Exporting Data

You can group data listings together for export as Export Definitions from the Export area of EDC Clinical Reporting. For each Export Definition, you can add one or more of the data listings from your study. When you generate the export package, you can choose to generate it in CSV or SAS (sas7bdat) format. Note that the encoding for CSV and SAS files is UTF-8. It is recommended to set your encoding to UTF-8 when viewing these files in programs like Excel™.

After you select your desired format, Clinical Reporting then generates a set of files, one for each export listing. Once you generate the export package, you or any other Clinical Reporting user with access to your Study can download the export package (a ZIP file containing the collection of listing files, either CSV or sas7bdat, and the manifest, “manifest.json”, describing the package contents). Then, you can share it with study stakeholders, such as regulatory authorities, medical monitors, and statisticians. You can also send datasets from the Study Data Extract job in EDC Tools to Clinical Reporting

Accessing Export

You can access your Export Definitions from the Export area of EDC Clinical Reporting. You can navigate to the Export area from the Navigation Drawer or the Study menu.

Viewing Exports

The Export page has two tabs, Definitions and Packages. From Export > Definitions, you can view, create, and edit Export Definitions for your Study. From Export > Packages, you can view all generated export packages and review an error log for any failures.

Definitions

Clinical Reportinglists all Export Definitions for your study in Export > Definitions. The table below details each column of the Export Definition listing:

You can sort this listing by Latest Package, Modified By, Modified Date, or Name. Select a sort column and order from the Sort By menu.

Click Reset in the Sort By menu to return to the default sort order (Descending, Modified Date).

Packages

Clinical Reporting lists all packages generated for a Study in Export > Packages. The table below lists the details of each column for the package listing:

Sort Packages

You can sort this listing by Name, Processed By, Process Date, and Process Status. Select a sort column and order from the Sort By menu.

Click Reset in the Sort By menu to return to the default sort order (Descending, Process Date).

Errors

If package generation fails, you can view a list of errors from Export > Packages.

To view errors:

1. Navigate to Export > Packages for your Study.
2. Locate the failed package in the list.

3. Click View Issue Log ().

4. Clinical Reporting opens the Issues panel. This lists each error that occurred during package generation.
5. Optional: Click Download () to download the issue log.
6. Click Close () to close the Issues panel.

Export Types

Clinical Reporting supports three types of exports: None, Raw, and SDTM. The default is None, which allows you to create your own export definition without the defined conventions that the Raw and SDTM types include.

Raw

When creating an Export Definition, you can choose to use Raw format (by selecting Raw for Type). Raw export packages have the following characteristics:

• The package contains an export listing for each core listing within the study, even if the form has no data.
• Any date and datetime items display both the default and the RawDate() format. See the table below for examples of RawDate() format dates.
• Items with units include columns for the translated name and unit value. See the table below for examples of unit columns.
• The package contains additional System Listings for contextual header information. See a detailed list below.

Export Listings for Forms

Each form’s listing in your raw export will include the following columns, in addition to columns for each Item on the Form:

• Study.Name
• Site.Number
• Subject.Name
• EventGroup.Name
• EventGroup.SeqNbr
• Event.Name
• Event.Date
• Event.Status
• Form.Name
• Form.DataSource
• Form.SeqNbr
• Form.LastModifiedDate
• ItemGroup.SeqNbr

System Listings

Raw export types include the following System Listings by default. These listings provide operational metadata for your study. For None export types, System Listings are not included by default but can be added if needed.

The table below lists the columns included in each System Listing.

Raw Date Formats

For date and datetime items, Clinical Reporting includes the default date format and the RawDate() format for the date. In RawDate() format, partial dates and times display without any modifications.

Items with Unit Columns

For unit-type Items, Clinical Reporting includes additional columns for the translated name and unit value. The table below shows the included columns for the “Weight” item, which is collected in kilograms.

Codelist Decodes

Raw export definitions include decoded values for codelist items. These values appear after the original item column in a new column with _DECODE appended to the item name. In the case of duplicate column headers, the name is followed by a number such as 2, 3, or 4.

For example, “signed_consent_form_DECODE_2”:

DECODE is added only for new export definitions and altered existing definitions. The DECODE column is included in the manifest file along with the itemtype attribute.

Duplicate Column Handling

Clinical Reporting allows duplicate columns and will display them in the UI.

System-generated columns, such as ones that have “_RAW” or “_UOM” appended, for example, automatically have “_2” appended to prevent duplicate column conflicts in certain scenarios. This occurs during the export transformaiton, before the Export Listing is exported to CSV or SAS.

For user-defined item names, Clinical Reporting attempts to preserve the original name by prepending the Name of the Item Group. This occurs when the CSV or SAS file is generated.

