Home
Forms Library
Incident Adverse Event Form

Incident Adverse Event Form 2025

Incident Adverse Event Form Preview on Page 1

Show 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, serious adverse event, and unanticipated adverse event, and includes sections for detailed reporting of incidents.

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 modify Incident Adverse Event Form in PDF format online

Ease of Setup

DocHub User Ratings on G2

Ease of Use

DocHub User Ratings on G2

Handling documents with our feature-rich and intuitive PDF editor is easy. Follow the instructions below to complete Incident Adverse Event Form online easily and quickly:

Sign in to your account. Sign up with your email and password or create a free account to try the product before upgrading the subscription.
Import a document. Drag and drop the file from your device or import it from other services, like Google Drive, OneDrive, Dropbox, or an external link.
Edit Incident Adverse Event Form. Easily add and highlight text, insert images, checkmarks, and icons, drop new fillable fields, and rearrange or remove pages from your paperwork.
Get the Incident Adverse Event Form completed. Download your modified document, export it to the cloud, print it from the editor, or share it with other people through a Shareable link or as an email attachment.

Benefit from DocHub, one of the most easy-to-use editors to quickly handle your documentation online!

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 [KEY]?

Yes, you can utilize DocHub for signing any business and private documentation, including your [KEY]. 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 [KEY] online?

With DocHub, you have several convenient methods to edit your [KEY] 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 is the standard definition of adverse event?

An adverse event is any untoward or unfavorable medical occurrence in a human. subject, including any abnormal sign (for example, abnormal physical exam or. laboratory finding), symptom, or disease, temporally associated with the subjects.

How do you record adverse events?

Using accepted medical terminology, enter the diagnosis (if known); otherwise enter a sign or symptom. Death should not be recorded as an event but should be recorded as the outcome of the event. The condition that resulted in the death should be recorded as the AE.

What are the 4 types of adverse events?

Adverse events that occur with medical treatment can include medication side effects, injury, psychological harm or trauma, or death.

What is an example of a SAE in a clinical trial?

Serious Adverse Events SAEs are a subset of adverse events. {Some protocols may list events specific to the protocol that should be reported as serious. Examples might be post-extraction bleeding in anticoagulated participants and anaphylactic reaction after lidocaine or analgesic administration.}

What is the difference between an incident and an adverse event?

An adverse event or incident is an event that causes or could have caused damage to the patient, and which is not the result of the patients underlying condition. Adverse drug events could be dosage errors, incorrect administration of the medicine or mix-ups of product names or packaging.

What are the 4 elements of an adverse event?

There are only four requirements for a valid adverse drug reaction report: patient identifier, medicine, reaction, reporter details.

What is an example of an adverse event?

Examples include allergic brochospasm (a serious problem with breathing) requiring treatment in an emergency room, serious blood dyscrasias (blood disorders) or seizures/convulsions that do not result in hospitalization.

How do you write an adverse event?

How to write an serious adverse event narrative? Mention every detail about concomitant conditions and their onset dates. Also include relevant past conditions. The treatment medication received for the event, and the previous medication details need to be provided. This includes background and rescue medications.

Incident Adverse Event Form 2025

Here's how it works