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Lock/Unlock protocol deviation record

In CTMS, whenever a protocol deviation occurs, you can record it by using a protocol deviation template. Recording a deviation is necessary for avoiding such deviation from occurring in the future, or it can be a requirement of the sponsor as well.

In case you have a record added that for any reason must not be amended or otherwise interacted with by other system users, then you can lock a record and prevent it from alterations. Later, whenever required, you can unlock the record to allow the system users to update it.

To lock or unlock a protocol deviation record

  1. Access the study management page in one of the following ways:

    • In the CTMS application header, select the DASHBOARD tab and then select the study dashboard of your interest.

      Accessing study management from dashboard
      Figure 1. Accessing study management from dashboard

    • In the CTMS application header, select the STUDY MANAGEMENT tab. Then from the Study Data List table, select the study name of your interest.

      Accessing study management from study data list
      Figure 2. Accessing study management from study data list

  2. On the study page, in the left pane, expand Protocol Deviation and select Protocol Deviation Record.

  3. On the page that opens, from the content panel, select the needed tab.

    Accessing protocol deviation records
    Figure 3. Accessing protocol deviation records

    Tip

    If the same protocol deviation template is associated with two or more entities—study, site, or subject—they are displayed in a single tab named through a slash, such as Study/Site, Study/Site/Subject, or else. Whereas, the entities associated with unique template forms are displayed in separate tabs, such as Study, Site, or Subject.

  4. In the table, locate the record you want to lock or unlock and then perform any of the following actions:

    1. Next to the record you want to lock, select More more_icon.png > Lock lock_icon.png.

    2. Next to the locked record you want to unlock, select More more_icon.png > Unlock unlock_icon.png.

    Locing PD record
    Figure 4. Locing PD record

Once the needed option is selected, the record is locked or unlocked.

In this section:

A divergence from the IRB or sponsor-approved study design or procedures defined in the protocol, consent document, or study materials. The deviation can occur due to multiple reasons, such as a subject missing their visit, enrolling a participant who did not meet all the inclusion criteria, failing to perform a required lab test, and so on.

Any person, company, institution, group, or organization that is a client of EDETEK and a user of the eClinical system.

In the eClinical system, the Sponsor role is assigned to the user who oversees or pays for a clinical trial and collects and analyzes the data. Before the study goes live, the Sponsor users work closely with the data managers, configuring CRFs and other aspects to make sure everything meets their requirements before giving the green light for the study to go live. In the course of a trial, the Sponsor users make requests for amendments in the system according to a new protocol version, changes in business requirements, or other needs.