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Issue with Source Data Verification (SDV)


I don't know if this question has already been discussed, if yes please indicate me where i may find the discussion!

As I started using Open Clinica, I have been very upset by the fact, that there is no "SDV" button(s) on the pages.
This is a big issue I think...
It forces us to use other tools in order to record our SDV activity: this makes the work double and increases the possible sources of mistake...

I think one of the biggest target for Open Clinica are the Investigator Initiated Trials (IITs), and these trials often have very complicated, specific and reduced SDV plans (e.g.: every 10th patient has to be 100% SDVed, then only certain pages and certains values have to be SDVed for the other patients).
In this case, not being able to record precisely what has been SDVed or not, is a massive problem for the management of the study and potentially an important source of time loss and/or mistakes.

My recommendations:
- MUST HAVE: an SDV tickbox for each and every element on the page
- MUST HAVE: a button to tick every tickbox on the page at once if needed
- MUST HAVE: tickboxes and button only accessible for Monitors (CRAs) and Project Managers (CPMs), visible for Data Management (DM) but not for site staff.
- NICE TO HAVE: a "monitoring comment field" on each page, only accessible to CRAs and CPMs, visible for DM but not for site Staff.
- NICE TO HAVE: being able to search SDVed elements/pages the same way as the queries can be searched

I hope this feedback will help improving the EDC!

Kind regards,


  • kristiakkristiak Posts: 1,340 ✭✭✭
    Sure there is a SDV function in OC. You will find under Tasks, Monitor and Manage Data. Our monitors like it very much!
  • FoxtrotAlphaFoxtrotAlpha Posts: 5

    yes I had already seen this, and I am sorry to tell you:
    this is not a proper SDV recording method.

    Also, in my access, there is a weird mix of "whole event" and/or "whole patient" SDV, and I cannot see on which criteria it has been differentiated.
    But this might also be, that the Data Management for the study I am working on messed up with the settings.

    But still:
    if you are not able to SDV a page from within the page, this is a source for huge time loss and a source for mistakes.
    I do not intend to sound mean or unfair, I know the community must have invested countless hours in this project, but this is a big quality issue... :/

    I think a "whole event" SDV is suitable for very simple studies, typically Phase 1 with very little elements for each visit.

    But in all other studies, and especially for the case of IITs as I mentioned earlier, this is not suitable at all: SDV is sometime a looong shot, made of a lot of little steps that need to be documented in "real time".

    For the study I am working on, it has been decided to print the eCRF and record our SDV activity on the printed form, then record it as accurate as possible in the report so that there is a trace somewhere of it...

    Here are some of the problems we have to face:
    - This is a non-clouded and non-cooperative method: only one person may work on it at a time and if this person loses the file/paper, then it is lost forever and for everyone
    - Changes in the eCRF render the old printed version useless or at least difficult to follow.
    - taking over the work from somebody else is a nightmare and a source of mistake

    But the worst is: this is the best solution we could come up with...
    The SDV cannot be recorded in the EDC before the very end of the SDV... which is delayed because of how it is built.

    The lack of a solid and reliable SDV system implemented on each page, similarly to the "query flags" if you want, is in my eye a major problem and one of the reasons why I decided to join the forum and try to help develop.

    Please do not discard my comment as "accessory", and please do not think of it as an attack on the team: I really wish to provide constructive criticism and help improve.
    That's why I wrote the two huge pieces here :D

  • kristiakkristiak Posts: 1,340 ✭✭✭
    via Email
    Hi Florian,

    Try to logon as a monitor and you will get access to the full functionality


  • FoxtrotAlphaFoxtrotAlpha Posts: 5
    You are not reading my comments I think, and you are discarding me as a troll obviously.

    I made a very detailed account of a basic eCRF feature that is missing in this EDC: SDV recording on each and every page and/or field.

    Igf I may be so bold: SDV on each and every page/field is not a decoration, this is something that should have been implemented from the very beginning on.

    As long as this is missing, there is a problem.

    Please answer to me with arguments and counter-arguments, not with general statements implying that I am not skilled enough to operate the EDC.

    I am trying to be constructive, if this is not appreciated and/or wanted, please kick me out of this forum.

  • kristiakkristiak Posts: 1,340 ✭✭✭
    We have successfully worked with the OpenClinica feuters since 2007 and our monitors are very hapy with the way it is functioning. We developed the first RDE system in 1988 and used a similar approach.

    You should try OC 4.0 where it is functioning slightly different.


    EDC Scandinavia AB
  • FoxtrotAlphaFoxtrotAlpha Posts: 5
    Dear Krister,

    thank you for answering my question partially: so there may be several versions being used?

    Please allow me to address a limitation here:
    I am a CRA, which means, a trial and the EDC are set-up by a sponsor and the Data Management, I get an unique access and I have absolutely no choice of what I am using.
    If an update is made, it should be made available for everyone.

    I do not doubt that many Monitors are very happy with your system, but I do doubt that all the unhappy monitor contact you and provide feedback.
    I know several of them, and they are not interested in communicating with your team.

    If this EDC had not been an Open Source Project, I would not have cared at all and I would have put it in the category "not suitable/not good enough for big studies" and I would have recommended my clients not to use it.
    And I would not be answering once again a one-liner from you with a detailed argumentation.
    I am a freelancer, I usually invoice the time I spend on work related topics.
    Here I gladly don't, my friends from the Free Software Foundation know why and know my interest in this area.

    I had to laugh while reading your comment, because 1988 is actually the year of my birth, which is now 3 decades ago: internet was not even spread at that time, how is it an argument to justify the way a modern EDC should work?

    Your credentials are impressive, I'll give you that!
    But, I am an (end-)user giving you a feedback: developping a tool for users, as you most certainly know better than I do, is not about how you think the tool works, it's about how the users are able to use the tool.

    And if the screwdriver is awesome, but only screws screws with the rarest heads, it is not a suitable screwdriver for everyday use.

    If you do not want to hear the users, or a constructive criticism, I do not know why this forum exists.

    In the hope a discussion will truly start,
  • kristiakkristiak Posts: 1,340 ✭✭✭
    via Email
    Dear Florian,

    You must have misunderstood me. I have nothing to do with OpenClinica and I have experience from most EDC systems on the market today. At the same time I'm proud to have been involved in the development of one of the first RDE (Remote Data Entry) system in the world at Merck & Co Inc. We developed this together with Digital Equipment Inc and it was running on a version of Unix. It was developed for the landmark 4S study. It replaced a complex IBM paper based system at Merck and saved the company a fortune.

    When OpenClinica became available in 2006 we started to use this system at e-Source Technology, as at that time the only system with all the features we asked for and it was free for use. It is still the far best free system to use and that is the reason we use it for mainly investigator based studies where the grants are limited. You cannot get everything for free and we have used it successfully for over ten years.

    If you want something much more sophisticated I would take a look at OpenClinica 4. In this system you will have everything you can ever dream of including EPRO where you with a click can make a CRF available for patient data entry plus all the other function you would need.


    EDC Scandinavia AB
  • FoxtrotAlphaFoxtrotAlpha Posts: 5
    Nice hearing from your experience.

    I was trying to help solve a problem here, and also tried to help showing the world that "free things" do not have to be "bad things".

    Glad you are a satisfied customer.
    Can someone from the programmer team answer now?
  • kristiakkristiak Posts: 1,340 ✭✭✭
    The SDV function is designed to work for the monitor role. Make sure your role is set to MONITOR.
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