groups » Data Management and Statistics » Platforms in use?
Hi all
Which platforms do you use for data management? Is MS Access the norm? I hope to find someone with some experience with OpenClinica to comment on it.
We're doing a lot of paper-to-electronic CRF capture, but the Access database I inherited does not seem very suitable.
Also (and this might be a stupid question...yes I'm new at this)
: What setup do you use to allow multiple users to work on the same database? We have an Access database and 3 capturers. Each having his/her own copy of the database isn't a good idea, and working from a network copy is better, but more than one person can't save a new file at the same time!
- How do you ensure that everyone is working on the latest version of the file, AND PROVIDING the latest version for others to work on?
Sam
data management data management platforms data management setups
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We (Tayside Clinical Trials Unit in Scotland) have decided to go with OpenClinica for regulated trials and most unregulated trials. It's been a good decision for us although there is a learning curve, which would be the case with any new system.
As Clemens mentioned, OpenClinica is not so good at exporting data. You can get the data out but it needs work to get the data into a form that statisticians can use. One of our developers is currently working on a bit of code that takes an OC export and a user template (an Excel spreadsheet) and generates an output file in the format the trial statistician wants. It's tricky but when finished will help a lot and if it looks like something others might be interested in, we could see if there are ways we could make it available.
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AS mentioned by Naomi we use OpenClinica (OC) here at KEMRI-WT and are very happy with it for Trials for the most part. Clemens is right that there is a learning curve but that's true of anything new and IMO OC is no more conceptually difficult than anything else - that offers a complet audit trails that is required for international standard regulaltory compliant trials. In terms of the DB it defaults to use PostgreSQL but also support Oracle for those who use that. Another alternative - although not yet ready for FDA regulatory compliant trials - is Redcap see www.project-redcap.org. This uses PHP/MySQL and is again a web based app that is designed specficially for inevstigators to quickly setup studies using a template filled out in an Excel worksheet - the same mechanism OC uses for CRF creation. It is not Open Source like OC as Vanderbilt University in Tenn, USA who are the initial devlopres required a signed license. However it is free for non-profits.
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4. I wish it could be easier to code rules! That said, one can code rules, both simple and complex. It takes changing the way you code rules - I came from Access, VFP and the like and to me a rule is simply the WHERE clause of an SQL statement. In OpenClinica it is essentially the same but significantly different. One needs to understand XML to some extent.
5. I wish it could be easier to export data. Try exporting grouped data from OpenClinica. That said, it has a very flexible data export mechanism. One just has to learn how to get the task done properly in OpenClinica.
6. When it misbehaves, it might be challenging to find out what the problem actually is - it could be Tomcat, then you would have to know how to decipher the logs and error messages. That said, there is a very strong community behind OpenClinica and one can always ask, the community usually reponds speedily.
As I said, there is so much to say about OpenClinica.
Clemens
exceeded the 1,00 word limit !
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Hi Sam,
About OpenClinica:
There is so much to comment on and I am not sure what it is that you are interested in.
My two cents:
1. Relatively easy to setup and configure (jus follow the instructions)
2. Has most functionality that I have become acustomed to from other data management systems
3. Superb for data entry. Expcet for the lack of skip patterns in the CRF. they are working on this :)
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Hi Sam,
About OpenClinica:
There is so much to comment on and I am not sure what it is that you are interested in.
My two cents:
1. Relatively easy to setup and configure (jus follow the instructions)
2. Has most functionality that I have become acustomed to from other data management systems
3. Superb for data entry. Expcet for the lack of skip patterns in the CRF. they are working on this :)
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Hi Sam,
About MS Access in a multiple user environment:
You would need to split your database into two files (.mdb)
a) One file should have the tables and queries that you need. let's call this the backend.
b) The other file will have the forms and reports that the user's use to interact with your application. Let's call this the front end. The forms in the front end will be linked to the tables/queries in the backend.
You would then put the backend on a central location (server ?) and put the front end on each user's computer.
Configured this way all the users will be reading from and writing to one location.
A major disadvantage, in my opinion, is when you change the front end. You have to make sure that you update the front end for each client.
I hope that this helps
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Hi Sam,
My experience is that there are better alternatives to Access and one of them is OpenClinica (an open source software)as explained by Naomi. The others are mostly off the shelf softwares.
With OC you need to have it installed on a server which different users can access remotely from their workstations via a web interface. Additionally, the person managing it can assign different access levels (rights) based on needs. You can also utilize OC in electronic data capture (EDC) and eliminate the need for paper CRF's.
I will post more materials on OC based on our experience but would also be willing to respond to specific questions regarding the same.Regards,
Ray. -
Hi Sam,
In a setting where you expect several users to access and update a database,you would want to set up a central database. This would take away the need to have version control as every user would be able to access most recently updated data.Users can update the database simultaneously (controlled by the database engine through locking the database at the field or table level while a user updates a record). You have mentioned OpenClinica and it is a good example of a multi-user data management system with a centrally located database.OpenClinica is a web-based application therefore all a user needs would be a web browser(Mozilla, Internet Explore etc) and internet connection. The actual database and application are installed in a remote server.We are using OpenClinica and would be happy to answer more questions that you may have.
Best wishes,
Naomi
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