complianceelearn.com
Open in
urlscan Pro
52.21.50.230
Public Scan
Submitted URL: https://mail.ecomplyin.com/pub/cc?_ri_=X0Gzc2X%3DAQpglLjHJlCQGlzbIu4tzfsupqKjIIwpjgISzf6zfIi7D5rvXhchSG2uBh8DihbqbOVXtpKX%3...
Effective URL: https://complianceelearn.com/en-US/Clinical-Trial/The-Importance-Of-Protocol-Deviations-and-Violations-to-Subject-Safety-and-...
Submission: On September 29 via api from US — Scanned from DE
Effective URL: https://complianceelearn.com/en-US/Clinical-Trial/The-Importance-Of-Protocol-Deviations-and-Violations-to-Subject-Safety-and-...
Submission: On September 29 via api from US — Scanned from DE
Form analysis 6 forms found in the DOM
POST /en-US/auth/page/registration
<form method="post" action="/en-US/auth/page/registration" id="signup-form" class="login-form margin-clear" novalidate="novalidate">
<div class="modal-content">
<div class="modal-header">
<button type="button" class="close" data-dismiss="modal"><span aria-hidden="true">×</span><span class="sr-only">Close</span></button>
<h4 class="modal-title" id="mySmallModalLabel">Signup</h4>
</div>
<div class="modal-body" id="signup-form-modal-body">
<div class="row">
<div class="col-md-6">
<div class="form-group">
<label class="control-label" for="exampleInputEmail1">First Name*</label>
<input type="hidden" name="_csrf" value="c0ZFSDZOTEEKFigLVzdhEzwJcRthHjYyG3Atem8.YSYVCzYfWiV7IA==">
<input type="text" class="form-control required" name="RegistrationFormWithProfile[firstname]" size="15" required="" aria-required="true">
</div>
</div>
<div class="col-md-6">
<div class="form-group">
<label class="control-label" for="exampleInputEmail1">Last Name*</label>
<input type="text" class="form-control required" name="RegistrationFormWithProfile[lastname]" size="15" required="" aria-required="true">
</div>
</div>
<div class="col-md-6">
<div class="form-group">
<label class="control-label" for="exampleInputEmail1">Email*</label>
<input type="email" class="form-control required" name="RegistrationFormWithProfile[username]" size="15" required="" aria-required="true">
</div>
</div>
<div class="col-md-6">
<div class="form-group">
<label class="control-label" for="exampleInputEmail1">Phone Number*</label>
<input type="tel" class="form-control required" name="RegistrationFormWithProfile[phone]" size="12" required="" aria-required="true">
</div>
</div>
<div class="col-md-12">
<div class="form-group">
<label class="control-label" for="exampleInputEmail1">Area of Interest*</label>
<select id="exampleInputSource1" name="RegistrationFormWithProfile[topic_category][]" class="form-control required" multiple="" required="" aria-required="true">
<option value="35">Medical Devices</option>
<option value="32">Pharmaceutical</option>
<option value="31">Clinical Trial</option>
<option value="33">Food Safety & Dietary Supplements</option>
<option value="29">Hospital & Healthcare</option>
<option value="41">Accounting and Taxation</option>
<option value="42">Banking & Financial Services</option>
<option value="37">Governance, Risk & Compliance</option>
<option value="38">Human Resources</option>
<option value="81">IT Compliance</option>
<option value="39">Occupational Health & Safety</option>
<option value="40">Trade and Logistics</option>
</select>
</div>
</div>
<div class="col-md-6">
<div class="form-group">
<label class="control-label sign-up-my" for="exampleInputEmail1">Password*</label>
<input type="password" class="form-control required" name="RegistrationFormWithProfile[password]" minlength="6" size="15" required="" aria-required="true">
</div>
</div>
<div class="col-md-6">
<div class="form-group">
<label class="control-label sign-up-my" for="exampleInputEmail1">Re-Enter Password*</label>
<input type="password" class="form-control required" name="RegistrationFormWithProfile[repeat_password]" minlength="6" size="15" required="" aria-required="true">
</div>
</div>
<div class="col-md-12">
<div class="form-group">
<label class="control-label sign-up-my" for="exampleInputEmail1">
<input type="checkbox" class="" name="RegistrationFormWithProfile[is_receive_tips]" tabindex="7" value="1" checked="checked"> I would like to receive tips and events roundup from Compliance World</label>
</div>
</div>
<div id="for-error" class="col-md-12" style="display:none;color: #A94442;">
</div>
<div id="loader-signup" style="font-size: 70px;
position: fixed;
width: 100%;
height: 100%;
text-align: center;
background-color: rgba(128, 128, 128, 0.69);
color: #FFFFFF;
