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:
- Human Subject Protection & Federal Regulations of Clinical Trials
- Oncology Research & Clinical Trial Management System Electronic Medical Record & Artificial Intelligence
- Protecting Personal Health Information in Research
- Clinical Research & the HIPAA Privacy Rule
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
Centers for Disease Control and Prevention (CDC): Coronavirus Disease 2019 (COVID-19)
- Key Resource Documents
- Office of Extramural Research (OER) – Grants and Funding
- Coronavirus Disease 2019 (COVID-19): Information for NIH Applicants and Recipients of NIH Funding
Regulatory & Central IRB Links
IRB Forum – listserve to connect with other IRB and clinical research professionals ask questions and collaborate on regulatory
COVID – 19 Nursing References
Oncology Nursing Society (ONS): professional association committed to promoting excellence in oncology nursing and the transformation of cancer care.