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)
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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OpenClinica assessments
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 cds_training@imperial.ac.uk.
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.
The Collaborations Section is currently being updated.
If your request falls under one of the Therapeutic areas details for the relevant email can be found on the Therapeutic Area Contact Details Page.
For commercial sponsors
Visit our dedicated website for commercial sponsors interested in working with ICTU.
Temporary Clinical Trials Manager opportunity
We are looking for an experienced Clinical Trials Manager, preferably based in or near London, to join our supportive team on a temporary basis.
Based within the Department of Surgery and Cancer with the Imperial Vascular Unit at St Mary’s Hospital and at the Imperial Clinical Trials Unit (ICTU) in White City, you will be working with the Imperial Vascular Unit to deliver a long-term study to perform a multicentre randomised controlled trial in patients with uncomplicated type B aortic dissection, to answer the question whether thoracic endovascular aortic repair (TEVAR) in the subacute phase in addition to best medical therapy is beneficial compared to standard treatment.
You will be responsible for all aspects of trial management, including close liaison with the Chief Investigator and Principal Investigators at other centres, management of the associated study and implementing and adapting established ICTU systems to ensure the trial is developed and conducted to the highest scientific and regulatory standards.
A Bachelor’s degree or equivalent in a biomedical/scientific field or related field and proven clinical trial/project management and monitoring experience gained in multi-centre, randomised trials is essential. You will need to show strong leadership and motivational skills as well as effective communication, organisational and time management skills.
This full-time temporary post is available from September 2026 and is offered for 3 months. Travel is expected between the Imperial College campuses and research sites.
For more information, please review the EARNEST TM (Temp) Job Description Aug 2026.pdf.
To apply for this position, please send your CV and covering letter to t.sasikaran@imperial.ac.uk (Operations Manager, ICTU).
Advert closing date: Tuesday, 25 August 2026
Interview date: Friday, 28 August 2026
Start date: ASAP, available from September
If you are interested, get in touch, we would love to hear from you!