top: 0px;
padding-top: 125px;
display: none;">
<span class=" fa fa-spinner fa-pulse"></span>
</div>
</div>
</div>
<div class="modal-footer">
<!-- <button type="button" id="cancel" class="btn btn-sm btn-dark" data-dismiss="modal">Cancel</button> -->
<button type="submit" class="btn btn-sm btn-default" id="signupform">SIGNUP NOW</button>
</div>
</div>
</form>POST /en-US/auth/page/passwordrecovery
<form method="post" action="/en-US/auth/page/passwordrecovery" id="forgot-form" class="login-form margin-clear" novalidate="novalidate">
<div class="modal-content">
<div class="modal-header">
<button type="button" class="close" data-dismiss="modal"><span aria-hidden="true">×</span><span class="sr-only">Close</span></button>
<h4 class="modal-title" id="mySmallModalLabel">Forgot Password</h4>
</div>
<div class="modal-body" id="forgot-form-modal-body">
<div class="row">
<div class="col-md-6 col-md-offset-3 text-center">
<div class="form-group">
<label class="control-label" for="exampleInputEmail1">Enter Your Email</label>
<input type="email" class="form-control required" name="PasswordRecoveryForm[email]" size="15" placeholder="Your Email" required="" aria-required="true">
<input type="hidden" name="_csrf" value="c0ZFSDZOTEEKFigLVzdhEzwJcRthHjYyG3Atem8.YSYVCzYfWiV7IA==">
</div>
</div>
<div id="for-message" class="col-md-12" style="display:none;color: #A94442;">
</div>
<div id="loader-forgot" style="font-size: 70px;
position: fixed;
width: 100%;
height: 100%;
text-align: center;
background-color: rgba(128, 128, 128, 0.69);
color: #FFFFFF;
top: 0px;
padding-top: 125px;
display: none;">
<span class=" fa fa-spinner fa-pulse"></span>
</div>
</div>
</div>
<div class="modal-footer">
<button type="button" id="cancel" class="btn btn-sm btn-dark" data-dismiss="modal">Cancel</button>
<button type="submit" class="btn btn-sm btn-default" id="forgotform">Reset Password</button>
</div>
</div>
</form>POST
<form id="callback-form" action="" method="post" role="form" novalidate="novalidate">
<input type="hidden" id="callback-path" value="/en-US/site/page/savequery">
<div class="modal-content">
<div class="modal-header">
<button type="button" class="close" data-dismiss="modal"><span aria-hidden="true">×</span><span class="sr-only">Close</span></button>
<h4 class="modal-title" id="mySmallModalLabel">Request a callback</h4>
</div>
<div class="modal-body">
<div class="row">
<input type="hidden" value="1" name="Query[type]">
<div class="col-md-6">
<div class="form-group margin-errore">
<label class="control-label" for="exampleInputName1">Name</label>
<input type="text" class="form-control required" id="exampleInputName1" placeholder="Name" name="Query[name]" aria-required="true">
</div>
</div>
<div class="col-md-6">
<div class="form-group margin-errore">
<label class="control-label" for="exampleInputEmail1">Email address</label>
<input type="email" class="form-control required" id="exampleInputEmail1" placeholder="Email" name="Query[email_id]" aria-required="true">
</div>
</div>
<div class="col-md-6">
<div class="form-group margin-errore">
<label class="control-label" for="exampleInputPh1">Phone</label>
<input class="form-control required" id="exampleInputPh1" placeholder="Phone" name="Query[phone_no]" aria-required="true">
</div>
</div>
<div class="col-md-6">
<div class="form-group margin-errore">
<label class="control-label" for="exampleInputSource1">How did you learn about us?</label>
<select class="form-control" id="exampleInputSource1" name="Query[about_us]">
<option>Google search</option>
<option>Emails</option>
<option>Friends reference</option>
<option>Social media</option>
<option>Others</option>
</select>
</div>
</div>
<div class="col-md-12">
<div class="form-group margin-errore">
<label class="control-label" for="exampleInputSource1">Interested in</label>
<select class="form-control" id="exampleInputSource1" name="Query[intersted_in]">
<option value="35">Medical Devices</option>
<option value="32">Pharmaceutical</option>
<option value="31">Clinical Trial</option>
<option value="33">Food Safety & Dietary Supplements</option>
<option value="29">Hospital & Healthcare</option>
<option value="41">Accounting and Taxation</option>
<option value="42">Banking & Financial Services</option>
<option value="37">Governance, Risk & Compliance</option>
<option value="38">Human Resources</option>
<option value="81">IT Compliance</option>
<option value="39">Occupational Health & Safety</option>
