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View ICSR submissions

This PV functionality focuses on the expedited submission of ICSRs to the authorities, affiliates, partners, investigators, or ethics committees. The form of submission acceptable to each authority or partner is different.

For example, a sponsor of the clinical trial for the Investigational New Drug (IND) must submit Serious and Unexpected Suspected Adverse Reactions (SUSAR) to FDA in the IND safety report within 7 or 15 days depending on the seriousness criteria. 

Under the SUBMISSION tab, you can track the status of the ICSR submissions based on the study access permissions granted to you via ADMIN. Meaning that you can only see the cases that belong to the studies to which you have access.

The submission list is organized by creation time, so the latest generated submissions are at the top. Here, you can monitor the progress of submission processes, transmit them simultaneously in bulk, or update their ACK message in bulk.

When working with multiple submission records generated via the E2B Gateway approach, you can track them by the following indicator statuses:

  • EDI In: this indicator turns green when the submitted XML message has been successfully sent out to EDETEK’s EDI service. This indicator can have the Pending, Success, or Failed status.

  • EDI Out: this indicator turns green when the submitted XML message has been sent out from EDETEK’s EDI service and it is on the way to the receiving destination via the Internet. This indicator can have the Pending, Success, or Failed status.

  • MDN Received: this indicator turns green when the submitted XML message has reached the receiver but has not yet been loaded into the receiver’s local safety system. This indicator can have the Pending or Success status.

  • ACK Received: this indicator denotes the status of the acknowledgment (ACK) message after the receiver gets the submitted XML file. This indicator can have the Pending, Warning, Success, or Failed status.

To view submission records in bulk

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

  2. On the Submission List page that opens, view the list of all submission records for any ICSR case under the two tabs: E2B Gateway (submission records that are sent out with the E2B Gateway approach) and Other (submission records that need to be sent out manually).

    Viewing submission records in bulk
    Figure 1. Viewing submission records in bulk

    Tip

    Selecting the case number link opens the ICSR details page in the new browser tab.

  3. On the same page, you can perform the following actions with one or many submission records: transmit, update the ACK message, view the change history, and view the audit trail. Just select the checkboxes next to the needed submission records beforehand and then perform the relevant action.

Once viewed, you can proceed to generate a new submission record if needed.

In this section:

A safety service document that includes information required for reporting the adverse events and problems related to products and complaints filed by consumers with respect to any product.

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.

A national regulatory agency that controls the development of new drugs and standards compliance by clinical trial researchers.

Learn more about FDA on the official website.

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 pharmacovigilance, an official communication method for sponsors, regulatory authorities, and stakeholders to exchange information on the successful receipt or failure of the ICSR or other safety data and regulatory submission.