SDTM

When creating an Export Definition, you can choose to use SDTM format (by selecting SDTM for Type). SDTM export packages have the following characteristics:

• Every listing CSV includes a column for Domain (the Short Title of the listing).
• Listing CSV files are named using the short title (“short_title.csv”).
• All Date, DateTime, and Time items use ISO8601 format.
• Unknown dates and times are formatted as shown in the table below.
• Columns for data items use the SDTM Name or the External ID of the EDC definition, based on the selection during export definition creation.

Restricted (Blinded) Data in Export Packages

Clinical Reporting determines the inclusion of restricted (blinded) data in the export package based on the Blinded property of the Export Definition.

When the Unblinded checkbox is selected, and one or more Export Listings contain restricted data, Clinical Reporting only allows users who have the Restricted Data Access permission to download the resulting export packages.

If your Export Listings contain restricted (blinded) data, Clinical Reporting only exports the restricted data if your Study Role grants the Restricted Data Access permission. By default, this permission is assigned to users with the standard CDMS Lead Data Manager study role.

The list below describes how Clinical Reporting handles restricted data when generating the package for an unblinded export definiton:

• Source-level restriction: If an entire Source is restricted, which is only possible for third party data, the blinded export package will not contain any data from this source. If a listing only has data from the restricted source, then Clinical Reporting will not include that listing in the export package.
• Form-level restriction: If a Form is restricted, the blinded export package will not contain any data from that Form. If a listing only has data from the restricted Form, then Clinical Reporting will not include that listing in the export package. Clinical Reporting will not include any @HDR, @Form, or @ItemGroup information for the Form, and any Items from the Form are also excluded from export.
• Item-level restriction: If an Item is restricted, the blinded export package will not contain this Item. Clinical Reporting will not include any columns for the Item in any listings. If a listing uses this Item in the Listing Definition to derive the value of another column, that column will also be excluded.

Create an Export Definition

To create an Export Definition:

1. Navigate to Export > Definitions.

2. Click + Create ….

3. Enter a Title for your Export Definition. This displays in the Name column of the Export Definition list.
4. Select Raw or SDTM for Type to create an export definition of that type. Otherwise, leave this set to None.
5. If you choose SDTM, you can select Auto generate column labels with EDC External name to use the External ID for column labels. Otherwise, leave this set to Auto generate column labels with EDC SDTM name to use the SDTM Name.
6. Optional: Enter a Description.
7. Click Next.
8. Optional: Click Expand or Collapse to expand and collapse listing categories and export definitions. Clinical Reporting groups listings by Category in Available Listings and by Export Definition in Export Definitions.

9. Drag and drop a Listing or Listing Category from Available Listings to Selected Listings. You can also drag and drop an Export Definition to Selected Listings to automatically add every listing from that definition.

10. Continue dragging and dropping listings into Selected Listings until the Selected Listings include everything you want in your Export Definition.

11. To remove a listing from the definition, click Remove (). While you can’t remove System Listings for raw-type exports when creating an Export Definition, you can remove them later with the Modify Listings action.

12. When finished, click Next.
13. Optional: Enter a Short Title for your export listings. Clinical Reporting uses the Short Title as the filename for the listing inthe export package and to populate the Domain column in SDTM exports.
14. Optional: Edit the Title for your export listings.
15. Click Save.

You can now generate and download the export package for this Export Definition.

Export Definition Workflow

All Export Definitions start in the Draft status. Each listing within the definition also starts in Draft. Once all listings are marked as Ready, the Export Definition moves into the Published status. If at any time a listing is invalidated, the Export Definition moves into the Draft status. To return to Published, the invalid listing must be removed or updated. If any listings return to Draft, the Export Definition also returns to the Draft status.

You can generate an export package for an Export Definition that is in the Draft or Published statuses.

Look to the Status Badge to identify the status of an Export Listing or Export Definition. The Status Badge is displayed in the definition list, the list of listings within the definition, and on the listing page.

How to Mark a Listing as Ready

To mark an Export Listing as Ready:

1. Open the Export Listing in Clinical Reporting> Export > Definitions.
2. Verify that your listing is ready for use.
3. Click Ready in the Status Toggle.

You can return the listing to the Draft status by clicking Draft in the Status Toggle.

Export Change Detection

When you create an Export Definition, it’s made up of Export Listings. Those Export Listings are snapshots of the listings they were created from. A “parent listing” refers to a listing that was used as the source to create an Export Listing. When the parent listing’s syntax is updated upstream, in some cases, the export listing’s Listing Definition may become out of sync with that of the parent listing. This can lead to outdated listing structure in export packages. For example, if the Listing Definition statement for a public Custom Listing was updated, any Export Listing that was created from that parent listing will still reflect the original statement that the Export Listing was created with.