<option value="40">Trade and Logistics</option>
</select>
</div>
</div>
<div class="col-md-12">
<div class="form-group margin-errore">
<label for="exampleInputquery1">Query:</label>
<textarea class="form-control required" rows="3" id="exampleInputquery1" name="Query[query]" aria-required="true"></textarea>
</div>
</div>
</div>
</div>
<div class="modal-footer">
<button type="button" class="btn btn-sm btn-dark closemodal" data-dismiss="modal">Close</button>
<button type="submit" data-target=".bs-example-modal-sm" class="btn btn-sm btn-default">Submit</button>
</div>
</div>
</form>POST /en-US/compliance/page/brochuredownload
<form id="brochure-form" action="/en-US/compliance/page/brochuredownload" method="post" role="form" onsubmit="return false;">
<div class="modal-body">
<div class="form-group alert-danger" id="brochure-form-errors" style="display: none;">
</div>
<div class="form-group">
<input type="hidden" name="BrochureDownloadDetail[topic_id]" value="5540">
<input type="text" class="form-control required" placeholder="Full Name" name="BrochureDownloadDetail[full_name]">
</div>
<div class="form-group">
<input type="email" class="form-control required" placeholder="Email" name="BrochureDownloadDetail[email]">
</div>
<div class="form-group">
<input type="text" class="form-control required" placeholder="Phone" name="BrochureDownloadDetail[phone_number]">
</div>
<div class="form-group">
<input type="text" class="form-control required" placeholder="Job Title" name="BrochureDownloadDetail[job_title]">
<input type="hidden" name="BrochureDownloadDetail[industry_id]" value="4">
</div>
</div>
<div class="modal-footer">
<button type="submit" id="submit-download-brochure" class="btn btn-md btn-block btn-default">Submit</button>
</div>
</form>/en-US/search
<form action="/en-US/search" role="search" class="search-box margin-clear">
<div class="form-group has-feedback">
<input type="text" name="keyword" class="form-control" placeholder="Search">
<i class="icon-search form-control-feedback"></i>
</div>
</form>POST /en-US/site/page/subscribe
<form id="subscribe-form" action="/en-US/site/page/subscribe" method="post" role="form" class="form-inline margin-clear" novalidate="novalidate">
<div class="form-group has-feedback">
<label class="sr-only" for="subscribe3">Email address</label>
<input type="email" class="form-control form-control-lg required email" id="subscribe3" placeholder="Enter email" name="Subscribe[email_id]" aria-required="true">
<i class="fa fa-envelope form-control-feedback"></i>
</div>
<button id="subscribe-btn" type="submit" class="btn btn-lg btn-default btn-animated margin-clear">Subscribe <i class="fa fa-send"></i></button>
</form>Text Content
×Close
SIGNUP
First Name*
Last Name*
Email*
Phone Number*
Area of Interest* Medical Devices Pharmaceutical Clinical Trial Food Safety &
Dietary Supplements Hospital & Healthcare Accounting and Taxation Banking &
Financial Services Governance, Risk & Compliance Human Resources IT Compliance
Occupational Health & Safety Trade and Logistics
Password*
Re-Enter Password*
I would like to receive tips and events roundup from Compliance World
SIGNUP NOW
×Close
FORGOT PASSWORD
Enter Your Email
Cancel Reset Password
×Close
REQUEST A CALLBACK
Name
Email address
Phone
How did you learn about us? Google search Emails Friends reference Social media
Others
Interested in Medical Devices Pharmaceutical Clinical Trial Food Safety &
Dietary Supplements Hospital & Healthcare Accounting and Taxation Banking &
Financial Services Governance, Risk & Compliance Human Resources IT Compliance
Occupational Health & Safety Trade and Logistics
Query:
Close Submit
REQUEST A CALLBACK
THANKS FOR CALLBACK REQUEST..!
Close
×Close
CLASS CALENDAR
×Close
VENUE DETAILS
* Location
* Local Attraction
LOCATION
--------------------------------------------------------------------------------
LOCAL ATTRACTION
Close
PLEASE FILL THE DETAILS
Submit
THANK YOU FOR SUBSCRIBING
YOU ARE IN–YOU WILL NOW GET OUR WEEKLY EMAIL NEWSLETTER.
Close
DISCLAIMER
This website contains affiliate links in the form of banner ads and text links.
This means if you click on the link and purchase the item, Complianceelearn will
receive an affiliate commission. When you make a purchase, the price you pay
will be the same whether you use the affiliate link or go directly to the
vendor’s website using a non-affiliate link. Regardless, we only recommend
products or services that we believe will add value to our readers.
