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[Users] Randomization in OC

Hi All,
I am going to make the assertion that it seems like a mistake to have this external dependency for randomization. It is just one more thing that weakens a web application by using external services where one does not have the full control that a built-in solution offers. An external service also makes difficult if not impossible to have the desired coupling with internal actions such as just-in-time inventory control of clinical trial kits.
Our upcoming Randomization module will be built-in with all of the benefits of being so.
Nick Sophinos
Developer
OpenClinica
On Thu, Jun 27, 2013 at 3:14 PM, Tom Hickerson wrote:
Hi Tony and Giada,
In my experience it is possible to implement a randomization module integrated within an architecture stack like OpenClinica. With ClinCapture, we are rolling out a randomization solution built on top of randomize.net, provided by Biometrix.
The solution also required us to develop a special CRF, together with Java and Javascript built into ClinCapture's front-end code, which would make a separate call to the randomize.net service through their API. In doing so, we had to address many technical issues ourselves, including the following:
1. One sided authentication
2. Loose configuration options
3. Support for unique trial Ids or multiple trial Ids
4. Support for both XML and JSON
5. Assignment to subjects
The code is already being included in our developer's releases of ClinCapture; if you would like more details about our solution, you can contact me off-list.
Hope that helps, Tom
On Thu, Jun 27, 2013 at 10:37 AM, Giada Morpurgo wrote:
Dear George
we often develope RCT and we use to build a study web site for randomization / unblinding connected to OC db, adding a link to it in the CRF. But it's just an "external" solution...
BR,
giada
----- Messaggio originale -----
Da: "Tony George"
A: "UserOC" , [email protected]
Inviato: Lunedì, 24 giugno 2013 15:27:20
Oggetto: [Users] Randomization in OC
Dear All;
Do you have any suggestion on how can i used randomization in the OC? does OC support randomization?
Thank you very much.
George

Comments

  • nsophinosnsophinos Posts: 62
    From the FAQ page of randomize.net:
    We have randomize a patient using the wrong patient ID number?
    Have the coordinating centre contact us [email protected] and we will change ID number.
    Wow, that sounds like a good time.
    Nick Sophinos
    OpenClinica Developer
    On Thu, Jun 27, 2013 at 4:15 PM, Nick Sophinos wrote:
    Hi All,
    I am going to make the assertion that it seems like a mistake to have this external dependency for randomization. It is just one more thing that weakens a web application by using external services where one does not have the full control that a built-in solution offers. An external service also makes difficult if not impossible to have the desired coupling with internal actions such as just-in-time inventory control of clinical trial kits.
    Our upcoming Randomization module will be built-in with all of the benefits of being so.
    Nick Sophinos
    Developer
    OpenClinica
    On Thu, Jun 27, 2013 at 3:14 PM, Tom Hickerson wrote:
    Hi Tony and Giada,
    In my experience it is possible to implement a randomization module integrated within an architecture stack like OpenClinica. With ClinCapture, we are rolling out a randomization solution built on top of randomize.net, provided by Biometrix.
    The solution also required us to develop a special CRF, together with Java and Javascript built into ClinCapture's front-end code, which would make a separate call to the randomize.net service through their API. In doing so, we had to address many technical issues ourselves, including the following:
    1. One sided authentication
    2. Loose configuration options
    3. Support for unique trial Ids or multiple trial Ids
    4. Support for both XML and JSON
    5. Assignment to subjects
    The code is already being included in our developer's releases of ClinCapture; if you would like more details about our solution, you can contact me off-list.
    Hope that helps, Tom
    On Thu, Jun 27, 2013 at 10:37 AM, Giada Morpurgo wrote:
    Dear George
    we often develope RCT and we use to build a study web site for randomization / unblinding connected to OC db, adding a link to it in the CRF. But it's just an "external" solution...
    BR,
    giada
    ----- Messaggio originale -----
    Da: "Tony George"
    A: "UserOC" , [email protected]
    Inviato: Lunedì, 24 giugno 2013 15:27:20
    Oggetto: [Users] Randomization in OC
    Dear All;
    Do you have any suggestion on how can i used randomization in the OC? does OC support randomization?
    Thank you very much.
