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:
220.127.116.11 Example 2 (trial-specific configuration) production of user instruction and training of users
18.104.22.168 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)
OpenClinica e-learning modules
At Imperial College, we have identified different roles within clinical trial teams and aligned the OpenClinica training modules to reflect these and the responsibilities associated. Below, you will find the user groups and the relevant e-learning modules. Please take time to look at the instructions manual before you begin the modules.
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The OpenClinica assessments are now integrated into the training modules and there are no separate links to the quizzes. If you pass successfully, the certificate will be at the end of the module.
The quiz results are not recorded, so once the assessments are completed successfully, please print your certificate and email it to email@example.com.
Please note that in order for your account to be activated, you are required to complete the OpenClinica User Activation Form and submit to CDS_Support@imperial.ac.uk. Please ensure that the Study Manager or the CI has signed the form as well, otherwise your request may take longer to process.
Study specific access will only be issued once all the checks have been performed. You will then receive the login details.