PLEASE NOTE: This program is a work in progress and subject to change.

Agenda

7:00 AM - 8:00 AM
 
7:00 AM - 5:00 PM
 
8:00 AM - 8:15 AM
Plenary
8:15 AM - 9:30 AM
Plenary
9:30 AM - 10:00 AM
 
9:30 AM - 6:30 PM
 
9:35 AM - 9:55 AM
 
10:00 AM - 10:45 AM
Breakout
Breakout
Breakout
Breakout
Breakout
Breakout
10:45 AM - 11:30 AM
Breakout
Breakout
Breakout
Breakout
Breakout
Breakout
11:30 AM - 12:15 PM
Breakout
Breakout
Breakout
Breakout
Breakout
Breakout
12:15 PM - 1:00 PM
 
1:00 PM - 2:00 PM
 
1:05 PM - 1:25 PM
 
1:35 PM - 1:55 PM
 
2:00 PM - 2:45 PM
Breakout
Breakout
Breakout
Breakout
Breakout
Breakout
2:45 PM - 3:30 PM
Breakout
Breakout
Breakout
Breakout
Breakout
Breakout
3:30 PM - 4:00 PM
 
3:35 PM - 3:55 PM
 
4:00 PM - 5:15 PM
Plenary
5:15 PM - 6:30 PM
 
7:00 AM - 8:00 AM
 
7:00 AM - 5:00 PM
 
8:00 AM - 8:15 AM
Plenary
8:15 AM - 9:30 AM
Plenary
9:30 AM - 10:00 AM
 
9:30 AM - 5:30 PM
 
9:35 AM - 9:55 AM
 
10:00 AM - 10:45 AM
Breakout
Breakout
Breakout
Breakout
Breakout
10:45 AM - 11:30 AM
Breakout
Breakout
Breakout
Breakout
Breakout
11:30 AM - 12:15 PM
Breakout
Breakout
Breakout
Breakout
Breakout
12:15 PM - 1:00 PM
 
