Feature's and capabilities of OpenClinica

Hi All ,
I Have some question's for OpenClinica . I have a community version of OpenClinica installed and working and looking for below features , If these features are present in Enterprise version , mentioning that in the answers will be great .

My Environment details :-
Windows 2008 R2 , Java6 , Tomcat 6 , PostGre 8.4


1) PDF for archiving

Rather than printing individual CRFs for the patient. Can the openclinica system generate all the patients CRFs in the Study in pdf format for archiving at one click.
is there any solution around it


2) dynamic emails.

Is it possible to incorporate dynamic content like item vale etc in email rules.


3) dynamic CRFs

Can the entire CRFs be hidden based on the branching questions rather than item level show/hide options.

4) Rights and roles

Is it possible to add additional roles and define rights.

5)complex rule logic

Can complex rule logic like looping through multiple CRFs to check values possible (earliest date check, minimum previous value etc)

6) site level forms

Can we incorporate site level forms in openclinica. We need some forms attached at site level rather than subject level is it possible.

7) template for discrepancy

is it possible to incorporate customized template for Printing the Discrepancy (DCF). We need to put investigator comments and Signature in the DCF that
is sent to the user. is there any solution around this.

Thanks And Regards ,
Ajay Kumar Jha
+91-91633-91052

Comments

  • ajayjiitajayjiit Posts: 52
    Hi All ,
    I Have some question's for OpenClinica . I have a community version of OpenClinica installed and working and looking for below features , If these features are present in Enterprise version , mentioning that in the answers will be great .

    My Environment details :-
    Windows 2008 R2 , Java6 , Tomcat 6 , PostGre 8.4


    1) PDF for archiving

    Rather than printing individual CRFs for the patient. Can the openclinica system generate all the patients CRFs in the Study in pdf format for archiving at one click.
    is there any solution around it


    2) dynamic emails.

    Is it possible to incorporate dynamic content like item vale etc in email rules.


    3) dynamic CRFs

    Can the entire CRFs be hidden based on the branching questions rather than item level show/hide options.

    4) Rights and roles

    Is it possible to add additional roles and define rights.

    5)complex rule logic

    Can complex rule logic like looping through multiple CRFs to check values possible (earliest date check, minimum previous value etc)

    6) site level forms

    Can we incorporate site level forms in openclinica. We need some forms attached at site level rather than subject level is it possible.

    7) template for discrepancy

    is it possible to incorporate customized template for Printing the Discrepancy (DCF). We need to put investigator comments and Signature in the DCF that
    is sent to the user. is there any solution around this.

    Thanks And Regards ,
    Ajay Kumar Jha
    +91-91633-91052
  • Hi Ajay

    If you’re trying to decide between community and enterprise, the main selling point for enterprise is support - there’s only so much that the mail groups can do to help with certain issues, and the OpenClinica team know the software better than anyone else. Functionality-wise the versions are largely the same.

    Below are my thoughts on your feature questions

    1) PDF for archiving

    No.

    Better CRF printing planned for 3.1.4 though. In the meantime you could use this: http://www.trialdatasolutions.com/tds/howto/datalisting.jsp, or you could back up the entire study database to archive, or you could use any of the OpenClinica extract formats to archive your data. Probably the best format other than the original database is ‘ODM xml 1.3 with full OC extensions’, since it has the metadata, clinical data, notes and audit histories. Enterprise has Data Mart, which basically pivots your data such that you get a table per item group with the items as columns, but it doesn’t include much metadata or notes or audit history.

    2) Dynamic emails
    No.

    You can set the message once per rule. The email will contain a link to view the CRF in OpenClinica though. I believe it was deliberate that item values aren’t transmitted because email isn’t necessarily a secure transmission (unless you were to use pgp or something, but I don’t think that is supported / integrated)

    3) Dynamic CRFs
    Yes.

    You can nest hidden items so that they’re shown in a branching manner. A few major bugs with nesting simple conditional displays (SCDs) were squashed in 3.1.3, and from 3.1.2 you could target hidden items with a rule. So you could use show rules in combination with SCDs. It’s been a while since I checked but I think hide rules don’t work (happy to be corrected). Also in 3.1.3 I noticed you can get away with having all items on your 2nd, 3rd, 4th etc sections hidden, and when an item on that section shown with a rule the section will appear.

    4) Rights and roles
    No.

    I think this is one of the key features planned for a future release (not sure which).

    5) Complex rule logic
    Kind of.

    It largely depends on what you consider ‘complex’ to mean. You can do a lot with rules in OpenClinica, but it can’t do some things I would have thought weren’t complex, like insert a calculated value. To address your example:

    Last time I checked, specifying an event ordinal in a repeating event definition doesn’t work, so if you wanted to check the same CRF across multiple time points, the way to do that would be to create an event definition for each time point and compare across them. For example if you wanted to check that all the treatment visits were done every 3 weeks, instead of having a ‘Treatment’ event which is repeating, you’d need to set up events like ‘Treatment Cycle 1’, ‘Treatment Cycle 2’, ‘Treatment Cycle 3’, etc., which each have a copy of the same set of CRFs.

    Another approach to this is to have a field where the event repeat is specified, and then have each repeat in your Treatment event look back at the Enrol date on the non-repeating Enrol visit, with a rule checking the date is relatively correct. For example, if the selected EventRepeat on any repeat of the Treatment form is 1, the treatment date should be EnrolDate+0 days; if EventRepeat is 2, the treatment date should be EnrolDate+21 days; and so on.

    6) Site level forms
    Yes.

    You can set event definitions at the study level, and then for each site customise them. So you can hide a CRF that you never want a site to see, or show site A version A of your CRF and show site B version B of the same CRF.

    7) Template for discrepancy

    No.

