Study File Format API

The Study File Format (SFF) is a standardized method of exporting clinical data from Veeva EDC and CDB systems. SFF is accessed through the Study File Format API and comes as a single ZIP package that includes two main parts: the Study Data and the Study Definition.

SFF is useful for reporting on clinical and operational data and for integrating with other systems. The ZIP package contains a manifest file and CSVs that provide clinical, operational, and reference data. The manifest file details the relationship between the Study Definition and the Study Data.

Extraction Types: There are two types of SFF extraction, full and incremental. A full SFF extraction contains the entire dataset, from the start of data collection up to the latest SFF full extraction run. Full SFF extractions are available to users every 24 hours at 12:00PM UTC. Clinical and operational data can be generated incrementally to reflect any changes since the latest SFF extraction. Incremental extractions are only available to customers with a Study File Format API license. You can specify full or incremental when using the List Packages endpoint.

Licensing: Full SFF packages come with the Vault CDMS license, and can be enabled on a per-study basis by Study in EDC Tools. SFF incremental packages, which are published every 15 minutes, require an additional license (SFF API). Contact Veeva Support to request a Study File Format API license.

How to Enable Study File Format API

To enable the Study File Format feature in your vault:

1. Navigate to Tools > EDC Tools > Study Settings for your Study.

2. Click Edit.
3. Click Yes to Enable Study File Format API.

If you’re enabling SFF for the first time, wait until the first full SFF package is published and available through the API. This also applies if you disable the feature and then re-enable it for a Study.

Package Structure

SFF packages are provided in a ZIP file format. Inside the ZIP file, there is a folder named data that contains all the CSV files. In the root of the ZIP file, the “manifest.json” file contains the self-describing structure of the package, as well as the Study Design information.

The package file name format is as follows:

Study Name_SFF_Full/Incremental_YYYY_MM_DD_HH_MM_SS

For example, Natevba_SFF_Incremental_2024_08_16_00_30_00

The timestamp provided in the name indicates the publication time of the package.

Full Extraction

Full extraction of the ZIP package is available every 24 hours and is designed to help you update your downstream systems in situations such as:

• Enabling SFF for a Study for the first time
• During a new study design change or deployment
• Replacing your data with a full “refresh”
• Encountering a critical error that requires a restart

Study Design Data

Study design data in the manifest file is always extracted as a full dataset, not incrementally. The latest version of the study design data is captured with each extraction.

Labels and Override Labels

Labels and override labels include data from the latest study design version.

Incremental Extraction

Incremental extraction is available every 15 minutes to users holding the appropriate license (see Licensing above for more information). When using incremental extraction, if there are no changes between the last extract and the current extract, the file will be generated as a blank file with column headers only.

DELETES File

The DELETES CSV file is included in the incremental extraction’s reference data. It includes all deleted data necessary to identify which rows should be removed from your integrated systems.

ROWID Column

The ROWID column is included in every file, except the DELETES file, and can be used to identify updated and deleted rows. It consists of the ROWID (row ID), an underlying identifier used to create a unique row of data. The ROWID structure varies across files.

Tracking Changes

Any changes to the incremental extraction or ZIP package should be treated as an UPSERT (meaning update a row if the value already exists or insert a row if it doesn’t exist) versus an INSERT. The only exception to this is the DELETES file, which tracks deleted rows.

Manifest File

JSON is a structured format that can be used to map study design objects to Study Data. The manifest.json file allows users to consume data in a programmatic way. It defines the Study Data file structure and includes the study design.

The header information in the manifest file consists of the following:

• Study name
• Documentation URL
• SFF version
• Extract name
• Creation datetime
• Number of files in the package
• Whether the clinical data is incrementally generated or not
• What study design version the manifest refers to

The data is divided into four JSON code blocks:

• Operational Data
• Reference Data
• Clinical Data
• Study Design

Example Manifest File

Download an example manifest file.

  Download Example File

Operational & Reference Data

Operational Data (operational_data) defines operational data files, including system files, and Reference Data (reference_data) defines the reference data files associated with the Study.