1:00 PM - 2:00 PM
 
1:05 PM - 1:25 PM
 
1:35 PM - 1:55 PM
 
2:00 PM - 3:30 PM
Breakout
Breakout
3:30 PM - 4:00 PM
 
3:35 PM - 3:55 PM
 
4:00 PM - 5:30 PM
Plenary
7:30 AM - 8:30 AM
 
7:30 AM - 10:00 AM
 
8:30 AM - 10:00 AM
Plenary
10:00 AM - 10:30 AM
 
10:30 AM - 12:30 PM
Breakout
Breakout
Breakout
Time Name Speakers Track This Module is Eligible for
7:00 AM - 8:00 AMBreakfast  
7:00 AM - 5:00 PMRegistration  
8:00 AM - 10:30 AMGood Clinical Practice (GCP): Part 1WorkshopACRP CE Points, CCB Credits, CIP CE Units, CLE Credits, CME Credits, CNE Credits
8:00 AM - 10:30 AMDrug Development 101WorkshopACRP CE Points, CCB Credits, CIP CE Units, CLE Credits, CME Credits, CNE Credits
8:00 AM - 10:30 AMDissecting a Clinical Trial Agreement (CTA) Part 1WorkshopACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits
10:45 AM - 1:15 PMGood Clinical Practice (GCP): Part 2WorkshopACRP CE Points, CCB Credits, CIP CE Units, CLE Credits, CME Credits, CNE Credits
10:45 AM - 1:15 PMClinical Trial Designs and Concepts 101WorkshopACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits
10:45 AM - 1:15 PMFoundation Course: Billing ComplianceWorkshopACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits
10:45 AM - 1:15 PMDissecting a Clinical Trial Agreement (CTA) Part 2WorkshopACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits
1:15 PM - 2:30 PMBoxed Lunch  
2:30 PM - 4:00 PMGood Clinical Practice (GCP): Part 3WorkshopACRP CE Points, CCB Credits, CIP CE Units, CLE Credits, CME Credits, CNE Credits
2:30 PM - 4:00 PMProfessional Skills 101WorkshopACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits
2:30 PM - 4:00 PMMaster Course: Billing ComplianceWorkshopACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits
2:30 PM - 4:00 PMParticipant Recruitment: Innovations and Best PracticesWorkshopACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits
4:00 PM - 6:00 PMOpening Reception  
Time Name Speakers Track This Module is Eligible for
7:00 AM - 8:00 AMBreakfast  
7:00 AM - 5:00 PMRegistration  
8:00 AM - 8:15 AMOpening RemarksPlenary 
8:15 AM - 9:30 AMKeynote: The Importance of Clinical Research - A Patient’s PerspectivePlenaryACRP CE Points, CCB Credits, CIP CE Units, CLE Credits, CME Credits, CNE Credits
9:30 AM - 10:00 AMNetworking Break  
9:30 AM - 6:30 PMWCG MAGI Headshot Studio CCB Credits, CLE Credits, CME Credits, CNE Credits
9:35 AM - 9:55 AMAI is Everywhere Understand How Modern Language Models Work, Where They Work Best, and How to Identify Pitfalls and Risks. (Sponsored Session: Aspen Insights)  
10:00 AM - 10:45 AMContract Breakout: Creating and Using a Clinical Trial Agreement (CTA) PlaybookBreakoutACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits
10:00 AM - 10:45 AMClinical Trial Success: It’s All About Relationships - How to Start on the Right FootBreakoutACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits
10:00 AM - 10:45 AMResearch Ethics and IRBs Breakout: Proper Payment - Best Practices in Participant PaymentBreakoutACRP CE Points, CCB Credits, CIP CE Units, CLE Credits, CME Credits, CNE Credits
10:00 AM - 10:45 AMStudy Billing Breakout: Intro to Medicare Coverage AnalysisBreakoutACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits
10:00 AM - 10:45 AMQuality Breakout: How do YOU Define "Quality"?BreakoutACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits
10:00 AM - 10:45 AMMedical Devices 101 Breakout: Differences Between Medical Device and Drug RegulationsBreakoutACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits
10:45 AM - 11:30 AMContract Breakout: Indemnification Clauses: Taming the Beast!BreakoutACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits
10:45 AM - 11:30 AMClinical Trial Success: It’s All About Relationships - How to Achieve a Win-Win RelationshipBreakoutACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits
10:45 AM - 11:30 AMResearch Ethics Breakout: DSMBs and You - The Role of Data Safety Monitoring BoardsBreakoutACRP CE Points, CCB Credits, CIP CE Units, CLE Credits, CME Credits, CNE Credits
10:45 AM - 11:30 AMStudy Billing Breakout: Billing Compliance and Reimbursement for Device TrialsBreakoutACRP CE Points, CCB Credits, CIP CE Units, CME Credits, CNE Credits
