CRMS in the Study Lifecycle

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Contents

Introduction

The Clinical Research Management System (CRMS) is an on-line tool that provides centralized, role-based access to information about studies and their participants. Administrators, financial specialists, and the study team use this information to help track their study and meet billing compliance requirements, throughout the study. CRMS is linked to Epic for participant demographic data, and to the electronic Institutional Review Board (eIRB) for basic study information.

Effective July 1, 2008, all new studies submitted to the IRB that require a Prospective Reimbursement Analysis (PRA) must use CRMS. CRMS will be optional for all other studies unless otherwise mandated. Further information on the PRA process can be found in the online Orientation to Clinical Research Billing trainee course in MyLearning.

This help topic will guide you through the uses of CRMS during the phases of a study: preparation, IRB review, IRB Approval and Going Active, Enrolling Participants, Amendments, Study Closure to Accrual and Termination. It is intended for CRMS users, especially study team members. Throughout this topic, links are provided to more detailed instructions and checklists.

Study Preparation

In this phase, complete the eIRB application. Pay special attention to completing study team membership in eIRB as this is the mechanism for granting access to the study in CRMS. After you submit the application to the IRB, some of the key fields in eIRB will be pushed into CRMS overnight. The fields pushed into CRMS are controlled by eIRB, and are recognized by an Image:EIRB_larger_icon.gif icon next to them. In order to change eIRB controlled fields in CRMS, they must be changed in eIRB, as will be discussed in greater detail in the amendment section.

IRB Review

When your study is submitted to the IRB, the data in eIRB are locked during the review, and the corresponding CRMS fields are also locked. This is the time to start filling in the blank CRMS fields that are not connected to eIRB. Log in to CRMS. On your CRMS home page, you should see the study in your My Studies list under Pre-IRB. Click on one of the links to the study, and look through the various tabs for the study. (For more information about the study views, see the Guide to Study Tab Views help topic.)

At least do the following:

  • Go to the General tab and press the Edit button. Choose the correct Department for PI's Department/Division
  • Go to the Study Team tab and press the Edit button. Define any Internal or External Contacts for the study (e.g., a monitor).

This is also a good time to begin developing an eligibility checklist. By default, you get a one item "This person is eligible" checklist to record the participant's eligibility for a study. If you choose to, you can build a checklist with an item for each eligibility criterion, to match your research protocol. See the Eligibility Checklists help topic for more information.

It is not recommended that you begin defining the consents that study participants will sign at this time. The IRB needs to approve them first and entering them is a relatively quick process that can be completed after approval.

IRB Approval and Going Active

Once the IRB has approved your study, the IRB's initial approval date and expiration date will automatically be updated and appear in the CRMS.

At this time you should:

  1. Review the Eligibility checklist you created and make sure it is accurate. Then activate it by choosing Make Active on the Eligibility Checklist page. Note if you use the default eligibility checklist, you do not need to do anything. It will be there automatically when going through the enrollment process.
  2. Define and Activate your consent form(s). See the Defining Consents help topic for more information.
  3. Under the General tab, change CRMS Status to Active if you are ready to accrue participants.
  4. Under the Sites tab (if applicable), add sites and site information.
  5. Under the IND/IDE tab (if applicable), add appropriate data.

Enrolling Participants

The process of enrolling participants has six potential states: candidate, consented, eligible, enrolled, follow up and off study.

  • Candidate state: a person is being considered for participation in the study. A person who is no longer being considered for a trial should be moved to the Not Candidate status.
  • Consented state: the individual has given informed consent to participate in the study.
  • Eligible stage: the individual's eligibility for participation in the study is determined by answering the eligibilty question. A person who does not meet eligibility will show as Not Eligible on the Enrollment Tab. A person who is eligible for the study will show as Eligible on the Enrollment Tab.
  • Enrolled: the individual is actively participating in the study.
  • Follow up: the individual has completed all study related procedures (this status is best used when a person is being followed for survival or some other specified time that does not include any potential for study participant bills to be generated.
  • Off study: The indivdual will no longer be contacted for this study.

For more information, please see the Enrolling a Participant help topic.

Ongoing Throughout the Study

All enrollment data need to be kept up-to-date in "real time" so that the Clinical Research Billing Team can divert any research charges. This includes the on study, start intervention, last intervention, and off study dates. How these dates are defined depends on your actual protocol. See the Research Billing Orientation training at www.hopkinsinteractive.com for more information.

Additionally, the Subject Progress field is a good place to record real time information on a participant's progress on a study (e.g., Cycle 1) or to indicate the next step for this person (e.g., Cycle 2 due on 10/01/08).

Amendments/ FSAs/ Continuing Reviews

Amendments made to the eIRB application will not appear in CRMS until the IRB approves them. As your study team membership changes (i.e., team members leave your group and new employees join), remember to add or delete people in eIRB so that they have appropriate access to your study in CRMS.

When a continuing review is granted by the IRB, the new IRB expiration date will automatically be updated in the "IRB Expiration Date" in CRMS.

If your study amendment includes a change in consent, be sure to change the study consent information in CRMS so that you are documenting the correct version signed by the participant signed!

Study Closes to Accrual

When your study closes to accrual, you need record this study status change in CRMS:

  • When your study is closed to accrual, you can no longer add participants to the study. Go to the Enrollment tab and make sure all of the participants are listed before you change the status to Closed. You must continue to update the participants' study progress.
  • Go to the General tab and change the study Status to Closed. Fields will pop up, allowing you to record the Closed to Accrual Date, select who the study was Closed By from a list of roles, and the Reason Closed, also from a menu of options.

Closure information is seen on the Regulatory Tab. Closure information can be changed on this Tab also but it is more convenient to do this from the General Tab.

Study Termination

When a study is terminated in eIRB, the IRB Termination Date and status will be pulled into CRMS from eIRB.

Getting More Help

Clinical Research Management System (CRMS) Support Pool:

e-mail: crmshelp@jhmi.edu
phone: 443-615-1186

CRMS Training Website:

http://www.hopkinsinteractive.com

CRMS Website:

https://research-prod.jhmi.edu

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