Internet Based Data Retrieval - Section for Applied Clinical Research - Faculty of Medicine and Health Sciences
Remote data entry
Remote data entry
WebCRF used in multicenter studies
Unit for Applied Clinical Research offers an electronic solution for data collection. WebCRF is easy to use, can be reached from any computer with internet access and does not require extra installations of software. The program is made for multicenter studies and includes a module for randomisation if needed. WebCRF enhances the quality of the data, saves earlier answers when changes are made, makes it possible to monitor the study and presents the results in an SPSS file.
At present (des 2009) 18 studies have used or use our WebCRF solution for data collection. The solution is much admired by the researchers.
Advantages gained using WebCRF
- The program can be used for data collection in any kind of study. It is very suitable for multicenter studies ("real world patient management") where methods and treatments used on a daily basis are tested.
- Continuous Data collection reduces human error, leading to improved data quality and more solid conclusions.
- Data accuracy is enhanced by adding upper and lower value limits and setting the format of the answer.
- The program also offers monitor access, restricted to checking data and accepting each answer.
- The database to a new study can usually be established within days, if its setup (i.e. question and answer structure) is well prepared in advance.
- Using the program reduces the overall cost of a study.
- All involved can keep track of the progress, as the program offers some overview statistics of the number of included patients at each centre.
The database is located on this address: https://webcrf.medisin.ntnu.no/client/index.php
By logging into the database with username and password participants get access to their studies and to all patients recruited in their own hospital or study center. The database is organised in the same way as a paper CRF, with sections such as first visit, lab data and 3 months follow up. Data can be embedded continuously (if internet access is available). Alternatively, paper versions of the data can be printed or the data can be written in a paper CRF and transferred to the database when it is convenient.
Username and actual date are stored and linked to each answer filled out. The answers can be altered until the monitor has locked them. Each earlier answer with its provider and date are logged and can be found by pressing the button view log.
The study manager decides which questions should be mandatory. These will be marked with a red *. This is transferred into coloured signals that offer an overview over which study parts the user has filled in and which are yet to be done.
WebCRF uses basic statistics to present information like
- Number of included patients vs. expected number of patients at that time.
- Number of included patients per centre.
Chosen variables can be presented in diagrams comparing your own centre with the whole study.
- Part of study population successfully treated/ part of study population on your centre successfully treated.
- Part of study population with side effects/ part of study population on your centre with side effects
With these statistics the program supplies the user with up to date information through out the study period. The user can easily keep track of the development in their own centre compared to the whole study and be motivated by this.
The monitor has access to check the answers and lock them, but he or she can not alter them. Corrections can only be performed by the investigators. Locked answers are visible to the users, but can not be altered.
At the closure of the study or if there is a planned interim analysis, data are extracted into an excel or SPSS file. The WebCRF program is continuously improved.
WebCRF is approved by NSD (Norwegian Social Science Data Services), on the condition that the database contains no patient identifying data. Every study using the program has to get approval as usual before initiating.
The program is provided by the IT/Infrastructure Section at the Faculty of Medicine, which is responsible for technical support and for security. The database server is inside the Faculty of Medicine's firewall, which is regularly updated with the latest security patches. All data are backed up daily. Even in the unlikely event of a successful attack on the server, an intruder will be unable to identify patient data because the encryption key is kept on another server.
We have published articles both nationally and internationally on our experience of using the program, and have received positive responses in editorial columns (See reference list).
The program is available to anyone who wishes to carry out a multi-centre study. Investigators localized in Health Region IV in Norway or at NTNU may use the program without fee. Others will be asked to cover the direct costs related to setting up the actual study. For further information contact Unit for Applied Clinical Research by Berit M. Bjelkåsen or Sven M. Carlsen.
1. P.G. Farup, V. Skar. Collaboration by Use of the Internet Yields Data of High Quality and Detects Non-uniform Management of Patients with Helicobacter pylori Infection. Scand J Gastroenterol 2002; 37 1466-70
2. Norman L. Foster . New Opportunities to Study Real-World Patient Management. Scand J Gastroenterol 2003; 38, 341-2
3. P.G. Farup. Helicobacter pylori- behandling - resultater og erfaringer med samarbeid via Internett. Tidsskr Nor Lægeforen 2003; 123: 3214-7.