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Help required (Open Clinica0

I have been thro the quick start video demonstration of Open Clinica. It has been very helpful; however, there are few things I need help on.

Ø While creating the study, you have selected double data entry required. Where is the tab that allows you to complete first pass and second pass entry.
Ø How to create appropriate validations
Ø How to go about discrepancy management.

Kindly respond to this mail at the earliest

Thanks and Regards,

Nandini Diwakar
Business analyst @ DCG
Direct: 91 80 41562868
Mobile: 91 9986041250
Infosys®
P O W E R E D B Y I N T E L L E C T
D R I V E N B Y V A L U E S



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Comments

  • balabala Posts: 1
    hi
    even im facing problems
    atleast i think u ARE from a software background
    i dont know how to install also
    plz help me out

    bala
  • Below, I forward you some information from Ben that might be your start point. Let us know if you need more help.


    Good afternoon from Cambridge!

    The following video tutorials are now available for download from http://www.openclinica.org/page.php?pid=362:

    - OpenClinica QuickStart Tutorial - quick review of the basics on setting up a study in OpenClinica
    - OpenClinica Linux Install Tutorial - step-by-step walkthrough of how to install OpenClinica on Linux
    - OpenClinica Windows Install Tutorial - step-by-step walkthrough of how to install OpenClinica on Windows

    Each video is approximately 45 minutes in length and is in Windows Media (.wmv) format.



    Thanks,
    Yufang Wang
    Sent: Wednesday, July 25, 2007 2:08 AM
    To: [email protected]
    Subject: Re: [Users] Help required (Open Clinica0

    hi
    even im facing problems
    atleast i think u ARE from a software background
    i dont know how to install also
    plz help me out

    bala
  • Paul GalvinPaul Galvin Posts: 886
    Good Morning Nandini,

    When you are creating a study, you can configure it to allow Discrepancy Management, but the act of double data entry is chosen when you are assigning a CRF to an Event Definition. There is a check box to select whether or not you want to have the Double Data Entry performed for the CRF.

    Once that checkbox has been selected, the user will have to enter their data, Mark the CRF Complete, and then hit save. There will then be an icon signifying that “Initial Data Entry is Complete.” At that point, the second user can go in and perform the next round of data entry.

    The validations are created in the CRF Template before it is uploaded into the application. You can specify ranges as well as other types of validations. If you go to the instructions tab of the CRF Template there will be 2 examples for you as well as a link to other allowable regular expressions.

    Discrepancy Management can be found when you click on the link in the Manage Study module called Manage Discrepancies. The only time you will see any notes in here to manage is if a user has clicked on a discrepancy flag in the application and filled out a note. Otherwise, there will be a blank table. The link below can provide you some more useful information about discrepancy management.
    http://www.openclinica.org/OpenClinica/2.0/doc/4_8_discrepancyNotes_Help.html
    I hope this helps, but please let us know if you have any further questions.

    Thanks,
    Paul
    Sent: Wednesday, July 25, 2007 1:37 AM
    To: Yufang Wang; [email protected]
    Subject: [Users] Help required (Open Clinica0

    Hello,

    I have been thro the quick start video demonstration of Open Clinica. It has been very helpful; however, there are few things I need help on.

    Ø While creating the study, you have selected double data entry required. Where is the tab that allows you to complete first pass and second pass entry.
    Ø How to create appropriate validations
    Ø How to go about discrepancy management.

    Kindly respond to this mail at the earliest

    Thanks and Regards,

    Nandini Diwakar
    Business analyst @ DCG
    Direct: 91 80 41562868
    Mobile: 91 9986041250
    Infosys®
    P O W E R E D B Y I N T E L L E C T
    D R I V E N B Y V A L U E S



    **************** CAUTION - Disclaimer *****************
    This e-mail contains PRIVILEGED AND CONFIDENTIAL INFORMATION intended solely for the use of the addressee(s). If you are not the intended recipient, please notify the sender by e-mail and delete the original message. Further, you are not to copy, disclose, or distribute this e-mail or its contents to any other person and any such actions are unlawful. This e-mail may contain viruses. Infosys has taken every reasonable precaution to minimize this risk, but is not liable for any damage you may sustain as a result of any virus in this e-mail. You should carry out your own virus checks before opening the e-mail or attachment. Infosys reserves the right to monitor and review the content of all messages sent to or from this e-mail address. Messages sent to or from this e-mail address may be stored on the Infosys e-mail system.
    ***INFOSYS******** End of Disclaimer ********INFOSYS***
  • mervtynw28mervtynw28 Posts: 16
    Good Moring from Downunder - Can Openclinica currently be configured to perform cross-question checks ie. Depending on how you answer a previous question it limits or does a cross check when answering a subsequent question. If not - is there some work around for this.

