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Tuesday
11:00am - 03:45pm EDT - January 12, 2021
Track: Innovation in the Era of COVID

Unlock your potential by learning innovative new ways clinical research is being conducted in response to COVID-19.

This online, interactive program addresses telemedicine, remote monitoring, team management, study start-up and more in the era of COVID.


Tuesday
11:00am - 12:00pm EDT - January 12, 2021
Track: Innovation in the Era of COVID
Credits Available:
1.00 ACRP Credits

The rise of COVID-19 has fast-tracked the call for innovative clinical trial solutions and about whether the traditional Sponsor-PI-Patient centric model is sustainable. Discussions of an alternative model, hybrid clinical trials, would combine elements of both centralized and decentralized systems while also leaving the door open for new technologies. But what should the patient experience in a proposed hybrid model? What could the role of advanced technology such as AI, digital patient recruitment and mobile apps be? How would decision making and stakeholder collaboration be impacted? Explore these issues and discuss best practices you can implement in 2021.



Objectives:
  • Identify the feasibility and best practices of hybrid clinical trials.
  • List solutions, methods and possible standards that hybrid clinical trials offer which can still result in desirable outcomes.
  • Gain an understanding of what roles and challenges different stakeholders face when it comes to hybrid clinical trials.
Tuesday
12:15pm - 01:15pm EDT - January 12, 2021
Track: Innovation in the Era of COVID
Credits Available:
1.00 ACRP Credits

When the world is changing by the minute in the middle of a pandemic, you hold on tight and get ready for a wild ride. Join this session to learn how to expand research operations utilizing remote technology and existing resources and how the Medical University of South Carolina used this approach to activate a COVID-19 study in our rural research naive hospitals in under one week. Hear lessons learned and how the team adapted and overcame barriers to ensure the needs of the community were met.



Objectives:
  • Assess existing research resources available to mobilize for research expansion activities.
  • Become familiar with the framework needed to create a research expansion plan.
  • Recognize the importance of evaluating outcomes to identify when plan adjustments are needed.
Tuesday
01:30pm - 02:30pm EDT - January 12, 2021
Track: Innovation in the Era of COVID
Credits Available:
0.00 ACRP Credits

This session is presented by the DPO Centre, Ltd.

Join this 30-minute discussion of the data protection challenges relating to the handling of sensitive personal data of EU and UK trial participants, the effect of Brexit, such as the need to appoint EU and UK Representatives, and how COVID-19 has bought data protection to the forefront of people’s minds.

NOTE: This session does NOT offer ACRP Contact Hours.



Objectives:
  • Considerations when processing EU and/or UK trial participants’ personal data.
  • Understand when EU and UK Representation is required.
  • Considerations following Brexit and the spotlight that COVID-19 has put on data protection.
Wednesday
11:00am - 12:00pm EDT - January 13, 2021
Track: Innovation in the Era of COVID
Credits Available:
1.00 ACRP Credits

Explore decentralized clinical trials (DCT) and the oversight role of the sponsor. During COVID-19, many trials have been modified and changed to account for the inability to interact with subjects in person and many organizations have moved to a decentralized architecture. Session participants will: understand the regulations pertaining to decentralized clinical trials, learn the perceived benefits and challenges of a DCT, and discuss remote monitoring of DCTs.



Objectives:
  • Understand the regulations pertaining to decentralized clinical trials.
  • Learn the perceived benefits and challenges of a DCT.
  • Discuss remote monitoring of DCTs.
Wednesday
12:15pm - 01:15pm EDT - January 13, 2021
Track: Innovation in the Era of COVID
Credits Available:
1.00 ACRP Credits

Staff cuts. Furloughs. Realignments of roles and responsibilities. Pivoting to new SOPs and technologies. Remote work as the “new normal.” COVID-19 caused major disruptions in the clinical research workforce.

In this panel session, leadership from sites, sponsors, and CROs will share what they learned while navigating this unprecedented workforce shake-up. They’ll share changes that were thrust upon their teams, what worked, what didn’t – and most importantly, the potential lasting impacts the pandemic is likely to have on the workforce.


Wednesday
01:30pm - 02:30pm EDT - January 13, 2021
Track: Innovation in the Era of COVID
Credits Available:
0.00 ACRP Credits

This session is presented by Clinical Research IO.

Sites have been adopting eSource for the past several years, as a natural extension of their steady technology adoption. Initially, eSource was thought of as a discreet, stand-alone category of software. But several recent trends point toward eSource becoming an actual platform for industry transformation.

Join experts from Clinical Research IO to explore how several independent trends in research will make eSource a platform technology for sites:

1. The adoption of de-centralized trials and virtual monitoring strategies by sponsors and CRO’s

2. The rising consolidation of site networks and integration of research into care settings

3. Integration with EDC, eConsent, and other technologies

Learn more about why eSource has such transformational power and how eSource will emerge as the backbone of research operations.

NOTE: This session does NOT offer ACRP Contact Hours.



Objectives:
  • The role eSource plays in facilitating virtual monitoring.
  • How technology facilitates consolidation of research site activity.
  • How to prepare your site for a new era of hybrid virtual trials.
Thursday
11:00am - 12:00pm EDT - January 14, 2021
Track: Innovation in the Era of COVID
Credits Available:
1.00 ACRP Credits

Examine the coverage analysis and budgeting process, and how it interfaces with the contract negotiations in this interactive session providing tools and tips to implement right away.



Objectives:
  • Recognize how the industry has changed during pandemic.
  • Analyze the financial impact and assess changes necessary to become a profitable research site.
  • Explain the issues as a result of the pandemic in a site setting.
Thursday
12:15pm - 01:15pm EDT - January 14, 2021
Track: Innovation in the Era of COVID
Credits Available:
1.00 ACRP Credits

Hear straight from the experts that executed rapid study start-up and study management using a ‘no touch’ protocol while under quarantine, stay at home orders. The panel will share their real-world experience on rapid study deployment and lessons learned in developing and initiating two large randomized clinical trials studying the effects of hydroxychloroquine in outpatients with confirmed COVID-19 in under two weeks.



Objectives:
  • Describe resources for rapid deployment of emergency IRB review, eConsent, and DSMB review.
  • Demonstrate how to direct a high performing team and develop a quality risk assessment.
  • Identify database build requirements and collaboration with RCs, CRAs and Research Nurses.
Thursday
01:30pm - 02:30pm EDT - January 14, 2021
Track: Innovation in the Era of COVID
Credits Available:
0.00 ACRP Credits

This session is presented by Exostar.

Ready to simplify your technology footprint for 2021? All those accounts/passwords driving you crazy? Join Kenny Kong as he shares how many of your colleagues in the industry are streamlining their technology access and creating a better user experience.

NOTE: This session does NOT offer ACRP Contact Hours.



Objectives:
  • BUSINESS - Learn about options to help deal with technology issues causing stress while working virtually.
  • PERSONAL – Importance of establishing work/life balance. How to set and manage expectations.
  • THE FIX – The need to aggregate technology and simplify site user access.