Clinical Reporting, at specific trigger points, checks the parent listings of your export definition’s Export Listings for changes. When you or another user modifies a parent listing, Clinical Reporting displays a change indicator on the Export Definition. Then, you can optionally review the Listing Definition changes and choose to sync the Export Listing with the parent.

You must be the owner of the Export Definition or have the Vault Owner security profile to sync an Export Listing with the parent.

Detected Changes

Clinical Reporting detects only changes in the same environment, and it doesn’t detect changes across different studies.

Clinical Reporting detects the following changes:

• Updates to the Listing Definition
• Changes to a study’s design, such as a new Item or Item Group, that are applied to a Core Listing used in a raw or SDTM type export definition
• Updates to the Listing Definition for a parent listing whose child listing is used as an Export Listing

Clinical Reporting only considers study design changes that are applied to a Core Listing when that listing is used in an export definition with the Raw type.

Clinical Reporting doesn’t consider updates to a listing’s Name or other properties as changes.

Clinical Reporting checks for changes at these events:

• Swap (when new data becomes available after successful import): Clinical Reporting checks for changes across all Export Definitions.
• Saved changes to the LIsting Definition for public Custom Listings or Views: Clinical Reporting checks for changes in Export Definitions that contain the listing or view that was modified.

Review Listing Definition Changes

To review changes:

1. Navigate to Export > Definitions.
2. Click Impacted to filter the list of Export Definitions to only show those that are impacted by changes.
3. Click to open the Export Definition containing changes.

4. Click Impacted to filter the list of Export Listings to only show those out of sync with their parent.

5. For the listing that you want to review, click Compare. This opens the Change Comparison panel.

6. Review the changes.
7. When finished reviewing, if you don’t want to sync with the parent, click Close () to close the panel.

Once you have reviewed the changes, you can sync the listing with the parent.

Sync with the Parent

To sync an Export Listing with the parent:

1. Navigate to the impacted Export Definition.
2. Click Impacted to filter the list of Export Listings to only show those out of sync with their parent.
3. For the listing that you want to sync, click Compare.
4. In the Change Comparison panel, click Sync with Parent.
5. In the confirmation dialog, click Confirm.

To sync multiple Export Listings with their parents:

1. Navigate to the impacted Export Definition.
2. Click Impacted to filter the list of Export Listings to only show those out of sync with their parent.
3. Select the Export Listing checkbox for each listing that you want to sync.
4. Optional: Select the Select All checkbox to select all listings on the current page.

5. Click Sync with Parent.

6. In the confirmation dialog, click Confirm.

Edit an Export Definition

After creating an Export Definition, you can return later and modify which listings are included, edit the definition’s properties, and rename listings.

Note that you can only save changes to definitions that you created. To make changes to someone else’s listing, you can create a copy of it to make your changes.

How to Rename Listings

You can easily rename export listings in your Export Definition. Renaming a listing here only renames the Export Listing. It doesn’t rename the original data listing.

To rename a listing:

1. Navigate to Export > Definitions.
2. Open your Export Definition.

3. In the Export Listings table, click Edit () to enter Edit mode.

4. Enter the new name for your listing in the text field.

5. Click View () to return to View mode and save your changes.

How to Modify Included Listings

You can add and remove listings from an Export Definition.

To modify included listings:

1. Navigate to Export > Definitions.
2. Click to open your Export Definition.

3. From the Actions menu (), select Select Listings.

4. Optional: Click Expand or Collapse to expand and collapse listing categories and export definitions. Clinical Reporting groups listings by Category in Available Listings and by Export Definition in Export Definitions.

5. Drag and drop a Listing or Listing Category from Available Listings to Selected Listings. You can also drag and drop an Export Definition to Selected Listings to automatically add every listing from that definition.

6. Continue dragging and dropping listings into Selected Listings until the Selected Listings include everything you want in your Export Definition.

7. To remove a listing from the definition, click Remove ().

8. Click Next.
9. Optional: Enter a Short Title for your export listings. Clinical Reporting uses the Short Title as the filename for the listing in the export package.
10. Optional: Edit the Title for your export listings.
11. Click Save.

How to Edit Export Definition Properties

To edit the properties of an Export Definition:

1. Navigate to Export > Definitions.
2. Click to open an Export Definition.

3. From the Export Definition () menu, select Properties.

4. In the Properties dialog, click Edit.

5. Edit properties as needed.

6. Click Save.

Copy an Export Definition

You can copy an Export Definition using Save As.

To copy an Export Definition:

1. Navigate to Export > Definitions.
2. Click to open your Export Definition.

3. From the Export Definition () menu, select Save As.

4. Optional: Enter a Title for your new export definition. By default, the Title is the title of the original definition with a “2” appended to it.
5. Optional: Enter a Description.
6. Click Save.

Delete an Export Definition

Note that you can only delete Export Definitions that you created.

