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Analyze audit trail 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.

An audit trail is a documentation that descriptively records all the operations made with the safety distribution tasks. Keeping the audit trail makes it possible to reconstruct the course of events, and the lack of the audit trail can be considered a serious breach of data integrity.

To analyze the audit trail 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 audit trail you want to analyze. Then from the Actions column, select More info_icon.png > Audit Trail list_icon_gray.png.

    Accessing audit trail for safety distribution task
    Figure 2. Accessing audit trail for safety distribution task

    Tip

    To access the audit trail for all the tasks in one comprehensive log, from the workspace toolbar of Safety Distribution List, select Audit Trail list_icon_gray.png.

  4. In the Audit Trail dialog that opens, analyze the details of all the operations performed with the safety distribution task from its creation and up to date.

    Analyzing audit trail for safety distribution task
    Figure 3. Analyzing audit trail for safety distribution task

You have analyzed the audit trail 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.