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CRF that is used only rarely

kristiakkristiak Posts: 1,338 ✭✭✭
How do you suggest that we resolve this problem. In most studies Serious Adverse Events are only used on rare occasions. We have tried to mark the CRF as not required in the event set up, but it is still not possible to sign off on the patient without opening and saving the blank form. Is there no way of resolving this issue a little smarter. We can of course use the SHOW and HIDE feature but that still means that you have to open the CRF and mark it completed and SAVE!

Best regards

Krister
This e-mail (including any attached documents) is proprietary and confidential and may contain legally privileged information. It is intended for the named recipient(s) only. If you are not the intended recipient, you may not review, retain, copy or distribute this message, and we kindly ask you to notify the sender by reply e-mail immediately and delete this message from your system. E-mail is susceptible to unauthorised alterations which may corrupt the message of the e-mail. e-Source Technology EMR only sends and receives e-mails on the basis that e-Source Technology EMR is not liable for any unauthorised alterations.

Comments

  • kristiakkristiak Posts: 1,338 ✭✭✭
    How do you suggest that we resolve this problem. In most studies Serious Adverse Events are only used on rare occasions. We have tried to mark the CRF as not required in the event set up, but it is still not possible to sign off on the patient without opening and saving the blank form. Is there no way of resolving this issue a little smarter. We can of course use the SHOW and HIDE feature but that still means that you have to open the CRF and mark it completed and SAVE!

    Best regards

    Krister
    This e-mail (including any attached documents) is proprietary and confidential and may contain legally privileged information. It is intended for the named recipient(s) only. If you are not the intended recipient, you may not review, retain, copy or distribute this message, and we kindly ask you to notify the sender by reply e-mail immediately and delete this message from your system. E-mail is susceptible to unauthorised alterations which may corrupt the message of the e-mail. e-Source Technology EMR only sends and receives e-mails on the basis that e-Source Technology EMR is not liable for any unauthorised alterations.
  • neslonikneslonik Posts: 4
    Hi Krister,

    Will it work for you if you have Adverse Events CRF assigned to an Unscheduled Study Event, as OpenClinica documentation suggests?

    Thank you.
    Alla
    Sent: Wednesday, May 30, 2012 10:53 AM
    To: [email protected]; [email protected]
    Subject: [Users] CRF that is used only rarely

    How do you suggest that we resolve this problem. In most studies Serious Adverse Events are only used on rare occasions. We have tried to mark the CRF as not required in the event set up, but it is still not possible to sign off on the patient without opening and saving the blank form. Is there no way of resolving this issue a little smarter. We can of course use the SHOW and HIDE feature but that still means that you have to open the CRF and mark it completed and SAVE!

    Best regards

    Krister
    This e-mail (including any attached documents) is proprietary and confidential and may contain legally privileged information. It is intended for the named recipient(s) only. If you are not the intended recipient, you may not review, retain, copy or distribute this message, and we kindly ask you to notify the sender by reply e-mail immediately and delete this message from your system. E-mail is susceptible to unauthorised alterations which may corrupt the message of the e-mail. e-Source Technology EMR only sends and receives e-mails on the basis that e-Source Technology EMR is not liable for any unauthorised alterations.
  • LizRLizR Posts: 60
    I don't know if it helps, but I can tell you what we've got going on.
    Our SAE data is actually in with our AE data, so if a user indicates serious==yes, then we display a bunch of hidden fields relating to serious AEs.
    Our AEs are set up as unscheduled repeating events, one AE to an occurrence. The plus side of that is that each event gets marked complete in its own time, rather than the sort of ongoing nightmare of a log-style form. The down side of that is that navigating through a patient with a ton of AEs really requires a listing to know which occurrence to click on.
    Liz Robertson
    Director of Data Management
    TRACON Pharmaceuticals, Inc.
    [email protected]
    office: 858.550.0780 ext. 237
    cell: 760.481.5527
    Sent: Wednesday, May 30, 2012 10:57 AM
    To: [email protected]
    Subject: Re: [Users] CRF that is used only rarely
    Hi Krister,

    Will it work for you if you have Adverse Events CRF assigned to an Unscheduled Study Event, as OpenClinica documentation suggests?