Clinical Data

Clinical data (clinical_data) consists of the filename, source, form, and column headers:

Field	Description
Filename	Name of the CSV file (for example, “prescreening.csv”)
Source	The source of the clinical data file (for example, “EDC”)
Form	Name of the form definition
Columns	The array of file columns includes both pre-defined header columns and clinical item columns. Each item column represents a single Item Definition. Item Definition metadata is derived from EDC Studio. Items may have additional attributes, which are detailed in the Additional Item Attributes section below.

Additional Item Attributes

The following are examples of additional item attributes for clinical data in the manifest file:

• Name: Name of the attribute
• External_id: External ID of the attribute
• SDTM_name: SDTM name
• Datatype: Based on EDC data types (see section below)
• Length: Populated for text, number, codelist, and unit item types
• Precision: Populated for number and unit item types
• Unknown: Can be populated for date or datetime Item Definitions that allow for unknown parts
• Mask: Typically populated for unknown dates and datetimes
• Item_type: For example, edc__v, derived__v, read_only__v
• Itemgroups: Item Group Definition name(s)
  • If an Item Definition is reused across Item Group Definitions, all Item Group Definitions appear in the array in the order they are listed on the Form Definition
• Restricted: Restricted data, the boolean value equals true or false
• Codelist: Codelist Definition name
• Unit: Unit definition name

Datatype

Datatype item attributes are based on the following EDC data types:

• text
• codelist
• url
• label
• boolean
• number
• unit
• date
• datetime
• time

Study Design

The study design (study_design) block includes the following sections:

• Eventgroups: Defines all of the Event Group Definitions configured in the Study
• Events: Defines all of the Event Definitions configured in the Study
• Forms: Defines all of the Form Definitions configured in the Study
• Itemgroups: Defines all of the Item Group Definitions configured in the Study
• Codelists: Defines all of the Codelist Definitions used in the clinical data files (non-labs)
• Units: Defines all of the Unit Definitions used in the clinical data files (non-labs)
• Subject_groups: Defines all of the Subject Group Definitions configured in the Study

Information about each clinical item on a form is found within the clinical data JSON block of the manifest file. For each clinical file, there are reference keys to the Event Group, Event, and Form Definition names. This allows you to map the relationships between the clinical files and the study design objects.

The columns in the manifest file are not guaranteed to be in order. However, you can programmatically map each column to its corresponding CSV column header, which is preserved in order.

Study Data Files

The Study Data portion of SFF also consists of clinical, operational, and reference data. Clinical data files include header columns that indicate the Study, Site Country, Site, Event Group, Event, and Form associated with each subject. Each clinical item on a form will have its own column, positioned after the primary column headers.

Study Data files contain restricted data. The Study File Format API Access permission grants Restricted Data Access permission by default.

Names are typically used over labels for objects such as Event Group, Event, Form, Item Group, Item Definitions and Statuses. Labels can be found in the LABELS CSV file in the full SFF ZIP package. IDs are not visible in the SFF except as the ROWID, which is the unique identifier for a row of data.

Clinical Data Files

The clinical data files consist of one CSV file for each Form Definition. The title of the file is the same as the Form Definition Name. If there are multiple form definitions with the same name, the additional form definitions will have _2, _3, and so on appended to the file name. The order is determined by an alphabetical sort of both the Source Name and the Form Definition Name. Each file contains records representing a row of clinical data for a specific form instance. Clinical data includes forms in the Submitted and In Edit (in_progress_post_submit__v) status.

Clinical Data Headers

The clinical data headers are standard columns that represent the hierarchy of the clinical data within the form. The headers are common across all of the clinical data files.

