Copying Designs

When designing a study in EDC Studio, you can use templates or existing study objects. You can copy Items, Codelists, and Units from within your current Study. You can also copy some types of study objects to your current study from another study in the same vault, or from another study in a different vault that you have access to. To copy from another vault, the vault containing the study you are copying from must be in the same domain as the vault containing your current study, or you must be a cross-domain user with access to the domain that the other vault is in. The following study objects can be copied from other studies:

  • Event Groups
  • Events
  • Forms
  • Rules
  • Codelists
  • Units

Note that copying a study object also copies any associated translations. You may wish to have any copied translations reviewed before using them in a different study to avoid inconsistent localization.

Copying from the Current Study

You can easily create copies of definitions for Items, Codelists, and Units for use in the same Study. For example, you may want to collect the same data, with the same restrictions applied, for an Item on multiple Forms, but you would like to change the Label and Help Content for one of the Forms. You can create a copy of that Item through the Actions menu by next to the item.

To create a copy of an Item, Codelist, or Unit:

  1. In Studio, navigate to the object record you want to copy.

  2. Hover over the Name to show the Actions menu. Hover over the Name to show the Actions menu

  3. From the Actions menu, select Copy. From the Actions menu, select Copy

  4. Enter a new Name for your object definition, or append additional text to the existing name. For Vault to copy the object definition, this value must be unique.
  5. Click Save. Vault creates the new object definition record.

Once you have copied the Item, Codelist, or Unit, you can edit and use it in your study.

Copying from Another Study

When you copy study objects, Vault also copies their child components, for example, the Item Groups and Items associated with the copied Form. Vault also copies the coding configuration of any copied Forms.

Copying Event Groups

You can copy an Event Group (Event Group Definition) from one Study to another Study in the same vault or another vault that you have access to. When you copy an event group, Vault also copies that event group’s properties and, optionally, its rules. When you copy an Event Group, all the Events and Forms it contains, along with their Item Groups, Items, Codelists, and Units, are copied as well.

For example, Tracey, a clinical programmer at Verteo Pharma, designed the Veeofen study last month. This month, she is designing the Wonderdrug study. The Treatment Visits event group from Veeofen is identical to what she needs for the Wonderdrug study. Tracey can copy that Treatment Visits event group from Veeofen into Wonderdrug, instead of manually creating it a second time.

To copy an event group:

  1. Navigate to Studio > Event Groups.
  2. Click Copy From Study.
  3. Select Create a copy or Use existing to handle duplicates. See details below.
  4. Optional: Select the Rules checkbox to also copy any Rule Definitions associated with the event.
  5. Select a Vault.
  6. For Copy From Study, choose where you want to copy from (From Another Study or From Library.)
  7. Select a Study Environment to copy from.
  8. Search or scroll to locate the Event Definition you want to copy.
  9. Select the Event Group you want to copy.
  10. Optional: Select the Select all checkbox to select all Event Groups for copying.
  11. Click Copy Event Groups. Vault begins a job to copy the Event Group Definition into your Study. When finished, Vault will send you an email notification with a link to download the log file.
  12. Click Close. Once you click Close, you can no longer access the summary or log file.

Copying Events

You can copy an Event (Event Definition) from one Study to another Study in the same vault or another vault that you have access to. When you copy a form, Vault also copies that event’s properties and, optionally, its rules. When you copy an Event, all the Forms it contains, along with their Item Groups, Items, Codelists, and Units, are copied as well.

For example, Tracey, a clinical programmer at Verteo Pharma, designed the Veeofen study last month. This month, she is designing the Wonderdrug study. The Ongoing Treatment Visit from Veeofen is identical to what she needs for the Wonderdrug study. Tracey can copy that Ongoing Treatment Visit event from Veeofen into Wonderdrug, instead of manually creating it a second time.

