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The design for study has different arms

Dear All,

I just wonder if you could help.

Now I have a slightly complex study, which has three arms, the first two are similar, but has different procedures during the treatment, hence their CRFs will be slightly different, and the third arm will have total different treatment, which means it will have totally different CRFs. How could I do this in OpenClinica?

I was thinking using sites for different arms, as I could handle different CRFs for different sites, but I have not figured out how to hide the event from each site yet.

Do you have any suggestions?

Many thanks

Bin
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Comments

  • liu09liu09 Posts: 51
    Or I need to use one of the function i.e. Arm in the group subject, but how to use it, it would be great somebody could show how to use it. I check the manuals, but could not find it.

    Thanks

    Bin
  • toskriptoskrip Posts: 271 ✭✭✭
    Hi,

    subject group will not help you too much, because this variable cannot be use in any conditional logic (actually it behaves a little strange because as far as I know subject group is also not included in data exports - but this may be a bug). Also I think you cannot hide an event. To my knowledge there are only three possible options:

    - having common CRFs and arm specific CRFs in study events (data entry needs to choose which CRFs are relevant to fill out - unless you hide them within arm specific sites)

    - having common CRFs with arm specific versions (data entry need to choose a proper version of CRF before starting data entry - I did it once and I cannot recommend this as it is very user error prone) (unless you make them as default within arm specific sites)

    - having a common CRFs and having arm as one item in a CRF so you can create conditional logic that will depend on the value of the arm)

    It is hard to say which one is the best approach. Actually I like your idea to have separate sites per arm, because this will give you a good flexibility for specifying which CRFs and which CRF versions should be allowed for specific site.

    best

    T
  • liu09liu09 Posts: 51
    Hi Thomas,

    Many thanks for your input, any thoughts and suggestions are greatly received.

    Bin
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