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Approve/Reject subject replacement

During a clinical trial, the subject who is already enrolled can drop out of the study or decide to cease their participation due to various reasons. To maintain the study conduct uninterrupted and treatment assignment balanced, it is possible to replace such subjects with other ones that fit the same criteria and meet the expectations to be enrolled in the same cohort and arm and receive the same treatment.

To introduce an additional tier of scrutiny, you can enable the subject replacement approval functionality for your study. This way, the personnel in charge must review and approve the requests created for the subject replacement.

To approve or reject the subject replacement

  1. In the IWRS application header, select the SUBJECT tab.

  2. From Subject List that opens, select the needed site and subject.

    Selecting site and subject
    Figure 1. Selecting site and subject

  3. On the Subject Information page that opens, select SUBJECT REPLACEMENT.

    Accessing subject replacement request approval
    Figure 2. Accessing subject replacement request approval

  4. In the Subject Replacement dialog that appears, review the request as suggested in the following table.

    Approving subject replacement request
    Figure 3. Approving subject replacement request

    Tip

    In the following table, mandatory elements are marked with an asterisk (*).

    Element

    Details

    Decision*

    Select one of the following:

    • Approve: to confirm the request and enable the system to replace the current subject with the new one as soon as the appropriate one is enrolled.

    • Reject: to decline the request and prevent the replacement of the current subject.

    Comments*

    Enter the details to support your decision. The field is only mandatory upon rejection; for approval, the comments are optional.

    SAVE

    Select save_button_red.png to implement the changes.

    CANCEL REQUEST

    Select cancel_request_button_white_red.png to neither approve nor reject, but discard the request if it was made by mistake or became irrelevant.

Once saved, the result differs based on your decision:

  • If approved, the subject's status becomes Ready for Replacement and this subject will be replaced as soon as the appropriate one is enrolled in the study.

  • If rejected, the subject's replacement status becomes Rejected and this subject cannot be replaced. In the Subject Replacement dialog, the NEW REQUEST button appears to reinitiate the replacement request if needed.

    Reinitiating replacement request upon rejection
    Figure 4. Reinitiating replacement request upon rejection

Upon approval or rejection, the respective record is made in the Replacement Details module of IWRS, where you can analyze the result of the subject replacement process.

In this section:

A group of subjects who share a set of specific factors (characteristics) that is first defined and composed, then studied or tracked over a given time period. In a clinical trial, outlining the study cohort begins with clearly defined, study-specific inclusion criteria.

A group of subjects formed as a result of randomization for blinding purposes that has its own schedule of visits and treatment plan according to a study protocol.

Medical care given to a subject to mitigate or cure an illness, injury, or reduced health status. In a clinical trial, treatment may include prescribed drugs, biologics, devices, physical or psychotherapies, and such other procedures.