Table of Contents
- Title and Copyright Information
- Preface
- 1 Study configuration basics
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2
Set up clinical data models
- Create a file input clinical data model
- Create a clinical data model for InForm data
- Create a clinical data model for Clinical One data
- Create a target clinical data model for transformed data
- Add tables
- Add columns to a table manually
- Add constraints to tables
- Set up Unit of Work data processing for tables
- Configure table display on the Listings page
- Set up data blinding in tables
- Add Subject Visit and Subject tables
- Map columns to data to be derived from TMS
- Extract data from a clinical data model
- Generate text metadata (.mdd) files from a data model
- Modify a clinical data model
- Install a clinical data model
- Unblind and reblind data
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FAQs
- What happens the first time I run the Load Metadata job?
- What happens if there's a protocol change?
- How do InForm and DMW exchange data?
- When I copy a table, sometimes validation checks and custom listings are included in the copy and sometimes not included. Why?
- Can I use Oracle Thesaurus Management System in all three lifecycle stages?
- If I create a new version of a clinical data model in the Development lifecycle, can I revert to the previous Production version?
- Is it possible to get back data that has been deleted?
- Why am I getting error "ORA-00955: name is already used by an existing object"?
- 3 Create libraries of codelists and clinical data models
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4
Set up data transformations
- Map at the clinical data model level
- Use side transformations
- Map at the table level
- Map at the column level
- Cascade blinding and masking
- Table transformation types
- Use a custom program
- Install a transformation
- Upgrade transformations to synchronize with models
- Run transformations and view history
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FAQs
- Why can't I check out my transformation?
- Why can't I merge my side transformation?
- Why does it say Upgrade Required when I know the data model hasn't changed?
- I noticed the tables in the target model changed. Why?
- What happens when I mark tables and columns as Not Used?
- Can I display mappings in a spreadsheet?
- How does Automap work?
- Where are custom programs stored?
- Can I use a side model like any other model?
- Why doesn't a data load automatically trigger this transformation?
- Why can't I trigger other transformations when I run this one?
- What does this transformation validation error message mean?
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5
Manage validation checks
- Create a validation check batch
- Create a validation check
- Complete a validation check without a custom program
- Complete a validation check using a custom program
- Copy a validation check batch
- Copy a validation check
- Disable or enable a validation check
- Reorder validation checks within an ordered batch
- Install a validation check batch
- Secondary columns
- Submit a validation check batch
- View discrepancies created by a validation check
- Upgrade validation checks to synchronize with models
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FAQs
- Why can't I install my validation check batch?
- Why are some validation checks disabled?
- Do I have to check out the batch to disable a validation check?
- How do I close the discrepancies that were created by a validation check I disabled?
- Why does it say Upgrade Required?
- Why isn't the transformation triggering my validation check batch job?
- Where are custom programs stored?
- Why am I being warned about truncated discrepancy text?
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6
Create custom programs, listings, and filters, and set up reference data
- Create public custom listings
- Create public filters
- Create custom programs
- Set up reference data
- Develop a library of SQL functions
- Use the Expression Builder
- FAQ
- 7 Load data and run jobs
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8
Advanced topics
- Naming restrictions
- Checkout and checkin
- Clinical One and DMW lifecycle mapping
- Validation status and lifecycle stages
- Assign user groups to objects
- Snapshot labels
- Automatic triggering of transformations and validation checks
- Required syntax for metadata files
- Use SDTM identifiers to support important functionality
- How subject and visit filters work
- SDTM column equivalents in InForm
- How the system tracks data lineage
- Data blinding and authorization
- Data processing types and modes
- Installation
- InForm metadata change detection and synchronization
- Clinical One metadata change detection and synchronization
- Understanding internal objects and error messages about them