMF will be managed from the creation of the very first document through the archival of the set of content after the completion of the trial. It is becoming common practice to create an ISF management plan at each site level to capture the study-specific management requirements of the site-specific ISF. The ISF management plan doesn t have to be complicated, but it helps to ensure the full life cycle of the ISF is addressed and decisions on its management are captured and officially recorded. Having a plan in place will lead to ongoing active maintenance, which results in less intensive ISF preparations should a regulatory inspection be scheduled either during or after a trial. During this interactive workshop, you will be able to build an ISF management plan that can be used by the sponsor as a template for all sites in a study or by the investigative site for all studies they are conducting. The following topics will specifically be addressed as they pertain to both paper and electronic ISF content: The ISF life cycle from first document collection to archival to final disposition (destruction) Exploration of the differences for managing ISF in paper and electronic ISF documents The ISF management plan components critical to ensuring a complete and quality-infused process How to manage the components of an ISF to reduce duplications Lisa Mulcahy, Owner and Principal Consultant, MULCAHY CONSULTING, LLC *This workshop contains a 30-minute networking break. 12:00 LUNCHEON FOR WORKSHOP PARTICIPANTS AGENDA DAY ONE MONDAY, SEPTEMBER 19, :00 REGISTRATION FOR MAIN CONFERENCE ATTENDEES 2:45 NETWORKING BREAK 1:00 Co-Chairpersons' Opening Remarks Betsy Fallen, Global Head of Program and Business Development, SAFE-BIOPHARMA ASSOCIATION Terry Stubbs, President and CEO, ACTIVMED PRACTICES & RESEARCH, INC A BREAKDOWN OF STAKEHOLDER ROLES AND CONSIDERATIONS 1:15 Review Site Considerations and ISF Management Designate oversight of the various documents that must be kept in the ISF, e.g., patient consent forms, medical history, adverse event reports, etc. Regulate workloads for all site staff to ensure consistency and efficiency Create a management strategy for when deviations from protocol are documented and recorded in the ISF Lauren Lockhart, Clinical Research Site Manager, CHARLOTTESVILLE MEDICAL RESEARCH 2:00 Facilitate Strong Communication Channels Across All Stakeholders Hear about communication channels from the site perspective Provide best practices for how the sites, the sponsor and CROs are using the various avenues for efficient communication Identify actual case studies on how efficient communication between stakeholders minimized unforeseen events and avoided impacting budgets Terry Stubbs, President and CEO, ACTIVMED PRACTICES & RESEARCH, INC. 3:15 CASE STUDY: ISF Management When Switching from a Paper TMF to an etmf Learn how to manage different site capabilities Handle the documentation from the sponsor side Oversee training and metadata appropriation remotely Assess the costs and benefits of switching from a paper to an electronic TMF Carolyn Lucas, Regulatory Documentation Systems Specialist, AKEBIA THERAPEUTICS INDUSTRY TECHNOLOGICAL CHANGES 4:00 PANEL DISCUSSION: ISF/eISF Process Optimization and Technology Innovation Analyze full ISF integration methods with the trial TMF Address the recent industry shift toward the electronic world of eisf Coordinate with technology vendors about digital signatures and authentication Discuss the future of fully electronic submissions and inspections, such as those required by the MHRA Carolyn Lucas, Regulatory Documentation Systems Specialist, AKEBIA THERAPEUTICS Hether Seifert, Program Manager Protocol Development Unit, MAYO CLINIC ROCHESTER 5:00 DAY ONE CONCLUDES

4 AGENDA DAY TWO TUESDAY, SEPTEMBER 20, :30 CONTINENTAL BREAKFAST 9:00 Co-Chairpersons' Recap of Day One Betsy Fallen, Global Head of Program and Business Development, SAFE-BIOPHARMA ASSOCIATION Terry Stubbs, President and CEO, ACTIVMED PRACTICES & RESEARCH, INC 9:15 Optimize the Site-Sponsor Relationship by Leveraging Site Experiences Incorporate effective training methods across all involved parties Implement productive relationship management protocols for site monitoring visits and oversight Develop more efficient and transparent methods of communication and information sharing Explore the human element of a site/sponsor/cro relationship that's designed to operate at a high-quality level Adeline Mullin, Clinical Business Analyst, VERTEX PHARMACEUTICALS 10:00 Strategies for Complete ISF Integration into the Clinical