Naming Conventions

Developing naming conventions for CDMS-specific objects can help drive consistency in study builds and clarity during amendments.

Here are some general tips:

  • Follow industry standards as often as you can
  • Avoid the use of periods (.), hyphens/dashes (-), or slashes (/ or \)
  • Use underscores instead of whitespaces to separate parts of Names or External IDs
  • Ask sponsors if they have any preferences and follow the guidelines provided

Whichever format you choose, be consistent throughout your study’s design and across all of your studies.

The tables below shows some example conventions for your build standards. An asterisk (*) indicates a default that Veeva uses for Studies where customers have no preference.

Object Labels Names Notes & Examples
Schedule & Forms

Event Groups

  • Screening

  • Visit 1

  • SCR

  • eg_SCR*

  • eg_SCR_V1

  • eg_V1*

  • egV1

  • If an Event Group only contains one Event, use the same Name for both components.

  • An End of Treatment visit could use “eg_EOT” and “ev_EOT”, with the abbreviated component prepended to the visit name.

  • Follow industry standards and established libraries.

Events

  • Screening

  • Visit 1

  • SCR

  • ev_SCR*

  • ev_SCR_V1

  • ev_V1*

  • evV1

  • Match with the Event Group whenever possible.

  • Follow industry standards and established libraries.

Forms

  • Demographics

  • Hematology

  • DM

  • LBH

  • LBHEMA

  • Follow industry standards and established libraries.

Item Groups

  • Serious AE

  • SAE

  • ig_SAE*

  • igSAE

  • Each Item Group instance is its own record within data extracts. If you need specific data sets, you can name Item Groups similarly to Forms. Using the same Item Group across multiple Forms can help you easily identify records when subsetting or joining into one data set.

  • If the items in the group are all related to the same item or are for a shared purpose, describe that in the name. For example, if an Item Group on an AE form contains the item’s related to the AE’s seriousness, you could use “ig_AESER” or “ig_SAE” for the name.

  • Consider using the form’s External ID and the order in which the Item Group appears on the Form for the name, such as “ig_DM1”, “ig_DM2”, and so on.

  • Follow industry standards and established libraries.

Items

  • Serious

  • Start Date

  • End Date and Time

  • Results

  • AESER

  • AESTDAT

  • EGENDTC

  • LBORRES

  • Use eight (8) characters or fewer.

  • For the first two (2) letters of the item’s name, use letters that are similar to the form’s name, such as “AE” for items on an adverse event form.

  • For different Items across similar Forms, add the item’s SDTM destination, separated with an underscore (_), such as “PREG_LBORRES”.

  • Be consistent in the approach or follow the preferences of the sponsor or biostats.

  • Follow industry standards and established libraries.

Codelists

  • N/A

  • ETHNIC

  • cl_ETHNIC*

  • clETHNIC

  • Match the item’s External ID (formerly known as OID) whenever possible.

  • Follow industry standards and established libraries.

Units

  • N/A

  • HEIGHT*

  • muHEIGHT

  • In extracts, the unit’s name will display as “ITEMNAME_UNITS”

  • Follow industry standards and established libraries.

Label Items

  • N/A

  • PE_LBL1

  • Labels should be discrete from data collection items and easily identifiable on a form.

  • Use the form’s name, followed by an underscore (_) and a number, where the number indicates the order in which the label appears on the form. For example, the first label on a form is “PE_LBL1”, then “PE_LBL2”, and so on.

Rules by Action

Query

  • Match the rule’s Name

  • FORM_###

  • where “#” is the number of the rule for the form

  • Use the form Name and then number the rules that apply to the form, for example, “AE_001”, “AE_002”, “AE_003”, and so on.

Add Schedule, Add Event, Add Form

  • Match the rule’s Name

  • ADDEG_EventGroupName

  • ADDE_EventName

  • ADDF_FormName

  • Use “ADD” with the type and name of the component.

  • For example, use “ADDEG_ENR” for a rule that adds the Enrollment event group.

  • For example, use “ADDF_LBPREG” for a rule that adds the Pregnancy Test form.

Send Email

  • Match the rule’s Name

  • EMAIL_SAE

  • EMAIL_PREG

  • Prepend “EMAIL_” to the shortened form name.

Add Assessment

  • Match the rule’s Name

  • CA_ITEM

  • Use the Item that determines how the Assessment is added in the rule name.

Override Review Plan

  • Match the rule’s Name

  • REV_SAE

  • REV_AE

  • Use “REV” with the name of the Form or Item that controls the override.

  • For example, if the rule uses the “AESER” item to override the AE form’s SDV plan, name the rule “REV_AE” or “REV_AESER”.

Disable (For Studies created before 20R2)

  • Match the rule’s Name

  • FORM_DYN###

  • FORM_DYN_ItemName

  • Use the item’s Name in the rule name.

General Recommendations

To Be Removed/Deprecated Components

  • N/A

  • Prepend the existing Name with “OBSOLETE_”

  • During your initial build in development, if you have a component that you plan to remove later, indicate that in the Name. This way, these components will be listed next to together in listings and on the comparison report, for easy removal.