    Also – ouch! We’ve got studies with 100’s or 1000’s of notes; it would take whole forests of paper and months of time to do that - unless you’re only talking about signing off on eligibility waivers or something. If it’s a matter of verifying data, I’d try convincing who-ever-it-is to rely on the event or casebook signature feature: https://docs.openclinica.com/3.1/openclinica-user-guide/submit-data-module-overview/view-events#content-title-5095.

    If you absolutely have to though, you could:
    - If it was en-masse, work on a way of presenting the notes and data from an ODM 1.3 xml extract, possibly with Excel, Access or BIRT etc
    - If it was small scale, print the Notes window to pdf, save the pdf as an image, paste into Word and overlay whatever header / footer / signature fields were required.

    Best regards,

    Lindsay Stevens | Clinical Data Coordinator
    NHMRC Clinical Trials Centre, THE UNIVERSITY OF SYDNEY
    Office: Level 2, 6-10 Mallett St | Camperdown | NSW | 2050
    Mail: Locked Bag 77 | Camperdown | NSW | 1450
    T +61 2 9562 5369 | F +61 2 9562 5094
    E lindsay.stevens@ctc.usyd.edu.au | W www.ctc.usyd.edu.au
    Sent: Wednesday, 27 March 2013 12:28 AM
    To: Users@openclinica.org; developers@openclinica.org
    Subject: [Developers] Feature's and capabilities of OpenClinica

    Hi All ,
    I Have some question's for OpenClinica . I have a community version of OpenClinica installed and working and looking for below features , If these features are present in Enterprise version , mentioning that in the answers will be great .

    My Environment details :-
    Windows 2008 R2 , Java6 , Tomcat 6 , PostGre 8.4


    1) PDF for archiving

    Rather than printing individual CRFs for the patient. Can the openclinica system generate all the patients CRFs in the Study in pdf format for archiving at one click.
    is there any solution around it


    2) dynamic emails.

    Is it possible to incorporate dynamic content like item vale etc in email rules.


    3) dynamic CRFs

    Can the entire CRFs be hidden based on the branching questions rather than item level show/hide options.

    4) Rights and roles

    Is it possible to add additional roles and define rights.

    5)complex rule logic

    Can complex rule logic like looping through multiple CRFs to check values possible (earliest date check, minimum previous value etc)

    6) site level forms

    Can we incorporate site level forms in openclinica. We need some forms attached at site level rather than subject level is it possible.

    7) template for discrepancy

    is it possible to incorporate customized template for Printing the Discrepancy (DCF). We need to put investigator comments and Signature in the DCF that
    is sent to the user. is there any solution around this.

