| "I had a VERY non-compliant
site and using your methods and ideas, I was able to bring them back into
compliance (and exceed the ICH/GCP). They just had an audit and the person
conducting the audit was very impressed with our hard work. Norton
Training has been a God send!" Marti; Senior CRA
and On-Line Student, May, 2007
|
No time or travel
budget to attend one of our
Public Training
Classes
?
Looking for the
latest Skills and Knowledge
to advance your career?
Need training you can
complete any time of the day, week, or weekend?
Need
audio, visual, and hands-on elements
to maximize training effectiveness?
| "Your on-line demo is
great. It gave me the confidence in what I was paying for and
we really like the fact that each module is
narrated." Jen; CRO Owner and On-Line CRA
Program Customer, February, 2006
|
Then the Norton Training
Institute On-Line Training
may be what you are looking
for:
-
Developed by Former FDA
Investigators and Current Industry Auditors, Instructors and
Consultants
-
On-Line Internet-Based Subscription
Training -
Available 24/7
during your Subscription
-
Start, Pause, Restart and Repeat Training
as often as you like -
CEUs Included
with Every Course
-
Training Includes Audio, Visual and
Hands-On Content:
-
Instructor
Narration over Graphical Text -
Digital
Library
of
Reference Materials -
Terms Glossary -
Frequently Asked
Questions -
Area to Record your Personal
Training Notes -
Pass/Fail Quizzes to Ensure
Learning -
Personal Training Certificate. CEUs also
available -
-
-
Focus on Teaching Usable
Skills -
Applicable Laws, Regulation, GCP and ICH
References -
Real World Experience-Based Case
Studies -
Generally 1 to 4 Hours
in Length
| "I've completed the
RESEARCH and now into the Causalities Class. I wish I had taken
these months ago. I would have been better informed and more
confident." Rita; On-Line Student, January,
2006 |
Modules Available Now
:
-
-
Identifying Compliance Concerns Upfront,
before Research is Conducted -
Teaches the Systematic Skills for
Inspecting a Clinical Investigator, Including:
-
Interviewing,
Human Research Protection -
Quality Systems,
Training, Form FDA 1572 -
Equipment, Staff and Regulation
Knowledge
-
-
Presents the Key Quality
Systems for Investigators
-
Major
trends of Clinical Investigator Noncompliance -
Examine why Noncompliance
occurs within Clinical Trials -
Implementing
Corrective
and Preventative Actions (CAPA)
-
Four
Hours of Core Content plus Research Assignments -
For Auditors, Monitors,
Coordinators, Investigators and Site Staff
-
-
An 8 Step Process for Examining and Determining
Follow-Up to Noncompliance -
A Framework for Issue
Resolution and Case Development -
Case Studies on a CRO, Phase
I Facility Inspection and Phase III Clinic Data Audit -
Provides Step-by-Step Skills
for Handling Suspect Data and Scientific
Misconduct -
Four Hours of
Core Content plus Quizzes, Digital Library and
Glossary -
For Auditors, Monitors and
Investigators
-
-
Famous
Cases -
Legal, FDA and
ICH Definitions -
Detection, Prevention and Causation
-
Who is Blamed for
and Who Commits -
Whistleblower and False
Claims Laws -
Umbrella of Protection to
Prevent and Detect -
FDA
Process for Responding to Claims and Complaints -
How to Document, Burden of Proof and Elements to
Prove -
Responsibilities of
Sponsors, CROs, IRBs, and Investigators
- Legal Training for Determining Qualifications of Clinical
Investigators
- Build regulatory and legal skills
- Understanding of binding and legal agreements
between:
- FDA
- Sponsor
- IRB
- Clinical Investigator
- Study Team
- Learn laws governing the investigator's necessary
qualifications for:
- Receiving investigational drugs
- Conducting clinical research
- Examine laws as related to determining investigator's
qualifications to receive and treat with investigational drugs:
- 21 Title CFR 312
- FDA's Compliance Policy Program 7248.811
- Form FDA-1572
- International Conference on Harmonisation
(ICH)
Complete Training
Programs Available Now:
Clinical Research Associate
| "I feel like there is
somebody there and it is not just a class on the web. The
opportunity for a chat was great. My overall impression is one of
Norton Audits being a serious professional company. The class is
easy to access and run." Michelle; On-Line Student,
October, 2005 |
Complete Training
Programs Available Soon:
Clinical Research Coordinator
Modules
Available Soon Include:
Clinical Investigators and Research
Coordinators
Clinical Research
Auditing
-
Trend Analysis
Skills
-
Auditing the Informed Consent
Process -
Norton Methods: Skill-Based Auditing
Techniques – Series One -
Norton Methods: Skill-Based Auditing
Techniques – Series Two -
Norton Methods: Skill-Based Auditing
Techniques – Series Three
-
Examining Causality of Institutional Review
Boards Noncompliance
-
Examining Causality of Sponsor and Contract
Research Organizations Noncompliance
Monitoring
Skills for All Clinical Research
Professionals
-
Complaint Management
Skills -
Effective Regulatory Writing
Skills -
Effective Professional Interviewing
Skills -
Detection and Prevention of
Fraud and Misconduct
Industry Basics and
Trends
Standard Operating
Procedures
For more information
or Assistance in Course Registration, please contact
us.
|