To delete an Export Definition:

1. Navigate to Export > Definitions.
2. Locate your Export Definition in the list.
3. From the Export () menu, select Delete.

Generate & Download an Export Package

You can generate and download an export package from any existing Export Definition as a set of CSV or SAS files and a manifest file.

1. Navigate to Export > Definitions.
2. Locate an Export Definition in the list.

3. From the Export () menu, select Generate Package.

4. Select CSV or SAS for the export format.
5. Once Clinical Reporting generates the package, click Download () to download the export package (ZIP).

Example Manifest File

The manifest file consists of system-generated listings and one Core Listing, with each containing the following:

• A description of the CQL used to create the file
• A list of columns and their descriptions
• For Items, attributes such as the Name, Type, Item Type, Item Label, Source, and Form
• For Codelist Items, Codes and Decodes

See below for an example manifest file.

{
  "study" : "Cholecap_DEV1",
  "exportname" : "Raw_Export",
  "exportstartdatetime" : "2024-03-11 18:05:10",
  "filecount" : 6,
  "data" : [ {
    "filename" : "adverse_events.csv",
    "dateapplied" : "2024-03-11 17:39:54",
    "cql" : "SELECT\n  `@HDR`.`Study`.`Name`\n, `@Form`.`DataSource`\n, `@HDR`.`Site`.`Number`\n, `@HDR`.`Subject`.`Name`\n, `@HDR`.`EventGroup`.`Name`\n, `@HDR`.`EventGroup`.`SeqNbr`\n, `@HDR`.`Event`.`Name`\n, `@HDR`.`Event`.`Date`\n, `@HDR`.`Event`.`Status`\n, `@Form`.`Name`\n, `@Form`.`SeqNbr`\n, `@ItemGroup`.`SeqNbr`\n, `@Form`.`LastModifiedDate`\n, `EDC.adverse_events`.`common_forms_ig`.`adverse_event_term` `adverse_event_term`\n, codedstatus(`EDC.adverse_events`.`common_forms_ig.adverse_event_term`) `CodingStatus`\n, codeddictrel(`EDC.adverse_events`.`common_forms_ig.adverse_event_term`) `DictionaryRelease`\n, codedcode(`EDC.adverse_events`.`common_forms_ig.adverse_event_term`, 'LLTCD') `LLTCD`\n, codedterm(`EDC.adverse_events`.`common_forms_ig.adverse_event_term`, 'LLT') `LLT`\n, codedcode(`EDC.adverse_events`.`common_forms_ig.adverse_event_term`, 'PTCD') `PTCD`\n, codedterm(`EDC.adverse_events`.`common_forms_ig.adverse_event_term`, 'PT') `PT`\n, codedcode(`EDC.adverse_events`.`common_forms_ig.adverse_event_term`, 'HLTCD') `HLTCD`\n, codedterm(`EDC.adverse_events`.`common_forms_ig.adverse_event_term`, 'HLT') `HLT`\n, codedcode(`EDC.adverse_events`.`common_forms_ig.adverse_event_term`, 'HLGTCD') `HLGTCD`\n, codedterm(`EDC.adverse_events`.`common_forms_ig.adverse_event_term`, 'HLGT') `HLGT`\n, codedcode(`EDC.adverse_events`.`common_forms_ig.adverse_event_term`, 'SOCCD') `SOCCD`\n, codedterm(`EDC.adverse_events`.`common_forms_ig.adverse_event_term`, 'SOC') `SOC`\n, codedterm(`EDC.adverse_events`.`common_forms_ig.adverse_event_term`, 'Primary Path') `PrimaryPath`\n, codedby(`EDC.adverse_events`.`common_forms_ig.adverse_event_term`) `LastCodedBy`\n, lastcoded(`EDC.adverse_events`.`common_forms_ig.adverse_event_term`) `LastCodedDate`\n, `EDC.adverse_events`.`common_forms_ig`.`start_date` `start_date`\n, rawdate(`EDC.adverse_events`.`common_forms_ig`.`start_date`) `start_date_RAW`\n, `EDC.adverse_events`.`common_forms_ig`.`end_date` `end_date`\n, rawdate(`EDC.adverse_events`.`common_forms_ig`.`end_date`) `end_date_RAW`\n, `EDC.adverse_events`.`common_forms_ig`.`serious` `serious`\n, `EDC.adverse_events`.`common_forms_ig`.`outcome` `outcome`\nFROM\n  `EDC`.`adverse_events`\nWHERE ((`@Form`.`Status` = 'submitted__v') OR (`@HDR`.`Event`.`Status` IN ('did_not_occur__v')))\n",
    "columns" : [ {
      "name" : "Study.Name",
      "type" : "VARCHAR",
      "source" : "EDC"
    }, {
      "name" : "Form.DataSource",
      "type" : "VARCHAR",
      "source" : "EDC"
    }, {
      "name" : "Site.Number",
      "type" : "VARCHAR",
      "source" : "EDC"
    }, {
      "name" : "Subject.Name",
      "type" : "VARCHAR",
      "source" : "EDC"
    }, {
      "name" : "EventGroup.Name",
