Enter when the investigator, then the sponsor, became aware of a serious, unexpected and suspected adverse reaction. Get the calendar due date under the investigator 24-hour rule, FDA 21 CFR 312.32, the EU Clinical Trials Regulation and ICH E2A, with the clock start and the citation for each.
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Investigator to sponsor
Sat 30 Jan, 16:30
FDA / EU, 7 days
Fri 5 Feb 2027
Expedited safety reporting clocks in brief
Free tool
Choose the classification, then enter the dates. Each row shows the due date, when its clock starts and the provision it comes from. Nothing is saved or sent.
This tool times a case you have already assessed as serious, unexpected and with a reasonable possibility of being caused by the drug. It does not decide seriousness, expectedness or causality.
Reference aid, not legal or regulatory advice and not validated software. Periods are calendar days counted from the date shown (that date is day 0, so day 7 is seven days later); weekends and public holidays do not extend them. Your protocol, the sponsor's safety management plan, the regulator's letter or approval conditions and any IRB or ethics committee requirements govern, and they can be shorter. Other regions (UK MHRA, Health Canada, PMDA and others) have their own rules that this tool does not cover. Confirm the current text of the cited provisions before relying on a date. Nothing is stored or sent.
The rules, with citations
All periods are in calendar days. Wording is paraphrased from the provisions named in the last column; read the primary text before relying on it.
| Report | Period | Clock starts | Source |
|---|---|---|---|
| Investigator to sponsor, SAE | Without undue delay, no later than 24 hours (EU); immediately (US) | Investigator becomes aware | Reg (EU) 536/2014 Art 41(2); 21 CFR 312.64(b); ICH E6(R3) |
| FDA IND safety report, unexpected fatal or life-threatening suspected adverse reaction | As soon as possible, no later than 7 calendar days | Sponsor's initial receipt of the information | 21 CFR 312.32(c)(2) |
| FDA IND safety report, other qualifying events (serious and unexpected suspected adverse reaction and the other listed findings) | As soon as possible, no later than 15 calendar days | Sponsor determines the information qualifies for reporting | 21 CFR 312.32(c)(1)(i) to (iv) |
| EU SUSAR, fatal or life-threatening | As soon as possible, no later than 7 days | Sponsor becomes aware | Reg (EU) 536/2014 Art 42 |
| EU SUSAR, other | No later than 15 days | Sponsor becomes aware | Reg (EU) 536/2014 Art 42 |
| EU SUSAR first non-fatal, later fatal or life-threatening | New 7-day period | Sponsor learns of the change | Reg (EU) 536/2014 Art 42 |
| ICH E2A, fatal or life-threatening unexpected ADR | 7 calendar days, then a complete report within 8 additional calendar days | First knowledge by the sponsor that a case qualifies | ICH E2A, expedited reporting timeframes |
| ICH E2A, other serious unexpected ADR | 15 calendar days | First knowledge by the sponsor that a case qualifies | ICH E2A, expedited reporting timeframes |
EU reports go through the CTIS and EudraVigilance route; an initial, incomplete report is allowed to meet the date, with the complete report to follow. National regimes (UK, Canada, Japan and others) are not covered.
Reading the clocks
Teams often talk about "the 7-day and 15-day clock" as one thing, but the rules count from different moments. The investigator's 24 hours run from the investigator's own awareness, which may be hours or days before the sponsor hears anything. The FDA 7-day period runs from the sponsor's initial receipt of the information. The FDA 15-day period runs from the sponsor's determination that the information qualifies, which is after someone has assessed seriousness, expectedness against the investigator's brochure and the possibility that the drug caused the event. The EU period runs from the sponsor becoming aware of the SUSAR, and ICH E2A speaks of first knowledge that a case qualifies.
That is why the tool has three date fields rather than one. In a clean case all three are the same day and the answers are simple. In a real case the gap between receipt and determination is where timelines are lost, and the sponsor's safety management plan should say who assesses a case, within how many hours, and how the receipt date is evidenced. For how sites record and escalate events in the first place, see adverse event reporting software for clinical trials and the adverse event eCRF template.
Day counting is the other recurring error. The calculator treats the date the clock starts as day 0, so a 7-day period from Friday 29 January 2027 ends on Friday 5 February 2027 and a 15-day period ends on Saturday 13 February 2027. Month ends are handled by calendar arithmetic, including a leap day: 7 days from 25 February 2028 is 3 March 2028. Some sponsors count differently or add an internal buffer, which is sensible, so check how your quality system defines day 1.
