<aside>

Use this tool to determine where and within which timelines an adverse event or adverse reaction must be reported, based on case characteristics.

Follow the decision tree below and click the matching case type to view country-specific reporting requirements.

</aside>

Click the final box or use the links below to open the relevant case type.

flowchart LR
%% RegIntelHub — Case reportability tool (Expedited timelines)

A[Case type] --> PM[Post marketing]
A --> CT[Clinical trial]

%% ----------------
%% Post-marketing
%% ----------------
PM --> PM1([Fatal or life threatening])
PM --> PM2([Serious non fatal and non life threatening])
PM --> PM3([Non serious])

click PM1 "[<https://www.regintelhub.com/pm-fatal-or-life-threatening?source=copy_link>](<https://www.regintelhub.com/pm-fatal-or-life-threatening?source=copy_link>)"
click PM2 "[<https://www.regintelhub.com/pm-serious-non-fatal-and-non-life-threatening?source=copy_link>](<https://www.regintelhub.com/pm-serious-non-fatal-and-non-life-threatening?source=copy_link>)"
click PM3 "[<https://www.regintelhub.com/pm-non-serious?source=copy_link>](<https://www.regintelhub.com/pm-non-serious?source=copy_link>)"

%% ----------------
%% Clinical trial
%% ----------------
CT --> CTR{Related}

CTR -->|No| CTAE([Not related])
click CTAE "[<https://www.regintelhub.com/ct-ae-not-related?source=copy_link>](<https://www.regintelhub.com/ct-ae-not-related?source=copy_link>)"

CTR -->|Yes| CTREL[Related]
CTREL --> CTE{Expected}

CTE -->|Yes| CTEXP[Expected]
CTE -->|No| CTUNEXP[Unexpected]

%% Related + Expected endpoints
CTEXP --> CTEXP1([Fatal or life threatening])
CTEXP --> CTEXP2([Serious non fatal and non life threatening])
CTEXP --> CTEXP3([Non serious])

click CTEXP1 "[<https://www.regintelhub.com/ct-ar-related-expected-fatal-or-life-threatening?source=copy_link>](<https://www.regintelhub.com/ct-ar-related-expected-fatal-or-life-threatening?source=copy_link>)"
click CTEXP2 "[<https://www.regintelhub.com/CT-AR-Related-Expected-Serious-non-fatal-and-non-life-threatening-2c749d840dce8060a509c12048dc4e6c?source=copy_link>](<https://www.regintelhub.com/CT-AR-Related-Expected-Serious-non-fatal-and-non-life-threatening-2c749d840dce8060a509c12048dc4e6c>)"
click CTEXP3 "[<https://www.regintelhub.com/ct-ar-related-expected-non-serious?source=copy_link>](<https://www.regintelhub.com/ct-ar-related-expected-non-serious?source=copy_link>)"

%% Related + Unexpected endpoints
CTUNEXP --> CTUNEXP1([Fatal or life threatening])
CTUNEXP --> CTUNEXP2([Serious non fatal and non life threatening])
CTUNEXP --> CTUNEXP3([Non serious])

click CTUNEXP1 "[<https://www.regintelhub.com/ct-ar-related-unexpected-fatal-or-life-threatening?source=copy_link>](<https://www.regintelhub.com/ct-ar-related-unexpected-fatal-or-life-threatening?source=copy_link>)"
click CTUNEXP2 "[<https://www.regintelhub.com/CT-AR-Related-Unexpected-Serious-non-fatal-and-non-life-threatening-2c749d840dce80c7a975e8e8e3acf2e9?source=copy_link>](<https://www.regintelhub.com/CT-AR-Related-Unexpected-Serious-non-fatal-and-non-life-threatening-2c749d840dce80c7a975e8e8e3acf2e9>)"
click CTUNEXP3 "[<https://www.regintelhub.com/ct-ar-related-unexpected-non-serious?source=copy_link>](<https://www.regintelhub.com/ct-ar-related-unexpected-non-serious?source=copy_link>)"

Case type shortcuts:

<aside>

Post-marketing

PM – Fatal or life-threatening

PM – Serious non-fatal and non-life-threatening

PM – Non-serious

</aside>

<aside>

Clinical trial

CT – AE – Not related

</aside>

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