    George
  • mdesgroumdesgrou Posts: 6
    Nick,
    Just to clarify:
    This question pertains to a site randomizing the wrong patient. Which can happens regardless of the implementation. And no, it's not a lot of fun but the system allows to recover from this mishaps.
    Best,
    Marc
    Sent from my iPhone
    On Jun 27, 2013, at 6:57 PM, "Nick Sophinos" wrote:
    > From the FAQ page of randomize.net:
    >
    > We have randomize a patient using the wrong patient ID number?
    > Have the coordinating centre contact us [email protected] and we will change ID number.
    >
    > Wow, that sounds like a good time.
    >
    > Nick Sophinos
    > OpenClinica Developer
    >
    >
    > On Thu, Jun 27, 2013 at 4:15 PM, Nick Sophinos wrote:
    >
    > Hi All,
    >
    > I am going to make the assertion that it seems like a mistake to have this external dependency for randomization. It is just one more thing that weakens a web application by using external services where one does not have the full control that a built-in solution offers. An external service also makes difficult if not impossible to have the desired coupling with internal actions such as just-in-time inventory control of clinical trial kits.
    >
    > Our upcoming Randomization module will be built-in with all of the benefits of being so.
    >
    > Nick Sophinos
    > Developer
    > OpenClinica
    >
    >
    >
    > On Thu, Jun 27, 2013 at 3:14 PM, Tom Hickerson wrote:
    >
    > Hi Tony and Giada,
    >
    > In my experience it is possible to implement a randomization module integrated within an architecture stack like OpenClinica. With ClinCapture, we are rolling out a randomization solution built on top of randomize.net, provided by Biometrix.
    >
    > The solution also required us to develop a special CRF, together with Java and Javascript built into ClinCapture's front-end code, which would make a separate call to the randomize.net service through their API. In doing so, we had to address many technical issues ourselves, including the following:
    > 1. One sided authentication
    > 2. Loose configuration options
    > 3. Support for unique trial Ids or multiple trial Ids
    > 4. Support for both XML and JSON
    > 5. Assignment to subjects
    >
    > The code is already being included in our developer's releases of ClinCapture; if you would like more details about our solution, you can contact me off-list.
    >
    > Hope that helps, Tom
    >
    >
    > On Thu, Jun 27, 2013 at 10:37 AM, Giada Morpurgo wrote:
    >
    > Dear George
    > we often develope RCT and we use to build a study web site for randomization / unblinding connected to OC db, adding a link to it in the CRF. But it's just an "external" solution...
    > BR,
    >
    > giada
    >
    > ----- Messaggio originale -----
    > Da: "Tony George"
    > A: "UserOC" , [email protected]
    > Inviato: Lunedì, 24 giugno 2013 15:27:20
    > Oggetto: [Users] Randomization in OC
    >
    >
    >
    > Dear All;
    >
    > Do you have any suggestion on how can i used randomization in the OC? does OC support randomization?
    >
    > Thank you very much.
    >
    > George
    >
  • jfern.ocjfern.oc Posts: 3
    > Hi Tony and all,
    >
    > For a specific study, we have put in place a randomization system linked to OpenClinica 3.1.2 and our IRS solution (IVRS and IWRS) developed internally including randomization.
    > For community, I explain here our experience about it and the solution put in place.
    >
    > Basically, we can subdivide our system in 3 subsystems :
    >
    > 1) OpenClinica (and OC Web Services)
    > 2) time-based job scheduler : CRON and associated scripts
    > 3) Internal IWRS solution
    >
    >
    > 1) in OpenClinica we have :
    > a) added a link to our IWRS solution (opening in a new tab)
    > b) created an IWRS event with various fields (Treatment number, injection date... and a provisional calendar)
    >
    > 2) CRON launch :
    > a) a script to schedule the associated IWRS event (via OpenClinica Web Services)
    > b) a script to create automatically the subject (with some data like OpenClinica OIDs, gender, date...) in the IWRS system
    >
    > 3) IWRS solution
    > a) uses the OpenClinica Web Services for fill/update the OpenClinica IWRS event and specific fields (during creation and/or modification)
    >
    > I put in place this "architecture" because :
    > 1) I doesn't want to change and/or modify OpenClinica Enterprise code (to simplify the Validation process)
    > 2) Maybe the most important : the OpenClinica Web Services are coupled to the audit trail and working fine
    > 3) We have an efficient IWRS solution, including patient randomization and drug supply management
    > 4) Short implementation time
    >
    >
    > I working on a new approach to allow the randomization by clicking on a link (or button) only available for authorized people like the investigator .
