NEW ZEALAND
CTRU WEB‑BASED
DATA AND TRIAL
MANAGEMENT
SERVICES
November 2007
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CTRU Services
November 007
Web-based data management is becoming the norm now. CTRU have been providing this facility since the late 1990’s and are continually developing its systems and services to meet the needs of the research community. The main advantages are :
Speed of data collection
The chart shows time between clinic visit and data entry: Median time to entry
Paper: 6 weeks Web: 1 day
Distributed data entry to a centralised database has many advantages:
People who collect the data are responsible for handling it, reducing errors of interpretation
No paper handling delays means data are quickly in the central database and available for inclusion in reports Any updates to e-CRF screen questions or validation checks are immediately available to all sites
Speed of data clean‑up
Real-time query resolution is one of the benefits of the web-based system.
Our experience is that there is less missing data when queries are raised immediately.
40-50% of queries are resolved within 1 hour Median time to query resolution:
Paper: 10 weeks Web: 1 day
Advantages of faster cleaner data
Early detection of problems can reduce protocol violations, detect potential fraud and help monitor compliance levels, and drop-outs as well as avoid lost to follow-up patients and aids in identifying problem centers, and problem CRFs.
Less missing data means data safety monitoring data is more complete and results in an earlier data lock.
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Time between visit date and data entry Max 189 weeks Max 67 weeks
Paper based Web based
Weeks 16 12 8 4 0
Time between query raising and resolution Max 209 weeks Max 110 weeks
Paper based Web based
Weeks 20 16 12 8 4 0
Flexibility
Because all functions are web-based there is flexibility re who enters data and from where ie Site/clinic staff while with the participant
Site/clinic staff after seeing the participant Other people at the site/clinic
Others at remote sites worldwide, using fax transmission; staff at the receiving end keying data via the study website
eCRF Design features
Screen layout and navigation affects the accuracy of the data entered, particularly where the eye is drawn to the data to be entered, e.g. with drop down and input boxes close to the associated text and with navigation controls to prevent users answering illogical questions, by skipping intelligently between relevant questions. These features are standard on our e-CRF screens eg:
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CTRU Services
November 007
Access and Audit
The CTRU operates secure web servers, using 18 bit encryption, ensuring security for data being entered on the Internet.
Website access is controlled by role-based secure password and prior authentication of authorised users. Users only see menu items and functions they need to have access to depending on their role.
All data inputs are electronically signed and fully audit trailed so they can be tracked to the user who entered or edited the data.
Backup and security
The CTRU run Oracle relational databases with full backup and recovery systems in place. The servers are housed in a purpose built computer centre, containing both battery and generator backup power supplies. The centre also has specialist air conditioning and fire protection systems. The computer centre is manned 4 hours a day and requires authenticated access.
Additional Features
Registration, Randomisation & Unblinding
Participant registration direct into the central study database ensures that eligibility criteria are met and essential data items required for stratification are completed. Conducting Randomisation and Unblinding via a secure study website means it is available 4/7 and is centralised, so stratification/minimisation is ensured.
Study materials and communications
Study documents such as protocols, CRFs, manuals, newsletters etc can be easily accessed and maintained via the study website. ‘News’ can be added to the ‘Registered Users Page’ and ‘Broadcast messages’ can be sent to inform everyone of study news or milestones.
Reports
Study activities can be monitored with a range of dynamic live-to-data reports for example: Recruitment activity
Data completeness Data queries
Adverse events and SADR’s Retention and dropout rates Protocol compliance and violations
Participant verification & monitoring activity Treatment stock levels
Sampling / selection results Close-out activity
Reports can be presented as charts & graphs as well as cross-tab summaries or data listings.
Clinical Alerts
Any data collected through the e-CRFs can have automated alerts attached. These are commonly used to ensure participant safety if a participant’s health is compromised. The information is sent as an email to the designated recipient(s) in real-time.
Centre Monitoring
The web-based ‘Monitoring’ functions support on-site monitoring activities:
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CTRU Services
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Treatment supply
Use of the study website facilitates treatment supply tracking so that re-stocking happens in relation to volumes of packs used.
Coding
Coding of free text data is done using ICD-10, MEDRA, WHO-ATC or other recognised coding systems.
Calendar
The participant calendar view displays each participant’s actual and scheduled contacts and facilitates the planning of contacts. The colour coded symbols denote the status of each CRF/ contact as well as linking directly to the forms that require input or queries resolving.
Multi‑language
If necessary, the study web pages and eCRF screen displays can be made available in different languages including those that require non-ascii character sets eg Chinese.
Endpoint adjudication
E-tracking of adjudication status and input of adjudicators decisions results in quicker endpoint adjudication and quicker data availability for safety monitoring.
Training and support
Study site staff may or may not have hands-on experience using web-based data entry forms.
To address this, the CTRU has a training website which steps users through the data management procedures for a theoretical study.
Systems provided by CTRU come with full IT system support throughout the duration of the study, and often also include Data management support, depending upon the needs of the customer.
Contacting CTRU
General enquiries, cost estimates etc [email protected] Or, Phone 7 7599 Ext:
Sheila Fisher, Business Manager Ext 84717
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Amanda Milne, Data Services Manager Ext 8474
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Rina Prasad, Data Operations Manager Ext 8474
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Bio-Statistics enquiries Steve VanderHoorn, BioStatistics Manager
[email protected] Ext 8474
