eRegulatory Binder Checklist: What Does The FDA Require?
Excerpt from the Article:
eRegulatory binders help clinical sites organize and digitize the regulatory process. In this post, we take a brief look at what every FDA-regulated binder needs to have.
As a research coordinator or administrator, you’re responsible for managing forms, signatures, monitor visits, regulatory documentation and more. Not to mention squeezing in patient-related work at clinical sites. eRegulatory binders help manage the paper burden all this work creates, making it easier to move through each stage in the lifecycle of the study.
eRegulatory binders help establish compliance with Good Clinical Practice (GCP), an essential factor for clinical sites which depend on their reputation for business. Binders with all the appropriate documentation, up to date and in good order, keep all stakeholders happy – from the FDA to the trial sponsor.
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