Training and education

 

It is recommended that training and education of staff be completed prior to registering interest in conducting clinical trials. Specific training requirements include the following areas.


 

Good Clinical Practice (GCP)

GCP is a standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials that provide assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial participants are protected. [ICH-GCP E6 1.24]

 

The following link is to access The Guideline for Good Clinical Practice ICH-GCP E6: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6_R1/Step4/E6_R1__Guideline.pdf
The link to access Guidelines for Good Practice in the Conduct of Clinical Trials in Human Participants in South Africa: http://www.doh.gov.za/docs/policy/trials/trials_01.html

 

Research Ethics Training
"There are several reasons why it is important to adhere to ethical norms in research. First, norms promote the aims of research, such as knowledge, truth, and avoidance of error. For example, prohibitions against fabricating, falsifying, or misrepresenting research data promote the truth and avoid error. Second, since research often involves a great deal of cooperation and coordination among many different people in different disciplines and institutions, ethical standards promote the values that are essential to collaborative work, such as trust, accountability, mutual respect, and fairness." David B. Resnik, J.D., Ph.D.

 

Links to free research ethics training:
http://www.fhi360.org/en/rh/training/trainmat/ethicscurr/index.htm
http://ori.hhs.gov/education/products/montana_round1/research_ethics.html

 

Therapeutic Area Training
Therapeutic area training is applicable according to the disease area that is currently being researched. A good understanding of the disease and appropriate management supports the conduct of the clinical trial. Specific therapeutic area training for all staff according to the research focus at the research site should be considered

Dangerous Good Training:
Dangerous Goods Training is applicable to the staff on site that are responsible for the handling and packaging of biological specimens. The responsible staff are trained in the safe and appropriate handling and packaging of biological specimens to ensure safe shipment, transport and receipt of the specimens according to local and international regulations.
Link to the South African Civil Aviation Authority: www.caa.co.za


Dispensing License
All practicing pharmacists and dispensing doctors in the clinical trial environment are governed by local regulations, namely, The Pharmacy Act, 53 of 1974 and the Medicines and Related Substances Act, 101 of 1965. ICH-GCP E6 also makes reference that Investigational Product should be stored in accordance with applicable regulatory requirements (ICH-GCP E6 4.6.4).