Free Lesson Preview
This is just the beginning
The full CRC track covers 8 courses from study start-up to close-out — the skills sponsors actually look for.
View enrollment optionsAlready enrolled? Sign in
Free GCP training
Professional tracks
Clinical Research Coordinator
Full course · Study Start-Up and Site Activation
Free Lesson Preview
The full CRC track covers 8 courses from study start-up to close-out — the skills sponsors actually look for.
View enrollment optionsAlready enrolled? Sign in
Build visit-specific workflow templates, pre-approve standing orders, establish supply management systems, and create an internal study reference guide before the first participant arrives.
It is the morning of Visit 2. The protocol requires fasting labs drawn before 9:00 AM, a 12-lead ECG before dosing, vitals before and after dosing, the investigational product administration itself, a four-hour post-dose pharmacokinetic blood draw, an adverse event assessment, a concomitant medication review, and collection of the participant's dosing diary. Eight distinct procedures with specific timing dependencies. The participant arrives at 8:45 AM, having fasted since midnight--cooperative, punctual, doing everything right.
The coordinator pulls up the protocol, flips to the Visit 2 schedule of assessments, and reads through the table. Labs first. Then ECG. Then vitals. Then dosing. Then... wait. The PK draw is four hours post-dose. If dosing occurs at 10:00 AM, the PK draw is at 2:00 PM. But the adverse event assessment and conmed review were supposed to happen during that window too--and the investigator has afternoon clinic from 1:00 PM to 5:00 PM. Who will perform the AE assessment if the investigator is seeing clinic patients?
The coordinator looks at the next row in the schedule of assessments table. The diary was supposed to be collected at check-in. It is now 9:30 AM and nobody collected the diary. Nobody even asked the participant whether they brought it.
These are not complicated procedures. Individually, each one is routine. But a protocol schedule of assessments is a list, not a workflow. It tells you what to do. It does not tell you when, in what sequence, who does each task, what supplies must be staged, or what happens when two time-dependent procedures overlap. That translation--from protocol list to operational workflow--is the work of this lesson.
I have watched coordinators at some of the most capable research sites I know stumble through first visits because the protocol was clear and the workflow did not exist. The protocol had been reviewed in Module 1. The SIV had covered the science and the systems. But no one had built the internal machinery that turns protocol requirements into an orderly clinical morning. The visit template is that machinery.
What you will learn4 objectives
By the end of this lesson, you will be able to:
Progress saves itself — finish reading and this lesson completes