    Thank you.
    Alla
    Sent: Wednesday, May 30, 2012 10:53 AM
    To: [email protected]; [email protected]
    Subject: [Users] CRF that is used only rarely

    How do you suggest that we resolve this problem. In most studies Serious Adverse Events are only used on rare occasions. We have tried to mark the CRF as not required in the event set up, but it is still not possible to sign off on the patient without opening and saving the blank form. Is there no way of resolving this issue a little smarter. We can of course use the SHOW and HIDE feature but that still means that you have to open the CRF and mark it completed and SAVE!

    Best regards

    Krister
    This e-mail (including any attached documents) is proprietary and confidential and may contain legally privileged information. It is intended for the named recipient(s) only. If you are not the intended recipient, you may not review, retain, copy or distribute this message, and we kindly ask you to notify the sender by reply e-mail immediately and delete this message from your system. E-mail is susceptible to unauthorised alterations which may corrupt the message of the e-mail. e-Source Technology EMR only sends and receives e-mails on the basis that e-Source Technology EMR is not liable for any unauthorised alterations.
  • kristiakesourcekristiakesource Posts: 133
    Thank you Liz,

    We have considered doing that but we have 45 extra variables that Eudravigilance wants several as grouped variables so we abandoned that idea. But as it seems to work for you I will test it to see how it works. Now we have found a solution that seems to work. We put the SAE form as a separate event and did not make it required. We will test to see if it works as well as we think.

    Regards

    Krister
    Sent: Wednesday, May 30, 2012 8:11 PM
    To: [email protected]
    Subject: Re: [Users] CRF that is used only rarely

    I don't know if it helps, but I can tell you what we've got going on.
    Our SAE data is actually in with our AE data, so if a user indicates serious==yes, then we display a bunch of hidden fields relating to serious AEs.
    Our AEs are set up as unscheduled repeating events, one AE to an occurrence. The plus side of that is that each event gets marked complete in its own time, rather than the sort of ongoing nightmare of a log-style form. The down side of that is that navigating through a patient with a ton of AEs really requires a listing to know which occurrence to click on.

    Liz Robertson
    Director of Data Management
    TRACON Pharmaceuticals, Inc.
    [email protected]
    office: 858.550.0780 ext. 237
    cell: 760.481.5527
    Sent: Wednesday, May 30, 2012 10:57 AM
    To: [email protected]
    Subject: Re: [Users] CRF that is used only rarely
    Hi Krister,

    Will it work for you if you have Adverse Events CRF assigned to an Unscheduled Study Event, as OpenClinica documentation suggests?

    Thank you.
    Alla
    Sent: Wednesday, May 30, 2012 10:53 AM
    To: [email protected]; [email protected]
    Subject: [Users] CRF that is used only rarely

    How do you suggest that we resolve this problem. In most studies Serious Adverse Events are only used on rare occasions. We have tried to mark the CRF as not required in the event set up, but it is still not possible to sign off on the patient without opening and saving the blank form. Is there no way of resolving this issue a little smarter. We can of course use the SHOW and HIDE feature but that still means that you have to open the CRF and mark it completed and SAVE!

    Best regards

    Krister
    This e-mail (including any attached documents) is proprietary and confidential and may contain legally privileged information. It is intended for the named recipient(s) only. If you are not the intended recipient, you may not review, retain, copy or distribute this message, and we kindly ask you to notify the sender by reply e-mail immediately and delete this message from your system. E-mail is susceptible to unauthorised alterations which may corrupt the message of the e-mail. e-Source Technology EMR only sends and receives e-mails on the basis that e-Source Technology EMR is not liable for any unauthorised alterations.
  • kristiakesourcekristiakesource Posts: 133
    Hi Alla,

    Yes that is exactly the way we are testing it now. It seems to work quite well!

