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Strengths & Preferences

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Myers Briggs⁠

Enneagram⁠

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Clifton Strengths⁠

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Crystal Personality Profile⁠

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Working From Home & Career Topics

Takeda offers tips for transitioning to the new way of working.

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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

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EMA Guidance 20-Mar-2020⁠

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MHRA Guidance on COVID-19⁠

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FDA Resources

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FDA Guidance on COVID-19 updated 16-Apr-20⁠

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Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency⁠

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Slides from FDA presentation 12-Mar-2020⁠

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Additional US Government Resources

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CDC Latest Information⁠

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Daily Life and Coping⁠

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Understand and Identify Burnout and Secondary Traumatic Stress⁠

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Coronavirus.gov⁠

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USA.gov/Coronavirus⁠

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CTTI Best Practices

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Best Practices for Conducting Clinical Trials During COVID19⁠

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[webinar] Identifying Best Practices for Conducting Clinical Trials with the New FDA Guidance during the COVID-19 Pandemic⁠

DIA DIRECT Webinar Series

session held 08-April-2020

Conducting Clinical Trials During COVID-19: Case Studies from the Perspectives of Sponsor, CROs, Sites, and IP & CTS Distributors⁠

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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.

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Register to access resources (link)⁠

about COVID-19 from DIA.

Key takeaways and summary of discussion provided by

Lorraine Mercer⁠

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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