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CLINICAL TRIALS

The Humber Clinical Trials Simulation is a tool that allows you to take on the role of a Clinical Research professional related to site selection, participant selection, and study monitoring and reporting that are part of a clinical trial.

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THE COMPONENTS

The tool has three components: the Site Selector, the Participant Selector, and Monitoring and Reporting.

COMPONENTS

SITE SELECTOR

This module requires that you review potential sites and select those that meet the criteria, as outlined in the approved study protocol.

Details

PARTICIPANT SELECTOR

This module requires that you review potential participants' medical history and determine if they are eligible for participation in the study, according to the approved study protocol.

Details

MONITORING & REPORTING

This module requires that you monitor participants' progress through the trial and recognize and report participant responses, according to the approved study protocol.

Details

SITE SELECTOR

This exercise will take you through the process of site selection. To begin, read the protocol document thoroughly, and highlight areas which will help you in selecting appropriate sites for the study. Once you have reviewed the protocol, start the site selection procedure by reviewing the sites on the map, then submit your choices. Once you submit your selections, any errors will be highlighted.

Outcomes

    Identify features of trial sites that make them eligible to host a clinical research project, based on the approved protocol.
    Select trial sites that meet eligibility requirements for a clinical research project, based on the approved protocol.
    Respond to feedback on site review and selection, to improve skills appropriate to the responsibilities of a clinical research professional.

PARTICIPANT SELECTOR

This exercise will take you through the process of selecting participants for a trial. To begin, read the protocol document thoroughly and highlight important areas. Next, review all the potential participants on the list, and from these, choose a group of appropriate participants to recruit for the trial. Once you submit your selections, any errors will be highlighted.

Outcomes

    Identify features of potential study participants that make them eligible to enroll in a clinical research project, based on the approved protocol.
    Select participants that meet eligibility requirements for a clinical research project, based on the approved protocol.
    Respond to feedback on participant review and selection, to improve skills appropriate to the responsibilities of a clinical research professional.

MONITORING & REPORTING

The Monitoring and Reporting section is a simulation of the week-by-week trial monitoring process. Read the protocol first to familiarize yourself with what to look for when reviewing. Next, review each participant's progress, and flag and report any issues you notice. If your reported problem is valid, the participant will be removed and another participant recruited for the trial.

Outcomes

    Recognize features of participant responses that influence their continued participation in a clinical research project, based on the approved protocol.
    Select participant responses that require documentation and reporting, based on ICH Guidelines and the approved protocol.
    Document and report participant responses throughout a clinical research project in accordance with ICH Guidelines and the approved protocol.
    Respond to feedback on monitoring and reporting of participant responses throughout the clinical research project, to improve skills appropriate to the responsibilities of a clinical research professional.

RESOURCES

Below are links to further reference material.

Help

Information about using this tool can be found in the help page. This includes information on logging in and each of the components presented in this tool. Note that this page does not include any information about Blackboard, or other tools.

Help Page