COVID-19 Resources for Clinical Research Organizations

During the COVID-19 pandemic, many clinical research professionals have been trying to understand HIPAA and clinical trial regulations, as well as the impact on protocol management.

In order to provide support to the clinical research community, below are several guidance documents related to HIPPA and clinical trial regulations:

Clinical research organizations can also look to their CTMS to manage recruitment and enrollment via web applications. Along with the ability to promote recruitment – retention and enrollment virtually, a CTMS can help manage your entire clinical trial operations remotely.

Below are several links to valuable resources that clinical research organizations can reference in order to stay up to date with the latest regulations, resources, and informative webinars.

World Health Organization COVID 19: Coronavirus disease (COVID-19) Pandemic

FDA: FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic Guidance for Industry, Investigators, and Institutional Review Boards

Centers for Disease Control and Prevention (CDC):  Coronavirus Disease 2019 (COVID-19)

NIH Links:

National Institutes of Health

NIH: Fogarty International Center

NIH: Grants & Funding for Applicants & Recipients of NIH Funding 

International Links

UK: Medicines and Healthcare products Regulatory Agency: Advice for Management of Clinical Trials in Relation to Coronavirus

Ireland: the Health Products Regulatory Authority (HPRA): Guidance on the Management of Clinical Trials during COVID-19

Regulatory & Central IRB Links

HIPPA & Clinical Research

OHARP Guidance

 IRB Forum – listserve to connect with other IRB and clinical research professionals ask questions and collaborate on regulatory

IntegReview IRB

WCG COVID-19 Webinars

CIRB Central Institutional Review Board for the National Cancer Institute



COVID – 19 Nursing References

Oncology Nursing Society (ONS): professional association committed to promoting excellence in oncology nursing and the transformation of cancer care.

ONS Information Regarding the Coronavirus (COVID-19)

American Association of Colleges of Nursing – guidance documents

American Association of Critical Care Nurses -FREE training resources

Emotional Coping Strategies for COVID-19 (Focus on Nurses)

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