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SDV Requirement definitions

byarmas-fscbyarmas-fsc Posts: 40 ✭
in Users Mailing List
Hi all,
I'm trying to familiarize myself with the SDV function of openclinica as my company may be taking over responsibility for monitoring a study we're managing data for. One thing that's confusing me is when setting the SDV requirement for a CRF in an event "Partial Required" is an option. How does this differ from the 100% required, when the extent of what's captured by the SDV (that I can tell) is a check box, which by its nature seems either 100 or 0 %?

Brendan Yarmas,
System Manager
First Stop CBPD Corporation
Mobile: 301-917-7439

Comments

  • ccollinsccollins Posts: 383 admin
    Hi Brendan,
    Very good question. I added some clarification of this to the SDV user
    guide page (https://docs.openclinica.com/3.1/openclinica-user-guide/monitor-and-manage-data/source-data-verification),
    as follows:
    When you add CRFs as part of creating the Study Event Definition, you
    specify if Source Data Verification is not applicable, not required,
    partially required, or 100% required for the CRF.
    What does 'partially required' mean? Often there are CRFs which
    require 100% review, meaning every field on every CRF should be
    reviewed (such as for Adverse Events). Other CRFs, however, may only
    need to be partially reviewed. OpenClinica does not define what
    "partial" means, but it would be defined in your monitoring plan and
    you would instruct your team as to how to use this. Typically there
    are two ways that "partial" is used in organizations:
    An organization may identify several fields in a CRF which are
    critical to the study. Monitors would be instructed to review only
    these fields in a CRF (rather than the whole CRF) for all of the
    subjects.
    A monitor may review every field in the CRF but may only do this for a
    percentage of the subjects (instead of all subjects).
    Best,
    Cal
    On Tue, Jan 7, 2014 at 5:47 PM, Brendan Yarmas wrote:
    > > Hi all,
    > > I'm trying to familiarize myself with the SDV function of openclinica as my
    > > company may be taking over responsibility for monitoring a study we're
    > > managing data for. One thing that's confusing me is when setting the SDV
    > > requirement for a CRF in an event "Partial Required" is an option. How does
    > > this differ from the 100% required, when the extent of what's captured by
    > > the SDV (that I can tell) is a check box, which by its nature seems either
    > > 100 or 0 %?
    > >
    > > Brendan Yarmas,
    > > System Manager
    > > First Stop CBPD Corporation
    > > Mobile: 301-917-7439
    > >
    > >
    > >
  • mgaintymgainty Posts: 18
    > Date: Wed, 8 Jan 2014 12:39:16 -0500
    >
    > To: [email protected]; [email protected]
    > Subject: Re: [Users] SDV Requirement definitions
    >
    > Hi Brendan,
    >
    > Very good question. I added some clarification of this to the SDV user
    > guide page (https://docs.openclinica.com/3.1/openclinica-user-guide/monitor-and-manage-data/source-data-verification),
    > as follows:
    >
    > When you add CRFs as part of creating the Study Event Definition, you
    > specify if Source Data Verification is not applicable, not required,
    > partially required, or 100% required for the CRF.
    >
    > What does 'partially required' mean? Often there are CRFs which
    > require 100% review, meaning every field on every CRF should be
    > reviewed (such as for Adverse Events). Other CRFs, however, may only
    > need to be partially reviewed. OpenClinica does not define what
    > "partial" means, but it would be defined in your monitoring plan and
    > you would instruct your team as to how to use this. Typically there
    > are two ways that "partial" is used in organizations:
    >
    > An organization may identify several fields in a CRF which are
    > critical to the study. Monitors would be instructed to review only
    > these fields in a CRF (rather than the whole CRF) for all of the
    > subjects.
    > A monitor may review every field in the CRF but may only do this for a
    > percentage of the subjects (instead of all subjects).
    MG>Another waltham based CRF provider in mobile space alluded to the same answer but I was unable to gather specifics
    MG>since the ultimate goal is to pass clinical trials can we assume partial study information would not be presented to Investigator?
    MG>or if presented to Investigator...there would be footnote specifying for internal use by physician, CRF Operational Director
    MG>or another entity?
    > Best,
    > Cal
    MG>Many Thanks for "thinking this through"
    MG>Martin-
    >
    >
    > On Tue, Jan 7, 2014 at 5:47 PM, Brendan Yarmas wrote:
    > > Hi all,
    > > I'm trying to familiarize myself with the SDV function of openclinica as my
    > > company may be taking over responsibility for monitoring a study we're
    > > managing data for. One thing that's confusing me is when setting the SDV
    > > requirement for a CRF in an event "Partial Required" is an option. How does
    > > this differ from the 100% required, when the extent of what's captured by
    > > the SDV (that I can tell) is a check box, which by its nature seems either
    > > 100 or 0 %?
    > >
    > > Brendan Yarmas,
    > > System Manager
    > > First Stop CBPD Corporation
    > > Mobile: 301-917-7439
    > >
    > >
    > >
  • ASIF UDDINASIF UDDIN Posts: 9
    I agree with you
    *** This message has been sent using QMobile A8 ***
    Martin Gainty wrote:
    > Date: Wed, 8 Jan 2014 12:39:16 -0500
    >
