Study Progress Versioned Extracts
24R1 Version
You can run specific versions of Study Progress Listing jobs with Study Progress Versioned Extracts in EDC Tools. Each version contains different columns according to the selected release. Refer to the tables below for the columns included in the 24R1 versions of Study Progress Versioned Extract jobs.
Form Progress Versioned Extract
The following columns are included in the 24R1 version of the Form Progress Versioned Extract job:
| Column Header | Description |
|---|---|
| STUDY | Study Label |
| COUNTRY | Study Country Name |
| SITENUM | Site Number |
| SUBJECT | Subject Number |
| SUBSTATUS | Current Subject Status |
| EGROUP | Event Group Label of the Event Group where the Query is |
| EVENT | Event Label of the Event where the Query is |
| ESEQ | Event Group Sequence Number |
| EVENTDT | Event Date entered |
| FORM | Form Label |
| FSEQ | Form Sequence Number |
| FORMSTATUS | Form Status (Planned, Blank, In Progress, Submitted, In Progress Post Submit) |
| FIRSTSUBMITDT | Datetime when the form was first submitted |
| LASTSUBMITDT | Datetime when the form was last submitted |
| NSUBMITS | Total number of form submissions |
| RESTRICTED | Shows if the Form is Restricted or not (Yes/No value) |
| COMPLETE | Shows if the Form is complete/submitted, including ILB forms (Yes/No value) |
| ILB | Shows if the Form was Intentionally Left Blank (Yes/No value) |
| ILBREAS | The reason the Form was marked as Intentionally Left Blank |
| LATE | Shows if the Form is late based on the Event Date and the number of overdue days allowed (Yes/No value) |
| DAYSOVERDUE | Shows the number of days beyond the overdue date |
| ALLITEMS | Calculates the total number of items on the form |
| ITEMSVAL | Calculates the number of items on the form with a saved value |
| ITEMSVALCHG | Calculates the number of items on the form with at least one data value change |
| SDVPLAN | SDV Review Plan assigned to the Subject |
| SDVOVRPLAN | SDV Review Plan override for the Form (from an override rule) |
| SDVCOMP | Shows whether SDV was completed for the Form |
| SDVREQ | Shows whether SDV is required for the Form |
| SDVREREQ | Shows whether SDV needs to be completed again after being cleared due to updates by the site |
| ITEMSSDVREQCOMP | Number of items on the Form where SDV is required and completed |
| ITEMSSDVREQ | Number of items on the Form where SDV is required |
| SDVPCTCOMP | Percentage of required SDV complete for the Form |
| SDVAGE | How long the Form has been submitted without SDV |
| FIRSTSDVCOMPDT | Date the Form was marked SDV |
| DMRPLAN | DMR Review Plan assigned to the Subject |
| DMROVRPLAN | DMR Review Plan override for the Form (from an override rule) |
| DMRCOMP | Shows whether DMR was completed for the Form |
| DMRREQ | Shows whether DMR is required for the Form |
| DMRREREQ | Shows whether DMR needs to be completed again after being cleared due to updates by the site |
| ITEMSDMRREQCOMP | Number of items on the Form where DMR is required and completed |
| ITEMSDMRREQ | Number of items on the Form where DMR is required |
| DMRPCTCOMP | Percentage of DMR complete for the Form |
| DMRAGE | How long the Form has been submitted without DMR |
| FIRSTDMRCOMPDT | Datetime when the Form was first marked as DMR complete |
| DMRCOMPDT | Date the form was marked DMR |
| FROZEN | Whether or not the Form is frozen (Yes/No value) |
| FROZENDT | Date the Form was frozen |
| LOCKED | Whether or not the Form is locked (Yes/No value) |
| LOCKEDDT | Date the Form was locked |
| SIGNED | Whether or not the Form is signed |
| SIGNEDDT | Date the Form was signed |
| LASTSGNDT | Date the Form was last signed |
| TQUERIES | Total number of queries on the Form |
| OQUERIES | Total number of open queries on the Form |
| AQUERIES | Total number of answered queries on the Form |
| CQUERIES | Total number of closed queries on the Form |
| FORMVOFID | Vof ID of the Form |