    Thanks And Regards ,
    Ajay Kumar Jha
    +91-91633-91052
    This e-mail message has been scanned for Viruses and Content and cleared by MailMarshal
    IMPORTANT NOTICE: This e-mail and any attachment to it are intended only to be read or used by the named addressee. It is confidential and may contain legally privileged information. No confidentiality or privilege is waived or lost by any mistaken transmission to you. The CTC is not responsible for any unauthorised alterations to this e-mail or attachment to it. Views expressed in this message are those of the individual sender, and are not necessarily the views of the CTC. If you receive this e-mail in error, please immediately delete it and notify the sender. You must not disclose, copy or use any part of this e-mail if you are not the intended recipient.
  • GerbenRienkGerbenRienk Posts: 750 ✭✭✭
    Hi Ajay,
    Further to Linsay's great and elaborate answers:
    ad. 5) Complex rule logic
    You can use the event ordinal in a repeating event definition in Validations.
    However what I miss is the option to use a cursor to loop through rows in
    a RepeatingItemsGroup and compare for example a date with the date of the
    next row.
    Kind regards,
    Gerben Rienk
    > > Hi Ajay
    > >
    > > If you're trying to decide between community and enterprise, the main
    > > selling point for enterprise is support - there's only so much that the
    > > mail groups can do to help with certain issues, and the OpenClinica team
    > > know the software better than anyone else. Functionality-wise the versions
    > > are largely the same.
    > >
    > > Below are my thoughts on your feature questions
    > >
    > > 1) PDF for archiving
    > >
    > > No.
    > >
    > > Better CRF printing planned for 3.1.4 though. In the meantime you could
    > > use this: http://www.trialdatasolutions.com/tds/howto/datalisting.jsp, or
    > > you could back up the entire study database to archive, or you could use
    > > any of the OpenClinica extract formats to archive your data. Probably the
    > > best format other than the original database is 'ODM xml 1.3 with full OC
    > > extensions', since it has the metadata, clinical data, notes and audit
    > > histories. Enterprise has Data Mart, which basically pivots your data such
    > > that you get a table per item group with the items as columns, but it
    > > doesn't include much metadata or notes or audit history.
    > >
    > > 2) Dynamic emails
    > >
    > > No.
    > >
    > > You can set the message once per rule. The email will contain a link to
    > > view the CRF in OpenClinica though. I believe it was deliberate that item
    > > values aren't transmitted because email isn't necessarily a secure
    > > transmission (unless you were to use pgp or something, but I don't think
    > > that is supported / integrated)
    > >
    > > 3) Dynamic CRFs
    > >
    > > Yes.
    > >
    > > You can nest hidden items so that they're shown in a branching manner. A
    > > few major bugs with nesting simple conditional displays (SCDs) were
    > > squashed in 3.1.3, and from 3.1.2 you could target hidden items with a
    > > rule. So you could use show rules in combination with SCDs. It's been a
    > > while since I checked but I think hide rules don't work (happy to be
    > > corrected). Also in 3.1.3 I noticed you can get away with having all items
    > > on your 2nd, 3rd, 4th etc sections hidden, and when an item on that
    > > section shown with a rule the section will appear.
    > >
    > > 4) Rights and roles
    > >
    > > No.
    > >
    > > I think this is one of the key features planned for a future release (not
    > > sure which).
    > >
    > > 5) Complex rule logic
    > >
    > > Kind of.
    > >
    > > It largely depends on what you consider 'complex' to mean. You can do a
    > > lot with rules in OpenClinica, but it can't do some things I would have
    > > thought weren't complex, like insert a calculated value. To address your
    > > example:
    > >
    > > Last time I checked, specifying an event ordinal in a repeating event
    > > definition doesn't work, so if you wanted to check the same CRF across
    > > multiple time points, the way to do that would be to create an event
    > > definition for each time point and compare across them. For example if you
    > > wanted to check that all the treatment visits were done every 3 weeks,
    > > instead of having a 'Treatment' event which is repeating, you'd need to
    > > set up events like 'Treatment Cycle 1', 'Treatment Cycle 2', 'Treatment
    > > Cycle 3', etc., which each have a copy of the same set of CRFs.
    > >
    > > Another approach to this is to have a field where the event repeat is
    > > specified, and then have each repeat in your Treatment event look back at
    > > the Enrol date on the non-repeating Enrol visit, with a rule checking the
    > > date is relatively correct. For example, if the selected EventRepeat on
    > > any repeat of the Treatment form is 1, the treatment date should be
    > > EnrolDate+0 days; if EventRepeat is 2, the treatment date should be
    > > EnrolDate+21 days; and so on.
    > >
    > > 6) Site level forms
    > >
    > > Yes.
    > >
    > > You can set event definitions at the study level, and then for each site
    > > customise them. So you can hide a CRF that you never want a site to see,
    > > or show site A version A of your CRF and show site B version B of the same
    > > CRF.
    > >
    > > 7) Template for discrepancy
    > >
    > > No.
    > >
    > > Also - ouch! We've got studies with 100's or 1000's of notes; it would
    > > take whole forests of paper and months of time to do that - unless you're
    > > only talking about signing off on eligibility waivers or something. If
    > > it's a matter of verifying data, I'd try convincing who-ever-it-is to rely
    > > on the event or casebook signature feature:
    > > https://docs.openclinica.com/3.1/openclinica-user-guide/submit-data-module-overview/view-events#content-title-5095.
    > >
    > > If you absolutely have to though, you could:
    > >
    > > - If it was en-masse, work on a way of presenting the notes and data
    > > from an ODM 1.3 xml extract, possibly with Excel, Access or BIRT etc
    > >
    > > - If it was small scale, print the Notes window to pdf, save the pdf
    > > as an image, paste into Word and overlay whatever header / footer /
    > > signature fields were required.
    > >
    > > Best regards,
    > >
    > > Lindsay Stevens | Clinical Data Coordinator
    > >
    > > NHMRC Clinical Trials Centre, THE UNIVERSITY OF SYDNEY
    > > Office: Level 2, 6-10 Mallett St | Camperdown | NSW | 2050
    > > Mail: Locked Bag 77 | Camperdown | NSW | 1450
    > > T +61 2 9562 5369 | F +61 2 9562 5094
    > > E lindsay.stevens@ctc.usyd.edu.au
    > > | W www.ctc.usyd.edu.au
    > >
    > >
    > > [mailto:developers-bounces@openclinica.org] On Behalf Of Ajay Jha
    > > Sent: Wednesday, 27 March 2013 12:28 AM
    > > To: Users@openclinica.org; developers@openclinica.org
    > > Subject: [Developers] Feature's and capabilities of OpenClinica
    > >
    > > Hi All ,
    > > I Have some question's for OpenClinica . I have a community
    > > version of OpenClinica installed and working and looking for
    > > below features , If these features are present in Enterprise
    > > version , mentioning that in the answers will be great .
    > >
    > > My Environment details :-
    > > Windows 2008 R2 , Java6 , Tomcat 6 , PostGre 8.4
    > >
    > >
    > > 1) PDF for archiving
    > >
    > > Rather than printing individual CRFs for the patient. Can the openclinica
