Home
Forms Library
Incident Adverse Event Form

Incident Adverse Event Form 2026

Incident Adverse Event Form Preview on Page 1

See details

4 out of 5

51 votes

The document is an Incident/Adverse Event Form designed for reporting adverse events or reactions that occur during approved human subject research projects. It outlines the responsibilities of faculty sponsors and principal investigators in notifying the IRB chair about such events, defines what constitutes an adverse event, and includes sections for detailing the incident, including its seriousness and relation to the study intervention.

Here's how it works

01. Edit your form online

Type text, add images, blackout confidential details, add comments, highlights and more.

02. Sign it in a few clicks

Draw your signature, type it, upload its image, or use your mobile device as a signature pad.

03. Share your form with others

Send it via email, link, or fax. You can also download it, export it or print it out.

How to use or fill out Incident Adverse Event Form with our platform

Ease of Setup

DocHub User Ratings on G2

Ease of Use

DocHub User Ratings on G2

Click ‘Get Form’ to open the Incident Adverse Event Form in the editor.
Begin by entering the project title and IRB protocol number at the top of the form. This information is crucial for identifying your research project.
Fill in the number of subjects enrolled to date, along with details of the principal investigator, including their phone number and Samford email.
If applicable, provide details for the faculty sponsor, including their department and contact information.
In the 'Incident Report' section, accurately document the date and time of the incident, place of occurrence, affected subject ID/initials, and any witnesses present.
Indicate whether this is a serious or unanticipated adverse event by selecting 'Yes' or 'No' as appropriate. Provide detailed descriptions where required.
Complete any additional questions regarding medical treatment related to the event and outline safeguards to prevent recurrence if necessary.
Finally, ensure that all sections are filled out completely before submitting it to your faculty sponsor or directly to the IRB chair if no sponsor is present.

Start using our platform today for free to streamline your form completion process!

be ready to get more

Complete this form in 5 minutes or less

Get form

Got questions?

We have answers to the most popular questions from our customers. If you can't find an answer to your question, please contact us.

Can I use DocHub to generate legal eSignatures on my Incident Adverse Event Form?

Yes, you can utilize DocHub for signing any business and private documentation, including your Incident Adverse Event Form. All electronic signatures you create with our service are legally binding and court-admissible, as DocHub complies with criteria required by ESIGN and UETA. Save your completed document with a detailed Audit Trail if necessary.

How do you edit Incident Adverse Event Form online?

With DocHub, you have several convenient methods to edit your Incident Adverse Event Form online. You can drag and drop the form and edit it straight at the DocHub site or use our browser extension to fill out your form immediately. Additionally, you can edit your PDF on your phone, as DocHub works with all the available mobile platforms.

What qualifies as an adverse event?

The event is serious and should be reported to FDA when the patient outcome is: Death. Life-threatening. Hospitalization (initial or prolonged) Disability or Permanent Damage. Congenital Anomaly/Birth Defect. Required Intervention to Prevent Permanent Impairment or Damage (Devices) Other Serious (Important Medical Events)

What are the four types of adverse events?

Adverse drug events typically fall into four categories: potential, non-preventable, ameliorable, and preventable. Potential. A potential adverse drug event occurs when a medication error is caught and resolved before a patient takes the drug. Non-Preventable. Ameliorable. Preventable.

What is an adverse event form?

Adverse Events (AEs) are any unfavourable and unintended signs, including abnormal laboratory results, symptoms or a disease associated with treatment. These must always be recorded on a Case Report Form (CRF) and in the patients medical notes unless the protocol states otherwise.

What are grade 1, 2, 3, 4 adverse events?

Grade 1 adverse events are mild and generally not bothersome. Grade 2 events are bothersome and may interfere with doing some activities but are not dangerous. Grade 3 events are serious and interfere with a persons ability to do basic things like eat or get dressed.

What are the 4 criteria for adverse event reporting?

The minimum dataset required to consider information as a reportable AE is indeed minimal, namely (1) an identifiable patient, (2) an identifiable reporter, (3) product exposure, and (4) an event.

Incident Adverse Event Form 2026

Here's how it works

How to use or fill out Incident Adverse Event Form with our platform

Complete this form in 5 minutes or less

Got questions?

Can I use DocHub to generate legal eSignatures on my Incident Adverse Event Form?

How do you edit Incident Adverse Event Form online?

What qualifies as an adverse event?

What are the four types of adverse events?

What is an adverse event form?

People also ask

What are grade 1, 2, 3, 4 adverse events?

What are the 4 criteria for adverse event reporting?

Related links

Try more PDF tools

Incident Adverse Event Form 2026

Here's how it works

How to use or fill out Incident Adverse Event Form with our platform

Complete this form in 5 minutes or less

Got questions?

Can I use DocHub to generate legal eSignatures on my Incident Adverse Event Form?

How do you edit Incident Adverse Event Form online?

What qualifies as an adverse event?

What are the four types of adverse events?

What is an adverse event form?

Related Searches

People also ask

What are grade 1, 2, 3, 4 adverse events?

What are the 4 criteria for adverse event reporting?

Related links

Try more PDF tools