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Analyze change history for safety distribution task

By distributing the previously added safety distribution tasks, you are sending out the safety data report emails to the intended recipients at the study sites—investigators (PIs), clinical research coordinators (CRCs), clinical research associates (CRAs), and other responsible study personnel.

In the course of a clinical trial, various modifications can be made to the safety distribution task, and it is vital to keep record of such changes for compliance and traceability reasons. Change history provides an exhaustive, structured log of events, helping you trace what they were, who performed them, and when.

To analyze the change history for a safety distribution task

  1. In the PV application header, select the ICSR tab.

  2. On the page that opens, from the left pane, select Safety Distribution.

    Accessing safety distribution
    Figure 1. Accessing safety distribution

  3. In Safety Distribution List, locate the task whose change history you want to analyze. Then from the Actions column, select More info_icon.png > Change History history_icon.png.

    Accessing change history for safety distribution task
    Figure 2. Accessing change history for safety distribution task

    Tip

    To access the change history for all the tasks in one comprehensive log, from the workspace toolbar of Safety Distribution List, select Change History history_icon.png.

  4. In the Change History dialog that opens, analyze the details of all the modifications made to the [entity name] from its creation and up to date.

    Analyzing change history for safety distribution task
    Figure 3. Analyzing change history for safety distribution task

You have analyzed the change history for the safety distribution task. You can now select OK to close the dialog and return to Safety Distribution List.

In this section:

In Pharmacovigilance, all the data on adverse events and other occurrences related or suspected to be related to investigational products. In eClinical, it is mostly data collected from subjects during clinical trials; this data helps to evaluate product safety and efficacy.

A person who is involved in a clinical trial and is designated to ensure that an investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations; for protecting the rights, safety, and welfare of subjects under the investigator's care; and for the control of drugs under investigation. The clinical investigator must meet requirements set forth by regulatory bodies.

See also: principal investigator

A person responsible for the successful planning, execution, and management of clinical trials. The CRC’s scope of work might include study preparation, site setup, patient recruitment, regulatory compliance control, data collection, and more.

In the eClinical system, the Clinical Research Coordinator (CRC) user role is granted to a person who works on a site with subjects and is responsible for entering data to EDC, ensuring the data is entered correctly according to all requirements, and answering queries from data managers on any questionable data pieces.

A person responsible for overseeing and monitoring a clinical trial to ensure it is conducted in compliance with regulatory standards and protocols. The CRA’s scope of work might include protocol review, site selection and initiation, monitoring, data entry control, and more.

In the eClinical system, the Clinical Research Associate (CRA) user role is assigned to a person who works with the sites, and in EDC, mainly has to make sure that the entered data is truthful to the source document. CRA checks the source document in a process called source data verification and ensures that everything entered by the clinical research coordinators is valid to avoid any discrepancies caused by human errors.