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Producing a safety report, completing medical assessment and tracking the notification are different activities. Completion of one does not demonstrate completion of the others. A Türkiye SUSAR reporting workflow should bring assessment ownership, reporting timelines, electronic message quality and follow-up records together. This article translates the 2026 sources for human medicinal product trials into a practical team preparation framework.
The National SUSAR Module and the scope of the 2026 update
TİTCK's notice of 20 May 2026 describes development of the National SUSAR Module within the Clinical Trials Module. It identifies 15 May 2026 as the publication and effective date of the relevant guidance. The KAD-KLVZ-07 document reviewed is revision 13. These dates differ from this article's publication date of 27 October 2026.
Do not leave transition assessment solely to information technology staff. Pharmacovigilance, medical assessment, regulatory affairs and study operations should review the same sample case from their respective responsibilities. The aim is to demonstrate that internal handovers work, beyond confirming that the system screen opens.
Match each reporting timeline to the correct event and owner
Section 6.20 of KAD-KLVZ-07 specifies no later than seven days after the information reaches the sponsor for fatal or life-threatening SUSARs, and no later than 15 days after first receipt of information for other SUSARs. The investigator's 24-hour serious adverse event reporting rule is addressed in section 6.17, together with the protocol exception.
Our operational recommendation is to separate awareness, handover and submission records rather than use a single deadline column. Assign a deputy for each activity. This record does not automate medical classification; it helps establish what information reached whom and when. Verify the timeline calculation against the provision applicable to the case and study.
E2B(R3) XML validation involves more than a format check
Section 6.23.1 of KAD-KLVZ-07 describes individual E2B(R3) XML reporting for the relevant SUSARs occurring in Türkiye. Annex 2 distinguishes XSD conformance, field requirements and repetition rules, ICH business rules and additional TİTCK checks. An XML file that can be opened has not necessarily passed all content checks.
Turn a validation error into an actionable task: identify the affected field, observed error, correction owner and reassessment result. Instead of closing recurring errors by resubmitting, examine the source-system mapping. Use controlled fictional data rather than actual participant information when testing sample cases.
Read international standards alongside local business rules
ICH's January 2026 E2B(R3) Training Module III explains the importance of regional implementation guidance alongside the common standard. Transmission, receipt, acknowledgements and system outages are separate implementation topics. Generating a message suitable for one country does not demonstrate compliance with every local expectation in another.
For a practical adaptation exercise, map each data field to its counterpart in the source system first. Then identify Türkiye-specific checks, the handling of missing fields and scenarios requiring retesting after a version change. Treating the work as a one-off file conversion makes later updates harder to assess.
Control the submission tool and subsequent changes
EMA's guideline on computerised systems in clinical trials addresses individual accounts, role-appropriate access, traceability of data changes and fit-for-purpose validation. It is used here as an international reference for assessing the quality design of a multinational reporting system, rather than to introduce a new Türkiye submission requirement.
Following this framework, record the version of the software generating or editing messages. Reassess affected scenarios when a field mapping or control rule changes. Review access when personnel change and prevent unresolved notifications from losing their owner during a handover.
Connect follow-up records through the case identity
Different case names across teams make records harder to find and statuses harder to assess. In the operational register we recommend, the internal case identity, associated study, task owner and follow-up action are visible together. This organises communication between teams without changing clinical assessment.
Specify the evidence required to close an action at the outset. A transmission problem, a request for missing information and a pending medical assessment should have distinct statuses. A green management indicator should not conceal an unresolved dependency. A delay review can then show where the process became blocked instead of focusing only on individual error.
A practical team readiness checklist
- Are owners and deputies identified for assessment, technical file production and submission?
- Can awareness and handover records be traced to the same event?
- Have fictional examples been tested in both the normal workflow and invalid-field scenarios?
- Are a correction owner and reassessment record retained for validation errors?
- Are current official instructions and support channels accessible during an outage?
- Does the new owner explicitly accept outstanding follow-up actions at handover?
Frequently asked questions
- Is it sufficient that the SUSAR XML file can be opened?
- No. Annex 2 of KAD-KLVZ-07 distinguishes the technical schema, field rules, ICH content rules and TİTCK checks as separate stages.
- Does this article also cover medical device safety reporting?
- No. The source reviewed concerns human medicinal product trials. For devices, assess the official process applicable to the investigation and product scope separately.
- Does a portal file status prove that official reporting is complete?
- Not by itself. Distinguish internal task status from the record and outcome in the official process; close the action against the relevant evidence.