Clinical Data Systems

What Services can the Clinical Data Systems team provide?

The Clinical Data Systems team works collaboratively with Imperial College Investigators, Researchers, Study Managers and Statisticians, and Study Teams to provide an electronic data capture system for your Clinical Research Study, in line with regulatory standards.

We design and develop Electronic Case Report forms (eCRFs) according to the clinical study protocol, including edit rules, to ensure the data are collected accurately and stored securely.  User training and support is provided during the life cycle of the study to deal with forgotten passwords, questions on how the system works and any perceived issues with the system.  We also provide data extracts for safety committees, final reports, as requested.

How do we ensure a successful outcome?

There are two EDC tools that are available for electronic data capture depending on the clinical research being undertaken: OpenClinica V4.0 and REDCap (academic). In addition, we continue to support studies released into InForm 6.0.0.6, which will no longer be used for new study releases after Nov 2020.

The use of OpenClinica has been mandated for all Imperial College AHSC sponsored clinical trials of an IMP, however, other studies may use the OpenClinica system.

Acknowledgements

For all papers and publications that have benefited from the services of the Clinical Data Systems team, please include the following acknowledgment:

The authors thank the Imperial Clinical Trials Unit Clinical Data Systems team for designing the eCRFs and database capture system.

Accessibility Statements

Please read the full Accessibility Statement for OpenClinica

Please read the full Accessibility Statement (word) for InForm 6.0