Institutional Centers for Clinical and Translational Research (ICCTR)

ICCTR | COVID-19 Clinical Research Resources

Last updated: 6/26/2020

In response to the COVID-19 pandemic, we've created a list of guidelines and resources for investigators conducting clinical research at Boston Children's Hospital. This webpage will be regularly updated. Boston Children's remains open, despite the move to remote work, and we are very grateful to the dedicated staff who continue to report to our main campus every day to support our clinical research operations.

In addition to these resources you can find more information on Research Administration's COVID-19 website VPN symbol, which includes topics related to building access, human resources and parking. For questions related to Research Computing, read the monthly newsletter.

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Clinical Research Advisories

Internal ResourcesVPN logo Summary 
COVID-19 BCH Clinical Research Advisory 6.26.20
Four major announcements about Phase II of our re-entry process.
COVID-19 BCH Research Advisory 5.28.20 This memo provides a date for resumption of both Clinical and Basic Research.
COVID-19 BCH Research Advisory 5.22.20 Update on the opening of clinical research activities.
IRB Special Communication 4.16.20
Use of remote interpreters when using a short-form consent for research 
COVID-19 BCH Research Advisory 4.10.20
A further update to previous communications related to research operations during the coronavirus crisis.
IRB Q&A Guidance for COVID-19-Related Issues 4.7.20

Update includes remote consent, e-Consent and reliance issues

COVID-19 Disruptions of International Clinical Trials 4.3.20 
Comparing Guidances Issued by FDA, EMA, MHRA and PMDA, prepared by Ropes and Gray 

IRB Special Communication 3.31.20

Updates to CHeRP IRB SmartForms and COVID Review
COVID-19 Boston Children's  Clinical Research Advisory 3.31.20 This standard operating procedures outlines Boston Children’s interim process to enable external clinical trial monitors to conduct remote source data verification during the COVID-19 site closure (through April 2020).
COVID-19 Boston Children's  Clinical Research Advisory 3.24.20 This advisory addresses clinical research related to the coronavirus and individuals infected (or suspected to be infected) with this virus. Please note: All COVID-19 related research at Boston Children's must be approved by the Coronavirus Research Oversight Committee (CROC).
COVID-19 Boston Children's Clinical Research Advisory 3.16.20 This advisory provides guidelines about ongoing clinical research activities at Boston Children's.
COVID-19 Boston Children's Clinical Research Advisory 3.12.20 This communication is intended to provide the research enterprise with updated information regarding the COVID-19 outbreak.
IRB Guidance: Changes to Research Made in Response to COVID-19 The IRB has developed a Q&A document to assist investigators in considering clinical research questions related to the impact of the COVID-19 pandemic.
Office of Sponsored Programs Advisory This memo outlines issues related to current funding by NIH grants first, then issues related to new applications or reports and extensions on funded applications.

Research Town Hall Information

Research Town Halls will be held on Monday, Wednesday and Friday of each week at 12 p.m. via Zoom. Zoom Links will be provided on the morning of the date. Submit questions in advance.


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NIH and regulatory agency advisories

External Resources Summary 
National Institutes of Health (NIH) COVID-19 is an emerging, rapidly evolving situation. Receive the latest research and public health information available from the NIH about COVID-19, such as: Information for NIH Applicants and Recipients (grants and funding) and NIH Guidance on Travel and Meetings. You can also subscribe to COVID-19 updates from the NIH.
Food and Drug Administration (FDA) This guidance represents the current thinking of the FDA on conduct of clinical trials during the COVID-19 pandemic.

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Other resources

Areas Summary 
Workplace management Gallup.com conducts free webinars to help managers learn how to manage their teams with this new environment of virtual meetings and adapting to disruption.
ICCTR Online Education Resources ICCTR provides clinical research education to the Boston Children’s research community through workshops, seminars, classroom education and online training. These programs are available to investigators, study coordinators, research nurses, and trainees.
Biostatistics & Research Design Education In response to the COVID-19 pandemic, the Biostatistics and Research Design Center is providing direct access to educational materials associated with some of our biostatistics and research methodology course offerings.
edX edX is the trusted platform for education and learning. Founded by Harvard and MIT, edX is home to more than 20 million learners, the majority of top-ranked universities in the world and industry-leading companies. Access 2500+ Online Courses from 140 Institutions. Start Today!
Percipio VPN symbol Percipio is an eLearning platform that gives the Boston Children's community access to leadership development, business skills, productivity and collaboration content.
Harvard Catalyst: Online Education Resources Harvard Catalyst has more than 1,000 courses accessible online with a Harvard Key ID or an eCommons username. You can view the course listing at https://lr.catalyst.harvard.edu/. To request your Harvard Key ID, visit https://key.harvard.edu.
Family Resources
  • With kids being cooped up at home while school is closed, finding structure and fun activities to keep them occupied is important. View a list of family activities
  • Learn more about the coronavirus from Boston Children's.
Maintain your wellbeing during this challenging time Grokker’s robust digital community is a great place to connect with wellbeing experts and other users who will help you and your family stay healthy at home or wherever you may be.
Clinical research considerations Verrill Dana LLP has developed a list of issues that the virus may present in regard to ongoing research studies, new SARS-CoV-2/COVID-19-related research studies and expanded access treatment uses of investigational products for COVID-19 patients. 
Building on our extraordinary leadership in pediatric science at Boston Children’s, we translate our findings — and those of others — to fundamentally change how disease is treated and cured.

David A. Williams, MD
Senior Vice President and Chief Scientific Officer

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