| LASTRUN | Datetime when the listing was last run |
Event Progress Versioned Extract
The following columns are included in the 24R1 version of the Event Progress Versioned Extract job:
| Column Header | Description |
|---|---|
| STUDY | Study Name |
| COUNTRY | Study Country Name |
| SITENUM | Site number |
| SUBJECT | Subject number |
| SUBSTATUS | Current Subject status |
| EGROUP | Event Group Label |
| EVENT | Event Label |
| EGSEQ | Event Group Sequence Number |
| EVENTTYPE | Event Type |
| EVENTDT | Event Date entered |
| VISMETHOD | Visit Method selected for this event |
| EVENTSTATUS | Event status (Planned, Blank, In Progress, Submitted, Did Not Occur) |
| DNO | Indicates if the event was marked as Did Not Occur (Yes/No value) |
| DNOREAS | Change Reason entered if the event was marked as Did Not Occur |
| RESTRICTED | Shows if the event is restricted or not (Yes/No value) |
| EPLANNEDDT | The low date relative to study design plan and not considered out of window |
| PLANNEDDT | The date from study design the event was planned for |
| LPLANNEDDT | The high date relative to study design plan and not considered out of window |
| OOW | If the event is out of window (below Early, above Late), or if missing (and past late grace) |
| DAYSOW | If Out of Window, display the number of days out of window |
| SDVPLAN | The SDV plan assigned to subject at time of generation |
| EVDTSDVCOMP | Shows whether the Event Date completed SDV (Yes/No value) |
| EVDTSDVREQ | Shows if SDV was required for the Event Date (Required, Optional, Not Required, Blank) |
| EVDTFSDVCOMPDT | Shows the date that the Event Date first underwent SDV |
| EVDTSDVCOMPDT | Shows the date when the Event Date underwent SDV |
| VMSDVCOMP | Shows whether the Visit Method completed SDV, if configured |
| VMSDVREQ | Shows if SDV was required for the Visit Method (Required, Optional, Not Required, Blank) |
| VMSDVCOMPDT | Shows the date when the Visit Method underwent SDV, if configured |
| TFSDVCOMP | Shows the total number of forms that completed SDV |
| TFSDVREQ | Total number of forms completed for this event, where at least one field is SDV required |
| SFSDVREQ | Number of submitted forms where SDV is required at the event |
| FSDVPCTCOMP | Percentage of forms that underwent SDV at this event |
| SDVCOMPDT | The date on which all forms at this event completed SDV for this subject |
| DMRPLAN | The DMR plan assigned to subject at time of generation |
| EVDTDMRCOMP | Shows whether the Event Date completed DMR (Yes/No value) |
| EVDTDMRREQ | Shows if DMR was required for the Event Date (Required, Optional, Not Required, Blank) |
| EVDTFDMRCOMPDT | Shows the date when the Event Date first underwent DMR |
| EVDTDMRCOMPDT | Shows the date when the Event Date underwent DMR |
| VMDMRCOMP | Shows whether DMR was completed for the Visit Method, if configured |
| VMDMRREQ | Shows if DMR was required for the Visit Method (Required, Optional, Not Required, Blank) |
| VMDMRCOMPDT | Shows the date the Visit Method underwent DMR, if configured |
| TFDMRCOMP | Total number of forms that underwent DMR for this event |
| TFDMRREQ | Total number of forms completed for this event, where at least one field is DMR required |
| SFDMRREQ | Number of submitted forms where DMR is required at the event |
| FDMRPCTCOMP | Percentage of forms that underwent DMR at this event |
| DMRCOMPDT | The date on which all forms at this event completed DMR for this subject |
| EVDTFROZEN | Shows if the Event Date was frozen (Yes/No value) |
| EVDTFROZENDT | The date that the Event Date was frozen |
| EVDTLOCKED | Shows if the Event Date was locked (Yes/No value) |
| EVDTLOCKEDDT | The date that the Event Date was locked |
| EVDTSIGNED | Shows if event date is signed (Yes/No value) |
| EVDTSIGNEDDT | The date when the event date was signed |
| VMFROZEN | Shows whether the Visit Method is frozen, if configured |
| VMFROZENDT | The date when the Visit Method was frozen |
