ICORG
ICORG
ICORG
ICORG

  •      Welcome    
  •       Course dates   
  •     Booking form
  •       Training programme 
  •    Agendas

Welcome to the training section of the ICORG website. 

It is mandatory that all research staff attend GCP training at a minimum every 2 years.  This includes research nurses, data managers, investigators, research registrar’s, CRA’s and research pharmacists.  For this purpose we run a refresher/update to GCP course at the ICORG scientific meetings held in April and September each year.

In addition ICORG recommends that all research staff who works exclusively in research eg CRA’s, research nurses and data managers attend ICORG’s 2 day programme within 6 months of starting in their positions.

If you have any queries regarding your training requirements please do not hesitate to contact the ICORG office on 01 66 77 211 or temp@icorg.ie

Courses 2010 :

Date

DAY 1

Principles of GCP, Investigator Responsibilities, Essential Documents

DAY 2

Principles of GCP, Sponsor Responsibilities, Ethics Committees

Audit Preparation
Presentation Skills
April 2010
14th
Available
     
15th  
Available
   
September 2010
7th
Available
     
8th  
Available
   
9th            Available
December 2010
7th
Available
     
8th  
Available
   

 

Booking form:

Course Title:
Date of Course:
Name of Delegate(s):
Position:
Institution:
Phone:
Email:

 

Training Programme for ICORG affiliated Research Personnel
Course Module
Course Title
Investigator
Research Nurse
Data Managers
Administrators
Introduction to drug development
Introduction to clinical
research & GCP
X
X
X
X
Introduction to clinical research
Introduction to clinical
research & GCP
X
X
X
X
Introduction to clinical research regulations
Introduction to clinical
research & GCP
X
X
X
X
Introduction to ethical principles in clinical research
Introduction to clinical
research & GCP
X
X
X
X
Introduction to required documentation
Introduction to clinical
research & GCP
X
X
X
X
Clinical trial planning & resourcing
Advanced GCP & clinical research
X
X
X
opt
Role of the ethics committee in clinical research
Introduction to clinical
research & GCP
X
X
X
X
Role of the monitor in clinical research
Introduction to clinical
research & GCP
X
X
X
X
Role of the investigator in clinical research
Introduction to clinical
research & GCP
X
X
X
X
Role of the sponsor in clinical research
Advanced GCP & clinical research
X
X
X
opt
Introduction to GCP audits and inspections
Advanced GCP & clinical research
X
X
X
opt
Patient Information Leaflets the requirements
Advanced GCP & clinical research
X
X
X
opt
The consent process
Advanced GCP & clinical research
X
X
X
opt
Clinical trial protocols
Advanced Clinical Trial Principles
opt
X
X
NA
CRF development
Advanced Clinical Trial Principles
opt
X
X
NA
Data queries
Advanced Clinical Trial Principles
opt
X
X
NA
Electronic CRF’s
Advanced Clinical Trial Principles
opt
X
X
NA
Clinical Trial Statistics
Advanced Clinical Trial Principles
opt
X
X
NA
Clinical Trial Data Management
Advanced Clinical Trial Principles
opt
X
X
NA
Preparation for a GCP Inspection
GCP Inspections
opt
X
opt
opt
Findings from previous GCP Inspections
GCP Inspections
opt
X
opt
opt
Presentation skills beginners
Presentation skills
opt
X
opt
NA
Presentation skills advanced
Presentation skills
opt
X
opt
NA

X = mandatory course and must be completed within one year of starting position or documentation of attendance at similar course in previous 3 years.
 
Opt = Optional down to local management to decide if appropriate to attend
 
NA = not applicable, no requirement to attend this course.

Terms & Conditions

Only staff working with ICORG clinical trials can attend these courses.  

All courses can be booked by completing a booking form or by contacting ICORG office on 01 66 77 211 or temp@icorg.ie

Places will be allocated in the order that bookings are received. Confirmation of attendance will be issued within a few days of booking. As spaces are limited if booked courses need to be cancelled this must be done at least 2 weeks prior to the course. 

Substitution with a colleague is acceptable but a cancellation fee will apply if course places are cancelled with less than two weeks notice. 

All courses will take place at the ICORG offices, 120 Pembroke Road, Dublin 4 unless otherwise advised.

All refreshments will be provided at the training courses and casual dress is acceptable.


Training Course Agendas


Preparation for a GCP Audit/Inspection

DAY 1

Principles of GCP, Investigator Responsibilities, Essential Documents

09:30 
Introduction & Registration
09:30 
Introduction to drug development
Drug development from bench to clinic
09:45 
Regulations concerning inspections/audits
09:45 
Introduction to clinical research
Phases I to IV, pharmacoeconomics, trial design, statistics
10:15
IMB Audit process
10:15
Regulations in clinical research
Requirements for commencing clinical trials in Europe, ICH, Declaration of Helsinki & the EU Directive
10:45
Coffee
10:30
Coffee
11:00
Audit preparation at sponsor 
10:45
Principles of ICH GCP
11:30  
Audit preparation at site
11:15
Data & Documentation
12:15
FDA Audit process
11:45 
Planning & Resourcing
12:30
Lunch
12:00
Responsibilities of the ethics committee
13:30
Workshop
12:45 
Lunch
14:30 
IMB Inspection findings
14:00
Workshop
15:30 
Coffee
15:00 
Responsibilities of the monitor
15:45
Exam for certification
15:30 
 Exam for certification
16:15
END
16:30
END
       

DAY 2

Principles of GCP, Sponsor Responsibilities, Ethics Committees

Presentation skills agenda

09:30 
Responsibilities of the sponsor
09:30
Introduction & objectives
10:15
Patient recruitment & enrollment
09:35
The importance of presentation skills
10:45
Coffee
09:45
1st Presentation
11:00
AE reporting
Definitions of ADR's and SAE’s, reporting requirements
10:45
Coffee
11:45 
Informed consent
The consent process, required elements for patient information leaflets.
11:00
Planning a presentation
12:30 
Lunch
11:45
Powerpoint and AV equipment basics
13:45 
GCP audits and inspections
Overview of audits, inspections and common findings
12:30
Lunch
15:00
Exam for Certification
13:30
Controlling fear
16:00
END
14:00
Breathing & vocal exercises
   
14:15
Last minute tips
   
14:30
Preparation of presentation
   
15:00
Presentations
   
16:00
Feedback
   
16:30
Close