To ensure that trials are conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s), our monitors must perform ongoing review of subject records and regulatory documents including:
Site qualification and initiation
Routine monitoring
Confirmation of subject eligibility
Documentation of informed consent
Protocol adherence
Data collection and quality
Source documentation review
Study drug/device management and accountability
Adverse event review and compliance with reporting obligations
Compliance with sponsor-investigator obligations
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