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

Study Calendar is created and notification sent for review

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Enter all required fields in the Study Summary page

Submit a Study Calendar creation request in REDCap

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Review and verify the calendar's clinical details

Review and verify the calendar's financial details

Setup Payment Milestones

2 STUDY ACTIVATION

Use the Study Activation Form as your guide to make sure all elements are in place prior to activation.

Coordinator

CTO

Enter Study Status:

MCA In Progress for initiation
MCA Complete when signed

CTA In Progress for initiation
CTA Executed when signed

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

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:

Budget In Progress upon initiation
Budget Finalized when negotiations are complete

3 STUDY CONDUCT

Make sure study subjects are marked enrolled and off-study as soon as possible to avoid billing issues

Coordinator

CTO

Run relevant reports periodically to perform quality check on the data

Keep track of invoiceable items

Add study subject records for each study with Patient Study Status of Screen Failure or Enrolled as applicable

Associate appropriate Study Calendar to generate a Patient Schedule

Update Visit/ Event Status. If relevant, don't forget to record invoiceable items!

Run relevant reports periodically to perform quality check on the data

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

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

Study Title
Principal Investigator
Primary Objective
Primary Purpose
Department
Division
Phase
Study Sponsor Type
Clinical Research Category
Blinding/Masking
Randomization
Funding Type
Keywords

ADDITIONAL FIELDS FOR A COMPLETE STUDY RECORD

Summary
NCT Number
Sponsor Protocol Number
External IRB Number (if applicable)
Lawson Numbers
CTO Number
eRES Number

eIRB INTERFACE

A status of 'Tufts: IRB Preparation' (entered by Coordinator) sends the study record to the eIRB system
With the above step, a connection between the two systems is established and subsequent Tufts IRB statuses will automatically populate the CTMS
NOTE: External IRB approval (if applicable) must be entered manually

EPIC INTERFACE

A status of 'Ready for Epic' (entered by CTO) sends the study to Epic
With the above step, a connection between the two systems is established and subsequent updates will be sent over automatically

IMPORTANT PATIENT STATUSES

Screen Failure
Enrolled
Off Study

NOTE: The above information is automatically sent over to Epic for studies that have been flagged as such

HELPFUL REPORTS

Study Enrollment Log
Upcoming Visits
Done Events

IMPORTANT STUDY CLOSURE STATUSES

Sponsor Closeout Complete
Tufts IRB Closeout Complete
Study Completed/ Retired