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Testing/Validating rules?

Hi Forum,
For the usage of OC in clinical trials we have to validate the used rules.
Could anybody please explain how you did this on your site?
We're using OC 3.0.4
Thanks in advance,
Best regards
Bernd

Comments

  • Validation is a long and involved process.
    First, you need to determine what OC can do and test each and every function. Each test is perfomed and the results are documented and filed. It took me nearly two months to validate a software we were using.
    Jeff Magouirk
    303-389-1223
    [email protected]


    -----Original Message-----
    Sent: Wednesday, January 26, 2011 9:54 AM
    To: [email protected]
    Subject: [Users] Testing/Validating rules?
    Hi Forum,
    For the usage of OC in clinical trials we have to validate the used rules.
    Could anybody please explain how you did this on your site?
    We're using OC 3.0.4
    Thanks in advance,
    Best regards
    Bernd
  • bernd, you sound like you're talking just about validating rules, not the oc software as a whole. Is this the case? For clinical trials purposes, your software should be validated. That's a different process than documenting the testing of your rules.
    Sent from myTouch 4G
    ----- Reply message -----
    From: "Magouirk, Jeffrey"
    To: "'[email protected]'"
    Subject: [Users] Testing/Validating rules?
    Date: Wed, Jan 26, 2011 8:59 am
    Validation is a long and involved process.
    First, you need to determine what OC can do and test each and every function. Each test is perfomed and the results are documented and filed. It took me nearly two months to validate a software we were using.
    Jeff Magouirk
    303-389-1223
    [email protected]
    -----Original Message-----
    Sent: Wednesday, January 26, 2011 9:54 AM
    To: [email protected]
    Subject: [Users] Testing/Validating rules?
    Hi Forum,
    For the usage of OC in clinical trials we have to validate the used rules.
    Could anybody please explain how you did this on your site?
    We're using OC 3.0.4
    Thanks in advance,
    Best regards
    Bernd
  • tschapellertschapeller Posts: 27
    hi,

    you got me right. As far as I know by now, the validation of OC as a whole can be done by purchasing the validation package and running/documenting the contained test cases.
    Anybody there who has already run through this process and would like to share his/her experiences?

    My actual issue starts after completion of IQ/OQ/PQ. I have to validate my eCRF (and containing rules/checks etc.) to ensure, that the build eCRF works like it should. So any experiences to that usecase?

    Thanks in advance,
    Best Regards,
    Bernd


    Von: [email protected] [mailto:[email protected]] Im Auftrag von [email protected]
    Gesendet: Donnerstag, 27. Jänner 2011 00:50
    An: [email protected]
    Betreff: Re: [Users] Testing/Validating rules?
    bernd, you sound like you're talking just about validating rules, not the oc software as a whole. Is this the case? For clinical trials purposes, your software should be validated. That's a different process than documenting the testing of your rules.
    Sent from myTouch 4G
    ----- Reply message -----
    From: "Magouirk, Jeffrey"
    To: "'[email protected]'"
    Subject: [Users] Testing/Validating rules?
    Date: Wed, Jan 26, 2011 8:59 am
    Validation is a long and involved process.
    First, you need to determine what OC can do and test each and every function. Each test is perfomed and the results are documented and filed. It took me nearly two months to validate a software we were using.
    Jeff Magouirk
    303-389-1223
    [email protected]
    -----Original Message-----
    Sent: Wednesday, January 26, 2011 9:54 AM
    To: [email protected]
    Subject: [Users] Testing/Validating rules?
    Hi Forum,
    For the usage of OC in clinical trials we have to validate the used rules.
    Could anybody please explain how you did this on your site?
    We're using OC 3.0.4
    Thanks in advance,
    Best regards
    Bernd
  • tschapellertschapeller Posts: 27
    hi,

    you got me right. As far as I know by now, the validation of OC as a whole can be done by purchasing the validation package and running/documenting the contained test cases.
    Anybody there who has already run through this process and would like to share his/her experiences?

    My actual issue starts after completion of IQ/OQ/PQ. I have to validate my eCRF (and containing rules/checks etc.) to ensure, that the build eCRF works like it should. So any experiences to that usecase?

    Thanks in advance,
    Best Regards,
    Bernd


    Von: [email protected] [mailto:[email protected]] Im Auftrag von [email protected]
    Gesendet: Donnerstag, 27. Jänner 2011 00:50
    An: [email protected]
    Betreff: Re: [Users] Testing/Validating rules?
    bernd, you sound like you're talking just about validating rules, not the oc software as a whole. Is this the case? For clinical trials purposes, your software should be validated. That's a different process than documenting the testing of your rules.
    Sent from myTouch 4G
    ----- Reply message -----
    From: "Magouirk, Jeffrey"
    To: "'[email protected]'"
    Subject: [Users] Testing/Validating rules?
    Date: Wed, Jan 26, 2011 8:59 am
    Validation is a long and involved process.
    First, you need to determine what OC can do and test each and every function. Each test is perfomed and the results are documented and filed. It took me nearly two months to validate a software we were using.
    Jeff Magouirk
    303-389-1223
    [email protected]
    -----Original Message-----
    Sent: Wednesday, January 26, 2011 9:54 AM
    To: [email protected]
    Subject: [Users] Testing/Validating rules?
    Hi Forum,
    For the usage of OC in clinical trials we have to validate the used rules.
    Could anybody please explain how you did this on your site?
    We're using OC 3.0.4
    Thanks in advance,
    Best regards
    Bernd
  • Hi Bernd,

    We have validated several versions of OpenClinica. Since we are a commercial CRO, our needs for validation and change control tend to be more strict than those of academic users. We have used the Akaza test cases and we have developed our own.