The list of columns are as follows:

Column	Data Type	Description
STUDYNAME	text	Study Name
SITECOUNTRY	text	Study Site Three-Letter Country Code
SITENUM	text	Site Number
SUBJID	text	Subject Name
EGROUPNAME	text	Event Group Name
EGSEQ	number	Event Group Sequence
EVENTNAME	text	Event Name
FORMNAME	text	Form Name
FSEQ	number	Form Sequence
IGSEQ	number	Item Group Sequence
FORMSTATUS	text	Form Status
CREATEDDT	datetime	Datetime Form Created
FIRSTSUBMITDT	datetime	Datetime Form First Submitted
LASTSUBMITDT	datetime	Datetime Form Last Submitted
FORMLASTMODDT	datetime	Datetime Form Last Modified
Item Columns	varies	Item Columns (expands for the number of items on the form)
ROWWRITEDT	datetime	Datetime the row was written to the file
ROWID	text	Row ID

Clinical Item Data

Clinical Items appear after the header columns listed above for each clinical file, with each Item Definition Name in its own column. Data is dynamically added when necessary. For example, if an Item Group is non-repeating, the corresponding Item Group sequence will not be displayed in the clinical form.

Data Types & Formatting

Data Type	Format	Description
Text	String	For clinical data items, text can be represented as a codelist or URL data type. Statuses are represented with the name value. For example: submitted__v
Number	Digit	Defined precision and/or length
Dates	System dates are formatted as YYYY-MM-DD. Each clinical date has two columns: the Derived/ISO8601 Date and the RAW Date as entered.	There are two columns for each date, the derived ISO8601 format, and the RAW format. For example: BIRTHDT: 1990-01-25 and BIRTHDT_RAW: 25-Jan-1990
Datetimes	System datetimes have a UTC timezone. Each clinical datetime has two columns: the Derived/ISO8601 Datetime and the RAW Datetime as entered.	There are two columns for each datetime, the derived ISO8601 format, and the RAW format. For example: LBDTC: 2021-01-01T12:00:00 and BIRTHDT_RAW: 01-Jan-2021 12:00:00:
Times	HH:mm:ss	Standard format, ISO8601
Unknowns	For a date with an unknown day, the derived date format is 2024-06-01, and the RAW date format is UN-Jun-2024. For a datetime with an unknown day, the derived datetime format is 2024-06-01T00:00:00, and the RAW datetime format is UN-Jun-2024 UN:UN:UN. For a date with an unknown month + day, the derived date format is 2024-01-01, and the RAW date format is UN-UNK-2024. For a datetime with an unknown month + day, the derived datetime format is2024-01-01T00:00:00, and the RAW datetime format is UN-Jun-2024 UN-UNK-2024 UN:UN:UN. For an unknown time, the derived date format is 2024-06-02T00:00:00, and the RAW date format is 02-Jun-2024 UN:UN:UN.	The manner in which RAW date and datetime outputs represent unknown dates and datetimes. For the Derived date and datetime, the system will default the unknown portion (Month, Day, or Time) to January 1 at 00:00:00 UTC.
Booleans	True/False
Units	(item)_UOM (item)_TRANSLATED (item)_UOM_TRANSLATED	For each unit item, there is the unit value, translated value, and the translated unit value. These are denoted by appending suffixes to the clinical item name. The unit of measure (UOM) and translated unit of measure display the unit label.
Codelists	(item) (item)_DECODE	The code value is the item value. The DECODE or label is a secondary column dynamically added with a suffix appended to the item name. For example: ethnicity_DECODE

Operational Data & System Datasets

Along with clinical data, the SFF ZIP package contains several system datasets that contain operational data.

System datasets provide data related to specific CDMS objects and track the progress of all subjects within the Study. They are automatically included in the ZIP package and include the following files:

• SYS_EVENTS.csv
• SYS_FORMS.csv
• SYS_SUBJECTS.csv
• SYS_ILB.csv
• SYS_LINKS.csv
• SYS_SITES.csv
• QUERIES.csv
• QUERY_MSGS.csv

SYS_EVENTS

The SYS_EVENTS dataset describes the Event and Event Group associated with a particular subject, along with their current statuses and change reasons.

