Adverse event form.

fill at the bedside
export to pdf
sign and attach

Generate a printable Adverse Event form for clinical research. Fill in the volunteer's details on phone or tablet at the bedside, export a clean PDF, print, sign, and attach to the CRF. Aligned with ICH E2A terminology.

Form header

optional · printed at top

Form Code

Form Version

Form Version Date

Effective Date

Study identifiers

required

Study Code*

Screening No*

Volunteer No*

Event identifiers

one form per AE

AE Number*

Description of adverse event

required · max 500 chars

Describe what was reported*

0 / 500

Date & time

required

Starting*

Ending

Last dose before AE

None — subject had not yet received drug

Assessment

select one per row

Seriousness

1Not serious2Serious

Severity

1MildNot effect daily activity2ModerateEffect daily activity3SevereNot possible to continue daily activity

Duration / Type

1Single2Intermittent3Continual4Not known

Drug Relationship

1Certain2Probable / likely3Possible4Unlikely5Conditional / unclassified6Unassessable / unclassified

Action Taken

Multiple selections allowed. If you select any of the options numbered 2, 3, or 5, please fill in the “Action Taken” field in the Action Details section.

1Not necessary2Original treatment3Dosage reducing4Dropped-out5Other

Result

1Fully recovery2Recovery3Not changed4Aggravation5Death6Not known

Action details

optional

Informed person (phone / email)

Action taken — specify

Report & signature

signed manually after printing

Date of report

Investigator name*

The signature line on the printed PDF is left blank for a manual pen signature. The investigator name above is typed under that line.

Randomization·Time Table·Meal Log·Sample Shipment·Tube Labels·Adverse Event