    >
    > To be synthetic:
    > 1) A popup opens with a brief summary of the patient
    > |__ I used embedded javascript code inside the CRF to open the link
    > 2) The investigator fill his password and click on "Randomize". I think, the randomization is as important as the document signature (and I need to verify his identity).
    > 3) The system verify if the randomization is allowed and schedule/fill a specific event/field with data in that case
    >
    > I took the decision not to modify OpenClinica code (see below or just a little : one jsp file).
    > I use some php or Java (my choice is not blocked) scripts for the interface and to make the link between : OpenClinica, our IWRS solution and OpenClinica WebServices.
    > I will update this post when I will reach my goal (if someone are interested).
    >
    > Julien,
    > Cardinal Systems Julien FERNANDEZ
    > Sr. Clinical IT Specialist
    >
    > 91, avenue de la République / F-75011 Paris
    > Phone: +33 1 53 36 24 61
    > Fax: +33 1 40 21 94 95
    > Mailto: [email protected]
    > Website: http://www.cardinal-sys.com
  • LizRLizR Posts: 60
    Julien,
    Did you home grow your IWRS?
    Liz Robertson
    Director of Data Management and IT
    TRACON Pharmaceuticals, Inc.
    [email protected]
    office: 858.550.0780 ext. 237
    cell: 760.481.5527
    Sent: Monday, July 01, 2013 10:19 AM
    To: [email protected]
    Cc: [email protected]
    Subject: Re: [Developers] [Users] Randomization in OC
    > Hi Tony and all,
    >
    > For a specific study, we have put in place a randomization system linked to OpenClinica 3.1.2 and our IRS solution (IVRS and IWRS) developed internally including randomization.
    > For community, I explain here our experience about it and the solution put in place.
    >
    > Basically, we can subdivide our system in 3 subsystems :
    >
    > 1) OpenClinica (and OC Web Services)
    > 2) time-based job scheduler : CRON and associated scripts
    > 3) Internal IWRS solution
    >
    >
    > 1) in OpenClinica we have :
    > a) added a link to our IWRS solution (opening in a new tab)
    > b) created an IWRS event with various fields (Treatment number, injection date... and a provisional calendar)
    >
    > 2) CRON launch :
    > a) a script to schedule the associated IWRS event (via OpenClinica Web Services)
    > b) a script to create automatically the subject (with some data like OpenClinica OIDs, gender, date...) in the IWRS system
    >
    > 3) IWRS solution
    > a) uses the OpenClinica Web Services for fill/update the OpenClinica IWRS event and specific fields (during creation and/or modification)
    >
    > I put in place this "architecture" because :
    > 1) I doesn't want to change and/or modify OpenClinica Enterprise code (to simplify the Validation process)
    > 2) Maybe the most important : the OpenClinica Web Services are coupled to the audit trail and working fine
    > 3) We have an efficient IWRS solution, including patient randomization and drug supply management
    > 4) Short implementation time
    >
    >
    > I working on a new approach to allow the randomization by clicking on a link (or button) only available for authorized people like the investigator .
    >
    > To be synthetic:
    > 1) A popup opens with a brief summary of the patient
    > |__ I used embedded javascript code inside the CRF to open the link
    > 2) The investigator fill his password and click on "Randomize". I think, the randomization is as important as the document signature (and I need to verify his identity).
    > 3) The system verify if the randomization is allowed and schedule/fill a specific event/field with data in that case
    >
    > I took the decision not to modify OpenClinica code (see below or just a little : one jsp file).
    > I use some php or Java (my choice is not blocked) scripts for the interface and to make the link between : OpenClinica, our IWRS solution and OpenClinica WebServices.
    > I will update this post when I will reach my goal (if someone are interested).
    >
    > Julien,
    > Julien FERNANDEZ
    > Sr. Clinical IT Specialist
    >
    > 91, avenue de la République / F-75011 Paris
    > Phone: +33 1 53 36 24 61
    > Fax: +33 1 40 21 94 95
    > Mailto: [email protected]
    > Website: http://www.cardinal-sys.com
This discussion has been closed.