      "type" : "VARCHAR",
      "source" : "EDC"
    }, {
      "name" : "EventGroup.SeqNbr",
      "type" : "INTEGER",
      "source" : "EDC"
    }, {
      "name" : "Event.Name",
      "type" : "VARCHAR",
      "source" : "EDC"
    }, {
      "name" : "Event.Date",
      "type" : "DATE",
      "source" : "EDC"
    }, {
      "name" : "Event.Status",
      "type" : "VARCHAR",
      "source" : "EDC"
    }, {
      "name" : "Form.Name",
      "type" : "VARCHAR",
      "source" : "EDC"
    }, {
      "name" : "Form.SeqNbr",
      "type" : "INTEGER",
      "source" : "EDC"
    }, {
      "name" : "ItemGroup.SeqNbr",
      "type" : "INTEGER",
      "source" : "EDC"
    }, {
      "name" : "Form.LastModifiedDate",
      "type" : "DATETIME",
      "source" : "EDC"
    }, {
      "name" : "adverse_event_term",
      "type" : "VARCHAR",
      "itemlabel" : "Adverse Event Term",
      "source" : "EDC",
      "form" : "adverse_events"
    }, {
      "name" : "CodingStatus",
      "type" : "VARCHAR",
      "itemtype" : [ "cdbderived" ],
      "itemlabel" : "Adverse Event Term",
      "source" : "EDC",
      "form" : "adverse_events"
    }, {
      "name" : "DictionaryRelease",
      "type" : "VARCHAR",
      "itemtype" : [ "cdbderived" ],
      "itemlabel" : "Adverse Event Term",
      "source" : "EDC",
      "form" : "adverse_events"
    }, {
      "name" : "LLTCD",
      "type" : "VARCHAR",
      "itemtype" : [ "cdbderived" ],
      "itemlabel" : "Adverse Event Term",
      "source" : "EDC",
      "form" : "adverse_events"
    }, {
      "name" : "LLT",
      "type" : "VARCHAR",
      "itemtype" : [ "cdbderived" ],
      "itemlabel" : "Adverse Event Term",
      "source" : "EDC",
      "form" : "adverse_events"
    }, {
      "name" : "PTCD",
      "type" : "VARCHAR",
      "itemtype" : [ "cdbderived" ],
      "itemlabel" : "Adverse Event Term",
      "source" : "EDC",
      "form" : "adverse_events"
    }, {
      "name" : "PT",
      "type" : "VARCHAR",
      "itemtype" : [ "cdbderived" ],
      "itemlabel" : "Adverse Event Term",
      "source" : "EDC",
      "form" : "adverse_events"
    }, {
      "name" : "HLTCD",
      "type" : "VARCHAR",
      "itemtype" : [ "cdbderived" ],
      "itemlabel" : "Adverse Event Term",
      "source" : "EDC",
      "form" : "adverse_events"
    }, {
      "name" : "HLT",
      "type" : "VARCHAR",
      "itemtype" : [ "cdbderived" ],
      "itemlabel" : "Adverse Event Term",
      "source" : "EDC",
      "form" : "adverse_events"
    }, {
      "name" : "HLGTCD",
      "type" : "VARCHAR",
      "itemtype" : [ "cdbderived" ],
      "itemlabel" : "Adverse Event Term",
      "source" : "EDC",
      "form" : "adverse_events"
    }, {
      "name" : "HLGT",
      "type" : "VARCHAR",
      "itemtype" : [ "cdbderived" ],
      "itemlabel" : "Adverse Event Term",
      "source" : "EDC",
      "form" : "adverse_events"
    }, {
      "name" : "SOCCD",
      "type" : "VARCHAR",
      "itemtype" : [ "cdbderived" ],
      "itemlabel" : "Adverse Event Term",
      "source" : "EDC",
      "form" : "adverse_events"
    }, {
      "name" : "SOC",
      "type" : "VARCHAR",
      "itemtype" : [ "cdbderived" ],
      "itemlabel" : "Adverse Event Term",
      "source" : "EDC",
      "form" : "adverse_events"
    }, {
      "name" : "PrimaryPath",
      "type" : "VARCHAR",
      "itemtype" : [ "cdbderived" ],
      "itemlabel" : "Adverse Event Term",
      "source" : "EDC",
      "form" : "adverse_events"
    }, {
      "name" : "LastCodedBy",
      "type" : "INTEGER",
      "itemtype" : [ "cdbderived" ],
      "itemlabel" : "Adverse Event Term",
      "source" : "EDC",
      "form" : "adverse_events"
    }, {
      "name" : "LastCodedDate",
      "type" : "DATETIME",
      "itemtype" : [ "cdbderived" ],
      "itemlabel" : "Adverse Event Term",
      "source" : "EDC",
      "form" : "adverse_events"
    }, {
      "name" : "start_date",
      "type" : "DATE",
