Frequently Asked Questions:

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Problems logging into RDC:
  1. I am receiving error “ORA-01017: invalid username/password; access denied” and I know my username and password are correct.

    After trying to log in three times with an invalid password your account is automatically locked.  After this point you will receive the same error even if you enter your correct user credentials.  Call the Biogen Idec RDC Support Center to unlock your account. 

  2. When I log in to RDC I receive the error  "No Access to any RDC accessible Studies.  Contact your system administrator."

    This error indicates you have not yet received production access to the study you are trying to log into. Please contact the Biogen Idec RDC Support Center for assistance.

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Problems seeing study or patient numbers once I log in:
  1. When I log in I do not see the study I am currently working on.  How do I switch to the study I need to enter data for?

    You probably have access to several studies on the RDC server. You continue to have Browse access to the old study and may have Production access to the new study. In order to access the new study go to the activity list and click "Change study". If no other studies show up please contact the Biogen Idec RDC Support Centerfor assistance with gaining production access to the study in question.


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Problems approving CRFs:
  1. When I try to group approve my patients the option is grayed out.

    This usually happens if you have not received approval rights or you have selected "Show all data for Study ________" from the activity list. Go back to the activity list, select the site number that you would like to approve patients on, select "Show all data for Site _______" and the group approval option should be available. If it is still grayed out, contact the Biogen Idec RDC Support Center


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Password reset FAQ:
  1. Are there any rules to creating and updating my password?

    Your password must be at least 8 characters in length and can be as long as 30 characters. It must contain at least one alpha or numeric character and cannot start with a number.

    When changing your password, Oracle Clinical expects that the new password will have at least two characters that are different from the previous password.

    To keep it easy to remember, use your favorite password and add either two alpha or numeric characters to the end, these characters can be changed every 90 days for example

    Marley11-> Marley22->Marley33 etc.
    070409aa->070409bb

    A password cannot be reused for a period of one year from the date it was taken out of service (i.e., changed to a new password).


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RDC Onsite Discrepancy Configuration Changes effective 1st Feb 2014:
  1. All RDC Site Users can see, and action, discrepancies on Subjects, CRFs and data fields that contain unresolved discrepancies, whether requiring an action by the Site User or not. This configuration change of RDC Onsite 4.6 will hide discrepancies not directed to Site Users. This will not impact any other role (CRA, Data Manager, Read Only or Principal Investigator).;

  2. To maintain data integrity throughout the course of a clinical trial, participating sites should maintain ownership and responsibility for their trial data. Best practices at Biogen Idec should ensure that Biogen Idec, through the CRA, does not adversely influence the recording of the data. Currently, all RDC CRA Users can see, and action, discrepancies on Subjects, CRFs and data fields that contain unresolved discrepancies, whether these queries require an action by the Site User or not. This configuration change of RDC Onsite 4.6 will not allow RDC CRA Users action discrepancies directed to other RDC Users. This will not impact any other role (Site User, Data Manager, Read Only or Principal Investigator).

    Read more...

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