Close
×Close
A MEMBERSHIP PLAN, PACKED WITH AWESOME BENEFITS
Select from 400+ video courses
Get free video courses –
1 Per Week
(each $249 value)
Get unlimited access to
Q&A Bank
Get access to exclusive
Live Webinars -
1 Per Month
Get special discounts -
20% off on Webinars/Rec
5% off on Seminars
Earn completion certificates for each course
Help and Support
Request a callback
(315) 632-0735, (315) 750-4379
Toggle navigation menu
*
* All courses
* * Life Sciences
* Banking & Financial Services
* Human Resources
* IT Compliance
* Occupational Safety & Health Administration
* Trade and Logistics
* Medical Devices
* Pharmaceutical
* Clinical Trial
* Food Safety & Dietary Supplements
* Hospital & Healthcare
* Accounting and Taxation
* Banking & Financial Services
* Governance, Risk & Compliance
* Human Resources
* IT Compliance
* Occupational Health & Safety
* Trade and Logistics
* Live Sessions
* Recorded Sessions
*
GET STARTED FREE
1. Home
2. Life Sciences
3. Clinical Trial
4. The Importance Of Protocol Deviations and Violations to Subject Safety and
Data Integrity Will Surprise You
THE IMPORTANCE OF PROTOCOL DEVIATIONS AND VIOLATIONS TO SUBJECT SAFETY AND DATA
INTEGRITY WILL SURPRISE YOU
AddThis Sharing Buttons
Share to FacebookFacebookShare to TwitterTwitterShare to LinkedInLinkedInShare
to EmailEmail
Starting at
$249
Single registration
Buy Now
About Course Price / Register Speaker
With the increasing frequency of real-time FDA audits, the importance of the
seriousness and frequency of evidence of "Not following the Protocol" has gained
increasing importance. Deviations and Violations from the agreed upon protocol
may very well affect the scientific validity of the research. For this reason, a
well-written protocol, taking onto account the role of all the Inclusion and
Exclusion criteria in subject enrollment is a key element in having deviation
free study conduct. A major challenge is to know the differences between and
differing significances of "Deviations" and "Violations". This must be clearly
understood by all persons involved in the conduct of clinical research studies.
Protocol Deviations and Violations are one of the most common problems
identified by FDA Investigators and is a main reason for the rejection of
clinical data from a particular site or even a study. Forewarned is forearmed
COURSE OBJECTIVE
Protocol Deviations and Violations are one of the most common problems
identified by FDA Investigators and is a main reason for the rejection of
clinical data from a particular site or even a study. Forewarned is forearmed.
Deviations and Violations from the agreed upon protocol may very well affect
Subject and Public safety in addition to the scientific validity of the
research.
For this reason, a well-written protocol, taking onto account the role of all
the Inclusion and Exclusion criteria in subject enrollment is a key element in
having deviation free study conduct. If and when a deviation or violation of the
protocol is found, meaning that the protocol was not followed (PNF) it must be
reported, reviewed and acted upon for Corrective and Preventative Action (CAPA).
Also, the differences between and differing significance of "Deviations" and
"Violations" must be clearly understood by all persons involved in the conduct
of clinical research studies.
COURSE OUTLINE
* How to know when the protocol is not followed (PNF)?
* What is the difference between a deviation and a violation?
* Importance of the "Protocol" in the number of deviations occurring
* How to ensure that the protocol will be followed exactly?
* What is in the Regs about following the protocol?
* When may the Investigator make changes in the protocol?
* What are the causes of Protocol Deviations and Violations?
* How are Protocol Deviations managed?
* Examples of Protocol Violations and Deviations
TARGET AUDIENCE
* Principal Investigators and sub investigators
* Clinical Research Scientists (PKs, Bio-statisticians, ...)
* Research managers
* Safety Nurses
* Clinical Research Associates (CRAs) and Coordinators (CRCs)
* Recruiting staff
* QA / QC auditors and staff
* Study Monitors
* Clinical Research
* Data managers.
WEBINAR EVENTS
LIVE -COMING SOON!
--------------------------------------------------------------------------------
TRAINING CD-DVD
Physical CD-DVD of recorded session will be despatched after 72 hrs on
completion of payment
$ 599
--------------------------------------------------------------------------------
RECORDED VIDEO
Recorded video session
$ 349
--------------------------------------------------------------------------------
Enroll Now
--------------------------------------------------------------------------------
READY TO LEARN?
Try it free
--------------------------------------------------------------------------------
COMPANY
About Us
Contact us
Help & support
FOR BUSINESS
Onsite Training
Group Training
LEGAL
Privacy Policy
Refund Policy
Terms of Services
GET IN TOUCH
(315) 632-0735,
(315) 750-4379
SUBSCRIBE TO OUR NEWSLETTER
Subscribe to our newsletter and get industry updates along with exclusive deals
on related trainings
Email address
Subscribe
Copyright ©2017 Complianceelearn.com. All rights reserved.
Disclaimer: This website contains affiliate links in the form of Banner Ads and
Text Links. We receive a commission on sales via the hypertext link to
Compliance.world.