      "itemlabel" : "Start Date",
      "source" : "EDC",
      "form" : "adverse_events"
    }, {
      "name" : "start_date_RAW",
      "type" : "VARCHAR",
      "itemtype" : [ "cdbderived" ],
      "itemlabel" : "Start Date",
      "source" : "EDC",
      "form" : "adverse_events"
    }, {
      "name" : "end_date",
      "type" : "DATE",
      "itemlabel" : "End Date",
      "source" : "EDC",
      "form" : "adverse_events"
    }, {
      "name" : "end_date_RAW",
      "type" : "VARCHAR",
      "itemtype" : [ "cdbderived" ],
      "itemlabel" : "End Date",
      "source" : "EDC",
      "form" : "adverse_events"
    }, {
      "name" : "serious",
      "type" : "VARCHAR",
      "datatype" : "codelist",
      "itemlabel" : "Serious",
      "source" : "EDC",
      "form" : "adverse_events",
      "code_decode" : [ {
        "code" : "Y",
        "decode" : "Yes"
      }, {
        "code" : "N",
        "decode" : "No"
      } ]
    }, {
      "name" : "outcome",
      "type" : "VARCHAR",
      "itemlabel" : "Outcome",
      "source" : "EDC",
      "form" : "adverse_events"
    } ]
  }, {
    "filename" : "Sys_Forms.csv",
    "dateapplied" : "2024-03-11 17:39:54",
    "cql" : "CALL SYS_FORMS",
    "columns" : [ {
      "name" : "Study.Name",
      "type" : "VARCHAR",
      "source" : "EDC"
    }, {
      "name" : "Site.Country",
      "type" : "VARCHAR",
      "source" : "EDC"
    }, {
      "name" : "Site.Number",
      "type" : "VARCHAR",
      "source" : "EDC"
    }, {
      "name" : "Site.Name",
      "type" : "VARCHAR",
      "source" : "EDC"
    }, {
      "name" : "Site.PI",
      "type" : "VARCHAR",
      "source" : "EDC"
    }, {
      "name" : "Subject.Name",
      "type" : "VARCHAR",
      "source" : "EDC"
    }, {
      "name" : "Subject.Status",
      "type" : "VARCHAR",
      "source" : "EDC"
    }, {
      "name" : "EventGroup.Name",
      "type" : "VARCHAR",
      "source" : "EDC"
    }, {
      "name" : "EventGroup.SeqNbr",
      "type" : "INTEGER",
      "source" : "EDC"
    }, {
      "name" : "Event.Name",
      "type" : "VARCHAR",
      "source" : "EDC"
    }, {
      "name" : "Event.Date",
      "type" : "DATE",
      "source" : "EDC"
    }, {
      "name" : "Event.Status",
      "type" : "VARCHAR",
      "source" : "EDC"
    }, {
      "name" : "Form.Name",
      "type" : "VARCHAR",
      "source" : "EDC"
    }, {
      "name" : "Form.SeqNbr",
      "type" : "INTEGER",
      "source" : "EDC"
    }, {
      "name" : "Form.Status",
      "type" : "VARCHAR",
      "source" : "EDC"
    }, {
      "name" : "Form.CreatedDate",
      "type" : "DATETIME",
      "source" : "EDC"
    }, {
      "name" : "Form.SubmissionDate",
      "type" : "DATETIME",
      "source" : "EDC"
    }, {
      "name" : "Form.SubmissionCount",
      "type" : "INTEGER",
      "source" : "EDC"
    }, {
      "name" : "Form.ILB",
      "type" : "BOOLEAN",
      "source" : "EDC"
    }, {
      "name" : "Form.ILBReason",
      "type" : "VARCHAR",
      "source" : "EDC"
    }, {
      "name" : "Form.SDV",
      "type" : "BOOLEAN",
      "source" : "EDC"
    }, {
      "name" : "Form.SDVDate",
      "type" : "DATETIME",
      "source" : "EDC"
    }, {
      "name" : "Form.DMR",
      "type" : "BOOLEAN",
      "source" : "EDC"
    }, {
      "name" : "Form.DMRDate",
      "type" : "DATETIME",
      "source" : "EDC"
    }, {
      "name" : "Form.Frozen",
      "type" : "BOOLEAN",
      "source" : "EDC"
    }, {
      "name" : "Form.FrozenDate",
      "type" : "DATETIME",
      "source" : "EDC"
    }, {
      "name" : "Form.Locked",
      "type" : "BOOLEAN",
      "source" : "EDC"
    }, {
      "name" : "Form.LockedDate",
      "type" : "DATETIME",
      "source" : "EDC"
    }, {
      "name" : "Form.Signed",
      "type" : "BOOLEAN",
      "source" : "EDC"
    }, {
      "name" : "Form.SignatureDate",
      "type" : "DATETIME",
      "source" : "EDC"
    }, {
      "name" : "Form.LastModifiedDate",
      "type" : "DATETIME",