    > > system generate all the patients CRFs in the Study in pdf format for
    > > archiving at one click.
    > > is there any solution around it
    > >
    > >
    > > 2) dynamic emails.
    > >
    > > Is it possible to incorporate dynamic content like item vale etc in email
    > > rules.
    > >
    > >
    > > 3) dynamic CRFs
    > >
    > > Can the entire CRFs be hidden based on the branching questions rather than
    > > item level show/hide options.
    > >
    > > 4) Rights and roles
    > >
    > > Is it possible to add additional roles and define rights.
    > >
    > > 5)complex rule logic
    > >
    > > Can complex rule logic like looping through multiple CRFs to check values
    > > possible (earliest date check, minimum previous value etc)
    > >
    > > 6) site level forms
    > >
    > > Can we incorporate site level forms in openclinica. We need some forms
    > > attached at site level rather than subject level is it possible.
    > >
    > > 7) template for discrepancy
    > >
    > > is it possible to incorporate customized template for Printing the
    > > Discrepancy (DCF). We need to put investigator comments and Signature in
    > > the DCF that
    > > is sent to the user. is there any solution around this.
    > >
    > > Thanks And Regards ,
    > > Ajay Kumar Jha
    > > +91-91633-91052
    > >
    > > #####################################################################################
    > > This e-mail message has been scanned for Viruses and Content and cleared
    > > by MailMarshal
    > > #####################################################################################
    > >
    > > ####################################################################################################################
    > >
    > > IMPORTANT NOTICE: This e-mail and any attachment to it are intended only
    > > to be read or used by the named addressee.
    > > It is confidential and may contain legally privileged information. No
    > > confidentiality or privilege is waived or lost
    > > by any mistaken transmission to you. The CTC is not responsible for any
    > > unauthorised alterations to this e-mail or
    > > attachment to it. Views expressed in this message are those of the
    > > individual sender, and are not necessarily the
    > > views of the CTC. If you receive this e-mail in error, please immediately
    > > delete it and notify the sender. You must
    > > not disclose, copy or use any part of this e-mail if you are not the
    > > intended recipient.
    > >
    > > #####################################################################################################################
    > >
  • ajayjiitajayjiit Posts: 52
    Thank You So much Lindsay And Gerben,
    I Appreciate your effort to answer my question with such detailed explanation , I am going through all explanation one by one , I have many more queries , Adding one more here .
    Question: We understand that Open Clinical does not support Medical coding. Kindly confirm and please advise the following:
    a) OpenClinica team is planning to implement Coding solution in future releases?
    b) Do you recommend any Coding solution that can be integrated with OpenClinica? .
    Thanks And Regards ,
    Ajay Kumar Jha
    On Wed, Mar 27, 2013 at 7:32 PM, Gerben Rienk wrote:
    Hi Ajay,
    Further to Linsay's great and elaborate answers:
    ad. 5) Complex rule logic
    You can use the event ordinal in a repeating event definition in Validations.
    However what I miss is the option to use a cursor to loop through rows in
    a RepeatingItemsGroup and compare for example a date with the date of the
    next row.
    Kind regards,
    Gerben Rienk
    > Hi Ajay
    >
    > If you're trying to decide between community and enterprise, the main
    > selling point for enterprise is support - there's only so much that the
    > mail groups can do to help with certain issues, and the OpenClinica team
    > know the software better than anyone else. Functionality-wise the versions
    > are largely the same.
    >
    > Below are my thoughts on your feature questions
    >
    > 1) PDF for archiving
    >
    > No.
    >
    > Better CRF printing planned for 3.1.4 though. In the meantime you could
    > use this: http://www.trialdatasolutions.com/tds/howto/datalisting.jsp, or
    > you could back up the entire study database to archive, or you could use
    > any of the OpenClinica extract formats to archive your data. Probably the
    > best format other than the original database is 'ODM xml 1.3 with full OC
    > extensions', since it has the metadata, clinical data, notes and audit
    > histories. Enterprise has Data Mart, which basically pivots your data such
    > that you get a table per item group with the items as columns, but it
    > doesn't include much metadata or notes or audit history.
    >
    > 2) Dynamic emails
    >
    > No.
    >
    > You can set the message once per rule. The email will contain a link to
    > view the CRF in OpenClinica though. I believe it was deliberate that item
    > values aren't transmitted because email isn't necessarily a secure
    > transmission (unless you were to use pgp or something, but I don't think
    > that is supported / integrated)
    >
    > 3) Dynamic CRFs
    >
    > Yes.
    >
    > You can nest hidden items so that they're shown in a branching manner. A
    > few major bugs with nesting simple conditional displays (SCDs) were
    > squashed in 3.1.3, and from 3.1.2 you could target hidden items with a
    > rule. So you could use show rules in combination with SCDs. It's been a
    > while since I checked but I think hide rules don't work (happy to be
    > corrected). Also in 3.1.3 I noticed you can get away with having all items
    > on your 2nd, 3rd, 4th etc sections hidden, and when an item on that
    > section shown with a rule the section will appear.
    >
    > 4) Rights and roles
    >
    > No.
    >
    > I think this is one of the key features planned for a future release (not
    > sure which).
    >
    > 5) Complex rule logic
    >
    > Kind of.
    >
    > It largely depends on what you consider 'complex' to mean. You can do a
    > lot with rules in OpenClinica, but it can't do some things I would have
    > thought weren't complex, like insert a calculated value. To address your
    > example:
    >
    > Last time I checked, specifying an event ordinal in a repeating event
    > definition doesn't work, so if you wanted to check the same CRF across
    > multiple time points, the way to do that would be to create an event
    > definition for each time point and compare across them. For example if you
    > wanted to check that all the treatment visits were done every 3 weeks,
    > instead of having a 'Treatment' event which is repeating, you'd need to
    > set up events like 'Treatment Cycle 1', 'Treatment Cycle 2', 'Treatment
    > Cycle 3', etc., which each have a copy of the same set of CRFs.
    >
    > Another approach to this is to have a field where the event repeat is
    > specified, and then have each repeat in your Treatment event look back at
    > the Enrol date on the non-repeating Enrol visit, with a rule checking the
    > date is relatively correct. For example, if the selected EventRepeat on
    > any repeat of the Treatment form is 1, the treatment date should be
    > EnrolDate+0 days; if EventRepeat is 2, the treatment date should be
    > EnrolDate+21 days; and so on.
    >
    > 6) Site level forms
    >
    > Yes.
    >
    > You can set event definitions at the study level, and then for each site
    > customise them. So you can hide a CRF that you never want a site to see,
    > or show site A version A of your CRF and show site B version B of the same