    > To: [email protected]; [email protected]
    > Subject: Re: [Users] SDV Requirement definitions
    >
    > Hi Brendan,
    >
    > Very good question. I added some clarification of this to the SDV user
    > guide page (https://docs.openclinica.com/3.1/openclinica-user-guide/monitor-and-manage-data/source-data-verification),
    > as follows:
    >
    > When you add CRFs as part of creating the Study Event Definition, you
    > specify if Source Data Verification is not applicable, not required,
    > partially required, or 100% required for the CRF.
    >
    > What does 'partially required' mean? Often there are CRFs which
    > require 100% review, meaning every field on every CRF should be
    > reviewed (such as for Adverse Events). Other CRFs, however, may only
    > need to be partially reviewed. OpenClinica does not define what
    > "partial" means, but it would be defined in your monitoring plan and
    > you would instruct your team as to how to use this. Typically there
    > are two ways that "partial" is used in organizations:
    >
    > An organization may identify several fields in a CRF which are
    > critical to the study. Monitors would be instructed to review only
    > these fields in a CRF (rather than the whole CRF) for all of the
    > subjects.
    > A monitor may review every field in the CRF but may only do this for a
    > percentage of the subjects (instead of all subjects).
    MG>Another waltham based CRF provider in mobile space alluded to the same answer but I was unable to gather specifics
    MG>since the ultimate goal is to pass clinical trials can we assume partial study information would not be presented to Investigator?
    MG>or if presented to Investigator...there would be footnote specifying for internal use by physician, CRF Operational Director
    MG>or another entity?
    > Best,
    > Cal
    MG>Many Thanks for "thinking this through"
    MG>Martin-
    >
    >
    > On Tue, Jan 7, 2014 at 5:47 PM, Brendan Yarmas wrote:
    > > Hi all,
    > > I'm trying to familiarize myself with the SDV function of openclinica as my
    > > company may be taking over responsibility for monitoring a study we're
    > > managing data for. One thing that's confusing me is when setting the SDV
    > > requirement for a CRF in an event "Partial Required" is an option. How does
    > > this differ from the 100% required, when the extent of what's captured by
    > > the SDV (that I can tell) is a check box, which by its nature seems either
    > > 100 or 0 %?
    > >
    > > Brendan Yarmas,
    > > System Manager
    > > First Stop CBPD Corporation
    > > Mobile: 301-917-7439
    > >
    > >
    > >
  • byarmas-fscbyarmas-fsc Posts: 40 ✭
    Thanks for the clarification Cal. Glad to see I wasn't missing some system function behind the different settings. I checked the user guide for some meaning for the predefined terms before I asked, I hope your update can spare some other users my confusion.
    Brendan Yarmas,
    System Manager
    First Stop CBPD Corporation
    Mobile: 301-917-7439
    -
  • GARDELIS DIONYSIOSGARDELIS DIONYSIOS Posts: 5
    Can anyone get me out of this loop please?
    I have no idea why I am included...
    Dionysis Gardelis
    -----Original Message-----
    On Behalf Of Brendan Yarmas
    Sent: Τετάρτη, 8 Ιανουαρίου 2014 23:06
    To: Cal Collins; [email protected]
    Subject: Re: [Users] SDV Requirement definitions
    Thanks for the clarification Cal. Glad to see I wasn't missing some system
    function behind the different settings. I checked the user guide for some
    meaning for the predefined terms before I asked, I hope your update can
    spare some other users my confusion.
    Brendan Yarmas,
    System Manager
    First Stop CBPD Corporation
    Mobile: 301-917-7439
    -
  • ASIF UDDINASIF UDDIN Posts: 9
    Yes I have
    *** This message has been sent using QMobile A8 ***
    GARDELIS DIONYSIOS wrote:
    Can anyone get me out of this loop please?
    I have no idea why I am included...
    Dionysis Gardelis
    -----Original Message-----
    On Behalf Of Brendan Yarmas
    Sent: Τετάρτη, 8 Ιανουαρίου 2014 23:06
    To: Cal Collins; [email protected]
    Subject: Re: [Users] SDV Requirement definitions
    Thanks for the clarification Cal. Glad to see I wasn't missing some system
    function behind the different settings. I checked the user guide for some
    meaning for the predefined terms before I asked, I hope your update can
    spare some other users my confusion.
    Brendan Yarmas,
    System Manager
    First Stop CBPD Corporation
    Mobile: 301-917-7439
    -
  • ASIF UDDINASIF UDDIN Posts: 9
    Dear Mr. Dionysis Guerrilla
    I have a idea for this if you don't mind share with you ?
    Shaikh,
    Manager health informatocs
    *** This message has been sent using QMobile A8 ***
    SHAIKH ASIF UDDIN wrote:
    Yes I have
    *** This message has been sent using QMobile A8 ***
    GARDELIS DIONYSIOS wrote:
    Can anyone get me out of this loop please?
    I have no idea why I am included...
    Dionysis Gardelis
    -----Original Message-----
    On Behalf Of Brendan Yarmas
    Sent: Τετάρτη, 8 Ιανουαρίου 2014 23:06
    To: Cal Collins; [email protected]
    Subject: Re: [Users] SDV Requirement definitions
    Thanks for the clarification Cal. Glad to see I wasn't missing some system
    function behind the different settings. I checked the user guide for some
    meaning for the predefined terms before I asked, I hope your update can
    spare some other users my confusion.
    Brendan Yarmas,
    System Manager
    First Stop CBPD Corporation
    Mobile: 301-917-7439
    -
This discussion has been closed.