    Also does Openclinica have a auto-fill ability where eg. a response of say 'No' to a preceding question will automatically set a response to a group of subsequent questions to 'No' - so user does not have to respond to the group of questions individually.

    Thank you - Looking forward to your reply

    Regards
    Mervyn Wong
    GLCC Research Organisation Ltd
    Auckland
    New Zealand
    Tel. +6498202053
    Mob. +6421357151
    Email: [email protected]
    -----Original Message-----
    Sent: Thursday, 26 July 2007 2:14 a.m.
    To: [email protected]
    Subject: Re: [Users] Help required (Open Clinica0
    Good Morning Nandini,

    When you are creating a study, you can configure it to allow Discrepancy Management, but the act of double data entry is chosen when you are assigning a CRF to an Event Definition. There is a check box to select whether or not you want to have the Double Data Entry performed for the CRF.

    Once that checkbox has been selected, the user will have to enter their data, Mark the CRF Complete, and then hit save. There will then be an icon signifying that “Initial Data Entry is Complete.” At that point, the second user can go in and perform the next round of data entry.

    The validations are created in the CRF Template before it is uploaded into the application. You can specify ranges as well as other types of validations. If you go to the instructions tab of the CRF Template there will be 2 examples for you as well as a link to other allowable regular expressions.

    Discrepancy Management can be found when you click on the link in the Manage Study module called Manage Discrepancies. The only time you will see any notes in here to manage is if a user has clicked on a discrepancy flag in the application and filled out a note. Otherwise, there will be a blank table. The link below can provide you some more useful information about discrepancy management.
    http://www.openclinica.org/OpenClinica/2.0/doc/4_8_discrepancyNotes_Help.html
    I hope this helps, but please let us know if you have any further questions.

    Thanks,
    Paul
    Sent: Wednesday, July 25, 2007 1:37 AM
    To: Yufang Wang; [email protected]
    Subject: [Users] Help required (Open Clinica0

    Hello,

    I have been thro the quick start video demonstration of Open Clinica. It has been very helpful; however, there are few things I need help on.

    Ø While creating the study, you have selected double data entry required. Where is the tab that allows you to complete first pass and second pass entry.
    Ø How to create appropriate validations
    Ø How to go about discrepancy management.

    Kindly respond to this mail at the earliest

    Thanks and Regards,

    Nandini Diwakar
    Business analyst @ DCG
    Direct: 91 80 41562868
    Mobile: 91 9986041250
    Infosys®
    P O W E R E D B Y I N T E L L E C T
    D R I V E N B Y V A L U E S



    **************** CAUTION - Disclaimer *****************
    This e-mail contains PRIVILEGED AND CONFIDENTIAL INFORMATION intended solely for the use of the addressee(s). If you are not the intended recipient, please notify the sender by e-mail and delete the original message. Further, you are not to copy, disclose, or distribute this e-mail or its contents to any other person and any such actions are unlawful. This e-mail may contain viruses. Infosys has taken every reasonable precaution to minimize this risk, but is not liable for any damage you may sustain as a result of any virus in this e-mail. You should carry out your own virus checks before opening the e-mail or attachment. Infosys reserves the right to monitor and review the content of all messages sent to or from this e-mail address. Messages sent to or from this e-mail address may be stored on the Infosys e-mail system.
    ***INFOSYS******** End of Disclaimer ********INFOSYS***
  • Paul GalvinPaul Galvin Posts: 886
    Hi Mervyn,

    OpenClinica in its current form can not be configured to perform cross-question/cross field edit checks. However, this feature has been discussed extensively in the past and should be available in 2008. Potential work-arounds can be applied in the CRF template by using the Header, Sub-Header, Left Item Text, and Right Item Text etc. to tell your users what to do depending on how to fill in the field.

    For example, there could be a radio button to select whether the person is Male or Female. In one of the fields I mentioned above you could say something like “If you choose Male, please jump to Question 6. If you choose Female, continue to Question 2 and skip 6 through 10.”

    As for auto-filling a set of subsequent questions based on one particular response, I envision it working the same way as the cross field edit checks. In addition to skipping to another group of questions, it would populate a default value in the skipped fields which could be defined in the CRF template design. Would this make sense?

    I hope this helps, but please let me know if you have other questions.
    Thanks,
    Paul
    Sent: Wednesday, July 25, 2007 6:20 PM
    To: [email protected]
    Subject: RE: [Users] Help required (Open Clinica0

    Dear Paul
    Good Moring from Downunder - Can Openclinica currently be configured to perform cross-question checks ie. Depending on how you answer a previous question it limits or does a cross check when answering a subsequent question. If not - is there some work around for this.

    Also does Openclinica have a auto-fill ability where eg. a response of say 'No' to a preceding question will automatically set a response to a group of subsequent questions to 'No' - so user does not have to respond to the group of questions individually.

