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ICSR submission

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

The submission can be done only if ICSRs meet the submission conditions and the user has proper permissions.

Important

The submission permissions and conditions can be configured according to sponsor requirements by the EDETEK administrator.

Currently, the configured condition is that only the ICSR in the Case Submission workflow status can be submitted.

Depending on user access and sponsor requirements, the following types of submissions are available in the PV application:

  • E2B R3 Gateway. The recipients who have implemented the E2B R3 standard, support Electronic Data Interchange (EDI) submission, and have purchased EDETEK's EDI service can use this approach. The transmission of E2B data can occur with different standards including HL7, R2, R3, and so on. EDI is a trading partner's intermediate server gateway, often referred to simply as “E2B Gateway”. This gateway acts like a mail carrier to receive incoming messages and forward outgoing messages.

    Tip

    E2B R2 is the first standard used for the electronic transmission of safety information. E2B R3 is the latest standard version created to improve the pharmacovigilance data exchange. The PV application currently supports only the E2B R3 standard.

  • E2B R3 XML File. The recipients who have implemented the E2B R3 standard and support Electronic Data Interchange (EDI) submission but have not purchased EDETEK's EDI service can use this approach. The XML file generated as a part of the submission record needs to be downloaded and submitted to the regulatory instance manually.

  • Forms Submission. The recipients who are not using the E2B electronic submission can generate report forms such as MedWatch 3500A or CIOMS-I. These forms need to be completed manually and then submitted through email or any other way recommended by the sponsor.

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 ICH standard that is used for the electronic transmission of the adverse event information to ensure the efficacy of the clinical trial. The standard is used by the PV application.

A software that provides communication solutions with customers, suppliers, and other partners via the electronic exchange of business documents and transactions in a simplified fashion.