Enrolling a Participant

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The Stages of the Enrollment Process

In CRMS, enrolling a participant to a study is a multi-step process that progresses through these stages Enrollment Status:

  • Candidate: This person is being considered for participation in the study.
  • Consented: This person has given informed consent to participation in the study.
  • Eligible: This person meets eligibility requirements for the study.
  • Enrolled: This person is enrolled in the study.
  • Follow Up: This person is being followed for survival, they are no longer receiving any study interventions.
  • Off Study: This person is off the study and will no longer be contacted or seen for the study.

Reaching Candidate Status

Use the first option below to register a candidate that has a Johns Hopkins Hospital (JHH) History Number. Otherwise, use the second option.

Registering an Individual With a JHH History Number

To register an individual with a JHH History Number as a Candidate for your study:

  1. Go to the Enrollment Tab for your study.
  2. Choose Search for Patient:
  3. Enter the individual's JHH History Number and click on Search on CRMS and EPR.
  4. If the individual is listed under the CRMS Patient heading, and if that information does not match the EPR information, press Update Patient from EPR to reconcile them.
  5. If nothing is listed under the CRMS Patient heading, you have to add this individual:
    1. Select Create New Patient from EPR. Your study's Protocol Number will be inserted automatically.
    2. You must enter the participant's race and ethnicity data by hand, using the values in EPR. These data do not come over directly from EPR. If you do not know this information at the time you enter the participant as a Candidate, mark 'Unknown' and remember to update this information later.
  6. Either:
    • Select Save as Candidate. This takes you back to the Enrollment tab, where this individual's enrollment status for this project will be Candidate.
    • Select Save as Consented, if the individual has consented. This is a shortcut that saves a trip to the Enrollment tab. After entering consent form information, you end up at the Enrollment tab, where this individual's enrollment status will be Consented.

Registering an Individual Without a JHH History Number

To register an individual without a JHH History Number as a Candidate for your study:

  1. Go to the Enrollment Tab for your study.
  2. Select Create New Patient:
  3. Answer No to the question about a JHH history number.
  4. Select Create New Patient on this page, too:
  5. Enter the relevant information. Your study's Protocol Number will be inserted automatically.
  6. Either:
    • Select Save patient. This takes you back to the Enrollment tab, where this individual's enrollment status for this project will be Candidate.
    • Select Save as Consented, if the individual has consented. This is a shortcut that saves a trip to the Enrollment tab. After entering consent form information, you end up at the Enrollment tab, where this individual's enrollment status will be Consented.

Reaching Consented Status

To document that an individual has reached Consented status on your study:

  1. Go to the Enrollment Tab for your study.
  2. Check the box next to the name of the individual to be entered.
  3. Click Consent, found at the top and bottom of the enrollment list:
  4. Choose the Consent form that matches the one the signed by the participant. Only active consent forms are listed. (For more on managing consent forms, see Defining Consents.)
  5. Check the box for Reconsent if this individual is re-consenting for this study, that is, signing a consent form after already signing an earlier version. This would never be checked if this is the first time a participant signed a consent form for a study.
  6. If the study has an Embedded Agreement, those questions will appear next. Mark the answers given on the consent form:
  7. If the Consentor who also signed the consent form is an IRB-approved Study Team Consentor, choose that name from the Consented by pulldown menu:
  8. If the Consentor is not IRB-approved, select Unauthorized as the consentor and enter the person's name in the box provided. Note that this event is a protocol violation and must be reported to the IRB.
  9. If the Consentor is from an outside site on a Coordinating Center study, select the appropriate site name, and enter the study team member's name in box provided.
  10. Enter the date that the individual signed the consent form.
  11. Either:
    • Select Submit. This takes you back to the Enrollment tab, where this individual's enrollment status for this project will be "Consented".
    • Select Submit and Go To Eligibility. This takes you directly to the Eligibility Checklists for the study. On the Enrollment tab, this individual's enrollment status will be Consented until an eligibility checklist is completed.
    • Select Cancel. This takes you back to the Enrollment tab, without changing participant's enrollment status or consent information.

For more information on managing consent forms, see the Defining Consents help topic.

Reaching Eligible Status

To document the eligibility status of a participant on your study, you must complete the appropriate eligibility checklist for the individual and record the results.

  1. Go to the Enrollment Tab for your study.
  2. Check the box next to the individual's name.
  3. Click on Eligibility, found at the top and bottom of the enrollment list:
  4. Choose the Eligibility form that matches that for the participant. Only active eligibility checklists are listed. (For more on managing eligibility checklists see the Eligibility Checklists help topic.)
  5. Complete the eligibility checklist by entering responses to all criteria.
  6. Select Check eligibility to run the automated check of the answers you put in.
  7. If the eligibility check returns "is Eligible for study:"
    1. Enter the name of the study team member who verified eligibility from the dropdown menu at the bottom left of the screen. This may or may not be the staff member entering the checklist information. If the name of the study team member who verified eligibility is not in the list because the team member is at an outside site, select the site name in the dropdown menu at the bottom left of the screen and enter the name in the If outside site, enter name box.
    2. Select Mark as Eligible. This takes you back to the Enrollment tab, where this individual's enrollment status for this project will be Eligible.
  8. Choose one of the following if the eligibility check returns "is Not eligible for study:"
    • Re-answer/correct the questions and re-check eligibility. If the individual is now eligible, proceed as above.
    • Select Save to save the checklist, for completion later. Any information already entered will be saved. After saving an incomplete checklist, this symbol Image:Incomplete_larger.png will show next to the person's consent status on the enrollment tab to represent an eligibility checklist is in progress.
    • Select Close without saving changes. Any information entered will be lost. Either of these last two options will take you back to the Enrollment tab, where this individual's enrollment status for this project will still be Consented.
    • Confirm that the individual was not eligible for the study:
      1. At the bottom of the screen, from the dropdown menu, select the name of the study team member who verified eligibility. This may or may not be the staff member entering the checklist information.
      2. Select Mark as NOT eligible. This takes you back to the Enrollment tab, where this individual's enrollment status for this project will be Not Eligible.

Reaching Enrolled Status

To document that an individual has reached Enrolled status on your study:

  1. Go to the Enrollment Tab for your study.
  2. Check the box next to the individual's name.
  3. Click on Enroll, found at the top and bottom of the enrollment list:
  4. Enter the participant's assigned Subject number in the box.
  5. Choose Submit. This takes you back to the Enrollment tab, where this individual's enrollment status for this project will be Enrolled.

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.jhmi.edu

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