Clinical Research and GCP Update

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Did you need to make SOP changes?

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Did you make SOP changes?

• Changes to working practices – home based, virtual meetings. • Impact on study conduct̶ the informed consent process̶ study visits and procedures, study monitoring̶ adverse event reporting̶ changes in investigator(s), site staff, and/or monitor(s) secondary to travel restrictions, quarantine measures, or COVID-19 illness itself. • Maintaining oversight. • Data collection and maintaining data integrity. • Lack of audit/inspection – more responsibility to get it right and have a quality culture. • Procedures for getting SOPs changes and other documents signed off.

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