To copy an event:

  1. Navigate to Studio > Events.
  2. Click Copy From Study.
  3. Select Create a copy or Use existing to handle duplicates. See details below.
  4. Optional: Select the Rules checkbox to also copy any Rule Definitions associated with the event.
  5. Select a Vault.
  6. For Copy From Study, choose where you want to copy from (From Another Study or From Library.)
  7. Select a Study Environment to copy from.
  8. Search or scroll to locate the Event Definition you want to copy.
  9. Select the Event you want to copy.
  10. Optional: Select the Select all checkbox to select all Events for copying.
  11. Click Copy Events. Vault begins a job to copy the Event Definition into your Study. When finished, Vault will send you an email notification with a link to download the log file.
  12. Click Close. Once you click Close, you can no longer access the summary or log file.

Copying Forms

You can copy a Form (Form Definition) from one Study to another Study in the same vault or another vault that you have access to. When you copy a form, Vault also copies that form’s properties, its Item Groups, its Items, its Codelists and Units, and, optionally, its rules.

Rule Copy: Vault will not copy any cross-form Rules associated with a copied Form.

For example, Lateef, a clinical programmer at Bryce Pharma, designed the Deetoza study last month. This month, he is designing the Veeofen study. The Physical Exam form from Deetoza is identical to what he needs for the Veeofen study. He can copy that Physical Exam form, and all of its related records, from Deetoza into Veeofen, instead of manually creating those object records a second time.

To copy a form:

  1. Navigate to Studio > Forms in Browse view.
  2. Click Copy From Study.
  3. Select Create a copy or Use existing to handle duplicates. See details below.
  4. Optional: Select the Rules checkbox to also copy any Rule Definitions associated with the form.
  5. Optional: Select the Safety Configuration checkbox to also copy any configuration for the Safety Configuration associated with the form. Vault indicates which forms have safety configurations in the dialog’s Has Safety Configuration column. Note that this requires a Study Role with the Manage Safety Configuration permission.
  6. Select a Vault.
  7. For Copy From Study, choose where you want to copy from (From Another Study or From Library.)
  8. Select a Study Environment to copy from.
  9. Search or scroll to locate the Form Definition you want to copy.
  10. Select the Form you want to copy.
  11. Click Copy Forms. Vault begins copying the Form Definition into your Study.
  12. Optional: In the Copy from Study dialog: * Click View Summary to see a list of the copied forms and the status of the copy. * If you copied 20 or fewer Forms, click View Log to see detailed status information for each object record copied. If you copied more than 20 Forms, Vault will send you an email notification with a link to download the log file when finished.
  13. When finished, click Close. Once you click Close, you can no longer access the summary or log file.

Labs: Note that you can’t copy a Lab form with an existing Lab panel between studies.

Copying Rules

You can copy a Rule (Rule Definition and Rule Action) from one Study to another Study in the same vault or another vault that you have access to.

For example, Lateef, a clinical programmer for Bryce Pharma, designed the Deetoza study last month. He wrote several complicated date comparison rules. This month, he’s building rules for the Veeofen study. He can use the same rule expressions that he wrote for Deetoza’s date comparisons if he updates the identifiers to match Events in the Veeofen study. He can copy those date comparison rules from Deetoza into Veeofen, update the identifiers in the rule expressions, and then reactivate those rules to use them in the Veeofen study.

When you select rules to copy, Vault checks whether or not the rules are valid (if identifiers in the rule expressions match up to design definition records in the target study). On any invalid rules, Vault shows an Invalid indicator.

Invalid indicator on an invalid Add Assessment rule
Invalid indicator on an invalid Add Assessment rule

You can still copy these invalid rules into your Study, but Vault moves them into the Inactive status. You’ll have to update the rule expression and rule action to point to identifiers or objects that exist in your study before you can use these rules.

To copy rules:

  1. Navigate to Studio > Rules.

  2. Click Copy From Study. Copy From Study button for Rules

  3. Select Create a copy or Use existing to handle duplicates. See details below.
  4. Select a Vault.
  5. For Copy From Study, choose where you want to copy from (From Another Study or From Library.)
  6. Select a Study Environment to copy from.
  7. Search for or scroll to locate the Rule Definition you want to copy.
  8. Select the rules you want to copy.
  9. Optional: Select the Select all checkbox to copy all rules.
  10. Click Copy Rules. Vault begins a job to copy the Rule Definitions and related records into your Study. When finished, Vault will send you an email notification with a link to download the log file.
  11. Click Close.

