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Question: Do we need to revise and report the reports that have already been submitted in the form of tracking reports if errors are found later?
Answer: According to Attachment 4 of the Implementation Guidelines for Individual Security Report E2B (R3) Region, C.1.11.1 Report Obsolescence/Correction: This data element represents a previously transmitted ICSR that has been determined to be invalid or needs to be corrected. Examples of invalid reports: for example, discovering that the entire case is incorrect; Example of correction report: For example, after internal review or based on expert opinions, some field values need to be corrected, such as adverse event/reaction terminology, severity, severity criteria, or causal relationship evaluation. In cases where a correction report needs to be submitted, the same "sender's (case) safety report unique identification code" (C1.1) and "global unique case identification code" (C.1.8) as previously submitted must be used (see C.1.1 for exceptions). If it is necessary to submit previously invalidated reports, new "Sender's (Case) Security Report Unique Identification Code" (C.1.1) and "Global Unique Case Identification Code" (C.1.8.1) should be assigned. If new information about the case has not been received from the main source in the revised or invalidated report, the date on which C.1.5 received the latest date of this report shall not be changed. This kind of correction does not count as a tracking report.