    > CRF.
    >
    > 7) Template for discrepancy
    >
    > No.
    >
    > Also - ouch! We've got studies with 100's or 1000's of notes; it would
    > take whole forests of paper and months of time to do that - unless you're
    > only talking about signing off on eligibility waivers or something. If
    > it's a matter of verifying data, I'd try convincing who-ever-it-is to rely
    > on the event or casebook signature feature:
    > https://docs.openclinica.com/3.1/openclinica-user-guide/submit-data-module-overview/view-events#content-title-5095.
    >
    > If you absolutely have to though, you could:
    >
    > - If it was en-masse, work on a way of presenting the notes and data
    > from an ODM 1.3 xml extract, possibly with Excel, Access or BIRT etc
    >
    > - If it was small scale, print the Notes window to pdf, save the pdf
    > as an image, paste into Word and overlay whatever header / footer /
    > signature fields were required.
    >
    > Best regards,
    >
    > Lindsay Stevens | Clinical Data Coordinator
    >
    > NHMRC Clinical Trials Centre, THE UNIVERSITY OF SYDNEY
    > Office: Level 2, 6-10 Mallett St | Camperdown | NSW | 2050
    > Mail: Locked Bag 77 | Camperdown | NSW | 1450
    > T +61 2 9562 5369 | F +61 2 9562 5094
    > E lindsay.stevens@ctc.usyd.edu.au
    > | W www.ctc.usyd.edu.au
    >
    >
    > [mailto:developers-bounces@openclinica.org] On Behalf Of Ajay Jha
    > Sent: Wednesday, 27 March 2013 12:28 AM
    > To: Users@openclinica.org; developers@openclinica.org
    > Subject: [Developers] Feature's and capabilities of OpenClinica
    >
    > Hi All ,
    > I Have some question's for OpenClinica . I have a community
    > version of OpenClinica installed and working and looking for
    > below features , If these features are present in Enterprise
    > version , mentioning that in the answers will be great .
    >
    > My Environment details :-
    > Windows 2008 R2 , Java6 , Tomcat 6 , PostGre 8.4
    >
    >
    > 1) PDF for archiving
    >
    > Rather than printing individual CRFs for the patient. Can the openclinica
    > system generate all the patients CRFs in the Study in pdf format for
    > archiving at one click.
    > is there any solution around it
    >
    >
    > 2) dynamic emails.
    >
    > Is it possible to incorporate dynamic content like item vale etc in email
    > rules.
    >
    >
    > 3) dynamic CRFs
    >
    > Can the entire CRFs be hidden based on the branching questions rather than
    > item level show/hide options.
    >
    > 4) Rights and roles
    >
    > Is it possible to add additional roles and define rights.
    >
    > 5)complex rule logic
    >
    > Can complex rule logic like looping through multiple CRFs to check values
    > possible (earliest date check, minimum previous value etc)
    >
    > 6) site level forms
    >
    > Can we incorporate site level forms in openclinica. We need some forms
    > attached at site level rather than subject level is it possible.
    >
    > 7) template for discrepancy
    >
    > is it possible to incorporate customized template for Printing the
    > Discrepancy (DCF). We need to put investigator comments and Signature in
    > the DCF that
    > is sent to the user. is there any solution around this.
    >
    > Thanks And Regards ,
    > Ajay Kumar Jha
    > +91-91633-91052
    >
    > #####################################################################################
    > This e-mail message has been scanned for Viruses and Content and cleared
    > by MailMarshal
    > #####################################################################################
    >
    > ####################################################################################################################
    >
    > IMPORTANT NOTICE: This e-mail and any attachment to it are intended only
    > to be read or used by the named addressee.
    > It is confidential and may contain legally privileged information. No
    > confidentiality or privilege is waived or lost
    > by any mistaken transmission to you. The CTC is not responsible for any
    > unauthorised alterations to this e-mail or
    > attachment to it. Views expressed in this message are those of the
    > individual sender, and are not necessarily the
    > views of the CTC. If you receive this e-mail in error, please immediately
    > delete it and notify the sender. You must
    > not disclose, copy or use any part of this e-mail if you are not the
    > intended recipient.
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  • Hi Gerben,
    Thanks - you were right about the event ordinals. This will let me simplify my future study designs somewhat. I checked in 3.1.3.1 and could get the following types of rules to work:
    a) Treatment visit date in event repeat 1 should be before Treatment visit date in event repeat 2
    b) Baseline visit date should be before Treatment visit date in event repeat 1
    Both a) and b) are fine when I upload from a rule xml. However b) will validate in rules designer, but show a NullPointerException error on attempting to save. Weird!
    Specifying an event ordinal in an insertaction destination still doesn't work though, even when trying to copy a value from one repeat of the same event definition to another repeat. The rule fails to validate in both rule xml upload and rules designer.
    Best regards,
    Lindsay Stevens | Clinical Data Coordinator
    NHMRC Clinical Trials Centre, THE UNIVERSITY OF SYDNEY
    Office: Level 2, 6-10 Mallett St | Camperdown | NSW | 2050
    Mail: Locked Bag 77 | Camperdown | NSW | 1450
    T +61 2 9562 5369 | F +61 2 9562 5094
    E lindsay.stevens@ctc.usyd.edu.au | W www.ctc.usyd.edu.au
    -----Original Message-----
    Sent: Thursday, 28 March 2013 1:03 AM
    To: developers@openclinica.org
    Subject: Re: [Developers] Feature's and capabilities of OpenClinica
    Hi Ajay,
    Further to Linsay's great and elaborate answers:
    ad. 5) Complex rule logic
    You can use the event ordinal in a repeating event definition in Validations.
    However what I miss is the option to use a cursor to loop through rows in
    a RepeatingItemsGroup and compare for example a date with the date of the
    next row.
    Kind regards,
    Gerben Rienk
    > > Hi Ajay
    > >
    > > If you're trying to decide between community and enterprise, the main
    > > selling point for enterprise is support - there's only so much that the
    > > mail groups can do to help with certain issues, and the OpenClinica team
    > > know the software better than anyone else. Functionality-wise the versions
    > > are largely the same.
    > >
    > > Below are my thoughts on your feature questions
    > >
    > > 1) PDF for archiving
    > >
    > > No.
    > >
    > > Better CRF printing planned for 3.1.4 though. In the meantime you could
    > > use this: http://www.trialdatasolutions.com/tds/howto/datalisting.jsp, or
    > > you could back up the entire study database to archive, or you could use
    > > any of the OpenClinica extract formats to archive your data. Probably the
    > > best format other than the original database is 'ODM xml 1.3 with full OC
    > > extensions', since it has the metadata, clinical data, notes and audit
    > > histories. Enterprise has Data Mart, which basically pivots your data such
    > > that you get a table per item group with the items as columns, but it
    > > doesn't include much metadata or notes or audit history.
    > >
    > > 2) Dynamic emails
    > >
    > > No.
    > >
    > > You can set the message once per rule. The email will contain a link to
    > > view the CRF in OpenClinica though. I believe it was deliberate that item