    Thank you - Looking forward to your reply

    Regards
    Mervyn Wong
    GLCC Research Organisation Ltd
    Auckland
    New Zealand
    Tel. +6498202053
    Mob. +6421357151
    Email: [email protected]
    -----Original Message-----
    Sent: Thursday, 26 July 2007 2:14 a.m.
    To: [email protected]
    Subject: Re: [Users] Help required (Open Clinica0
    Good Morning Nandini,

    When you are creating a study, you can configure it to allow Discrepancy Management, but the act of double data entry is chosen when you are assigning a CRF to an Event Definition. There is a check box to select whether or not you want to have the Double Data Entry performed for the CRF.

    Once that checkbox has been selected, the user will have to enter their data, Mark the CRF Complete, and then hit save. There will then be an icon signifying that “Initial Data Entry is Complete.” At that point, the second user can go in and perform the next round of data entry.

    The validations are created in the CRF Template before it is uploaded into the application. You can specify ranges as well as other types of validations. If you go to the instructions tab of the CRF Template there will be 2 examples for you as well as a link to other allowable regular expressions.

    Discrepancy Management can be found when you click on the link in the Manage Study module called Manage Discrepancies. The only time you will see any notes in here to manage is if a user has clicked on a discrepancy flag in the application and filled out a note. Otherwise, there will be a blank table. The link below can provide you some more useful information about discrepancy management.
    http://www.openclinica.org/OpenClinica/2.0/doc/4_8_discrepancyNotes_Help.html
    I hope this helps, but please let us know if you have any further questions.

    Thanks,
    Paul
    Sent: Wednesday, July 25, 2007 1:37 AM
    To: Yufang Wang; [email protected]
    Subject: [Users] Help required (Open Clinica0

    Hello,

    I have been thro the quick start video demonstration of Open Clinica. It has been very helpful; however, there are few things I need help on.

    Ø While creating the study, you have selected double data entry required. Where is the tab that allows you to complete first pass and second pass entry.
    Ø How to create appropriate validations
    Ø How to go about discrepancy management.

    Kindly respond to this mail at the earliest

    Thanks and Regards,

    Nandini Diwakar
    Business analyst @ DCG
    Direct: 91 80 41562868
    Mobile: 91 9986041250
    Infosys®
    P O W E R E D B Y I N T E L L E C T
    D R I V E N B Y V A L U E S



    **************** CAUTION - Disclaimer *****************
    This e-mail contains PRIVILEGED AND CONFIDENTIAL INFORMATION intended solely for the use of the addressee(s). If you are not the intended recipient, please notify the sender by e-mail and delete the original message. Further, you are not to copy, disclose, or distribute this e-mail or its contents to any other person and any such actions are unlawful. This e-mail may contain viruses. Infosys has taken every reasonable precaution to minimize this risk, but is not liable for any damage you may sustain as a result of any virus in this e-mail. You should carry out your own virus checks before opening the e-mail or attachment. Infosys reserves the right to monitor and review the content of all messages sent to or from this e-mail address. Messages sent to or from this e-mail address may be stored on the Infosys e-mail system.
    ***INFOSYS******** End of Disclaimer ********INFOSYS***
  • JozefJozef Posts: 71
    All these can easily be defined using CDISC ODM 1.3, the international (and by the FDA embraced) open standard for setting up clinical studies, for exchange between systems of metadata and data, and for submission to the FDA.

    Any plans to have OpenClinica read ODM 1.3 study definition files to set up the forms, visits, etc.. ?

    Jozef
  • Cal CollinsCal Collins Posts: 111
    Jozef,
    Yes, this use of CDISC ODM is indeed on the OpenClinica development roadmap. If you are interested in being involved in building this feature OpenClinica would certainly benefit from your expertise - drop me an email off list and we can discuss.
    On a related note, over the next few months we will be rolling out more structured ways for participants to take a stake in the OpenClinica community - both developers contributing code and users guiding product design and direction. We will have more for all of you on this topic in early fall, though your thoughts & feedback are appreciated anytime.
    Thanks,
    Cal Collins
    [email protected]
    617-504-4664 mobile
    -----Original Message-----
    From: "Jozef Aerts - XML4Pharma"
    To: "[email protected]"
    Sent: 7/26/2007 4:03 PM
    Subject: Re: [Users] Help required (Open Clinica0
    All these can easily be defined using CDISC ODM 1.3, the international (and by the FDA embraced) open standard for setting up clinical studies, for exchange between systems of metadata and data, and for submission to the FDA.
    Any plans to have OpenClinica read ODM 1.3 study definition files to set up the forms, visits, etc.. ?
    Jozef
  • sveroniksveronik Posts: 4
  • sveroniksveronik Posts: 4
This discussion has been closed.