2 InForm integration

After a LIVE deployment, do not remove forms or items from your InForm study

  • Recommendation: Do not remove forms or items after you deploy your InForm study to LIVE.

  • Rationale: When you remove a form or item after a LIVE deployment, the database column that corresponds to the removed form or item is removed from the reporting schema for the study. This causes destructive changes to the InForm data model in the DMW Production lifecycle.

  • Additional information: Instead of removing a form:

    • Add a global condition to the study, and include a triggering condition for the form that can't be met. As a result, the form is not triggered to appear for additional subjects.

      For example:

      this.<visitrefname>.<formrefname>.<sectionrefname>.<itemrefname>.Empty && 1==2
    • Make sure that the refpath that you use is for a valid item in the study so that the expression is properly validated and attached to the study design.

    Instead of removing an item:

    • Create an in-place study revision and configure the following properties for the item:

      • Display Override - Hidden

      • SDV Required - False

      • Required - False

After a LIVE deployment, do not modify form or item RefNames

  • Recommendation: Do not modify form or item RefNames.

  • Rationale: If you modify a study object's RefName, its column is removed from the reporting database schema, and a new column is created for the new RefName. This is a destructive change to the integrated InForm data model in DMW.

  • Additional information: Instead of modifying a form or item RefName in the study design, rename its corresponding column in the target data model in DMW.

Re-load study data after each round of testing

  • Recommendation: If you integrate InForm UAT or TRN studies with DMW in the Development or QC lifecycles, re-load study metadata after each round of testing to ensure that you are always using the latest study version.

  • Rationale: InForm UAT or TRN studies might contain columns that don't exist in the Production study, or column properties that differ substantially. If there is a mismatch between the metadata in DMW and the metadata in the study's database, DMW doesn't allow you to promote the study to the Production lifecycle.

  • Additional information: You can run the Meta Data Difference Report to determine if there are differences between the InForm Production database and the InForm data model in the DMW QC lifecycle.

Keep the InForm data model in sync between the Development and QC lifecycles

  • Recommendation: Refrain from promoting your InForm data model until you are ready to QC all data models and transformations. After you promote, make sure to continue promoting all changes so that the study in each lifecycle is consistent.

  • Rationale: It is important to keep the InForm study versions as consistent as possible between lifecycles. Interim changes that are not promoted to higher lifecycles can cause deprecated object references, which creates objects in invalid states in the InForm QC data model.

  • Additional information: If you add or remove forms during review rounds, each lifecycle that has a defined data model should see the different metadata versions in order to properly manage the changes in each lifecycle.

Do not promote standard libraries or templates to Production

  • Recommendation: Use standard libraries and templates in Development and QC lifecycles only.

  • Rationale: When you promote a study to the Production lifecycle, you can no longer make destructive changes to it. However, because standards are updated often, there is a reasonable expectation that you might want to make changes that aren't allowed in Production. Maintaining these libraries and templates in QC provides you with the freedom to make those significant changes.

  • Additional information: Standard libraries are not intended to collect Production data, so this recommendation should not limit the functionality of those studies.

Run a full data model installation after an InForm UAT study reset

  • Recommendation: If you perform an InForm UAT study reset, we recommend that you run a full installation for the InForm data model.

  • Rationale: An InForm UAT reset wipes out metadata and clinical data from the UAT study so that a new study design can be tested. In DMW, when you run a full installation, DMW drops and recreates all tables, and their data. As a result, you can make sure that objects and data that were removed in InForm are removed in DMW.

  • Additional information: Good InForm SDLC dictates that UAT should be a simulation of the Live InForm study configuration. In order to keep this accurate, you must reset the InForm study in between rounds of testing so that only Central Designer deployments that were deployed or will potentially be deployed to Production are present and installed in the UAT study. These InForm resets wipe all data from the InForm study between rounds of testing, and when you redeploy, new unique IDs are created for metadata columns like VISITID, FORMID, ITEMSETID, etc.

    In DMW, tables in the InForm data model and in the InForm operational views do not drop data that was deleted in InForm after the study reset. The only way to make sure DMW data accurately reflects the current state of the InForm study is to run a full install to load the latest metadata has been loaded. The correct procedure for this is as follows:

    1. Reset the InForm UAT study.

    2. Deploy packages from Central Designer to InForm.

    3. In DMW, reload metadata changes to the Development lifecycle.

    4. Run a Full Installation in the Development lifecycle.

    5. Import clinical data to the Development lifecycle.

    6. Promote the study to the QC lifecycle.

    7. Run a Full Installation in the QC lifecycle.

    8. Import clinical data to the Development lifecycle.

    Note that you only need to promote the changes to QC and perform that Full install if you have already promoted InForm to QC before the change. This recommendation also assumes that both DEV and QC lifecycles are integrated to the same InForm UAT study.