    > > values aren't transmitted because email isn't necessarily a secure
    > > transmission (unless you were to use pgp or something, but I don't think
    > > that is supported / integrated)
    > >
    > > 3) Dynamic CRFs
    > >
    > > Yes.
    > >
    > > You can nest hidden items so that they're shown in a branching manner. A
    > > few major bugs with nesting simple conditional displays (SCDs) were
    > > squashed in 3.1.3, and from 3.1.2 you could target hidden items with a
    > > rule. So you could use show rules in combination with SCDs. It's been a
    > > while since I checked but I think hide rules don't work (happy to be
    > > corrected). Also in 3.1.3 I noticed you can get away with having all items
    > > on your 2nd, 3rd, 4th etc sections hidden, and when an item on that
    > > section shown with a rule the section will appear.
    > >
    > > 4) Rights and roles
    > >
    > > No.
    > >
    > > I think this is one of the key features planned for a future release (not
    > > sure which).
    > >
    > > 5) Complex rule logic
    > >
    > > Kind of.
    > >
    > > It largely depends on what you consider 'complex' to mean. You can do a
    > > lot with rules in OpenClinica, but it can't do some things I would have
    > > thought weren't complex, like insert a calculated value. To address your
    > > example:
    > >
    > > Last time I checked, specifying an event ordinal in a repeating event
    > > definition doesn't work, so if you wanted to check the same CRF across
    > > multiple time points, the way to do that would be to create an event
    > > definition for each time point and compare across them. For example if you
    > > wanted to check that all the treatment visits were done every 3 weeks,
    > > instead of having a 'Treatment' event which is repeating, you'd need to
    > > set up events like 'Treatment Cycle 1', 'Treatment Cycle 2', 'Treatment
    > > Cycle 3', etc., which each have a copy of the same set of CRFs.
    > >
    > > Another approach to this is to have a field where the event repeat is
    > > specified, and then have each repeat in your Treatment event look back at
    > > the Enrol date on the non-repeating Enrol visit, with a rule checking the
    > > date is relatively correct. For example, if the selected EventRepeat on
    > > any repeat of the Treatment form is 1, the treatment date should be
    > > EnrolDate+0 days; if EventRepeat is 2, the treatment date should be
    > > EnrolDate+21 days; and so on.
    > >
    > > 6) Site level forms
    > >
    > > Yes.
    > >
    > > You can set event definitions at the study level, and then for each site
    > > customise them. So you can hide a CRF that you never want a site to see,
    > > or show site A version A of your CRF and show site B version B of the same
    > > CRF.
    > >
    > > 7) Template for discrepancy
    > >
    > > No.
    > >
    > > Also - ouch! We've got studies with 100's or 1000's of notes; it would
    > > take whole forests of paper and months of time to do that - unless you're
    > > only talking about signing off on eligibility waivers or something. If
    > > it's a matter of verifying data, I'd try convincing who-ever-it-is to rely
    > > on the event or casebook signature feature:
    > > https://docs.openclinica.com/3.1/openclinica-user-guide/submit-data-module-overview/view-events#content-title-5095.
    > >
    > > If you absolutely have to though, you could:
    > >
    > > - If it was en-masse, work on a way of presenting the notes and data
    > > from an ODM 1.3 xml extract, possibly with Excel, Access or BIRT etc
    > >
    > > - If it was small scale, print the Notes window to pdf, save the pdf
    > > as an image, paste into Word and overlay whatever header / footer /
    > > signature fields were required.
    > >
    > > Best regards,
    > >
    > > Lindsay Stevens | Clinical Data Coordinator
    > >
    > > NHMRC Clinical Trials Centre, THE UNIVERSITY OF SYDNEY
    > > Office: Level 2, 6-10 Mallett St | Camperdown | NSW | 2050
    > > Mail: Locked Bag 77 | Camperdown | NSW | 1450
    > > T +61 2 9562 5369 | F +61 2 9562 5094
    > > E lindsay.stevens@ctc.usyd.edu.au
    > > | W www.ctc.usyd.edu.au
    > >
    > >
    > > [mailto:developers-bounces@openclinica.org] On Behalf Of Ajay Jha
    > > Sent: Wednesday, 27 March 2013 12:28 AM
    > > To: Users@openclinica.org; developers@openclinica.org
    > > Subject: [Developers] Feature's and capabilities of OpenClinica
    > >
    > > Hi All ,
    > > I Have some question's for OpenClinica . I have a community
    > > version of OpenClinica installed and working and looking for
    > > below features , If these features are present in Enterprise
    > > version , mentioning that in the answers will be great .
    > >
    > > My Environment details :-
    > > Windows 2008 R2 , Java6 , Tomcat 6 , PostGre 8.4
    > >
    > >
    > > 1) PDF for archiving
    > >
    > > Rather than printing individual CRFs for the patient. Can the openclinica
    > > system generate all the patients CRFs in the Study in pdf format for
    > > archiving at one click.
    > > is there any solution around it
    > >
    > >
    > > 2) dynamic emails.
    > >
    > > Is it possible to incorporate dynamic content like item vale etc in email
    > > rules.
    > >
    > >
    > > 3) dynamic CRFs
    > >
    > > Can the entire CRFs be hidden based on the branching questions rather than
    > > item level show/hide options.
    > >
    > > 4) Rights and roles
    > >
    > > Is it possible to add additional roles and define rights.
    > >
    > > 5)complex rule logic
    > >
    > > Can complex rule logic like looping through multiple CRFs to check values
    > > possible (earliest date check, minimum previous value etc)
    > >
    > > 6) site level forms
    > >
    > > Can we incorporate site level forms in openclinica. We need some forms
    > > attached at site level rather than subject level is it possible.
    > >
    > > 7) template for discrepancy
    > >
    > > is it possible to incorporate customized template for Printing the
    > > Discrepancy (DCF). We need to put investigator comments and Signature in
    > > the DCF that
    > > is sent to the user. is there any solution around this.
    > >
    > > Thanks And Regards ,
    > > Ajay Kumar Jha
    > > +91-91633-91052
    > >
    > > #####################################################################################
    > > This e-mail message has been scanned for Viruses and Content and cleared
    > > by MailMarshal
    > > #####################################################################################
    > >
    > > ####################################################################################################################
    > >
    > > IMPORTANT NOTICE: This e-mail and any attachment to it are intended only
    > > to be read or used by the named addressee.
    > > It is confidential and may contain legally privileged information. No
    > > confidentiality or privilege is waived or lost
    > > by any mistaken transmission to you. The CTC is not responsible for any
    > > unauthorised alterations to this e-mail or
    > > attachment to it. Views expressed in this message are those of the
    > > individual sender, and are not necessarily the
    > > views of the CTC. If you receive this e-mail in error, please immediately
    > > delete it and notify the sender. You must
    > > not disclose, copy or use any part of this e-mail if you are not the
    > > intended recipient.
    > >
    > > #####################################################################################################################
    > >
  • Hi Ajay

