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Strengths & Preferences
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Working From Home & Career Topics
Takeda offers tips for transitioning to the new way of working.
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Networking Tips
Career Tips
Watch a rebroadcast of a webinar that discusses how to Reinvent your Reality. Learn how to Stand Out and how to Pivot during any moment of your life with two renowned-authors: Dorie Clark and Jenny Blake
replay the event held 09-April-2020
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COVID-19 Resources
FDA Resources
Additional US Government Resources
CTTI Best Practices
DIA DIRECT Webinar Series
New trials are being put on hold and recruitment of patients is being suspended, given the lack of hospital staff available to manage clinical trials while healthcare systems are gearing up to handle the flood of COVID-19 patients.
Multiple regulatory agencies from across the globe have issued guidance on the management of clinical trials during this COVID-19 pandemic. In order to exchange ideas and provide insights into this impacted world of clinical trials, the DIA Clinical Research Community has brought together a multidisciplinary team of panelists who will provide perspectives from sponsors and clinical trial sites, and on clinical site monitoring, and clinical trial logistics. Each panelist will describe the biggest challenges they are facing today, how they are handling them, what their biggest concerns are, and how they envision clinical trials post-COVID-19.
about COVID-19 from DIA.
Key takeaways and summary of discussion provided by .
Moderator –Ghasalek Gouya MD
Site – Faith Holmes MD
Dawn Sauro – Clinical Operations
Alexander Felkovsky – CTS Logistics
Vladimir Misik PHD – Moderator
Leanne – EU Clinical Operations
USFDA/EMA have both issued guidances
Call for Central Monitoring
Remote Patient Visits + Plan for Out of Window Visits
Changes will not be considered a Protocol Violations long as the changed process id documented in NTF and submitted to regulatory

Business Impacts to Study Sponsors
Site qualification, selection, and initiation may be done remotely
Some trials closed to enrollment or delaying enrolling patients (33% holding according to survey)
Patients already in screening can be rescreened in the future
Create a memo or policy for risk management and infection control
Remote monitoring is being implemented
Manage Risk of Investigational Product Supply Issues
Increase manufacturing and supply
Ensure availability of rescue medications, comparators, and background therapies
For patients that can self-administer drugs, consider a plan to ship IP directly to patients

Resource Management
Help colleagues cope with new environment
For remote workers we may need to allow for Job share to manage children at home. One parent works and one manage children and switch.

Implement a Business Continuity Plan BCP
How to communicate to team when the message can change frequently
Communicate status of current processes
Update as things progress

Leadership Best Practices
Be *proactive* in making decisions
Do not just discuss - meetings should result in decision and action plan
Prioritize ongoing studies above initiating new work
Communication

Strategies for Clinical Sites
Sponsor and representatives are granted access to the Source data remotely
Visits can be conducted remotely
Use Home Health Nurse for home visits
Personal Protection Equipment PPE is need both for staff, patients and testing facility
Have a remote site contact for regulatory compliance and for Reconsent of patients when protocol is modified for remote monitoring and drug supply
Safety is important for both the site and the patients as well as the employee
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