Pre Subject Screening CRFs

Hello,

I’m creating an study by duplicating existing paper CRFs into OpenClinica’s electronic format.

Some of the paper CRFs are used at a stage in the trial before Subjects have been selected; for example, Investigator Screening forms. However, at the data entry stage, a Subject ID is required for my ‘Investigator Screening Event’ but that is not suitable for this time in the trial.

My question is, is it possible to have CRFs available for data entry that are not associated with a particular Subject or is it that OpenClinica is designed to be used only at, and after, the Subject screening stage?

Thanks,
Dave

Comments

  • JanusJanus Posts: 260
    Hi Dave,
    I think OC is designed for the latter case, but if you use the screening
    number as a subject identifier you're on your way. Use a CRF with a subject
    ID field (e.g. as the last field on your screening CRF) to collect the
    subject ID or change it after the subject has been screened and found
    usable: View Study Subject > expand the Study Subject Record > Edit record.
    Best regards,
    Janus

    David Judge
    To
    Sent by: "[email protected]"
    [email protected]
    nclinica.org cc

    Subject
    28-10-2010 12:38 [Users] Pre Subject Screening CRFs


    Please respond to
    [email protected]
    .org


    Hello,
    I’m creating an study by duplicating existing paper CRFs into OpenClinica’s
    electronic format.
    Some of the paper CRFs are used at a stage in the trial before Subjects
    have been selected; for example, Investigator Screening forms. However, at
    the data entry stage, a Subject ID is required for my ‘Investigator
    Screening Event’ but that is not suitable for this time in the trial.
    My question is, is it possible to have CRFs available for data entry that
    are not associated with a particular Subject or is it that OpenClinica is
    designed to be used only at, and after, the Subject screening stage?
    Thanks,
    Dave
  • Hi Dave,
    Openclinica requires a primary ID be created to create a subject and start entry. All the data entry CRFs are attached to this ID. You could consider a screening ID as the primary and add another field for their enrollment ID. This is pretty common in clinical trials. Your other option is to wait and only enter data after the subjects have passed screening. This is common as well.
    Best regards,
    Mark Paul
    StatWorks, Inc.
    Sent: Thursday, October 28, 2010 6:30 AM
    To: [email protected]
    Subject: [Users] Pre Subject Screening CRFs
    Hello,

    I’m creating an study by duplicating existing paper CRFs into OpenClinica’s electronic format.

    Some of the paper CRFs are used at a stage in the trial before Subjects have been selected; for example, Investigator Screening forms. However, at the data entry stage, a Subject ID is required for my ‘Investigator Screening Event’ but that is not suitable for this time in the trial.

    My question is, is it possible to have CRFs available for data entry that are not associated with a particular Subject or is it that OpenClinica is designed to be used only at, and after, the Subject screening stage?

    Thanks,
    Dave
  • DJudgeDJudge Posts: 35
    Thanks Janus.
    I think, as you say, I'll need some sort of dummy Subject ID for the Investigator screening.
    Cheers,
    Dave
    -----Original Message-----
    Sent: 28 October 2010 12:32
    To: [email protected]
    Subject: Re: [Users] Pre Subject Screening CRFs
    Hi Dave,
    I think OC is designed for the latter case, but if you use the screening
    number as a subject identifier you're on your way. Use a CRF with a subject
    ID field (e.g. as the last field on your screening CRF) to collect the
    subject ID or change it after the subject has been screened and found
    usable: View Study Subject > expand the Study Subject Record > Edit record.
    Best regards,
    Janus

    David Judge
    To
    Sent by: "[email protected]"
    [email protected]
    nclinica.org cc

    Subject
    28-10-2010 12:38 [Users] Pre Subject Screening CRFs


    Please respond to
    [email protected]
    .org


    Hello,
    I’m creating an study by duplicating existing paper CRFs into OpenClinica’s
    electronic format.
    Some of the paper CRFs are used at a stage in the trial before Subjects
    have been selected; for example, Investigator Screening forms. However, at
    the data entry stage, a Subject ID is required for my ‘Investigator
    Screening Event’ but that is not suitable for this time in the trial.
    My question is, is it possible to have CRFs available for data entry that
    are not associated with a particular Subject or is it that OpenClinica is
    designed to be used only at, and after, the Subject screening stage?
    Thanks,
    Dave
This discussion has been closed.