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A question about Data Manager Role

-----Original Message-----
From: "Michel Acosta"
To: [email protected]
Date: Mon, 02 Dec 2013 20:38:09 +0000
Subject: A question about Data Manager Role
Hi

I have a question about the Data Manager Role. In The Clinical Trial Process only the sponsor can choose the staff, in OpenClinica it can be done by Data Managers and by the Study Director. What can I do to avoid data managers to add users to system and to studies, keeping the ability of creating CRFs (they do carry out this task in the process).
If anybody think that the current way is correct, please explain me why. I´ll appreciate it. I´m responsible for providing a software for managing information obout clinical trials in my working center, I think OpenClinica is very very good but this point could be a disadvantage in case of a regulatory entity audit.
Thanks in advance.
Ing. Michel Acosta.

Comments

  • macostamacosta Posts: 2
    Hi

    I have a question about the Data Manager Role. In The Clinical Trial Process only the sponsor can choose the staff, in OpenClinica it can be done by Data Managers and by the Study Director. What can I do to avoid data managers to add users to system and to studies, keeping the ability of creating CRFs (they do carry out this task in the process).
    If anybody think that the current way is correct, please explain me why. I´ll appreciate it. I´m responsible for providing a software for managing information obout clinical trials in my working center, I think OpenClinica is very very good but this point could be a disadvantage in case of a regulatory entity audit.
    Thanks in advance.
    Ing. Michel Acosta.
  • haenselhaensel Posts: 602 ✭✭✭
    Hi Michel
    Only users with user type of "Business Administrator" or "Technical Administrator" should see the administration menu. Changing the user type for your data manager to "user" should remove the administration menu.
    Regards,
    Christian
    ------------------------------------------------------------------------
    Dipl.-Inf. Christian Hänsel

    IT / Software Developer
    Tel.: +49-(0)89-5526189-16
    Fax : +49-(0)89-5526189-55
    E-Mail: [email protected]
    ReliaTec GmbH
    Schleissheimer Str. 37
    85748 Garching Germany
    HRB 150060 / AG München
    Gf Thomas Herbig
    http://www.reliatec.de
    =========================================================================
    Am 02.12.2013 21:39, schrieb Michel Acosta:
    > -----Original Message-----
    >
    > From: "Michel Acosta"
    >
    > To: [email protected]
    >
    > Date: Mon, 02 Dec 2013 20:38:09 +0000
    >
    > Subject: A question about Data Manager Role
    >
    >
    >
    >
    > Hi
    >
    >
    >
    > I have a question about the Data Manager Role. In The Clinical Trial
    > Process only the sponsor can choose the staff, in OpenClinica it can be done
    >
    > by Data Managers and by the Study Director. What can I do to avoid data
    > managers to add users to system and to studies, keeping the ability of
    > creating CRFs (they do carry out this task in the process).
    >
    > If anybody think that the current way is correct, please explain me
    > why. I´ll appreciate it. I´m responsible for providing a software for
    > managing information obout clinical trials in my working center, I think
    > OpenClinica is very very good but this point could be a disadvantage in case
    >
    > of a regulatory entity audit.
    >
    > Thanks in advance.
    >
    > Ing. Michel Acosta.
    >
    >
    >
    >
This discussion has been closed.