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Revoke subject replacement approval/rejection

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.

When subject replacement approval is enabled for the study, each request for subject replacement must be validated by the personnel in charge. However, if the decision was made prematurely or by mistake, you can revoke the approval status of the subject replacement request.

To revoke the subject replacement approval or rejection

  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 to revoke
    Figure 2. Accessing subject replacement request to revoke

  4. In the Subject Replacement dialog that appears, select REVOKE.

    Revoking subject replacement status
    Figure 3. Revoking subject replacement status

  5. In the confirmation dialog that appears, select CONFIRM to proceed with your action.

    Confirming to revoke subject replacement status
    Figure 4. Confirming to revoke subject replacement status

Once confirmed, the previous replacement status of the subject is revoked and becomes Replacement Pending Approval. The user in charge now has to review and approve or reject this replacement request.

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.