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OpenClinica - Investigator - Study Event Sign-off issue

Dear Cal and All
Greetings - We are trying to get the investigator to sign-off an Study event – the event in this example is a Adverse Event CRF eg. subject 1021 which has a status of ‘Completed’ and we are logged on with ‘Study Director’ role.

Here is our process to Sign-off event:

1. Click on Subject 1021 Completed Adverse Event icon



2. Select ‘Edit’ icon


3. Click on ‘Edit’ to get:



If click ‘Status’ dropdown list – the ‘Signed’ is not available


The dropdown listbox does not show ‘Signed’ option.

Any ideas why the dropdown listbox does not show ‘Signed’ option

Also, there are no outstanding queries for this Adverse Event CRF.

Many thanks in advance for any assistance with this issue – much appreciated.

Kind Regards
Mervyn

mervynw3

"...If its not documented, it didn't happen... if its not signed, nobody did it..."

Comments

  • mervtynw28mervtynw28 Posts: 18
    Hi Cal and Folks
    I just found out why the ‘Signed’ was not appearing – it was because the role I assigned to the investigator user was wrong. I erroneously assigned ‘Study Director’ role to the investigator user thinking Study Director was the principal investigator. When I changed his role to ‘Data Specialist’ (which is equivalent to Site role of Investigator as I found out from documentation)– the ‘Signed’ option appeared in Status dropdown listbox

    Mystery resolved!

    Many thanks
    Kind Regards
    Mervyn
    Mervyn Wong | M.Sc.(Hons); PGDipCom.
    Information Systems Manager

    Working days: Mon-Tue

    "...If its not documented, it didn't happen... if its not signed, nobody did it..."


    From: Mervyn Wong
    Sent: Monday, 24 February 2014 1:20 p.m.
    To: [email protected]
    Cc: Mervyn Wong; Caroline Alsweiler
    Subject: OpenClinica - Investigator - Study Event Sign-off issue

    Dear Cal and All
    Greetings - We are trying to get the investigator to sign-off an Study event – the event in this example is a Adverse Event CRF eg. subject 1021 which has a status of ‘Completed’ and we are logged on with ‘Study Director’ role.

    Here is our process to Sign-off event:

    1. Click on Subject 1021 Completed Adverse Event icon



    2. Select ‘Edit’ icon


    3. Click on ‘Edit’ to get:



    If click ‘Status’ dropdown list – the ‘Signed’ is not available


    The dropdown listbox does not show ‘Signed’ option.

    Any ideas why the dropdown listbox does not show ‘Signed’ option

    Also, there are no outstanding queries for this Adverse Event CRF.

    Many thanks in advance for any assistance with this issue – much appreciated.

    Kind Regards
    Mervyn

    mervynw3

    "...If its not documented, it didn't happen... if its not signed, nobody did it..."
  • lindsay.stevenslindsay.stevens Posts: 404 ✭✭✭
    Could you try using an account with site investigator privileges?
    Best regards,
    Lindsay
    On Feb 24, 2014 11:23 AM, "Mervyn Wong" wrote:
    Dear Cal and All
    Greetings - We are trying to get the investigator to sign-off an Study event – the event in this example is a Adverse Event CRF eg. subject 1021 which has a status of ‘Completed’ and we are logged on with ‘Study Director’ role.

    Here is our process to Sign-off event:

    1. Click on Subject 1021 Completed Adverse Event icon



    2. Select ‘Edit’ icon


    3. Click on ‘Edit’ to get:



    If click ‘Status’ dropdown list – the ‘Signed’ is not available


    The dropdown listbox does not show ‘Signed’ option.

    Any ideas why the dropdown listbox does not show ‘Signed’ option

    Also, there are no outstanding queries for this Adverse Event CRF.

    Many thanks in advance for any assistance with this issue – much appreciated.

    Kind Regards
    Mervyn

    mervynw3

    "...If its not documented, it didn't happen... if its not signed, nobody did it..."
  • ccollinsccollins Posts: 378 admin
    Hi Mervyn,
    Yes that's correct. The privileges associated with different user roles are described here:
    https://docs.openclinica.com/3.1/manage-users/user-matrix
    Cal
    On Sun, Feb 23, 2014 at 8:13 PM, Mervyn Wong wrote:
    Hi Cal and Folks
    I just found out why the ‘Signed’ was not appearing – it was because the role I assigned to the investigator user was wrong. I erroneously assigned ‘Study Director’ role to the investigator user thinking Study Director was the principal investigator. When I changed his role to ‘Data Specialist’ (which is equivalent to Site role of Investigator as I found out from documentation)– the ‘Signed’ option appeared in Status dropdown listbox

    Mystery resolved!

