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

RA

 

 

 

 

 

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

RA

 

 

 

 

 

 

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

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

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