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Study Management Reference Guide
1 STUDY CREATION
Wondering which studies need to be entered into the CTMS? -- All studies with an informed consent!
Coordinator
CTMS Support
CTO
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Study Calendar is created and notification sent for review
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Enter all required fields in the Study Summary page
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Submit a Study Calendar creation request in REDCap
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Review and verify the calendar's clinical details
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Review and verify the calendar's financial details
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Setup Payment Milestones
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2 STUDY ACTIVATION
Use the Study Activation Form as your guide to make sure all elements are in place prior to activation.
Coordinator
CTO
RA
Enter Study Status:
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MCA In Progress for initiation
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MCA Complete when signed
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CTA In Progress for initiation
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CTA Executed when signed
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Review study creation and tasks for completion then activate Calendars and enter Study Status of Active/ Enrolling
Enter Study Status of Tufts: IRB Preparation when study is ready for IRB review
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Initiate review of budget, MCA & contract (outside CTMS)
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Submit Study Activation Form when all approvals and activities are complete
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Enter Study Status:
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Budget In Progress upon initiation
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Budget Finalized when negotiations are complete
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3 STUDY CONDUCT
Make sure study subjects are marked enrolled and off-study as soon as possible to avoid billing issues
Coordinator
CTO
RA
Run relevant reports periodically to perform quality check on the data
Keep track of invoiceable items
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Add study subject records for each study with Patient Study Status of Screen Failure or Enrolled as applicable
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Associate appropriate Study Calendar to generate a Patient Schedule
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Update Visit/ Event Status. If relevant, don't forget to record invoiceable items!
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Run relevant reports periodically to perform quality check on the data
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Keep track of invoiceable items
4 STUDY CLOSURE
Why is this important? It ensures that reconciliations are complete and integrated systems are synced
Coordinator
CTO
RA
Perform all verifications and enter study status of Study Completed/ Retired
Submit request for closure when IRB and Sponsor closeouts have occurred
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REQUIRED FIELDS FOR STUDY CREATION
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Study Title
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Principal Investigator
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Primary Objective
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Primary Purpose
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Department
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Division
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Phase
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Study Sponsor Type
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Clinical Research Category
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Blinding/Masking
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Randomization
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Funding Type
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Keywords
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ADDITIONAL FIELDS FOR A COMPLETE STUDY RECORD
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Summary
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NCT Number
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Sponsor Protocol Number
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External IRB Number (if applicable)
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Lawson Numbers
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CTO Number
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eRES Number
eIRB INTERFACE
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A status of 'Tufts: IRB Preparation' (entered by Coordinator) sends the study record to the eIRB system
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With the above step, a connection between the two systems is established and subsequent Tufts IRB statuses will automatically populate the CTMS
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NOTE: External IRB approval (if applicable) must be entered manually
EPIC INTERFACE
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A status of 'Ready for Epic' (entered by CTO) sends the study to Epic
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With the above step, a connection between the two systems is established and subsequent updates will be sent over automatically
IMPORTANT PATIENT STATUSES
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Screen Failure
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Enrolled
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Off Study
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NOTE: The above information is automatically sent over to Epic for studies that have been flagged as such
HELPFUL REPORTS
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Study Enrollment Log
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Upcoming Visits
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Done Events
IMPORTANT STUDY CLOSURE STATUSES
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Sponsor Closeout Complete
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Tufts IRB Closeout Complete
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Study Completed/ Retired