    a) Medical coding - plans

    If you have an issuetracker login, have a look at [1] – coding is on the roadmap for the next major release, but not the initial version. It’s a huge feature and it looks like they’re doing a thorough job (from what you can see at [2]), so I’d be surprised if it’s in any version released in the coming year, at least.

    b) Medical coding - now

    To some extent it is possible to do coding on the CRF already, by providing the dictionary of terms to the user. The main limitation is that we only have 4000 characters to play with for drop downs by default, but there are workarounds. If you can commit to not allowing any Internet Explorer users (or convince MS to allow cross-domain messaging), you could use PostMessage [3]; otherwise there is the LongLists masterpiece [4] – however this requires the placement of a source xml file in your OpenClinica install directory, which I don’t think you’re allowed to do with an enterprise install.

    Alternatively you could export your data from OpenClinica and import it into one of the many medical coding packages out there. I don’t have a particular package to recommend, because I haven’t had to use one myself.

    [1] https://issuetracker.openclinica.com/view.php?id=10183
    [2] http://www.trialdatasolutions.com/tds/howto/testaqua.jsp
    [3] http://www.trialdatasolutions.com/tds/howto/postmessage.jsp
    [4] http://en.wikibooks.org/wiki/OpenClinica_User_Manual/LongLists

    Best regards,

    Lindsay Stevens | Clinical Data Coordinator
    NHMRC Clinical Trials Centre, THE UNIVERSITY OF SYDNEY
    Office: Level 2, 6-10 Mallett St | Camperdown | NSW | 2050
    Mail: Locked Bag 77 | Camperdown | NSW | 1450
    T +61 2 9562 5369 | F +61 2 9562 5094
    E lindsay.stevens@ctc.usyd.edu.au | W www.ctc.usyd.edu.au

    From: Ajay Jha [mailto:ajoykumarjha@gmail.com]
    Sent: Thursday, 28 March 2013 1:57 AM
    To: Lindsay Stevens; developers@openclinica.org; Users@openclinica.org; gerben@xs4all.nl
    Subject: Re: [Developers] Feature's and capabilities of OpenClinica

    Thank You So much Lindsay And Gerben,
    I Appreciate your effort to answer my question with such detailed explanation , I am going through all explanation one by one , I have many more queries , Adding one more here .

    Question: We understand that Open Clinical does not support Medical coding. Kindly confirm and please advise the following:
    a) OpenClinica team is planning to implement Coding solution in future releases?
    b) Do you recommend any Coding solution that can be integrated with OpenClinica? .


