Planning how to manage study objects

Do you prefer to develop studies based on your data analysis and reporting needs or based on the forms used to collect data?

The Central Designer application supports both approaches:

• Data-based—You can start by developing mappings.
• Form-based—You can start by developing forms, items, and other study objects, or by creating a study workflow.

You can also work on both approaches simultaneously.

What types of libraries do you want to maintain?

For example, libraries for:

• Therapeutic areas.
• Functions.
• Codelists and codelist items.
• Customers (CRO).
• Mappings for SDTM or ODM.

Do you have an existing library that you want to use?

You can import libraries in CSML or ODM format.

How do you want to be able to search for study objects? (How will you categorize study objects?)

For example:

• By therapeutic area
• By customer (CRO)
• By study

What types of study objects will be reused in multiple studies?

For example:

• Standard forms.
• Study objects with rules.

Who will be responsible for setting up libraries and for determining the content of libraries?

Study object management tasks can include:

• Naming (for example, enforcing adherence to a naming convention).
• Categorizing.
• Making changes.
• Publishing (making study objects available for reuse).

How do you want to use study templates?

Any part of study object definition can be stored in a template, including a whole study, and you can create templates from all types of study objects and from mappings. For example, a study template can include:

• Standard study objects, including child study objects such as codelists.
• Default settings of study object properties.
• Team members.
• Full or partial workflows.
• Rules.
• Mappings

How will study object reuse affect your testing of study designs?

If you perform formal testing on study objects before saving them in a library, it should not be necessary to retest them each time they are reused.

Will you develop naming conventions for study objects? How will your reporting needs affect naming conventions?

Consider that study objects have RefNames and titles:

• A RefName is the formal name of a study object. RefNames are:
  • Referenced in rules.
  • Deployed to the InForm software.
• A title is an additional name that you can make more readable than a RefName (for example, titles can contain spaces and special characters). Titles are:
  • Not referenced in rules.
  • Not deployed to the InForm application.

Additionally, a data set and data series in a mapping can have an alias, which, if present, is used as the column heading in a customer-defined database (CDD).

How do you prefer to test study objects?

You could:

• Create study objects in a study, validate and deploy the study, and move tested study objects to a library.
• Create study objects in a test library, use them in a study to test them, and move tested study objects into a library for general use.