We hope you'll join us for our 4/23 webinar on using data tables to apply reference ranges and AE codes in OC4. For more information and to register, visit https://register.gotowebinar.com/register/2882170018956684555

anonymizing subjects

as a total rookie to both openclinica and prospective randomised controlled trials I am trying to figure out how and when to anonymize the database. Please forgive me if I the questions are too silly to answer.
To accomplish a 100%follow-up of the subjects enrolled I need their address, phone, name etc (which is protected information). Is it possible to anonymize patients while the trial is still running? And is it any good at all if I can get the patients' informed consent to keep such private information within the database?
If it's possible to anonymize during the trial, how do I de-identify the subjects? Can I do that in openclinica? Do I need an external application? Is the random subject ID generation enough for this purpose?
Is it possible to create a de-identification key which would be destroyed after successfully closing the trial and so provide for the database anonymization?
2. is there a "tool" within openclinica for randomisation of subjects into 2 study arms?
Thank you.
Dr.Green Horn
Department of Thoracic Surgery
Faculty Hospital
Bratislava
Slovakia

Comments

  • In a “regulated” trial the investigational sites would typically keep a paper enrolment log that relates the subject’s trial ID to their chart. You could use OpenClinica to generate the subject numbers and then write these in the log next to their identifiers, or you could manually number the entries in the log and then use these numbers in OpenClinica. Since the enrolment log is kept securely within the clinic this should satisfy privacy concerns. I believe there are electronic techniques for accomplishing the same thing and some of these have got past ethics, but I’m not certain how you can truly de-identify a subject and still have enough information for follow-up.

    Rick.
    Sent: April-30-08 1:52 PM
    To: [email protected]
    Subject: [Users] anonymizing subjects

    Dear users,
    as a total rookie to both openclinica and prospective randomised controlled trials I am trying to figure out how and when to anonymize the database. Please forgive me if I the questions are too silly to answer.
    To accomplish a 100%follow-up of the subjects enrolled I need their address, phone, name etc (which is protected information). Is it possible to anonymize patients while the trial is still running? And is it any good at all if I can get the patients' informed consent to keep such private information within the database?
    If it's possible to anonymize during the trial, how do I de-identify the subjects? Can I do that in openclinica? Do I need an external application? Is the random subject ID generation enough for this purpose?
    Is it possible to create a de-identification key which would be destroyed after successfully closing the trial and so provide for the database anonymization?
    2. is there a "tool" within openclinica for randomisation of subjects into 2 study arms?
    Thank you.
    Dr.Green Horn
    Department of Thoracic Surgery
    Faculty Hospital
    Bratislava
    Slovakia
    No virus found in this incoming message.
    Checked by AVG.
    Version: 7.5.524 / Virus Database: 269.23.6/1407 - Release Date: 30/04/2008 11:35 AM
    No virus found in this outgoing message.
    Checked by AVG.
    Version: 7.5.524 / Virus Database: 269.23.6/1407 - Release Date: 30/04/2008 11:35 AM
This discussion has been closed.