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

How do you track DM review in this database?

This is the first database I've experienced that does not offer tracking of DM review.  There is a check for SDV for the monitors but what about us DMs, upon our review we cannot check off that our review is complete - making life completely miserable!  What if sites change data and monitor quickly SDVs again - how would I know??!  Don't say audit trail - OCs audit trail is ridiculously long and sorting through it to be sure no single data point in an entire subject casebook is just counterproductive!

How do you keep track of DM review when using OC as your EDC system??
«13

Comments

  • kristiakkristiak Posts: 1,337 ✭✭✭
    via Email
    Click on flag next to each variable and you will find it!

    /Krister
  • eemshwileemshwil Posts: 10
    Clicking a flag next to each variable only shows me the audit trail - not if I've DM reviewed it.  Maybe I'm confused?
  • kristiakkristiak Posts: 1,337 ✭✭✭
    via Email
    No, that is not the audit trail. You can read more about it here: https://docs.openclinica.com/3.1/openclinica-user-guide/monitor-and-manage-data/notes-and-discrepancies#content-title-4409

    You can find additional tips and tricks here https://community.openclinica.com/extensions and at http://www.trialdatasolutions.com/tds/

    The most important will be your own SOP's and before you lock the database you have to have a SOP for running a final check query. You can find more about queries etc above. In the Enterprise edition you have additional tools available to you.

    Regards

    Krister
  • eemshwileemshwil Posts: 10
    I'm not sure you understand my question, Krister.  Clicking on the flag shows me the audit trail for that particular data field as well as opens a new and/or shows past query/annotation, etc.  While yes, a DM may do this during a review of data - this does not MARK the data as DM reviewed as the SDV feature does for a monitor.  When you go into OC to  DM review subjects, how do you remember which data points you've already reviewed or eCRF or even subject?  There's no feature in OC to mark this accordingly.  So I'm wondering if people keep track of their DM review via a separate excel spreadsheet, etc?  In other EDC systems, there is a checkbox for fields and/or entire eCRFs to mark as DM reviewed just as there is to mark as SDV'd by a monitor - OC does not have this and it's very inconvenient and makes review all the more difficult - as do the 300+ page pdf subject casebooks but that's an entirely different can of worms to open . . . 
  • juan.debonisjuan.debonis Posts: 36
    via Email
    Hi,

    for my experience using OC 3.1.2 I did not find any such feature,
    but never searched for anything similar.

    In our standard procedure we:

    1. convert the ODM database to csv (using xquery)
    2. perform comparison of tables using software that can link by key
    variables (beyond compare if you ask)

    This avoid us to check variable by variable and give us a picture
    of changes and decide wich subjects/forms to check/query again.

    Hope this comment helps.

    Regards, Juan.

    Juan De Bonis
    *3Eff S.A.*

    El 04/06/2015 a las 11:19, eemshwil escibió:
  • eemshwileemshwil Posts: 10
    Juan - thanks so much for your info, I appreciate you sharing what method you use in place of just the ability to mark as DM reviewed.  I think we'll end up doing something similar.  

    I'm just so surprised OC hasn't realized this is a crucial part of clinical data handling and its desperate need in their program!
  • kristiakkristiak Posts: 1,337 ✭✭✭
    via Email
    In our group we run our automatic query sets at regular intervals on all the data until it does not give us any output. Then we lock the database and no more changes can be made. Since we are dealing with thousands of patients a system that you seem to want is unpractical and too manpower intensive. If you need an integrated system you should go for the Enterprise version of OpenClinica.
  • eemshwileemshwil Posts: 10
    So Kristiak - do you only clean data at the very end of the study, before lock?

    And we do have the Enterprise version of OC - I'm not sure I understand what difference this makes in my request for marking of DM reviewed options within the system.  Does Enterprise offer this feature and I'm just not seeing it - our system admin/programmer assures us that there is no such option in OC??
  • kristiakkristiak Posts: 1,337 ✭✭✭
    via Email
    No, it is a continuous process as new patients enter the study and others complete the study and our automatic TDR (Trial Data Review) system checks the data continuously and we never have to mark any variables as reviewed, that is an completely obsolete method that we abandoned 15 years ago. We have a set of standard queries that we use in all studies and in addition for each new project we create a specific query set for the particular protocol.. The query sets have been developed together with investigators, statisticians and data managers and are very effective. They are based on my many years with Merck & Co Inc. I my largest project so far we had more than 21 billion data points.

    Best regards

    Krister
  • eemshwileemshwil Posts: 10
    Krister - yep, have worked with major pharma as well but used medidata rave which keeps track of DM review. So just tell me how you keep track in OC of what you've DM reviewed. Let's say you reviewed a totally SDVd subject at any point in time, the site went back and changed data, the CRA monitored and SDVd again immediately - how do you know that data has changed from your first DM review (outside looking at a ridiculously long audit trail)?? Do you do any manual review or do you completely rely on the system to issue queries?
This discussion has been closed.