It contains the following Event Statuses:

• blank__v (Blank)
• submitted__v (Submitted)
• in_progress__v (In Progress)
• planned__v (Planned)
• did_not_occur__v (Did Not Occur)

List of SYS_EVENTS columns:

Column	Data Type	Description
STUDYNAME	text	Study Name
SITECOUNTRY	text	Study Site Three-Letter Country Code
SITENUM	text	Site Number
SUBJID	text	Subject Name
EGROUPNAME	text	Event Group Name
EGROUPORDER	number	Event Group Order
EGSEQ	number	Event Group Sequence
EVENTNAME	text	Event Name
EVENTORDER	number	Event Order
EVENTDT	date	Event Date
VISMETHOD	text	Visit Method
PLANNEDDT	date	Planned Date
OVERDUEDT	date	Event Overdue Date
EVENTSTATUS	text	Event Status
EVENTRESTRICTED	boolean	Event Restricted
CHANGEREASON	text	Event Change Reason
EXPFORMS	number	Expected Number of Forms
FROZEN	boolean	Event Frozen
FROZENDT	datetime	Datetime Event is Frozen
LOCKED	boolean	Event Locked
LOCKEDDT	datetime	Datetime Event is Locked
SIGNED	boolean	Event Signed
SIGNEDDT	datetime	Datetime Event is Signed
EVENTDTLASTMODDT	datetime	Event Date Last Modified Datetime
ROWWRITEDT	datetime	Datetime the row is written to the file
ROWID	text	Row ID

SYS_FORMS

The SYS_FORMS dataset offers an overview of all forms containing subject data, including form status, form-level review statuses for SDV and DMR, and form-level ILB (Intentionally Left Blank) information.

It contains the following Form Statuses:

• blank__v (Blank)
• submitted__v (Submitted)
• in_progress__v (In Progress)
• in_progress_post_submit__v (In Edit)

List of SYS_FORMS columns:

Column	Data Type	Description
STUDYNAME	text	Study Name
SITECOUNTRY	text	Study Site Three-Letter Country Code
SITENUM	text	Site Number
SUBJID	text	Subject Name
EGROUPNAME	text	Event Group Name
EGSEQ	number	Event Group Sequence
EVENTNAME	text	Event Name
FORMNAME	text	Form Name
FSEQ	number	Form Sequence
FORMSTATUS	text	Form Status
FORMRESTRICTED	boolean	Form Restricted
CREATEDDT	datetime	Form Created Date
FIRSTSUBMITDT	datetime	Form First Submit Date
LASTSUBMITDT	datetime	Form Last Submit Date
NUMSUBMITS	number	Number of Form Submits
OVERDUEDT	date	Form Overdue Date
CHANGEREASON	text	Form Change Reason
SDVOVRPLAN	text	SDV Override Plan
SDVREQ	boolean	SDV Required
SDVCOMP	boolean	SDV Completed
FIRSTSDVDT	datetime	First SDV Date
SDVCOMPDT	datetime	SDV Completed Datetime
SDVUSERMODDT	datetime	SDV User Modified Date
DMROVRPLAN	text	DMR Override Plan
DMRREQ	boolean	DMR Required
DMRCOMP	boolean	DMR Completed
FIRSTDMRDT	datetime	First DMR Date
DMRCOMPDT	datetime	DMR Completed Datetime
DMRUSERMODDT	datetime	DMR User Modified Date
FROZEN	boolean	Form Frozen
FROZENDT	datetime	Datetime Form is Frozen
LOCKED	boolean	Form Locked
LOCKEDDT	datetime	Datetime Form is Locked
SIGNED	boolean	Form Signed
SIGNEDDT	datetime	Datetime Form is Signed
ILB	boolean	Form Intentionally Left Blank
ILBREASON	text	Reason for Form Intentionally Left Blank
FORMLASTMODBY	text	Form Last Modified By
FORMLASTMODDT	datetime	Form Last Modified Datetime
ROWWRITEDT	datetime	Datetime the row is written to the file
ROWID	text	Row ID

SYS_SUBJECTS

The SYS_SUBJECTS dataset contains data related to the subjects within the Study.