Trial TMF Create an all-encompassing checklist to ensure a complete ISF Instill a site mentality of constant vigilance regarding to proper filing of the ISF Streamline procedures to ensure quality document scanning is run properly and synchronized with the TMF Examine various integration solutions to determine what is best for your organization Betsy Fallen, Global Head of Program and Business Development, SAFE-BIOPHARMA ASSOCIATION 10:45 NETWORKING BREAK REGULATORY INSPECTIONS AND OTHER CONSIDERATIONS 11:15 Methods of Preparation for a Regulatory Inspection Manage contract details to make sure they are all properly filed and ready to be integrated into the TMF Review protocols and SOPs for site staff during an inspection Design efficient approaches for becoming inspection ready, and maintain them once a site is ready Develop a mobilization plan to act on when an impending inspection notice is received Jonathan Helfgott, Former Associate Director for Risk Science, OSI, CDER, FDA and Coordinator for Regulatory Science Graduate Program, JOHNS HOPKINS UNIVERSITY 12:00 Using Paperless Clinical Trials to Ensure 24/7 Audit Readiness Select digital tools to automate workflows and compliance Provide end-to-end integration and visibility Eliminate inefficiencies, improve compliance and create inspection-ready data Connect patients to sponsors, investigators and studies while empowering patients Simplify the investigator burden so they can focus on patient care Create engaging training and communications tools that track compliance Frances Abeton, Vice President, FIRECREST 12:45 LUNCHEON INVESTIGATIONAL SITE MANAGEMENT 1:45 Best Practices for Maintaining Privacy Within the ISF Ensure that all health information is protected and secure Efficiently maintain financial holdings and records Address HIPPA concerns and the potential for human errors Discuss breaches or mistakes and best practices for dealing with them 2:30 Maintenance Methods for the ISF During the Clinical Trial Life Cycle Ensure the ISF is updated properly and in a timely fashion throughout the course of the trial Maintain accurate amendment chronologies to any documents that are amended during the trial Keep track of all correspondence with the sponsor and file it along with other relevant correspondence Record any examples of where study documentation is not available or is stored elsewhere, e.g., a pharmacy site file Marie-Christine Poisson-Carvajal, TMF Operations Lead, PFIZER 3:15 Avoiding FDA 483s and Warning Letters in Investigator- Initiated Clinical Trials Describe the genesis of INDs Establish the role of investigator-initiated clinical trials Review sponsor-investigator responsibilities Discuss how to avoid FDA 483s and warning letters Ernest Prentice, Associate Vice Chancellor for Academic Affairs, UNIVERSITY OF NEBRASKA MEDICAL CENTER 4:00 CASE STUDY: Implementing an eisf in Phase 3 Clinical Trials Hear the rationale behind why Trevena chose to go in this direction Prepare the sites/sponsor team along with the site/cra/sponsor tools Determine who is responsible for what through process development and training Evaluate outcomes and lessons learned Emily Cook, Senior Clinical Trial Manager, TREVENA INC 4:45 SUMMIT CONCLUDES WHAT YOUR PEERS SAY ABOUT OTHER EXL CONFERENCES: Especially liked the actual case studies and I appreciate when vendors present new tools and technology. Senior CTA Clinical Systems, ALKERMES Awesome presentation, great delivery, nice to also see an interest in different-sizedcompanies. Clinical Documents Management, ACORDA THERAPEAUTICS

5 Pharmaceutical, Biotech, Medical Device and Service Provider Pricing EARLY BIRD PRICING Register by August 5, 2016 Conference $1,795 Conference + Workshop $2,095 STANDARD PRICING Register after August 5, 2016 Conference $1,5 Conference + Workshop $2,295 ONSITE PRICING Conference $2,095 Conference + Workshop $2,395 Clinical Trial Site Pricing EARLY BIRD PRICING Register by August 5, 2016 Conference $1,095 Conference + Workshop $1,395 STANDARD PRICING Register after August 5, 2016 Conference $1,295 Conference + Workshop $1,595 ONSITE PRICING Conference $1,495 Conference + Workshop $1,795 MEDIA PARTNERS GROUP DISCOUNT PROGRAMS *Offers may not be combined. Early Bird rates do not apply. To find out more on how you can take advantage of these group discounts, please call contact * our offices at (201) SAVE 25% For every three simultaneous registrations from your company, you will receive a fourth complimentary registration to the program (must register four). 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