Table of Contents
- Title and Copyright Information
- 1 General recommendations
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2
InForm integration
- After a LIVE deployment, do not remove forms or items from your InForm study
- After a LIVE deployment, do not modify form or item RefNames
- Re-load study data after each round of testing
- Keep the InForm data model in sync between the Development and QC lifecycles
- Do not promote standard libraries or templates to Production
- Run a full data model installation after an InForm UAT study reset
- 3 Clinical One integration
- 4 External data loads
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5
Clinical data models
- In DEV and QC, run a full data model installation only to revert destructive changes
- Install and promote data models after every change
- Check out the associated transformation when you update a target data model
- Limit data model size
- Check out a data model to remove or update its business areas
- Include a SUBJECTVISIT table
- Use SDTM Identifiers for as many columns as possible
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6
Transformations
- Use the Regenerate program definitions option to rebuild program definitions in a transformation
- Remove a source model from its transformations before deleting it
- Avoid using the Undo Checkout feature for transformations
- Use unique aliases
- Do not copy a transformation that needs an upgrade
- Wait to create staging tables
- 7 Custom listings
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8
Validation checks
- Make sure to select a relevant discrepant column
- Avoid renaming columns in VC listings
- Verify the validity of a validation check batch before you copy it
- Copy valid validation checks
- Copy blinded validation checks to blinded tables
- Do not remove a source table from a validation check
- Do not use staging tables as a source for validation checks
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9
Custom programs and functions
- Avoid using custom programs
- To create table descriptions for a custom program, copy existing table definitions in LSH
- Use cloning to create study-specific custom programs
- Include only columns for the Listing user interface in a custom program for a validation check
- Specify a static reference for secondary source code