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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:

  • MCA In Progress for initiation

  • MCA Complete when signed

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  • CTA In Progress for initiation

  • 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:

  • Budget In Progress upon initiation 

  • 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

  • Study Title

  • Principal Investigator

  • Primary Objective

  • Primary Purpose

  • Department

  • Division

  • Phase

  • Study Sponsor Type

  • Clinical Research Category

  • Blinding/Masking

  • Randomization

  • Funding Type

  • Keywords

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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

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  • 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

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  • 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

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  • Screen Failure

  • Enrolled

  • 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

  • Upcoming Visits

  • Done Events

IMPORTANT STUDY CLOSURE STATUSES

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  • Sponsor Closeout Complete

  • Tufts IRB Closeout Complete

  • Study Completed/ Retired

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