Guide to Study Tab Views

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Contents

Overview

The Clinical Research Management Tool (CRMS) is an on-line tool for managing information about clinical research studies and their participants. This help topic will review how to navigate through CRMS.

When you log into CRMS, the home page you see is the My Studies page, which lists the studies you are on, grouped by your role on those studies.

The annotations, by number, highlight these parts of the page:

  1. At the top right of the page is a row of external links, that is, links that take you out of the application. The Help link opens a new browser window on the CRMS Help site, and Logout logs you out.
  2. Your name is centered near the top of the page. Everything you see and do is logged, and must be done under your own name.
  3. At the left of the page is the left hand navigation. Most of these items have their own help topic. All CRMS pages have these items in the left hand navigation. When you are looking at a study, there are additional items related to that study.
  4. We are on the PI tab, and there is one other view, the Study Team tab. You will only see tabs that apply to you, e.g., a research coordinator would only see the Study Team Tab.
  5. IMPORTANT, the default view is only those studies with an Active Status in CRMS. Click on the CRMS Status dropdown box to see all statuses.

CRMS is linked to the electronic Institutional Review Board (eIRB), used by the Johns Hopkins Medicine Institutional Review Board (JHMIRB). Fields linked to eIRB, identified by an Image: EIRB_larger_icon.gif icon, can only be changed in eIRB. Changes made in eIRB are propagated to CRMS the evening after they are made. CRMS will not allow you to edit these fields.

Note that all tabs are views into the same collection of information. Fields may appear under more than one tab, and updating any one of them updates the underlying information.

The rest of this topic describes the tab views of a study. The tab list depends on the study, which may or may not have information in certain categories. It also depends on your roles, which control your access to information. All tabs that might be present are described below.

General Tab

The General Tab is the home page for a study. But before discussing specifics, have a look at the general layout of an example study page:

These differences are highlighted:

  1. These are the new left menu items that show up because we are looking at a single study. The top item, CRMS-7553, is a link back to this tab, the study's "home page." Protocol Consents, Eligibility Criteria, and Enrollment have their own help topics. . Regulatory Logs can be used to record information/correspondence about your study.
  2. These tabs provide views into the information about your study. The Enrollment tab provides the same view as the Enrollment button in the left hand navigation

The content under the General tab contains the basic information that identifies the study and provides some organizational overview:

  • Tracking numbers and codes,
  • PI name and department/division,
  • Whether multiple sites are involved, and whether Hopkins is the coordinating center if there are,
  • Basic information about the participant group (adult/pediatric, male/female), and
  • Current accruals.

Study Team Tab

Study team membership and roles are shown under the Study Team tab. Most of this information is linked to eIRB. There are some exceptions, so if you are allowed to edit this page you can add team members and assign them these roles:

  • Q/A Specialist: the person responsible for the internal auditing or monitoring of the study.
  • Administrative Program Managers: people who are involved with the study budget and need access to the Financial Tab view of this study.

Again, CRMS will not allow you to assign any roles that are linked to eIRB.

Internal and External Contacts sections can be used as a centralized repository of contact information for the people your team members need to contact often, like your study's External Monitor.

Regulatory/QA Tab

The Regulatory/QA tab includes:

  • A direct link to your study in eIRB - just click on the blue "Go to eIRB" hyperlink. If you have an older browser, you may get an error message - just refresh the page and this functionality should work.
  • Important dates: Initial IRB Approval Date, Last Approved Amendment Date, Last Approved Continuing Review Date, IRB Expiration Date, and IRB Termination Date are linked to eIRB. Other dates should be updated by the study team.
  • Study closure information: date, responsible role, and reason closed.
  • Accrual information: Projected accruals are defined in eIRB. Actual accruals, maintained in CRMS.
  • The Admin section shows if your study and study participant information is being sent to Epic. Any questions about this information should be sent to crmshelp@jhmi.edu.
  • Insurance Clearance Information is found at the bottom of this page. If your study has a Prospective Reimbursement Analysis then the PRA field will show as YES. If YES, then you must use the CRMS Insurance Clearance functionality and track study participation in CRMS!

Financial Tab

Access to the Financial tab is limited to those people with responsibility for the budget. Data items include:

  • Dates indicative of the length of the study.
  • Sponsors.
  • Projected and actual accruals, because of costs associated with participants.
  • Screen failures, because of costs associated with each failure and a possible limit on the number of failures. Screen failures are usually defined as participants who were screened for the study but were determined to be not eligible for enrollment on the study.

When adding sponsors, you can enter a number of items about the sponsor:

  • Whether their sponsorship is material, financial, or both.
  • Contract and budget dates.
  • Certain fees.
  • Contact information.

For detailed information, refer to the document "Entering a Budget Number in CRMS" found on the Main CRMS Help page.

Sites Tab

The Sites Tab tab provides information about sites participating in the study. Data items include:

  • The PI for each site, with contact information.
  • Important dates, such as the date the IRB approved the site's participation.
  • The status of the site's study, which is on its own schedule.
  • Accruals at this site.

The sites listed under this tab are used under the Enrollment tab to help you maintain accurate enrollment information. For example, if you are conducting a study at other sites and are responsible for study participant tracking at these sites, you would define those sites on the Sites Tab. Then, when documenting the Enrollment process in CRMS, those sites will show in the consenting dropdown box. If you choose a site when documenting consent, that site will show on the Enrollment Tab instead of "Hopkins".

Drug/Device Tab

The Drug/Device tab is a place to record if a study has an IND or IDE. In addition, the study team can document information about the IND/IDE.

Enrollment Tab

The Enrollment tab tracks the enrollment status of everyone on your study. As described in the Enrolling a Participant help topic, this is a multi-stage process, with information gathered at each step. That information is used for essential regulatory reporting and research billing compliance, as well as conducting the study.

Here is an example Enrollment tab view:

The numbered annotations highlight these parts of the page:

  1. The default view lists all participants in descending order of Consent Date. The highlighted choices allow you to see just what you want to see. You can limit results by enrollment status and site, change the sort key and order, and see all participants on one page instead of in batches. If Hopkins is not the Coordinating Center of a multi-site study, you will only see Hopkins participants. For studies where you are the coordinating center you would name people by some de-identified process such as Subject #1, etc.
  2. These buttons are used to move participants through the stages of the enrollment process, as described in the Enrolling a Participant help topic.
  3. The Search for Patient button allows you to search for your participant's demographic information as found in EPR. The Create New Patient button would only be used if the person has not seen here at Johns Hopkins (i.e., does not have a JHH medical record number). All of the participants above were added from one of these two buttons.
  4. A participant's study progress is summarized in these fields, some of which can be entered directly from this page. Fields include tracking numbers, milestone dates, treatment related dates, and a shortcut for marking a participant not eligible.

For complete details, see the Enrolling a Participant help topic.

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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