Services on offer

Good clinical practice (GCP) training courses

Clinical Trial ( GCP) Co-Ordination in Practical Training > Site staff i.e Study co-ordinators , Doctors , Pharmacists

 

Introduction to (CRA) Clinical Research Associate GCP practical training > CRA's & CTA's clinical trial assistant ( 2 Day )

 

Clinical Trial Site Data Capturing (GCP) Practical Training (Basic GCP/ 1 Day / refresher / 2 days )

 

The frequency of the course:

Monthly on set dates

Or Bookings done on request.

The training consists of lectures with practical demonstrations which the students are involved with and a written test at the end. The course is credited by WITS CPD facility which CPD points are allocated and HPCSA / SACRA GCP committee which also has allocated a registration number. Accreditation CPD points and registration number are allocated on the certificate. When the theory and practical training is completed, a written test is done. Then the student is issued with a Certificate which can be submitted to MCC. The GCP courses are recognised by the Ethics Committees and Medicines Control Council and deemed compulsory before commencing clinical research. The course's have also being audited by the following :-WITS Health Consortium Ethics committee in Sep 2008. - HPCSA / SACRA GCP and Pharma Ethics committee Feb 2011

 

Course contents and the different levels of the course:

  1. Introduction course >No Experience
  2. Intermediate course> Basic experience
  3. Refresher course>Experienced
  4. A specific study site set up (phase 1 / 2/ 3/ 4/) training >this depends on what the site or study design needs are.
  5. Introduction to (CRA) Clinical Research Associate GCP practical training. (2Day) course>CRA / monitor Junior with no or little experience
  6. Other topics
    Modular specific training needs at the site.
    >For Example compiling source documentation, as demonstrated in the course contents.
    A specific trial setup and preparation before a study starts, during and until the end of a study.
    On site assistance during a study.
    On Site audit before setting up the site thus to help what we need to develop or change and implement
    On site preparation prior to an audit

 

Monitoring method GCP training

- An attendance register will be signed.

- A certificate of attendance will be issued after completion of the course,

- The pass rate is 75% written test.

 

On-site-training and mentoring of study co-ordinator, Site staff, Dr's until competent to work on their own.
On-site audits a report is completed from the auditor.
Training and mentoring of junior CRA'S on a study.

 

Topics covered in the training:

Introduction to clinical trials & Principles of Good Clinical Practice.

History of human research from abusing patients and to committees formed Nuremburg code, Declaration of Helsinki Responsibilities of the Ethics and Regulatory committees

Responsibilities of the sponsor & CRO

Responsibilities of the investigator

Delegation of duties

The clinical trial roles

The protocol

Clinical trial phases and designs

Investigator drug brochure & Package insert

Key stages & Feasibility phases of clinical trials

Pre-study visit & Patient recruitment / retention strategies

Site resources & emergency equipment and situations.

Regulatory and ethics submission documents

Investigator meeting & Study initiation meeting

Essential documents in the Site file.

Informed consent process

Data management & including

CRF & e-CRF processes

Data management of Source documents > practical training

Concomitant medication

Safety Reporting > adverse events, serious adverse events

Study medication

Procedure File

Good Laboratory practice

Practical training > Slide procedures to prepare blood smears, Centrifugation and transfer, Packaging of samples Courier services, collection of dangerous goods

Monitoring > practical training including laboratory & ECG results, protocol violations Administration > invoicing, calibration of equipment, temperature logs,

Study close out procedure

Archiving of documents

Standard operation procedure guidelines

Audits

Note: templates are given with the training material.

What is Unique about our training?

Overview

Can be done on site

Hands on approach

Assistance is offered in problems areas

One-on-One Training or small groups

After Training Support

Training designed for specific studies for the site.

Training Dates

Training dates on request

Note: training can be given on REQUEST on ANY days at the site. Cape Town, Durban, PE, on REQUEST

Two day training: 08:00 - 17:30
One day training: 08:30 - 16:30


Venue Gauteng: 11 Nonna Street, Birchleigh North,
Kempton Park



Bookings Contact:
Karen (Gauteng) -
Cell: 0823298707
wdmickey@worldonline.co.za


Address: 11 Nonna Street, Birchleigh North, Kempton Park
Telephone: + 27 82 3298 707 Fax: 086 652 7852
Email: wdmickey@worldonline.co.za
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