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View safety distribution task details

By adding the safety distribution tasks in PV, you automate the process of sending out the safety data reports to investigators (PIs), clinical research coordinators (CRCs), clinical research associates (CRAs), and other responsible study personnel.

Once the safety data is distributed, you can access all the pertinent details of the task in the Distributed status for review purposes and to perform some available actions.

To view the safety distribution task details

  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 according to which you want to distribute safety data. Then select the task ID or from the Actions column, select View info_icon.png.

    Accessing distributed task details
    Figure 2. Accessing distributed task details

  4. On the task details page, view the available details and perform actions as explained in the following table.

    Viewing details of distributed task
    Figure 3. Viewing details of distributed task

    Element

    Details

    Task ID

    Represents the unique identifier of the safety distribution task.

    Status*

    Represents the current status of the safety distribution task; for the task whose data is sent out, is set to Distributed.

    Task Type*

    Represents the method of how the safety distribution task was added to the system; for the task being created from scratch is set to Manual Create.

    Study of Origin*

    Represents the study to which the safety data belongs (for which the SUSAR, SAE, or other event occurred).

    Country of Origin*

    Represents the country where the safety data for the occurred event was collected.

    Site of Origin*

    Represents the unique identifier of the site where the safety data was collected.

    Include in Gap Pack*

    The positioning of the toggle (not editable) indicates the following:

    • If turned on, the report sent with this safety distribution task can be used in the future safety data distributions sent according to new tasks.

      For instance, the current safety distribution task for Site 001 has Include in Gap Pack enabled when the safety data is sent to the recipients of Site 001.

      Then the safety distribution task is created for Site 002, with Include in Gap Pack also enabled. Once you distribute the safety data according to this new task, the safety data report already distributed to Site 001 is now automatically sent to Site 002.

    • If turned off, the data is distributed once to the intended site, and no further automation events are expected for this safety distribution task.

    Email Template*

    Represents the template outlining the contents of the safety distribution letter.

    The email templates are predefined according to the business requirements of the sponsor by EDETEK administrators upon request.

    File*

    Represents the linked name of the safety data report file that was distributed according to this task. Select the link to download the file to your computer.

    Cover Letter

    Represents the linked name of the cover letter file with auxiliary details on your safety report. Select the link to download the file to your computer.

    Associated ICSR Record

    Represents the unique identifier of the ICSR existing in PV that relates to the safety data distributed according to this task.

    Associated Submission Record

    Represents the unique identifier of the submission record created in PV for the ICSR related to the safety data distributed according to this task.

    Email Subject

    Represents the subject of the letter sent out according to this safety distribution task.

    Workspace toolbar actions

    Audit Trail

    Select list_icon_gray.png to access the descriptive log of operations—from recipient selection to data sending and delivery details.

    Change History

    Select history_icon.png to access the structured log of operations—from recipient selection to data sending and delivery details.

    Export

    Select export_icon.png to extract the safety report pertaining to this task.

    Distribute

    Select submit_icon.png to distribute the safety data again to the same or different sites.

    Recipient List

    First Name

    Represents the first name of the recipient to whom the safety data was sent.

    Last Name

    Represents the last name of the recipient to whom the safety data was sent.

    Email

    Represents the email address of the recipient to which the safety data was sent.

    Study / Country / Site

    Represents the name of the study, country, and site code—divided by a slash—where the safety data recipient is operating.

    Status

    Represents the current status of the safety data delivery as follows:

    • Sent: the safety data email is sent by the PV system but not yet delivered to the recipient.

    • Delivered: the safety data email is already delivered to the recipient but not yet viewed by them.

    • Viewed: the safety data email is already opened by the recipient.

    • Bounced: the mail server of the recipient rejected the email.

    • Failed: technical failure occurred, preventing safety data distribution.

    Sent Time

    Represents the exact date, time, and time zone indicator when the safety data email is sent by the PV system.

    Delivered Time

    Represents the exact date, time, and time zone indicator when the safety data email is delivered to the recipient's email.

    Viewed Time

    Represents the exact date, time, and time zone indicator when the safety data email is opened by the recipient.

    Creator

    Represents the name of the PV user who created the safety distribution task.

    Created Time

    Represents the exact date, time, and time zone indicator when the safety distribution task was created.

    Modified By

    Represents the name of the user who performed the latest modification action to the safety distribution task or displays system if the latest change was introduced automatically by the PV system.

    Modified Time

    Represents the exact date, time, and time zone indicator of the latest modification action.

    Recipient list actions

    Resend

    Select send_email_icon.png to send the report again to the same recipients, for instance, for technical reasons.

    Audit Trail

    Select list_icon_gray.png to access the descriptive log of operations—from task creation to adding recipients and other details.

    Change History

    Select history_icon.png to access the structured log of operations—from task creation to adding recipients and other details.

    Back to List

    Select arrow_left_icon.png to discard the changes without saving and return to Safety Distribution List.

You have reviewed the details of the distributed task.

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.

In a clinical trial, a location where the subject treatment and drug dispensation occur. It can be a hospital, a private laboratory, or other institutions.