Home
Forms Library
IRB Adverse Event Unanticip - Valencia College

IRB Adverse Event Unanticip - Valencia College 2025

IRB Adverse Event Unanticip - Valencia College Preview on Page 1

Show details

4 out of 5

48 votes

The document is a report form for the Valencia College Human Research Protection Institutional Review Board (IRB) that outlines the process for reporting adverse events, unanticipated problems, or increased risks associated with research protocols. It specifies the types of events that must be reported, including unexpected and serious adverse events, and mandates reporting within five working days. The form requires details about the principal investigator, the nature of the event, and includes sections for initial and follow-up reports.

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 edit IRB Adverse Event Unanticip - Valencia College in PDF format online

Ease of Setup

DocHub User Ratings on G2

Ease of Use

DocHub User Ratings on G2

Working on paperwork with our feature-rich and intuitive PDF editor is easy. Adhere to the instructions below to complete IRB Adverse Event Unanticip - Valencia College online easily and quickly:

Sign in to your account. Log in with your email and password or register a free account to test the service prior to choosing the subscription.
Upload a form. Drag and drop the file from your device or import it from other services, like Google Drive, OneDrive, Dropbox, or an external link.
Edit IRB Adverse Event Unanticip - Valencia College. Easily add and underline text, insert images, checkmarks, and symbols, drop new fillable fields, and rearrange or delete pages from your paperwork.
Get the IRB Adverse Event Unanticip - Valencia College accomplished. Download your updated document, export it to the cloud, print it from the editor, or share it with other participants using a Shareable link or as an email attachment.

Benefit from DocHub, the most straightforward editor 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.

What is considered an adverse event?

Table 3Categories of adverse events Type of Adverse EventsExample Infectious (Non-Respiratory) Adverse Event Vaginitis, urinary tract infection, influenza Musculoskeletal Adverse Event Muscle cramps, myalgia, tendonitis, rigors, musculoskeletal pain, muscle soreness Neurological Adverse Event Tremor, headache, seizure, rigors13 more rows

What is an adverse event in IRB?

An adverse event is any undesirable and unintended, although not necessarily unexpected, effect of the research occurring in human subjects as a result of (a) the interventions and interactions used in the research; or (b) the collection of identifiable private information under the research (Adapted from the 1993

When must all serious adverse events be reported to the research sites institutional review board?

IRB Reporting Criteria For Serious Adverse Events: The IRB requires that all Internal, Serious, Unexpected adverse events be reported to the IRB using the IRB Online program within 7 days of the time the study team receives knowledge of the event.

What are the 4 criteria for adverse event reporting?

What is a Serious Adverse Event? 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)