The clock starts at knowledge
Timelines run from when the investigator becomes aware of the SAE, not from when it is confirmed as trial-related.
When a Serious Adverse Event (SAE) occurs in a clinical trial, every party has a defined responsibility and deadline — from the investigator’s 24-hour notification to compensation to the participant, if any.
Initial SAE notification
Due-analysis reports
Ethics Committee report
Expert committee
Licensing Authority order
Compensation paid
From the onset of a serious adverse event in a patient to compensation, if any, to the patient or their representative.
The clock starts when the investigator gains knowledge of the occurrence.
Within 24 hours of knowledge of occurrence — to the Licensing Authority, sponsor, Ethics Committee and head of institution.
Within 14 calendar days of knowledge of occurrence — to the Licensing Authority, Chairman of the EC and head of institution.
Within 14 calendar days of knowledge of occurrence — to the Licensing Authority, Chairman of the EC and head of institution.
Within 30 calendar days of receipt of the investigator’s report, with its opinion on compensation, if any.
Reviews reports from investigator, sponsor and EC via the Licensing Authority; recommends within 60 calendar days of receipt.
Letter to sponsor for compensation, if any, within 90 calendar days.
Within 30 calendar days of receipt of the order from the Licensing Authority.
| Report / action | Responsible | Sent to | Deadline |
|---|---|---|---|
| Initial notification of SAE | Investigator | Licensing Authority, sponsor/representative, Ethics Committee, head of institution | 24 hoursof knowledge of occurrence |
| Due-analysis report of SAE | Investigator | Licensing Authority, Chairman of Ethics Committee, head of institution | 14 calendar daysof knowledge of occurrence |
| Due-analysis report of SAE | Sponsor / representative | Licensing Authority, Chairman of Ethics Committee, head of institution | 14 calendar daysof knowledge of occurrence |
| EC report with opinion on compensation | Ethics Committee | Licensing Authority | 30 calendar daysfrom receipt of investigator’s report |
| Recommendation on cause and compensation | Expert committee | Licensing Authority | 60 calendar daysfrom receipt of reports via the Licensing Authority |
| Order / letter to sponsor for compensation | Licensing Authority | Sponsor / representative | 90 calendar daysof receipt of the SAE report |
| Compensation, if any | Sponsor / representative | Patient / representative | 30 calendar daysfrom receipt of order from Licensing Authority |
Enter the date and time the site became aware of the SAE to see the investigator and sponsor deadlines. Later stages depend on when each report is received, so they are shown as the latest expected dates.
Calendar days are counted, including weekends and holidays. Always confirm deadlines against the current NDCT Rules and your study’s SOPs.
Timelines run from when the investigator becomes aware of the SAE, not from when it is confirmed as trial-related.
If the investigator misses the 24-hour window, reasons for the delay must be furnished to the Licensing Authority along with the report.
Reporting runs alongside — never instead of — free medical management of the participant for trial-related injury.
Download the timeline chart, read the SAE reporting user manual, or see how compensation is determined.
Prepared by the Clinical Research Centre, KG Hospital, as per the New Drugs and Clinical Trials Rules, 2019 (Rule 42). For general guidance only; refer to the official Rules and current CDSCO notifications for authoritative requirements.