Day-1 Break-In Site Ops: GCP Consent and Source Documents

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Day-1 Break-In Site Ops: GCP Consent and Source Documents

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In this episode, we break down the real first steps new coordinators need on day one and beyond—no fluff, just practical site ops. Learn how to ground your work in good clinical practice, master informed consent conversations, and keep source documents accurate from the start. These habits protect participants, satisfy monitors, and build confidence fast in a role where the first forty-eight hours set the tone.

Key takeaways include:
- Review core GCP principles the night before to follow protocols, report deviations same-day, and secure investigational products immediately.
- Practice consent delivery by reading forms aloud, pausing for questions, and documenting exact times for signatures and discussions.
- Record source data in real time—vitals, labs, adverse events—with precise dates, times, and details to avoid later gaps.

A quick end-of-day cross-check keeps everything aligned and defensible. 📩 Have questions or want to share your experience? Reach out at .

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📩 Have questions or want to share your experience? Reach out at prettyscumbag.nick@gmail.com.
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