Ideogen

Adverse Event Report Form

Please fax or e-mail this report to Pharmacovigilance within 24 hours of becoming aware, to:
phone number: +44 746 858 28 32
E-mail: [email protected]

By completing this form, you acknowledge that all personal data provided in this form shall be processed by Ideogen for it to comply with its pharmacovigilance/ reporting obligations and for reasons of public health and public interest. Ideogen may share this personal data with competent regulatory authorities, manufacturers of the product identified in this form and its third-party licensing, distribution and pharmacovigilance service providers. All data provided in this form is treated as confidential and will only be shared with third parties where it is necessary to do so for pharmacovigilance purposes.
If you have any further questions about why or how we use the personal data collected in this form and your rights in relation to the personal data, please contact us via the details provided above.

Section A – Administrative Details

Suspect Product:

Country:

Date of Report:

Report Type:

Initial

Follow Up

Correction to the latest report

Section B – Event(s)

In the reporter’s opinion (if a HCP) was the event:

Serious

Non-Serious

Adverse Event(s) Information: (Please provide the description of the reported event(s) as described by the reporter; If applicable, include drugs/procedure given/performed to treat Adverse Event(s); If an adverse event is not reported but a product safety issue is, describe it* and state ‘No adverse event’))

Onset Date:

Resolution Date:

Serious Criteria:

Hospitalisation

Hospitalisation Prolonged

Disability/Incapacity

Important/Significant Medical Event

Congenital Anomaly/Birth Defect

Life-threatening

Fatal

Hospitalisation Dates:

Admission:

Discharge:

Event Outcome

Resolved

Resolved with sequelae

Resolving

Not Resolved

Fatal

Unknown

Other (specify):

Event abated after the suspect product was discontinued or dose reduced:

Yes

N/A

Event reappeared after reintroduction of the suspect product

Yes

N/A

If Fatal, Cause of Death:

Date of Death:

Postmortem Performed:

Yes

If yes, please provide postmortem results (if known)

Section C- Patient Information*

Patient Initials:

Weight:

Date of Birth / Age:

Height:

Gender:

Male

Female

Ethnicity:

If female, Pregnant?

Yes

Relevant Lab Data

Unknown

None

Relevant Medical History

Unknown

None

History of Allergies

Unknown

None

Section D – Product

Suspect Product:

Dose, Units & Route of Administration:

Indication:

Frequency:

Batch Number:(If Known)

Product Start Date

Expiration Date:

Product Stop Date:

Action Taken:

Maintained

Temporarily Discontinued

Permanently Discontinued

Dose Increased

Dose Reduced

Unknown

Oh adverse event

Oh adverse event

Adverse Event Report Form

Section A – Administrative Details

Section B – Event(s)

Section C- Patient Information*

Section D – Product

Section E – Reporter’s Details*

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