Once you click Close, you can no longer access the summary or log file.

Copying Codelists

You can copy a Codelist (a Codelist Definition and its Codelist Definition Items) from one Study to another Study in the same vault or another vault that you have access to. To copy a codelist:

  1. Navigate to Studio > Codelists.
  2. Click Copy From Study.
  3. Select Create a copy or Use existing to handle duplicates. See details below.
  4. Select a Vault.
  5. For Copy From Study, choose where you want to copy from (From Another Study or From Library.)
  6. Select a Study Environment to copy from.
  7. Search or scroll to locate the Codelist you want to copy.
  8. Select the Codelist you want to copy.
  9. Optional: Select the Select all checkbox to copy all codelists.
  10. Click Copy Codelists. Vault begins am job to copy the Codelist into your Study. When finished, Vault will send you an email notification with a link to download the log file.
  11. When finished, click Close.

Once you click Close, you can no longer access the summary or log file.

Copying Units

You can copy a Unit (a Unit Definition and its Unit Definition Items) from one Study to another Study in the same vault or another vault that you have access to. To copy a unit:

  1. Navigate to Studio > Units.
  2. Click Copy From Study.
  3. Select Create a copy or Use existing to handle duplicates. See details below.
  4. Select a Vault.
  5. For Copy From Study, choose where you want to copy from (From Another Study or From Library.)
  6. Select a Study Environment to copy from.
  7. Search or scroll to locate the Unit you want to copy.
  8. Select the Unit you want to copy.
  9. Optional: Select the Select all checkbox to copy all units.
  10. Click Copy Units. Vault begins a job to copy the Units into your Study. When finished, Vault will send you an email notification with a link to download the log file.
  11. Click Close.

Once you click Close, you can no longer access the summary or log file.

Protocol Deviations

For Protocol Deviations, you can copy the Categories, Subcategories, and Severity from another Study in the same vault or another vault that you have access to.

To copy from another study:

  1. Navigate to your Study in Studio > Studies.
  2. Open Protocol Deviations.

  3. Click Copy From Study. Copy From Study button

  4. In the Copy From Study dialog, select the Vault that contains the Study you want to copy. If you only have access to one copyable vault, it is automatically selected.

  5. For Copy From Study, choose where you want to copy from (From Another Study or From Library). Copy From Study dialog

  6. Select a Study.
  7. Select an Environment.
  8. By default, Vault includes Categories and Subcategories and Severities in the copy. Clear either of these checkboxes to exclude that component from the copy.
  9. Click Copy. Vault begins a job to copy from the other study. When finished, Vault sends you an email notification.

Duplicate Handling

If you attempt to copy a Form or Event from another Study that already exists in your Study, you can choose how Vault handles the conflict. Vault identifies duplicates by the CDM Key value. For both of these options, Vault creates a new object record if there are no duplicates.

Create a Copy

If you choose Create a copy, Vault copies the existing definition record into a new Form, Event, or Event Group and adds the new record to your study.

Use Existing & Update with Changes

If you choose Use existing, Vault uses the existing definition record and logs the reuse.

If you select Update with Changes, Vault uses the existing definition record, but it also applies any changes from the matching record in the other study. These changes are included in the log.

Copy Log

If you copy 20 or fewer objects, you can choose to download a CSV log for your copy job from within the Copy from Study dialog. Note that once you close that dialog, you can no longer access the log file. If you copy 20 or more objects, Vault will send you an email notification when finished copying. This email includes a link to download this log file.

The log file lists each object that was copied, whether or not the copy was successful, and details about any errors that occurred during the copy.

Versioning for Copied Definitions

When you copy a Form, Vault sets the Form and its related object records to the same version as the Study you’re copying it into.