    Thanks

    Krister
    Sent: Wednesday, May 30, 2012 7:58 PM
    To: [email protected]
    Subject: Re: [Users] CRF that is used only rarely

    Hi Krister,

    Will it work for you if you have Adverse Events CRF assigned to an Unscheduled Study Event, as OpenClinica documentation suggests?

    Thank you.
    Alla
    Sent: Wednesday, May 30, 2012 10:53 AM
    To: [email protected]; [email protected]
    Subject: [Users] CRF that is used only rarely

    How do you suggest that we resolve this problem. In most studies Serious Adverse Events are only used on rare occasions. We have tried to mark the CRF as not required in the event set up, but it is still not possible to sign off on the patient without opening and saving the blank form. Is there no way of resolving this issue a little smarter. We can of course use the SHOW and HIDE feature but that still means that you have to open the CRF and mark it completed and SAVE!

    Best regards

    Krister
    This e-mail (including any attached documents) is proprietary and confidential and may contain legally privileged information. It is intended for the named recipient(s) only. If you are not the intended recipient, you may not review, retain, copy or distribute this message, and we kindly ask you to notify the sender by reply e-mail immediately and delete this message from your system. E-mail is susceptible to unauthorised alterations which may corrupt the message of the e-mail. e-Source Technology EMR only sends and receives e-mails on the basis that e-Source Technology EMR is not liable for any unauthorised alterations.
  • LizRLizR Posts: 60
    45 is over twice as many extra fields as I have to collect. At that point, I'd want it broken out into a separate form, too.
    Liz Robertson
    Director of Data Management
    TRACON Pharmaceuticals, Inc.
    [email protected]
    office: 858.550.0780 ext. 237
    cell: 760.481.5527
    Sent: Wednesday, May 30, 2012 1:21 PM
    To: [email protected]
    Subject: Re: [Users] CRF that is used only rarely
    Thank you Liz,

    We have considered doing that but we have 45 extra variables that Eudravigilance wants several as grouped variables so we abandoned that idea. But as it seems to work for you I will test it to see how it works. Now we have found a solution that seems to work. We put the SAE form as a separate event and did not make it required. We will test to see if it works as well as we think.

    Regards

    Krister
    Sent: Wednesday, May 30, 2012 8:11 PM
    To: [email protected]
    Subject: Re: [Users] CRF that is used only rarely

    I don't know if it helps, but I can tell you what we've got going on.
    Our SAE data is actually in with our AE data, so if a user indicates serious==yes, then we display a bunch of hidden fields relating to serious AEs.
    Our AEs are set up as unscheduled repeating events, one AE to an occurrence. The plus side of that is that each event gets marked complete in its own time, rather than the sort of ongoing nightmare of a log-style form. The down side of that is that navigating through a patient with a ton of AEs really requires a listing to know which occurrence to click on.

    Liz Robertson
    Director of Data Management
    TRACON Pharmaceuticals, Inc.
    [email protected]
    office: 858.550.0780 ext. 237
    cell: 760.481.5527
    Sent: Wednesday, May 30, 2012 10:57 AM
    To: [email protected]
    Subject: Re: [Users] CRF that is used only rarely
    Hi Krister,

    Will it work for you if you have Adverse Events CRF assigned to an Unscheduled Study Event, as OpenClinica documentation suggests?

    Thank you.
    Alla
    Sent: Wednesday, May 30, 2012 10:53 AM
    To: [email protected]; [email protected]
    Subject: [Users] CRF that is used only rarely

    How do you suggest that we resolve this problem. In most studies Serious Adverse Events are only used on rare occasions. We have tried to mark the CRF as not required in the event set up, but it is still not possible to sign off on the patient without opening and saving the blank form. Is there no way of resolving this issue a little smarter. We can of course use the SHOW and HIDE feature but that still means that you have to open the CRF and mark it completed and SAVE!