    Many thanks
    Kind Regards
    Mervyn
    Mervyn Wong | M.Sc.(Hons); PGDipCom.
    Information Systems Manager

    Working days: Mon-Tue

    "...If its not documented, it didn't happen... if its not signed, nobody did it..."


    From: Mervyn Wong
    Sent: Monday, 24 February 2014 1:20 p.m.
    To: [email protected]
    Cc: Mervyn Wong; Caroline Alsweiler
    Subject: OpenClinica - Investigator - Study Event Sign-off issue

    Dear Cal and All
    Greetings - We are trying to get the investigator to sign-off an Study event – the event in this example is a Adverse Event CRF eg. subject 1021 which has a status of ‘Completed’ and we are logged on with ‘Study Director’ role.

    Here is our process to Sign-off event:

    1. Click on Subject 1021 Completed Adverse Event icon



    2. Select ‘Edit’ icon


    3. Click on ‘Edit’ to get:



    If click ‘Status’ dropdown list – the ‘Signed’ is not available


    The dropdown listbox does not show ‘Signed’ option.

    Any ideas why the dropdown listbox does not show ‘Signed’ option

    Also, there are no outstanding queries for this Adverse Event CRF.

    Many thanks in advance for any assistance with this issue – much appreciated.

    Kind Regards
    Mervyn

    mervynw3

    "...If its not documented, it didn't happen... if its not signed, nobody did it..."
  • mervtynw28mervtynw28 Posts: 18
    Hi Caroline
    Many thanks - I'll need it - haven't done any formal study for a while - Real estate is very verbose compared to the technical stuff I have previously studied - but still quite interesting - never too late to learn something new - just hope my ankle holds up :o)
    Cheers
    Mervyn
    Sent from my iPhone
    On 25/02/2014, at 9:44 am, "Caroline Alsweiler" wrote:
    > Great work thanks Mervyn! Good luck for your exam on Friday J
    >
    >
    >
    > From: Mervyn Wong
    > Sent: Monday, 24 February 2014 2:13 p.m.
    > To: [email protected]
    > Cc: Caroline Alsweiler; Mervyn Wong
    > Subject: RE: OpenClinica - Investigator - Study Event Sign-off issue
    >
    >
    >
    > Hi Cal and Folks
    >
    > I just found out why the ‘Signed’ was not appearing – it was because the role I assigned to the investigator user was wrong. I erroneously assigned ‘Study Director’ role to the investigator user thinking Study Director was the principal investigator. When I changed his role to ‘Data Specialist’ (which is equivalent to Site role of Investigator as I found out from documentation)– the ‘Signed’ option appeared in Status dropdown listbox
    >
    >
    >
    > Mystery resolved!
    >
    >
    >
    > Many thanks
    >
    > Kind Regards
    >
    > Mervyn
    >
    > Mervyn Wong | M.Sc.(Hons); PGDipCom.
    >
    > Information Systems Manager
    >
    >
    >
    > Working days: Mon-Tue
    >
    >
    >
    > "...If its not documented, it didn't happen... if its not signed, nobody did it..."
    >
    >
    >
    >
    >
    > From: Mervyn Wong
    > Sent: Monday, 24 February 2014 1:20 p.m.
    > To: [email protected]
    > Cc: Mervyn Wong; Caroline Alsweiler
    > Subject: OpenClinica - Investigator - Study Event Sign-off issue
    >
    >
    >
    > Dear Cal and All
    >
    > Greetings - We are trying to get the investigator to sign-off an Study event – the event in this example is a Adverse Event CRF eg. subject 1021 which has a status of ‘Completed’ and we are logged on with ‘Study Director’ role.
    >
    >
    >
    > Here is our process to Sign-off event:
    >
    >
    >
    > 1. Click on Subject 1021 Completed Adverse Event icon
    >
    >
    >
    >
    >
    >
    >
    >
    >
    > 2. Select ‘Edit’ icon
    >
    >
    >
    >
    >
    >
    >
    > 3. Click on ‘Edit’ to get:
    >
    >
    >
    >
    >
    >
    >
    >
    >
    > If click ‘Status’ dropdown list – the ‘Signed’ is not available
    >
    >
    >
    >
    >
    >
    >
    > The dropdown listbox does not show ‘Signed’ option.
    >
    >
    >
    > Any ideas why the dropdown listbox does not show ‘Signed’ option
    >
    >
    >
    > Also, there are no outstanding queries for this Adverse Event CRF.
    >
    >
    >
    > Many thanks in advance for any assistance with this issue – much appreciated.
    >
    >
    >
    > Kind Regards
    >
    > Mervyn
    >
    >
    >
    >
    >
    >
    >
    > "...If its not documented, it didn't happen... if its not signed, nobody did it..."
    >
    >
This discussion has been closed.