| VMLOCKED | Shows whether the Visit Method is locked, if configured |
| VMLOCKEDDT | The date when the Visit Method was locked |
| VMSIGNED | Shows whether the Visit Method is signed, if configured |
| VMSIGNEDDT | The date when the Visit Method was signed |
| EVSIGNED | Shows whether the event is signed |
| EVSIGNEDDT | The date when the event was signed |
| EVFROZEN | Shows if the event is frozen (Yes/No value) |
| EVFROZENDT | The date when the event was frozen |
| EVLOCKED | Shows if the event is locked (Yes/No value) |
| EVLOCKED | The date when the event was locked |
| EVENTVOFID | Vof ID of the event |
| LASTRUN | Datetime when the listing was last run |
Query Detail Versioned Extract
The following columns are included in the 24R1 version of the Query Detail Versioned Extract job:
| Column Header | Description |
|---|---|
| STUDY | Study Name |
| COUNTRY | Study Country Name |
| SITENUM | Site Number |
| SUBJECT | Subject Number |
| SUBSTATUS | Current Subject Status |
| EGROUP | Event Group Label of the Event Group where the query is |
| EVENT | Event Label of the Event where the query is |
| EGSEQ | Event Group Sequence Number |
| EVENTDT | Event Date entered |
| VISMETHOD | Shows the selected Visit Method, if configured |
| FORM | Form Label of the Form where the query is |
| FSEQ | Form Sequence Number |
| FORMSTATUS | Form Status |
| IGROUP | Item Group Label of the Item Group where the query is |
| IGSEQ | Item Group Sequence Number |
| ITEMEID | External ID (OID) of the item that the query is attached to |
| ITEM | Label of the item that the query is attached to |
| QUERYID | The query name (VV-XXXXX) (not the internal vault ID) |
| QUERYSTATUS | Current Status of the query |
| RESTRICTED | Shows if the query is Restricted or not (Yes/No value) |
| QUERYTEAM | Query Team assigned to the query |
| DAYSUR | Days the query has been unresolved |
| MANUAL | Shows if the query was manually created (Yes/No value) |
| QUERYRULE | If a query rule, the rule that originates the query |
| QTEXT | First message text of the query |
| LQTEXT | Latest query message |
| LQANSTEXT | Last answer of the query |
| NUMMSG | The number of query messages on a query |
| ITEMVALBQ | Value of the item the query is attached to before query creation |
| ITEMVALNOW | Value of the item the query is attached to at the time of run |
| ITEMVALCHG | Shows whether the value of the queried item changed (Yes/No value) |
| QCHGDATA | Shows whether the query caused a data change (Yes/No value). This field is determined by checking if the item value was modified between creation and closing of the query (by dates). |
| CREATEDDT | Datetime of the creation of the query |
| CREATEDBY | User that created the query (or System) |
| CREATEDBYROLE | Role name of the user that created the query (or System) |
| CREATEDBYQTEAM | Query Team of the user that created the query |
| ANSDT | Datetime of last answer of the query |
| ANSBY | User that last answered the query |
| ANSBYROLE | Role name of the user that last answered the query |
| ANSBYQTEAM | Query Team of the user that last answered the query |
| CLOSEDDT | Datetime of last closing of the query |
| CLOSEDBY | User that last closed the query (or System) |
| CLOSEDBYROLE | Role name of the user that last closed the query (or System) |
| CLOSEDBYQTEAM | Query Team of the user that last closed the query |
| QUERYVOFID | Vault Query Object |
| LASTRUN | Datetime when the listing was last run |
Subject Progress Versioned Extract
The following columns are included in the 24R1 version of the Subject Progress Versioned Extract job:
| Column Header | Description |
|---|---|
| STUDY | Study Name |
| COUNTRY | Study Country Name |
| SITENUM | Site Number |
| SUBJECT | Subject Number |
| SUBSTATUS | Current Subject status |
| RESTRICTED | Shows if the Subject is Restricted (Yes/No value) |
| MRVISIT | Last visit/event label of scheduled visits |