List of SYS_SUBJECTS columns:

Column	Data Type	Description
STUDYNAME	text	Study Name
SITECOUNTRY	text	Study Site Three-Letter Country Code
SITENUM	text	Site Number
SUBJID	text	Subject Name
EGROUPNAME	text	Event Group Name
EGSEQ	number	Event Group Sequence
EVENTNAME	text	Event Name
FORMNAME	text	Form Name
FSEQ	number	Form Sequence
FORMSTATUS	text	Form Status
FORMRESTRICTED	boolean	Form Restricted
CREATEDDT	datetime	Form Created Date
FIRSTSUBMITDT	datetime	Form First Submit Date
LASTSUBMITDT	datetime	Form Last Submit Date
NUMSUBMITS	number	Number of Form Submits
OVERDUEDT	date	Form Overdue Date
EVDTTOSUB	number	Days from Event Date to Submit
CHANGEREASON	text	Form Change Reason
SDVOVRPLAN	text	SDV Override Plan
SDVREQ	boolean	SDV Required
SDVCOMP	boolean	SDV Completed
FIRSTSDVDT	datetime	First SDV Date
SDVCOMPDT	datetime	SDV Completed Datetime
SDVUSERMODDT	datetime	SDV User Modified Date
SUBTOSDV	number	Days from Submit to SDV
DMROVRPLAN	text	DMR Override Plan
DMRREQ	boolean	DMR Required
DMRCOMP	boolean	DMR Completed
FIRSTDMRDT	datetime	First DMR Date
DMRCOMPDT	datetime	DMR Completed Datetime
DMRUSERMODDT	datetime	DMR User Modified Date
SUBTODMR	number	Days from Submit to DMR
FROZEN	boolean	Form Frozen
FROZENDT	datetime	Datetime Form is Frozen
SUBTOFROZEN	number	Days from Submit to Frozen
LOCKED	boolean	Form Locked
LOCKEDDT	datetime	Datetime Form is Locked
SUBTOLOCKED	number	Days from Submit to Locked
SIGNED	boolean	Form Signed
SIGNEDDT	datetime	Datetime Form is Signed
SUBTOSIGNED	number	Days from Submit to Signed
ILB	boolean	Form Intentionally Left Blank
ILBREASON	text	Reason for Form Intentionally Left Blank
FORMLASTMODBY	text	Form Last Modified By
FORMLASTMODDT	datetime	Form Last Modified Datetime
ROWWRITEDT	datetime	Datetime the row is written to the file
ROWID	text	Row ID

SYS_ILB

The SYS_ILB dataset contains Intentionally Left Blank data for relevant items on a particular form for each subject across all study sites. It includes data in the Submitted status.

List of SYS_ILB columns:

Column	Data Type	Description
STUDYNAME	text	Study Name
SITECOUNTRY	text	Study Site Three-Letter Country Code
SITENUM	text	Site Number
SUBJID	text	Subject Name
EGROUPNAME	text	Event Group Name
EGSEQ	number	Event Group Sequence
EVENTNAME	text	Event Name
FORMNAME	text	Form Name
FSEQ	number	Form Sequence
IGROUPNAME	text	Item Group Name
IGSEQ	number	Item Group Sequence
ITEMNAME	text	Item Name
ILBREASON	text	Intentionally Left Blank Reason
ROWWRITEDT	datetime	Datetime the row is written to the file
ROWID	text	Row ID

SYS_LINKS

The SYS_LINKS dataset contains information regarding any links added to the clinical data for form-to-form linking.

