The InForm system
The InForm team aims to provide Investigators and Clinical Trial Teams across Imperial College with a comprehensive service to support the collection, management and analysis of data from clinical trials.
What do we do?
We work collaboratively with Investigators, Trial Managers, Trial Statisticians and Trial Teams to design the structure of the trial in line with the clinical protocol. We design and build the eCRFs (electronic case report forms) and validation rules for data entry to ensure the data can be collected accurately and stored securely. User support is provided during the life cycle of the trial to deal with forgotten passwords, questions on how the system works and any perceived issues with the system. The team also provide assistance with ad hoc report development and provide research data extracts for safety committees, final reports or as requested.
How do we do it?
The service is provided using InForm ITM (Integrated Trial Management) System, a web-based data entry system which builds an Oracle database for each individual clinical trial. InForm, supplied by Oracle | Phase Forward, is widely used across the pharmaceutical industry and Imperial College was the first academic organisation in the UK to adopt it. The databases are hosted on Imperial College's infrastructure and can be analysed using an inbuilt reporting package, Cognos.
Central Designer, also supplied by Oracle | Phase Forward, is the tool used to design and build the eCRFs (electronic case report forms) and data entry rules for trials.
Our business benefits!
- Consistent approach to data collection
- Real time validation of data input
- Full audit trail of data entry and changes
- Consistent user-friendly interface
- Role and site based security
- Fully protected centralised data storage
- Disaster recovery provision
- Supports compliance with the legislation and regulatory guidance on management of clinical research
- Comprehensive reporting functionality
- Automated e-mail alerts for safety reporting
- Documented requirements and sign-off
Imperial College and Academic Health Science Centre staff working on clinical trials and research studies.
Collaborators on Imperial College sponsored clinical research, e.g. pharmaceutical companies, charitable bodies and ultimately the people who will benefit from the new drugs and treatments that result from successful trials.
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