| MRVISITDT | Last visit/event date of scheduled visits |
| MEMRVISIT | Last visit/Visit Method |
| NXTEVENT | Next visit/event label of scheduled visits |
| ENTRYCOMP | Shows if all forms expected for a Subject have been submitted (Yes/No value) |
| SDVPLAN | SDV Plan assigned to the Subject |
| SDVCOMP | Shows if all forms and all event dates that require SDV have been marked SDV for the Subject |
| FSDVCOMPDT | The date that SDV was completed on all forms for the Subject |
| DMRPLAN | DMR plan assigned to the Subject |
| DMRCOMP | Shows if all forms and all event dates that require DMR have been marked DMR for the Subject |
| FDMRCOMPDT | The date that DMR was completed on all forms for the Subject |
| FROZEN | Shows if all forms and all event dates have been frozen for the Subject |
| LOCKED | Shows if all forms and all event dates have been locked for the Subject |
| SIGNED | Shows if all submitted forms and all event dates have been signed for the Subject |
| CLOSEDQUERIES | Shows if all queries for the Subject have been closed |
| CLEAN | Shows if a Subject is "clean," meaning that all forms are submitted, signed, and locked and all queries are closed. SDV and DMR should also be completed (Yes/No value) |
| NUMFORMS | Total number of forms for Subject |
| FORMSCOMP | Number of forms submitted |
| FORMSINC | Number of forms that are blank or in progress (e.g. forms that are not submitted yet) |
| FSDVCOMP | Number of forms that were marked as SDV reviewed for the subject |
| FSDVREQ | Number of forms that are SDV required for the subject |
| SFSDVREQ | Number of submitted forms that are SDV required for the subject |
| FSDVPCTCOMP | Percentage of forms that were marked as SDV reviewed for the subject compared to the number of forms marked SDV required |
| FNOTSDV | Number of forms submitted that require SDV based on the review plan but have not been marked for SDV |
| EVDTNOTSDV | Number of event dates that require SDV that have not been marked SDV for the Subject |
| VMNOTSDV | Number of Visit Methods that require SDV that have not been marked SDV for the Subject |
| FDMRCOMP | Number of forms that were marked as DMR reviewed for the Subject |
| FDMRREQ | Number of forms that are DMR required for the subject |
| SFDMRREQ | Number of submitted forms that are DMR required for the subject |
| FDMRPCTCOMP | Percentage of forms that were marked as DMR reviewed for the subject compared to the number of forms marked DMR required |
| FNOTDMR | Number of forms submitted that require DMR based on the review plan but have not been marked for DMR |
| EVDTNOTDMR | Number of event dates that require DMR that have not been marked DMR for the Subject |
| VMNOTDMR | Number of Visit Methods that require DMR that have not been marked DMR for the Subject |
| FNOTFROZEN | Total number of submitted forms that are not frozen |
| EVDTNOTFROZEN | Total number of event dates that are not frozen |
| VMNOTFROZEN | Total number of Visit Methods to be frozen |
| FNOTLOCKED | Total number of submitted forms that are not locked |
| EVDTNOTLOCKED | Total number of event dates that are not locked |
| VMNOTLOCKED | Total number of Visit Methods to be locked |
| FNOTSIGNED | Total number of submitted forms that are not signed |
| EVDTNOTSIGNED | Total number of event dates that are not signed |
| VMNOTSIGNED | Total number of Visit Methods to be signed |
| TOTALMC | Total Medical Coding Requests for the Subject |
| MEDDRAMC | Total MedDRA Medical Coding Requests |
| WHORDRUGMC | Total WHODrug Medical Coding Requests |
| MEDDRANC | MedDRA Medical Coding Requests that are not yet coded |
| WHODRUGNC | WHODrug Medical Coding Requests that are not yet coded |
| TQUERIES | Total number of queries |
| OQUERIES | Total number of open queries |
| AQUERIES | Total number of answered queries |
| CQUERIES | Total number of closed queries |
| SUBVOFID | Vof ID of the Subject |
| LASTRUN | Datetime when the listing was last run |