    Best regards

    Krister
    This e-mail (including any attached documents) is proprietary and confidential and may contain legally privileged information. It is intended for the named recipient(s) only. If you are not the intended recipient, you may not review, retain, copy or distribute this message, and we kindly ask you to notify the sender by reply e-mail immediately and delete this message from your system. E-mail is susceptible to unauthorised alterations which may corrupt the message of the e-mail. e-Source Technology EMR only sends and receives e-mails on the basis that e-Source Technology EMR is not liable for any unauthorised alterations.
  • kristiakkristiak Posts: 1,338 ✭✭✭
    I agree, it is sort of ridiculous!

    /Krister
    Sent: Wednesday, May 30, 2012 10:39 PM
    To: [email protected]
    Subject: Re: [Users] CRF that is used only rarely

    45 is over twice as many extra fields as I have to collect. At that point, I'd want it broken out into a separate form, too.

    Liz Robertson
    Director of Data Management
    TRACON Pharmaceuticals, Inc.
    [email protected]
    office: 858.550.0780 ext. 237
    cell: 760.481.5527
    Sent: Wednesday, May 30, 2012 1:21 PM
    To: [email protected]
    Subject: Re: [Users] CRF that is used only rarely
    Thank you Liz,

    We have considered doing that but we have 45 extra variables that Eudravigilance wants several as grouped variables so we abandoned that idea. But as it seems to work for you I will test it to see how it works. Now we have found a solution that seems to work. We put the SAE form as a separate event and did not make it required. We will test to see if it works as well as we think.

    Regards

    Krister
    Sent: Wednesday, May 30, 2012 8:11 PM
    To: [email protected]
    Subject: Re: [Users] CRF that is used only rarely

    I don't know if it helps, but I can tell you what we've got going on.
    Our SAE data is actually in with our AE data, so if a user indicates serious==yes, then we display a bunch of hidden fields relating to serious AEs.
    Our AEs are set up as unscheduled repeating events, one AE to an occurrence. The plus side of that is that each event gets marked complete in its own time, rather than the sort of ongoing nightmare of a log-style form. The down side of that is that navigating through a patient with a ton of AEs really requires a listing to know which occurrence to click on.

    Liz Robertson
    Director of Data Management
    TRACON Pharmaceuticals, Inc.
    [email protected]
    office: 858.550.0780 ext. 237
    cell: 760.481.5527
    Sent: Wednesday, May 30, 2012 10:57 AM
    To: [email protected]
    Subject: Re: [Users] CRF that is used only rarely
    Hi Krister,

    Will it work for you if you have Adverse Events CRF assigned to an Unscheduled Study Event, as OpenClinica documentation suggests?

    Thank you.
    Alla
    Sent: Wednesday, May 30, 2012 10:53 AM
    To: [email protected]; [email protected]
    Subject: [Users] CRF that is used only rarely

    How do you suggest that we resolve this problem. In most studies Serious Adverse Events are only used on rare occasions. We have tried to mark the CRF as not required in the event set up, but it is still not possible to sign off on the patient without opening and saving the blank form. Is there no way of resolving this issue a little smarter. We can of course use the SHOW and HIDE feature but that still means that you have to open the CRF and mark it completed and SAVE!

    Best regards

    Krister
    This e-mail (including any attached documents) is proprietary and confidential and may contain legally privileged information. It is intended for the named recipient(s) only. If you are not the intended recipient, you may not review, retain, copy or distribute this message, and we kindly ask you to notify the sender by reply e-mail immediately and delete this message from your system. E-mail is susceptible to unauthorised alterations which may corrupt the message of the e-mail. e-Source Technology EMR only sends and receives e-mails on the basis that e-Source Technology EMR is not liable for any unauthorised alterations.
This discussion has been closed.