List of SYS_LINKS columns:

Column	Data Type	Description
STUDYNAME	text	Study Name
SITECOUNTRY	text	Study Site Three-Letter Country Code
SITENUM	text	Site Number
SUBJID	text	Subject Name
EGROUPNAME	text	Event Group Name
EGSEQ	number	Event Group Sequence
EVENTNAME	text	Event Name
FORMNAME	text	Form Name
FSEQ	number	Form Sequence
LINKID	text	Link Vault ID
LINKCREATEDBY	text	Link Created By
LINKCREATEDDT	datetime	Link Created Datetime
ROWWRITEDT	datetime	Datetime the row is written to the file
ROWID	text	Row ID

SYS_SITES

This dataset contains data about Study Sites.

List of SYS_SITES columns:

Column	Data Type	Description
STUDYNAME	text	Study Name
SITECOUNTRY	text	Study Site Three-Letter Country Code
SITENUM	text	Site Number
SITENAME	text	Site Name
SITEPI	text	Site Principal Investigator
SITESTATUS	text	Site Status
SITETIMEZONE	text	Site Timezone
ROWWRITEDT	datetime	Datetime the row is written to the file
ROWID	text	Row ID

Queries

The Queries file contains a record of each query created in the Study, along with operational metrics such as when the query was opened, when it was closed, and who created it. You can use this data to calculate additional metrics for downstream reporting and analytics.

List of columns in the Queries file:

Column	Data Type	Description
STUDYNAME	text	Study Name
SITECOUNTRY	text	Study Site Three-Letter Country Code
SITENUM	text	Site Number
SUBJID	text	Subject Name
EGROUPNAME	text	Event Group Name
EGSEQ	number	Event Group Sequence
EVENTNAME	text	Event Name
EVENTDT	date	Event Date
EVENTSTATUS	text	Event Status
FORMNAME	text	Form Name
FSEQ	number	Form Sequence
IGROUPNAME	text	Item Group Name
IGSEQ	number	Item Group Sequence
ITEMNAME	text	Item Name
QUERYNAME	text	Query Name
QUERYID	text	Query ID
ORIGINSYS	text	Originating System
ORIGINID	text	Originating ID
ORIGINNAME	text	Originating Name
QUERYSTATUS	text	Query Status
QUERYTYPE	text	Query Type
QUERYRESTRICTED	boolean	Restricted Query
MANUALQUERY	boolean	Manual or System Query
RULEDEF	text	Rule Definition Name
TRIGID	text	Trigger Name
FIRSTQUERYMSG	text	First Query Message
QUERYTEAM	text	Query Team
QUERYROWEXTERNALID	text	Query Row External ID (Populated for queries on Non-Veeva EDC data if set)
QUERYCREATEDBY	text	Query Created By
QUERYCREATEDDT	datetime	Query Created Datetime
QUERYLASTCLOSEDDT	datetime	Query Last Closed Datetime
ROWWRITEDT	datetime	Datetime the row is written to the file
ROWID	text	Row ID

Query Messages

The Query Messages file complements the Queries file by displaying each message associated with a particular query. You can use the Query ID as a key to map between the Queries file and the Query Messages file.

List of columns in the Query Messages file:

Column	Data Type	Description
STUDYNAME	text	Study Name
SITECOUNTRY	text	Study Site Three-Letter Country Code
SITENUM	text	Site Number
SUBJID	text	Subject Name
QUERYNAME	text	Query Name
QUERYID	text	Query ID
QUERYMSGSTATUS	text	Query Message Status
RESTRICTEDMSG	boolean	Restricted Query Message
QUERYMSG	text	Query Message
QUERYMSGBY	text	Message Created By
QUERYMSGDT	datetime	Query Message Date
QUERYTEAM	text	Query Team that created the message
ROWWRITEDT	datetime	Datetime the row is written to the file
ROWID	text	Row ID

Reference Data Files

The reference data includes files for Labels, Display Override Labels, Deletes, Local Lab Unit Definitions, and Local Lab Codelist Definitions.

See Incremental Extraction for information regarding the DELETES file.

Labels

The Labels file displays labels related to Study Definition objects such as: Event Groups, Events, Forms, Item Groups and Items. The file includes labels from the latest study design version and is only available with the full SFF ZIP package. Labels are displayed in the language set for the vault in use.