    In terms of validating rules, we have a process for doing this since each rule needs to be validated. We design and enter pass/fail data for each check and run this data through each CRF page while documenting the results. This process is a collaboration of our programming and data management groups. We have our own SQL based rules system that we test as well. It's pain staking but necessary to ensure Part 11 compliance and get the high quality data output that our sponsors expect.

    Best regards,
    Mark Paul
    StatWorks
    Sent: Thursday, January 27, 2011 3:24 AM
    To: [email protected]; [email protected]
    Subject: Re: [Users] Testing/Validating rules?
    hi,

    you got me right. As far as I know by now, the validation of OC as a whole can be done by purchasing the validation package and running/documenting the contained test cases.
    Anybody there who has already run through this process and would like to share his/her experiences?

    My actual issue starts after completion of IQ/OQ/PQ. I have to validate my eCRF (and containing rules/checks etc.) to ensure, that the build eCRF works like it should. So any experiences to that usecase?

    Thanks in advance,
    Best Regards,
    Bernd


    Von: [email protected] [mailto:[email protected]] Im Auftrag von [email protected]
    Gesendet: Donnerstag, 27. Jänner 2011 00:50
    An: [email protected]
    Betreff: Re: [Users] Testing/Validating rules?
    bernd, you sound like you're talking just about validating rules, not the oc software as a whole. Is this the case? For clinical trials purposes, your software should be validated. That's a different process than documenting the testing of your rules.
    Sent from myTouch 4G
    ----- Reply message -----
    From: "Magouirk, Jeffrey"
    To: "'[email protected]'"
    Subject: [Users] Testing/Validating rules?
    Date: Wed, Jan 26, 2011 8:59 am
    Validation is a long and involved process.
    First, you need to determine what OC can do and test each and every function. Each test is perfomed and the results are documented and filed. It took me nearly two months to validate a software we were using.
    Jeff Magouirk
    303-389-1223
    [email protected]
    -----Original Message-----
    Sent: Wednesday, January 26, 2011 9:54 AM
    To: [email protected]
    Subject: [Users] Testing/Validating rules?
    Hi Forum,
    For the usage of OC in clinical trials we have to validate the used rules.
    Could anybody please explain how you did this on your site?
    We're using OC 3.0.4
    Thanks in advance,
    Best regards
    Bernd
  • Hi Bernd,

    We have validated several versions of OpenClinica. Since we are a commercial CRO, our needs for validation and change control tend to be more strict than those of academic users. We have used the Akaza test cases and we have developed our own.

    In terms of validating rules, we have a process for doing this since each rule needs to be validated. We design and enter pass/fail data for each check and run this data through each CRF page while documenting the results. This process is a collaboration of our programming and data management groups. We have our own SQL based rules system that we test as well. It's pain staking but necessary to ensure Part 11 compliance and get the high quality data output that our sponsors expect.

    Best regards,
    Mark Paul
    StatWorks
    Sent: Thursday, January 27, 2011 3:24 AM
    To: [email protected]; [email protected]
    Subject: Re: [Users] Testing/Validating rules?
    hi,

    you got me right. As far as I know by now, the validation of OC as a whole can be done by purchasing the validation package and running/documenting the contained test cases.
    Anybody there who has already run through this process and would like to share his/her experiences?

    My actual issue starts after completion of IQ/OQ/PQ. I have to validate my eCRF (and containing rules/checks etc.) to ensure, that the build eCRF works like it should. So any experiences to that usecase?

    Thanks in advance,
    Best Regards,
    Bernd


    Von: [email protected] [mailto:[email protected]] Im Auftrag von [email protected]
    Gesendet: Donnerstag, 27. Jänner 2011 00:50
    An: [email protected]
    Betreff: Re: [Users] Testing/Validating rules?
    bernd, you sound like you're talking just about validating rules, not the oc software as a whole. Is this the case? For clinical trials purposes, your software should be validated. That's a different process than documenting the testing of your rules.
    Sent from myTouch 4G
    ----- Reply message -----
    From: "Magouirk, Jeffrey"
    To: "'[email protected]'"
    Subject: [Users] Testing/Validating rules?
    Date: Wed, Jan 26, 2011 8:59 am
    Validation is a long and involved process.
    First, you need to determine what OC can do and test each and every function. Each test is perfomed and the results are documented and filed. It took me nearly two months to validate a software we were using.
    Jeff Magouirk
    303-389-1223
    [email protected]
    -----Original Message-----
    Sent: Wednesday, January 26, 2011 9:54 AM
    To: [email protected]
    Subject: [Users] Testing/Validating rules?
    Hi Forum,
    For the usage of OC in clinical trials we have to validate the used rules.
    Could anybody please explain how you did this on your site?
    We're using OC 3.0.4
    Thanks in advance,
    Best regards
    Bernd
This discussion has been closed.