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Locking by Record or Field

Having worked with two companies that have used OpenClinica Enterprise the most consistent user complaint I have received involves limited data locking capabilities. Currently you can only lock by visit. The problem that this creates is that this allows modification of the data in of the CRFs that are part of the visit. A visit can contain multiple forms each containing numerous records. It would be a great improvement if data could be locked by table record. For example, if each subject's adverse event record could be locked, a monitor could verify each adverse event data at various times in the study as opposed to saving this task for the end. A study that goes on for years could have subjects with over 100 adverse events. This would also prevent erroneous data modification. I think locking by record is a modest request since other EDC systems can lock by individual data fields.

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Comments

  • haenselhaensel Posts: 602 ✭✭✭
    Hi brandsxb

    This is a nice topic for a poll. Would be interessting what others think about this feature (especially if they are willing to check every single row or field). Another option could be to hightlight the changes since the last validation.

    Regards,
    Christian
  • brandsxbbrandsxb Posts: 25
    In my original post in regards to monitoring "lock" may be the wrong word. If source data verification could be tracked by field or record that would be an improvement. Currently if one data field is changed after a monitor verifies the visit data the monitor has to find what in the visit was changed. I know you can download the audit trail to excel and search by date and time but this takes time and monitors don't want to do this.
  • haenselhaensel Posts: 602 ✭✭✭
    edited November 2014
    Therefore I would recommend to hightlight the changes (means highlight the unvalidated fields). This will require the state "partially verified".

    Regards,
    Christian
  • lindsay.stevenslindsay.stevens Posts: 404 ✭✭✭
    I'll take this opportunity to remind people that OpenClinica has a jira instance [1], which is good way to communicate feature requests and issues. You should be able to log in with your forum account credentials.

    It is possible to:
    - vote in support of resolving an existing ticket
    - comment on an existing ticket
    - reopen a an existing ticket
    - make a new ticket

    A few long-standing. nice-to-have, seemingly simple but probably a bit complicated features like more granular locking had their tickets closed in the recent cull. For example, these were opened in Jun-2012:

    - OC-1200: Allow lock of individual event CRF [2]
    - OC-1201: Allow lock of individual event CRF items [3]

    Also, from Jun-2014:

    - OC-5759: Ability to sign CRFs after changing the study status to Frozen [4]
    - OC-5760: Ability to freeze/ lock at the subject level, study event and form level [5]

    There is an issue system on github [6], but it seems like jira is the main spot for issues still.

    Lastly, seeing as it's open source and OpenClinica are accepting pull requests, it is possible to write this feature yourself and get it added.

  • haenselhaensel Posts: 602 ✭✭✭
    Hi Lindsay

    Thank's for pointing this out (so detailed). Discussing a feature in the community before making it a feature request might help to reduce JIRA polution (and checking if a similar request already exist). I personally find it very hard to keep on track with the endless tickets.

    Regards,
    Christian
  • lindsay.stevenslindsay.stevens Posts: 404 ✭✭✭
    via Email
    I'll take this opportunity to remind people that OpenClinica has a jira
    instance [1], which is good way to communicate feature requests and issues.
    You should be able to log in with your forum account credentials.

    It is possible to:
    - vote in support of resolving an existing ticket
    - comment on an existing ticket
    - reopen a an existing ticket
    - make a new ticket

    A few long-standing. nice-to-have, seemingly simple but probably a bit
    complicated features like more granular locking had their tickets closed in
    the recent cull. For example, these were opened in Jun-2012:

    - OC-1200: Allow lock of individual event CRF [2]
    - OC-1201: Allow lock of individual event CRF items [3]

    Also, from Jun-2014:

    - OC-5759: Ability to sign CRFs after changing the study status to Frozen
    [4]
    - OC-5760: Ability to freeze/ lock at the subject level, study event and
    form level [5]

    There is an issue system on github [6], but it seems like jira is the main
    spot for issues still.

    Lastly, seeing as it's open source and OpenClinica are accepting pull
    requests, it is possible to write this feature yourself and get it added.

    [1] https://jira.openclinica.com/
    [2] https://jira.openclinica.com/browse/OC-1200
    [3] https://jira.openclinica.com/browse/OC-1201
    [4] https://jira.openclinica.com/browse/OC-5759
    [5] https://jira.openclinica.com/browse/OC-5760
    [6] https://github.com/OpenClinica/OpenClinica
  • gpinkhamgpinkham Posts: 37
    as a note.. you could use the note/discrepancy listing page.. filter it by the subjects you monitored and the date since monitoring. and set the type to "reason for change".. that would provide any CRF that has changed since monitoring.. of course you need to keep track of the list of subjects and when since I don't think that is available in OC.. Maybe if OC provided the date of SDV on the notes/discrepancy table that might help... (for the record.. I haven't used OC yet. investigating it now.. so YMMV)..
This discussion has been closed.