List of columns in the Labels file:

Column	Data Type	Description
NAME	text	Object Name
LABEL	text	Object Label
TYPE	text	Object Type (such as eventgroup, event, form, itemgroup, item)
ROWWRITEDT	datetime	Datetime the row is written to the file
ROWID	text	Row ID

Example of a Labels file:

NAME	LABEL	TYPE	ROWWRITEDT	ROWID
prescreening	PreScreening	eventgroup	2024-06-01T21:06:00Z	prescreening_eventgroup
visit1	Visit 1	event	2024-06-01T21:06:00Z	visit1_event
physical_exam	Physical Exam	form	2024-06-01T21:06:00Z	physical_exam_form
ig_prescreen	PreScreening	itemgroup	2024-06-01T21:06:00Z	ig_prescreen_itemgroup
dob	Date of Birth	item	2024-06-01T21:06:00Z	dob_item
in_progress__v	In Progress	event_status	2024-06-01T21:06:00Z	in_progress__v_event_status
submitted__v	Submitted	event_status	2024-06-01T21:06:00Z	submitted__v_event_status
blank__v	Blank	event_status	2024-06-01T21:06:00Z	blank__v_event_status
did_not_occur__v	Did Not Occur	event_status	2024-06-01T21:06:00Z	did_not_occur__v_event_status
planned__v	Planned	event_status	2024-06-01T21:06:00Z	planned__v_event_status

Override Labels

List of columns in the Override Labels file:

Column	Data Type	Description
SRCDEFINITION	text	Source (Object) Definition Name
SRCLABELTYPE	text	Source (Object) Label Type: such as an eventgroup
TARGETDEFINITION	text	Target (Object) Definition Name
TARGETLABELTYPE	text	Target (Object) Label Type: such as an event
TARGETOVERRIDELABEL	text	Target (Object) Override Label
ROWWRITEDT	datetime	Datetime the row is written to the file
ROWID	text	Row ID

Local Lab Units

The Local Lab Units file displays the Unit Definitions related to the Local Labs module.

List of columns in the Lab Units file:

Column	Data Type	Description
UNITNAME	text	Unit Definition Name
UNITEXTID	text	Unit Definition External ID
UNITTYPE	text	Unit Definition Type
UNITITEMCODE	text	Unit Item Definition Code
UNITITEMDECODE	text	Unit Item Definition Decode
UNITITEMEXTID	text	Unit Item Definition External ID
UNITITEMABBR	text	Unit Item Definition Abbreviation
UNITITEMSTANDARD	boolean	Unit Item Definition Standard
UNITITEMCONV	text	Unit Item Definition Conversion Formula
ROWWRITEDT	datetime	Datetime the row is written to the file
ROWID	text	Row ID

Local Lab Codelists

The Local Lab Codelists file displays the Codelist Definitions related to the Local Labs module.

List of columns in the Local Lab Codelists file:

Column	Data Type	Description
CODELISTNAME	text	Codelist Definition Name
CODELISTEXTID	text	Codelist Definition External ID
CODELISTITEMCODE	text	Codelist Item Definition Code
CODELISTITEMDECODE	text	Codelist Item Definition Decode
ROWWRITEDT	datetime	Datetime the row is written to the file
ROWID	text	Row ID

For information on error handling, refer to the CDB-Specific Errors section in the CDMS Developer’s Portal.

Understanding Study Design Changes

If a study design change occurs in EDC, a new casebook version is published. When this occurs, the APIresponse returns the full_required field for both full and incremental extraction packages.

The response from the SFF API is interpreted differently depending on whether it is an incremental extraction or a full one:

• For an incremental package, if full_required equals true, incremental changes have stopped, and you have to wait for the next full SFF package to resume updates.
• For the full package, if full_required equals true, the package can be used to refresh your data with the latest full set.

If an error prevents incremental packages from capturing changes, the packages will still be produced but will be empty. This differs from packages being empty because there were no changes to the files.