Tag: protocol
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Courtesy Review for Your Initial Protocol or Amendment
Protocols, and their amendments, frequently involve billables and require careful attention to ensure proper documentation, communication, and adherence to relevant regulations and policies. These changes can impact the budget, funding, and overall study design, and may require a Coverage Analysis (CA). A Coverage Analysis is a process of determining how each billable item and service…
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Effective October 1: IRB Protocol and Consent Template Updates
The IRB has released new protocol and consent templates for biomedical research, available on the IRB website. Additional templates will be updated in the near future. Biomedical Protocol updates include: Clarity around information needed Attestation checkboxes Removal of the checklist DSMP questionnaire now embedded within the protocol Updated DSMP charts Biomedical Consent updates include: More…