Summary

Managing subject progression through a trial, including data collection and assessments.

Roles

Recommended

• Study Coordinator

• Study Designer

Optional

• Investigator

• Volunteer Recruiter

• Data Manager

Pre-course activities

Explore the Study Conduct flow charts for Screening, Lead-In, and Treatment:

Study Conduct Workflow

Click the task links in the 'Order of Operations' chart to learn more about a given step in the study conduct workflow. 

Classroom

Optional in-person or remote instructor led training.

Post-course homework

Practice each of the tasks in the following gantt charts to progress a subject through a trial (from screening through treatment):

• Screening

• Lead-In

• Treatment 

Also think about workflows for various study conduct processes in ClinSpark.  Some examples of processes that might require some thought include:

• Cohort management

• Informed consent

• Eligibility determination

• AE/CM management

• PI oversight and assessments

• Repeated activities