Protocol Specific

January 4, 2012

Services

Cost: To be negotiated

These courses include training in important aspects and best practices of clinical research that are not necessarily covered by GCP guidance alone. The courses can be customized to any level of staff e.g. basic entry-level for lay field workers, intermediate level for study coordinators or research nurses, or advanced for PIs or sub-Investigators. These courses can be designed to take into account the client’s specific protocol.

If your site has a particular need or gap CREDE can tailor make a course to fit your needs.

Some examples of these courses:

  • Good documentation practice (GDP): training in designing, completing and quality control of study documentation such as source documents and CRFs
  • Quality Management including Quality Assurance and Quality Control systems, the Quality Management Plan, the Corrective Action Preventative Action plan (CAPA), and much more
  • Informed consent: in-depth training in taking informed consent including special circumstances such illiterate participants, language disparities and translators, underage participants etc.
  • Study Specific Standard Operating Procedure (SOP) training: training designed around study specific SOP’s or assistance with the development of study specific SOPs.
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