Training: OpenClinica 4.0

• 2.8 Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s).
• 5.5.3 ADDENDUM The SOPs should cover system setup, installation, and use. The SOPs should describe system validation and functionality testing, data collection and handling, system maintenance, system security measures, change control, data backup, recovery, contingency planning, and decommissioning. The responsibilities of the sponsor, investigator, and other parties with respect to the use of these computerized systems should be clear, and the users should be provided with training in their use.  (Please read section 5.5 as this is most relevant).
• 5.6.1 The sponsor is responsible for selecting the investigator(s)/institution(s). Each investigator should be qualified by training and experience and should have adequate resources (see 4.1, 4.2) to properly conduct the trial for which the investigator is selected. If organization of a coordinating committee and/or selection of coordinating investigator(s) are to be utilized in multicentre trials, their organization and/or selection are the sponsor's responsibility.

Taken from Grey guide Section 1.1.4 Non-commercial sponsorship section:

• Performing a pre-assessment of the capabilities of the investigator and/or host site, and arranging for appropriate training in research methods and GCP for the Chief investigator and members of the research team as required. – NOTE (this includes the use of an EDC system where applicable)
• Specifically Section 14.5 Computer system validation - please see:
  14.5.2.2 Example 2 (trial-specific configuration) production of user instruction and training of users
  14.5.2.3 Example 3 bespoke system training records

Taken from UK Clinical Trials Regulations (SI 2004/1031, as amended)

• “each individual involved in conducting a trial shall be qualified by education, training and experience to perform his tasks” (Schedule 1, Part 2, 2)