10:45 AM - 11:30 AMQuality Breakout: The Top 10 Site KRIs Sponsors are Measuring and How They Use the ResultsBreakoutACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits
10:45 AM - 11:30 AMMedical Devices 101 Breakout: Categorizing Medical Devices - IDE, Assessing Risk Level, and What the IRB Will Want To KnowBreakoutACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits
11:30 AM - 12:15 PMContract Breakout: InsuranceBreakoutACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits
11:30 AM - 12:15 PMClinical Trial Success: It’s All About Relationships - Can We Just Talk About it?BreakoutACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits
11:30 AM - 12:15 PMResearch Ethics and IRBs Breakout: Complicated Inclusion - When Employees Are Study ParticipantsBreakoutACRP CE Points, CCB Credits, CIP CE Units, CLE Credits, CME Credits, CNE Credits
11:30 AM - 12:15 PMStudy Billing Breakout: Medicare Coverage Analysis Out of the OrdinaryBreakoutACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits
11:30 AM - 12:15 PMQuality Breakout: Creating a Quality Culture In Your OrganizationBreakoutACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits
11:30 AM - 12:15 PMMedical Devices 101 Breakout: Site Operations for Medical Device StudiesBreakoutACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits
12:15 PM - 1:00 PMLunch in the MAGI Cafe: Birds of a Feather  
1:00 PM - 2:00 PMDessert in the MAGI Lounge  
1:05 PM - 1:25 PMUnlock the Key to Fast and Accurate Patient Recruitment (Sponsored Session: VigiLanz)  
1:35 PM - 1:55 PMPrecision Patient Care: Pathology, Explainable AI & Trial Matching Solutions (Sponsored Session: Inspirata)  
2:00 PM - 2:45 PMContract Breakout: Deal Breaker Terms in Clinical Trial Agreements (CTA)BreakoutACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits
2:00 PM - 2:45 PMData Privacy and GDPR Breakout: Watch out for HIPAA! Data Sharing and the Mischaracterization of Data SetsBreakoutACRP CE Points, CCB Credits, CIP CE Units, CLE Credits, CME Credits, CNE Credits
2:00 PM - 2:45 PMResearch Ethics Breakout: Ethics and Compliance - Where’s the Overlap?BreakoutACRP CE Points, CCB Credits, CIP CE Units, CLE Credits, CME Credits, CNE Credits
2:00 PM - 2:45 PMStudy Billing Breakout: Billing Audits and MonitoringBreakoutACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits
2:00 PM - 2:45 PMSpecial Considerations in Pediatric Research Breakout: Providing Gender-Affirming Care in Pediatric ResearchBreakoutACRP CE Points, CCB Credits, CIP CE Units, CLE Credits, CME Credits, CNE Credits
2:00 PM - 2:45 PMInvestigator Initiated Trials (IIT) Breakout: I'm Doing What?! Regulatory Responsibilities When the Investigator is Also the SponsorBreakoutACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits
2:45 PM - 3:30 PMContract Breakout: Subject Injury: Contracting and Billing ConsiderationsBreakoutACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits
2:45 PM - 3:30 PMData Privacy and GDPR Breakout: Understanding GDPR - Where are the Lines?BreakoutACRP CE Points, CCB Credits, CIP CE Units, CLE Credits, CME Credits, CNE Credits
2:45 PM - 3:30 PMResearch Ethics Breakout: Dealing with Data: Future Use and Data SharingBreakoutACRP CE Points, CCB Credits, CIP CE Units, CLE Credits, CME Credits, CNE Credits
2:45 PM - 3:30 PMStudy Billing Breakout: Panel Discussion: Operationalizing Your Research Billing Compliance PlanBreakoutACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits
2:45 PM - 3:30 PMSpecial Considerations in Pediatric Research Breakout: Assent, Permission, One or Two Parents - Getting Consent in Pediatric Research is Different!BreakoutACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits
2:45 PM - 3:30 PMInvestigator-Initiated Trials (IIT) Breakout: Pros and Cons of IIT Program Structures - Which One Is Right for Your Organization?BreakoutACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits
3:30 PM - 4:00 PMNetworking Break  
3:35 PM - 3:55 PMWrong Technology for the Right Job: Applying Technology Where it Isn’t Needed. (Sponsored Session: Clinical.ly)  
4:00 PM - 5:15 PMSolving the Challenges of Decentralized Clinical Trials (DCTs)PlenaryACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits
5:15 PM - 6:30 PMNetworking Reception and Book Signing  