Worked examples
Demo data, not real events.
| Item | Case A: fatal, unexpected, related | Case B: serious, unexpected, related |
|---|---|---|
| Investigator aware | Fri 29 Jan 2027, 16:30 | Fri 29 Jan 2027, 09:00 |
| Sponsor receipt | Fri 29 Jan 2027 | Fri 29 Jan 2027 |
| Sponsor determination | Fri 29 Jan 2027 | Mon 1 Feb 2027 |
| Investigator to sponsor (24 h) | Sat 30 Jan 2027, 16:30 | Sat 30 Jan 2027, 09:00 |
| FDA 7-day / 15-day | 7-day: Fri 5 Feb 2027 | 15-day: Tue 16 Feb 2027 |
| EU CTR | 7 days: Fri 5 Feb 2027 | 15 days: Sat 13 Feb 2027 |
| ICH E2A | Initial Fri 5 Feb; complete Sat 13 Feb 2027 | 15 days: Tue 16 Feb 2027 |
In case B the EU date falls on a Saturday and arrives before the FDA date, because the EU clock runs from awareness and the FDA clock from determination. If the case is later reclassified as life-threatening on Monday 8 February 2027, a new EU 7-day period would end on Monday 15 February 2027.
Raise a test SAE in the free sandbox and follow it through the alert, the acknowledgement and the investigator sign-off.
Limits of the tool
It does not classify the event. Whether an event is serious, unexpected and reasonably possibly caused by the drug is a clinical and regulatory judgement, made against the investigator's brochure or product information in force. The tool assumes you have already made it. If you want a structured way to grade severity, the CTCAE grade lookup shows the grade wording, but severity is not the same thing as seriousness.
It covers three frameworks, not every regime. The UK MHRA, Health Canada, PMDA, device vigilance (MDR, ISO 14155) and many national rules have their own periods. Where a study is both FDA-regulated and in the EU, you must meet both, and the earlier date wins. The FDA IND guide for academic sponsors and the EU CTR software overview give background on each system.
Your documents govern. The protocol, the safety management plan, the regulator's acceptance letter, ethics committee or IRB requirements and the contract with any CRO can all set a shorter period or add recipients such as participating investigators. Treat the dates here as a check against those documents, not a substitute. This page is general reference information, not legal or regulatory advice.
It does not file anything. The expedited report itself goes through the sponsor's safety process to the regulator. The IRB glossary entry is a starting point for the separate ethics reporting obligations.
Safety process
Investigator-to-sponsor time, and any events that do not need immediate reporting, stated.
Every route a site can use is time-stamped so the sponsor's receipt date is provable.
Who decides seriousness, expectedness and causality, and within what time.
The investigator's brochure version in force is known and distributed.
A named person can assess and submit on a Saturday, because the days are calendar days.
Serious events raise an alert that a named person must acknowledge, with an audit record.
Site attestation and investigator sign-off recorded under electronic signature.
Under 21 CFR 312.32 a sponsor reports an unexpected fatal or life-threatening suspected adverse reaction to the FDA within 7 calendar days of initial receipt, and other qualifying IND safety reports within 15 calendar days of determining they qualify. The EU CTR and ICH E2A use the same 7 and 15 day structure with different clock starts.
It depends on the rule. FDA: initial receipt for the 7-day report and the sponsor's determination for the 15-day report. EU CTR: the sponsor becoming aware. ICH E2A: first knowledge by the sponsor that a case qualifies. The calculator keeps those dates separate.
Calendar days. A deadline that falls on a weekend or public holiday is not extended, so plan weekend cover for the safety team.
Under Article 41(2) of the EU Clinical Trials Regulation, without undue delay and no later than 24 hours after becoming aware, unless the protocol provides otherwise for certain events. In the US, 21 CFR 312.64(b) requires the investigator to report serious adverse events to the sponsor immediately. The protocol usually specifies the window.
Under the EU CTR a case first reported as non-fatal that becomes fatal or life-threatening is reported within 7 days of the sponsor learning of the change. Enter that date in the optional field.
No. It is a reference aid that applies published periods to the dates you enter. The protocol, the regulator's letter and your own regulatory team determine your obligations, and you should read the cited provisions yourself.
No. It covers the investigator 24-hour rule, FDA 21 CFR 312.32, the EU Clinical Trials Regulation and ICH E2A only.
No. The dates are calculated in your browser and nothing you enter is saved or transmitted.
Keep exploring
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AE and SAE capture with sign-off.
Adverse event eCRF template
The AE form fields.
CTCAE grade lookup
Severity grade wording.
EU CTR clinical trial software
Working under Regulation 536/2014.
FDA IND guide for academics
US sponsor-investigator basics.
Edit checks software
Catch incomplete safety data at entry.
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