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Add safety distribution task

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.

Tip

The list of recipients is preconfigured in CTMS by providing the safety distribution level of access to the site personnel.

To add 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. From the workspace toolbar of Safety Distribution List, select New add_new_icon.png.

    Selecting option to add safety distribution task
    Figure 2. Selecting option to add safety distribution task

  4. In the form that opens, enter the safety distribution task details as explained in the following table.

    Completing safety distribution task details
    Figure 3. Completing safety distribution task details

    Tip

    In the following table, mandatory elements are marked with an asterisk (*).

    Element

    Details

    Task ID

    Represents the empty, uneditable field to be autopopulated with the unique identifier of the safety distribution task once it is saved.

    Status*

    Represents the current status of the safety distribution task; for the task being created is set to Ready to Distribute by default.

    Task Type*

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

    Study of Origin*

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

    The studies on the list are based on the access permission granted to you via ADMIN.

    Country of Origin*

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

    Site of Origin*

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

    The sites on the list are based on the access permission granted to you via ADMIN.

    Include in Gap Pack*

    Turn the toggle on or off as follows:

    • 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, you create a safety distribution task for Site 001 and turn on the Include in Gap Pack toggle. Then the safety data is distributed—email sent out 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 sent 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*

    Select the template that outlines 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*

    Select upload_icon.png to upload the safety data report file that you want to be distributed according to this task.

    Cover Letter

    Select upload_icon.png to upload the cover letter file with auxiliary details to your safety report.

    Delete

    Select trash_can_icon.png next to the uploaded safety data or cover letter file to remove it.

    Associated ICSR Record

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

    Associated Submission Record

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

    Email Subject

    The field is editable to enter the subject of the letter to be sent out according to this safety distribution task. However, you can leave it blank to be autopopulated with the safety data details as soon as you save the task.

    SAVE

    Select save_button_red_white.png to implement the changes.

    Back to List

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

Once saved, the task is created. You can now distribute the safety data.

Tip

The task details remain editable until the data is distributed.

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.

An eClinical application that is mainly used to manage and control the personnel, communication, budget, progress, expenses, documents, and declaration involved in the entire clinical trial. It provides study and site management, study quality control, study progress tracking, project management, risk management, reports, and a visualized dashboard.

Get to know all the possibilities of the app with the comprehensive CTMS User Guide.

An eClinical application that represents an administrative system used to manage users, authorities, and sponsors at the company level. It provides studies, sites, and sponsors with high-granularity role-based access management across all eClinical applications.

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.