    Thanks And Regards ,
    Ajay Kumar Jha





    On Wed, Mar 27, 2013 at 7:32 PM, Gerben Rienk wrote:
    Hi Ajay,
    Further to Linsay's great and elaborate answers:
    ad. 5) Complex rule logic
    You can use the event ordinal in a repeating event definition in Validations.
    However what I miss is the option to use a cursor to loop through rows in
    a RepeatingItemsGroup and compare for example a date with the date of the
    next row.
    Kind regards,
    Gerben Rienk
    > Hi Ajay
    >
    > If you're trying to decide between community and enterprise, the main
    > selling point for enterprise is support - there's only so much that the
    > mail groups can do to help with certain issues, and the OpenClinica team
    > know the software better than anyone else. Functionality-wise the versions
    > are largely the same.
    >
    > Below are my thoughts on your feature questions
    >
    > 1) PDF for archiving
    >
    > No.
    >
    > Better CRF printing planned for 3.1.4 though. In the meantime you could
    > use this: http://www.trialdatasolutions.com/tds/howto/datalisting.jsp, or
    > you could back up the entire study database to archive, or you could use
    > any of the OpenClinica extract formats to archive your data. Probably the
    > best format other than the original database is 'ODM xml 1.3 with full OC
    > extensions', since it has the metadata, clinical data, notes and audit
    > histories. Enterprise has Data Mart, which basically pivots your data such
    > that you get a table per item group with the items as columns, but it
    > doesn't include much metadata or notes or audit history.
    >
    > 2) Dynamic emails
    >
    > No.
    >
    > You can set the message once per rule. The email will contain a link to
    > view the CRF in OpenClinica though. I believe it was deliberate that item
    > values aren't transmitted because email isn't necessarily a secure
    > transmission (unless you were to use pgp or something, but I don't think
    > that is supported / integrated)
    >
    > 3) Dynamic CRFs
    >
    > Yes.
    >
    > You can nest hidden items so that they're shown in a branching manner. A
    > few major bugs with nesting simple conditional displays (SCDs) were
    > squashed in 3.1.3, and from 3.1.2 you could target hidden items with a
    > rule. So you could use show rules in combination with SCDs. It's been a
    > while since I checked but I think hide rules don't work (happy to be
    > corrected). Also in 3.1.3 I noticed you can get away with having all items
    > on your 2nd, 3rd, 4th etc sections hidden, and when an item on that
    > section shown with a rule the section will appear.
    >
    > 4) Rights and roles
    >
    > No.
    >
    > I think this is one of the key features planned for a future release (not
    > sure which).
    >
    > 5) Complex rule logic
    >
    > Kind of.
    >
    > It largely depends on what you consider 'complex' to mean. You can do a
    > lot with rules in OpenClinica, but it can't do some things I would have
    > thought weren't complex, like insert a calculated value. To address your
    > example:
    >
    > Last time I checked, specifying an event ordinal in a repeating event
    > definition doesn't work, so if you wanted to check the same CRF across
    > multiple time points, the way to do that would be to create an event
    > definition for each time point and compare across them. For example if you
    > wanted to check that all the treatment visits were done every 3 weeks,
    > instead of having a 'Treatment' event which is repeating, you'd need to
    > set up events like 'Treatment Cycle 1', 'Treatment Cycle 2', 'Treatment
    > Cycle 3', etc., which each have a copy of the same set of CRFs.
    >
    > Another approach to this is to have a field where the event repeat is
    > specified, and then have each repeat in your Treatment event look back at
    > the Enrol date on the non-repeating Enrol visit, with a rule checking the
    > date is relatively correct. For example, if the selected EventRepeat on
    > any repeat of the Treatment form is 1, the treatment date should be
    > EnrolDate+0 days; if EventRepeat is 2, the treatment date should be
    > EnrolDate+21 days; and so on.
    >
    > 6) Site level forms
    >
    > Yes.
    >
    > You can set event definitions at the study level, and then for each site
    > customise them. So you can hide a CRF that you never want a site to see,
    > or show site A version A of your CRF and show site B version B of the same
    > CRF.
    >
    > 7) Template for discrepancy
    >
    > No.
    >
    > Also - ouch! We've got studies with 100's or 1000's of notes; it would
    > take whole forests of paper and months of time to do that - unless you're
    > only talking about signing off on eligibility waivers or something. If
    > it's a matter of verifying data, I'd try convincing who-ever-it-is to rely
    > on the event or casebook signature feature:
    > https://docs.openclinica.com/3.1/openclinica-user-guide/submit-data-module-overview/view-events#content-title-5095.
    >
    > If you absolutely have to though, you could:
    >
    > - If it was en-masse, work on a way of presenting the notes and data
    > from an ODM 1.3 xml extract, possibly with Excel, Access or BIRT etc
    >
    > - If it was small scale, print the Notes window to pdf, save the pdf
    > as an image, paste into Word and overlay whatever header / footer /
    > signature fields were required.
    >
    > Best regards,
    >
    > Lindsay Stevens | Clinical Data Coordinator
    >
    > NHMRC Clinical Trials Centre, THE UNIVERSITY OF SYDNEY
    > Office: Level 2, 6-10 Mallett St | Camperdown | NSW | 2050
    > Mail: Locked Bag 77 | Camperdown | NSW | 1450
    > T +61 2 9562 5369 | F +61 2 9562 5094
    > E lindsay.stevens@ctc.usyd.edu.au
    > | W www.ctc.usyd.edu.au
    >
    >
    > [mailto:developers-bounces@openclinica.org] On Behalf Of Ajay Jha
    > Sent: Wednesday, 27 March 2013 12:28 AM
    > To: Users@openclinica.org; developers@openclinica.org
    > Subject: [Developers] Feature's and capabilities of OpenClinica
    >
    > Hi All ,
    > I Have some question's for OpenClinica . I have a community
    > version of OpenClinica installed and working and looking for
    > below features , If these features are present in Enterprise
    > version , mentioning that in the answers will be great .
    >
    > My Environment details :-
    > Windows 2008 R2 , Java6 , Tomcat 6 , PostGre 8.4
    >
    >
    > 1) PDF for archiving
    >
    > Rather than printing individual CRFs for the patient. Can the openclinica
    > system generate all the patients CRFs in the Study in pdf format for
    > archiving at one click.
    > is there any solution around it
    >
    >
    > 2) dynamic emails.
    >
    > Is it possible to incorporate dynamic content like item vale etc in email
    > rules.
    >
    >
    > 3) dynamic CRFs
    >
    > Can the entire CRFs be hidden based on the branching questions rather than
    > item level show/hide options.
    >
    > 4) Rights and roles
    >
    > Is it possible to add additional roles and define rights.
    >
    > 5)complex rule logic
    >
    > Can complex rule logic like looping through multiple CRFs to check values
    > possible (earliest date check, minimum previous value etc)
    >
    > 6) site level forms
    >
    > Can we incorporate site level forms in openclinica. We need some forms
    > attached at site level rather than subject level is it possible.
    >
    > 7) template for discrepancy
    >
    > is it possible to incorporate customized template for Printing the
    > Discrepancy (DCF). We need to put investigator comments and Signature in
    > the DCF that
    > is sent to the user. is there any solution around this.
    >
    > Thanks And Regards ,
    > Ajay Kumar Jha
    > +91-91633-91052
    >
    > #####################################################################################
    > This e-mail message has been scanned for Viruses and Content and cleared
    > by MailMarshal
    > #####################################################################################
    >
    > ####################################################################################################################
    >
    > IMPORTANT NOTICE: This e-mail and any attachment to it are intended only
    > to be read or used by the named addressee.
    > It is confidential and may contain legally privileged information. No
    > confidentiality or privilege is waived or lost
    > by any mistaken transmission to you. The CTC is not responsible for any
    > unauthorised alterations to this e-mail or
    > attachment to it. Views expressed in this message are those of the
    > individual sender, and are not necessarily the
    > views of the CTC. If you receive this e-mail in error, please immediately
    > delete it and notify the sender. You must
    > not disclose, copy or use any part of this e-mail if you are not the
    > intended recipient.
    >
    > #####################################################################################################################
    >
This discussion has been closed.