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RE: Open Clinica questions

From: Gabriela Prokůpková [mailto:[email protected]]
Sent: Wednesday, November 21, 2007 10:38 AM
To: Yufang Wang; [email protected]
Cc: Jeff Halperin; Baranníková; Petr Bartík; [email protected]; Jan Červený; Lahovský
Subject: Open Clinica questions
Dear Yufang!
I would like to ask you for answers to some questions regarding Open Clinica.

1) Double Data Entry philosophy – we tested this possibility however could you confirm me the procedure?: the investigator enters data, than other person or the same person who entered the initial data will check the accuracy and completeness of this data according to source data for the second time– if it is OK this person will check “Mark complete” item on e-CRF. Is our assumption right?
2) Possibility to monitor data entered. In other e-CRF systems there is a module for “Data Monitoring”. The person who performs monitoring (monitor) is able only “check” data according to source documentation, he/she is not allowed to correct anything, he/she can enter comments or discrepancy notes. After data monitoring the icon “M” will appear in the respective item. We have not found yet the way how to manage such as monitoring in Open Clinica.

Would so kind and try to answer the above questions?

Many thanks!

Best regards

Gabriela and our data management team


Ing. Gabriela Prokupkova, Ph.D.
Clinical Research Associate
---------------------------------------
A-Pharma s.r.o.
K Ohrade 528/2
155 00 Prague 5
Phone:+420-251 081 244 - personal
+420-251 081 230 - office
Mobil: +420-739 432 805
Fax: +420-251 081 247
E-mail: [email protected]
http: www.a-pharma.cz

Comments

  • Hello, Gabriela -

    1. Double data entry requires the same data to be entered twice, in order to make sure that the data entry people are transcribing the paper CRFs correctly. The double data entry option must be selected in the event definition, and then the data must be entered twice.

    If the user for the second data entry is the same as the user for the first data entry, then the second entry must be 12 hours after the first entry. If they are different users, the system allows the second data entry immediately. If the second entry does not match, the system will alert the second user to the difference between the entries. Both users must mark the CRF as complete.

    2. OpenClinica 2.0.1 and 2.2 do not have a special monitor role to allow entry of data only in discrepancy notes and block data entry in the CRF fields themselves. Currently, users handle this with SOPs to restrict monitors to data entry only in discrepancy notes.

    I hope this helps. Please let us know if we can provide more information.

    Best Regards,

    - Jeff
    From: Gabriela Prokůpková [mailto:[email protected]]
    Sent: Wednesday, November 21, 2007 10:38 AM
    To: Yufang Wang; [email protected]
    Cc: Jeff Halperin; Baranníková; Petr Bartík; [email protected]; Jan Červený; Lahovský
    Subject: Open Clinica questions
    Dear Yufang!
    I would like to ask you for answers to some questions regarding Open Clinica.

    1) Double Data Entry philosophy – we tested this possibility however could you confirm me the procedure?: the investigator enters data, than other person or the same person who entered the initial data will check the accuracy and completeness of this data according to source data for the second time– if it is OK this person will check “Mark complete” item on e-CRF. Is our assumption right?
    2) Possibility to monitor data entered. In other e-CRF systems there is a module for “Data Monitoring”. The person who performs monitoring (monitor) is able only “check” data according to source documentation, he/she is not allowed to correct anything, he/she can enter comments or discrepancy notes. After data monitoring the icon “M” will appear in the respective item. We have not found yet the way how to manage such as monitoring in Open Clinica.

    Would so kind and try to answer the above questions?

    Many thanks!

    Best regards

    Gabriela and our data management team


    Ing. Gabriela Prokupkova, Ph.D.
    Clinical Research Associate
    ---------------------------------------
    A-Pharma s.r.o.
    K Ohrade 528/2
    155 00 Prague 5
    Phone:+420-251 081 244 - personal
    +420-251 081 230 - office
    Mobil: +420-739 432 805
    Fax: +420-251 081 247
    E-mail: [email protected]
    http: www.a-pharma.cz
This discussion has been closed.