      "source" : "EDC"
    }, {
      "name" : "Form.Version",
      "type" : "VARCHAR",
      "source" : "EDC"
    }, {
      "name" : "Form.ExternalID",
      "type" : "VARCHAR",
      "source" : "EDC"
    } ]
  }, {
    "filename" : "Sys_ILB.csv",
    "dateapplied" : "2024-03-11 17:39:54",
    "cql" : "CALL SYS_ILB",
    "columns" : [ {
      "name" : "Study.Name",
      "type" : "VARCHAR",
      "source" : "EDC"
    }, {
      "name" : "Site.Number",
      "type" : "VARCHAR",
      "source" : "EDC"
    }, {
      "name" : "Subject.Name",
      "type" : "VARCHAR",
      "source" : "EDC"
    }, {
      "name" : "EventGroup.Name",
      "type" : "VARCHAR",
      "source" : "EDC"
    }, {
      "name" : "EventGroup.SeqNbr",
      "type" : "INTEGER",
      "source" : "EDC"
    }, {
      "name" : "Event.Name",
      "type" : "VARCHAR",
      "source" : "EDC"
    }, {
      "name" : "Form.Name",
      "type" : "VARCHAR",
      "source" : "EDC"
    }, {
      "name" : "Form.SeqNbr",
      "type" : "INTEGER",
      "source" : "EDC"
    }, {
      "name" : "ItemGroup.Name",
      "type" : "VARCHAR",
      "source" : "EDC"
    }, {
      "name" : "ItemGroup.SeqNbr",
      "type" : "INTEGER",
      "source" : "EDC"
    }, {
      "name" : "Item.Name",
      "type" : "VARCHAR",
      "source" : "EDC"
    }, {
      "name" : "ILB Reason",
      "type" : "VARCHAR",
      "source" : "EDC"
    } ]
  }, {
    "filename" : "Sys_Links.csv",
    "dateapplied" : "2024-03-11 17:39:54",
    "cql" : "CALL SYS_LINKS",
    "columns" : [ {
      "name" : "Study.Name",
      "type" : "VARCHAR",
      "source" : "EDC"
    }, {
      "name" : "Site.Country",
      "type" : "VARCHAR",
      "source" : "EDC"
    }, {
      "name" : "Site.Number",
      "type" : "VARCHAR",
      "source" : "EDC"
    }, {
      "name" : "Subject.Name",
      "type" : "VARCHAR",
      "source" : "EDC"
    }, {
      "name" : "EventGroup.Name",
      "type" : "VARCHAR",
      "source" : "EDC"
    }, {
      "name" : "EventGroup.SeqNbr",
      "type" : "INTEGER",
      "source" : "EDC"
    }, {
      "name" : "Event.Name",
      "type" : "VARCHAR",
      "source" : "EDC"
    }, {
      "name" : "Form.Name",
      "type" : "VARCHAR",
      "source" : "EDC"
    }, {
      "name" : "Form.SeqNbr",
      "type" : "INTEGER",
      "source" : "EDC"
    }, {
      "name" : "ItemGroup.Name",
      "type" : "VARCHAR",
      "source" : "EDC"
    }, {
      "name" : "ItemGroup.SeqNbr",
      "type" : "INTEGER",
      "source" : "EDC"
    }, {
      "name" : "FormLink.Name",
      "type" : "VARCHAR",
      "source" : "EDC"
    }, {
      "name" : "Form.LinkCreatedDate",
      "type" : "DATETIME",
      "source" : "EDC"
    }, {
      "name" : "Form.LinkID",
      "type" : "VARCHAR",
      "source" : "EDC"
    } ]
  }, {
    "filename" : "Sys_Sites.csv",
    "dateapplied" : "2024-03-11 17:39:54",
    "cql" : "CALL SYS_SITES",
    "columns" : [ {
      "name" : "Study.Name",
      "type" : "VARCHAR",
      "source" : "EDC"
    }, {
      "name" : "Site.Country",
      "type" : "VARCHAR",
      "source" : "EDC"
    }, {
      "name" : "Site.Number",
      "type" : "VARCHAR",
      "source" : "EDC"
    }, {
      "name" : "Site.Name",
      "type" : "VARCHAR",
      "source" : "EDC"
    }, {
      "name" : "Site.PI",
      "type" : "VARCHAR",
      "source" : "EDC"
    } ]
  }, {
    "filename" : "Sys_Subjects.csv",
    "dateapplied" : "2024-03-11 17:39:54",
    "cql" : "CALL SYS_SUBJECTS",
    "columns" : [ {
      "name" : "Study.Name",
      "type" : "VARCHAR",
      "source" : "EDC"
    }, {
      "name" : "Site.Country",
      "type" : "VARCHAR",
      "source" : "EDC"
    }, {
      "name" : "Site.Number",
      "type" : "VARCHAR",
      "source" : "EDC"
    }, {
      "name" : "Subject.Name",
      "type" : "VARCHAR",
      "source" : "EDC"
    }, {
      "name" : "Subject.Status",
      "type" : "VARCHAR",
      "source" : "EDC"
    } ]
  } ]
}