Time Name Speakers Track This Module is Eligible for
7:00 AM - 8:00 AMBreakfast  
7:00 AM - 5:00 PMRegistration  
8:00 AM - 8:15 AMWelcome RemarksPlenary 
8:15 AM - 9:30 AMEnsuring Appropriate Representation in Clinical Trials to Advance Medicine and Reduce Health DisparitiesPlenaryACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits
9:30 AM - 10:00 AMNetworking Break  
9:30 AM - 5:30 PMWCG MAGI Headshot Studio  
9:35 AM - 9:55 AMCommunication Barriers: Facilitating Diverse Enrollments (Sponsored Session: Care Access)  
10:00 AM - 10:45 AMSite Management Breakout: Employee Retention and MotivationBreakoutACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits
10:00 AM - 10:45 AMStudy Budgets Breakout: Budget Development and Negotiations for SitesBreakoutACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits
10:00 AM - 10:45 AMGene Therapy Breakout: Gene Therapy 101BreakoutACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits
10:00 AM - 10:45 AMSpecial Issues in Oncology Clinical Trials Breakout: The Side Effects of Narrowing Eligibility Criteria in Oncology StudiesBreakoutACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits
10:00 AM - 10:45 AMRecruiting and Retaining Study Participants Breakout: Clinical Research Paid Marketing Strategies in an Ever-Changing WorldBreakoutACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits
10:45 AM - 11:30 AMSite Management Breakout: Right-sizing your SOPsBreakoutACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits
10:45 AM - 11:30 AMStudy Budgets Breakout: Hidden Costs for Sites and SponsorsBreakoutACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits
10:45 AM - 11:30 AMGene Therapy: Unique Operational Aspects of Gene Therapy ResearchBreakoutACRP CE Points, CCB Credits, CIP CE Units, CLE Credits, CME Credits, CNE Credits
10:45 AM - 11:30 AMSpecial Issues in Oncology Clinical Trials Breakout: Best Practices for Sites Interested in Conducting Phase 1 Oncology StudiesBreakoutACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits
10:45 AM - 11:30 AMRecruiting and Retaining Study Participants Breakout: Democratizing Clinical Trials – Bringing the Trial to the PatientBreakoutACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits
11:30 AM - 12:15 PMSite Management Breakout: How Research Operations and Compliance Can Work TogetherBreakoutACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits
11:30 AM - 12:15 PMStudy Budgets Breakout: Methodology for Measuring, Negotiating, and Managing Staff WorkloadBreakoutACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits
11:30 AM - 12:15 PMGene Therapy Breakout: Unique Ethical and Operational Issues in Gene Therapy ResearchBreakoutACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits
11:30 AM - 12:15 PMSpecial Issues in Oncology Clinical Trials Breakout: Managing and Retaining Health Care Providers Who Support ResearchBreakoutACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits
11:30 AM - 12:15 PMRecruiting and Retaining Study Participants Breakout: Keeping Patients Engaged Once You Find ThemBreakoutACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits
12:15 PM - 1:00 PMLunch in the MAGI Cafe: Regions  
1:00 PM - 2:00 PMDessert in the MAGI Lounge  
1:05 PM - 1:25 PMDirect Transfer of Data From EHR and eCOA to eCRF Eliminates the Double Data Entry and Time Spent with Monitors on SDV (Sponsored Session: Triomics)  
1:35 PM - 1:55 PMHow Sites Can Identify and Recruit Patients in their Own Health Systems and Community (Sponsored Session: BEKHealth)  
2:00 PM - 3:30 PMBest Practices for Incorporating Patient Feedback Into Drug Development ProgramsBreakoutACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits
2:00 PM - 3:30 PMA Pro/Con Debate: Should We Refer to Clinical Trials “as a Care Option”?BreakoutACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits
3:30 PM - 4:00 PMNetworking Break  
3:35 PM - 3:55 PMSponsored Session: Innovaccer  
4:00 PM - 5:30 PMTechnology in Clinical TrialsPlenaryACRP CE Points, CCB Credits, CLE Credits, CME Credits, CNE Credits

Exhibit Hall Hours

Sunday, October 16, 2022
4:00 PM - 6:00 PM
Monday, October 17, 2022
9:00 AM - 6:30 PM
Tuesday, October 18, 2022
9:00 AM - 4:00 PM