Refer to Importing 3rd Party Data for more information about manifest files in Clinical Reporting

Schedule Recurring Exports

You can schedule a daily, weekly, or monthly export and select users to notify of the export package’s availability. Once a scheduled export finishes generating the package, you can download it from Export > Definitions, or deliver it via FTP to a location of your choosing.

To schedule a recurring export:

1. Navigate to Export > Definitions.
2. Click to open an Export Definition.
3. From the Export Definition () menu, select Properties.
4. Click Edit.
5. If a scheduled export already exists, click Add Schedule. You can have up to five (5) scheduled exports per Export Definition. Clinical Reporting doesn’t allow duplicate schedules (matching date, time, interval, and format).
6. Select the Schedule checkbox.
7. Select a Date and Time. This is the date of the first export. Clinical Reporting will then generate future export packages after the chosen interval (step 8) has passed. For example, if you select “Weekly” and “7 December 2020, 12:00 AM”, Clinical Reporting will generate an export package at that time, and then the next export would occur on “14 December 2020, 12:00AM” .
8. Select Daily, Weekly, or Monthly as an Interval.
9. Select CSV or SAS for Format. This determines the type of files that Clinical Reporting generates for the export package.
10. Optional: Select the Delivery checkbox and select an FTP delivery location. See Create an FTP Destination for details about creating destinations for delivery.
11. Click Save.

How to Edit a Scheduled Export

To edit a scheduled export:

1. Navigate to Export > Definitions.
2. Click to open an Export Definition.
3. From the Export Definition () menu, select Properties.
4. Click Edit.
5. Make changes as needed to the export Schedule and Delivery.
6. Click Save.

How to Stop a Scheduled Export

At any time, you can stop a scheduled export. The export won’t reoccur until you start it again.

To stop a scheduled export:

1. Navigate to Export > Definitions.
2. Click to open an Export Definition.
3. From the Export Definition () menu, select Properties.
4. Click Edit.
5. Clear the Schedule checkbox.
6. Click Save.

Create an FTP Connection

Clinical Reporting supports the use of both the provided Veeva Vault FTP server and third party FTP servers. If you plan to use a location other than the provided Vault FTP server, you must already have that server set up.

A user with the Vault Owner security profile can set up the Destination for a scheduled export from Tools > EDC Tools > FTPs.

If your vault uses custom Study Roles, your role must have the following permissions:

To set up an FTP Connection:

1. Navigate to your Study in Tools > EDC Tools > FTPs.
2. Click + New FTP.

3. Enter an FTP Name. This name will display in the Delivery drop-down menu of the Export Definition in the Exports section of EDC Clinical Reporting.

4. Select CDB for Type, even if you’re creating a connection to send exports from Clinical Reporting to the Veeva Vault FTP.
5. Enter your User Name. For the Veeva Vault FTP server, this is the User Name that you use to log in to Vault, including the domain, with the host in front. For example, “verteopharma.veevavault.com+cordelia.hunter@verteopharma.com”.
6. Enter your Password.
7. Confirm password.
8. Select FTP Scheme. Select FTPS if you’re sending your export from Clinical Reporting to the Veeva Vault FTP server.
9. Enter the Host. For the Veeva Vault FTP server, this is the URL of your vault: {DNS}.veevavault.com. For example, “veepharm” is the DNS in veepharm.veevavault.com.
10. Enter Port.
11. Enter the Destination Path for where you want to deliver the package. If necessary, you can create a Destination Path in the FTP server prior to entering it here. To create a Destination Path in the Veeva Vault FTP server, a user needs API Access permission.
12. Click Save.

For more information on connection field details and how to edit the FTP record, see Connecting to an FTP Server from EDC Tools.

Subscribe for Package Notifications

Clinical Reportingcan send an email notification when an export package enters a given status. Work with your organization’s user administrator to subscribe.

Clinical Reporting - Export

Last Updated: 24R1

This video shows how to export reports from EDC Clinical Reporting.