Variable
Name |
Description |
Scope |
Data Type |
UI Field (if
applicable) |
Comments |
UI Comments (applicable when using the variable in Custom Field default
value formula) |
$assignedProviderId |
Programmatic
identifier of the service provider assigned |
Task or Cost |
integer |
-- |
This variable
is only available in the context of a task/resource algorithm or an indirect
cost algorithm |
The programmer
has to know the ID of the service provider(s) in which they are interested |
$avgGrantAmount |
The
amount per subject expected for investigator grants in the currency defined
for a cost |
Location |
floating-point
number |
-- |
This
variable is only available in the context of an indirect cost algorithm |
This
variable is only available in the context of an indirect cost algorithm |
$avgCrfPagesPerScreenedSubject |
The
number of CRF pages collected during screening |
Study |
integer |
Treatment
-> CRF Pages/screen subject |
This
variable represents the average across treatments and replaces the deprecated
$numCrfPagesPerScreenFailure variable |
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Treatment tab or beyond |
$bioFactor |
Indication-specific
factor of complexity |
Study |
floating-point
number |
-- |
Indication-specific
value |
Can
be used in a field on any tab |
$edcFactor |
Indication-specific
factor of complexity related to EDC |
Study |
floating-point
number |
-- |
Indication-specific
value |
Can
be used in a field on any tab |
$edcMaturityLevel |
Represents
the choice of maturity level for EDC |
Study |
integer
(identifier) |
Data
-> EDC Maturity Level |
Corresponds
to EDC Maturity Level Choices shown on the Lookups tab |
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Data tab or beyond |
$indicationID |
Numeric
identifier of the Indication |
Study |
integer
(identifier) |
-- |
Corresponds
to the Indications Lookup Table on the Lookups tab |
Can
be used in a field on any tab |
$invPaymentPerScreenFail |
The
amount paid per screen failure in the currency defined for a cost |
Location |
floating-point
number |
Treatment
-> Investigator payment per screen failure |
This
variable is only available in the context of an indirect cost algorithm |
This
variable is only available in the context of an indirect cost algorithm |
$isEDC |
Indicates
whether data collection method is Electronic Data Capture |
Study |
boolean |
Data
-> Data Collection Method |
Corresponds
specifically to the choice of Electronic Data Capture as the Data
Collection Method; returns false if
the choice is EDC 3rd Party |
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Data tab or beyond |
$isEDCThirdParty |
Indicates
whether Electronic Data Capture is done by a third-party |
Study |
boolean |
Data
-> Data Collection Method |
Corresponds
specifically to the choice of EDC 3rd Party as
the Data Collection Method; returns
false if the choice is Electronic Data Capture |
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Data tab or beyond |
$isEndpointTrial |
Indicates
whether the trial is modeled as an endpoint trial |
Study |
boolean |
Treatment
-> Is this an endpoint study? |
Always
false for Phase 1 (HV) |
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Treatment tab or beyond |
$isSupplementalCsrExpected |
Indicates
whether a supplemental, or end-of-study, CSR is expected |
Study |
boolean |
Data
-> Will there be a supplemental CSR |
This
variable is only applicable when one or more treatments defines a follow-up
period |
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Data tab or beyond |
$medicalMonitoringFactor |
Indication-specific
factor of complexity related to medical monitoring |
Study |
floating-point
number |
-- |
Indication-specific
value |
Can
be used in a field on any tab |
$mohDelay |
Location-specific
regulatory delay |
Location |
integer |
Locations
-> MOH/FDA Delay |
If
used in a study-scoped formula, returns 0 |
Can
be used in a field on any tab |
$monitoringTimeRequiredForBaselineVisit |
The
number of minutes required to monitor pages collected during baseline visit |
Study |
floating-point
number |
Treatment
-> Baseline visit monitoring time required (in minutes) |
Applies
only to crossover trials |
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Treatment tab or beyond |
$numAlternateSubjects |
The
number of alternate subjects to be screened and randomized |
Either |
integer |
Treatment
-> Alternate Subjects |
Applies
only to Phase 1 (HV) trials |
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Treatment tab or beyond |
$numBednightsDuringWashoutPeriod |
The
number of bednights expected during washout period |
Study |
integer |
Treatment
-> Number of bednights during the washout period |
Applies
only to Phase 1 (HV) crossover trials |
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Treatment tab or beyond |
$numBedNightsTreatmentA |
The
number of nights subjects will be confined to the study center for treatment
A |
Study |
integer |
Treatment
-> A -> Number of bednights |
Applies
only to Phase 1 (HV) trials |
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Treatment tab or beyond |
$numBedNightsTreatmentB |
The
number of nights subjects will be confined to the study center for treatment
B |
Study |
integer |
Treatment
-> B -> Number of bednights |
Applies
only to Phase 1 (HV) trials |
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Treatment tab or beyond |
$numBedNightsTreatmentC |
The
number of nights subjects will be confined to the study center for treatment
C |
Study |
integer |
Treatment
-> C -> Number of bednights |
Applies
only to Phase 1 (HV) trials |
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Treatment tab or beyond |
$numBedNightsTreatmentD |
The
number of nights subjects will be confined to the study center for treatment
D |
Study |
integer |
Treatment
-> D -> Number of bednights |
Applies
only to Phase 1 (HV) trials |
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Treatment tab or beyond |
$numBedNightsTreatmentE |
The
number of nights subjects will be confined to the study center for treatment
E |
Study |
integer |
Treatment
-> E -> Number of bednights |
Applies
only to Phase 1 (HV) trials |
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Treatment tab or beyond |
$numCohortEscalationReviews |
The
number of cohort escalation reviews |
Either |
integer |
-- |
Total
across (scope) |
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Treatment tab or beyond |
$numCrfBooksPrinted |
The
number of CRF books to be printed |
Study |
integer |
-- |
This
is based on the number of subjects |
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Data tab or beyond |
$numCrfPagesAudited |
The
number of CRF Page equivalents to be audited |
Either |
integer |
-- |
This
is based on Percent of database data to audit |
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Data tab or beyond |
$numCrfPagesInBaselineVisit |
The
number of CRF pages to be collected during baseline visit |
Study |
integer |
Treatment
-> Number of CRF pages collected in the baseline visit |
Applies
only to crossover trials* |
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Treatment tab or beyond |
$numCrfPagesPerExtendedVisitTreatmentA |
The
number of CRF pages per extended visit for treatment A |
Study |
integer |
Treatment
-> A -> Average CRF pages per extended visit |
Applies
only to endpoint studies |
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Treatment tab or beyond |
$numCrfPagesPerExtendedVisitTreatmentB |
The
number of CRF pages per extended visit for treatment B |
Study |
integer |
Treatment
-> B -> Average CRF pages per extended visit |
Applies
only to endpoint studies |
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Treatment tab or beyond |
$numCrfPagesPerExtendedVisitTreatmentC |
The
number of CRF pages per extended visit for treatment C |
Study |
integer |
Treatment
-> C -> Average CRF pages per extended visit |
Applies
only to endpoint studies |
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Treatment tab or beyond |
$numCrfPagesPerExtendedVisitTreatmentD |
The
number of CRF pages per extended visit for treatment D |
Study |
integer |
Treatment
-> D -> Average CRF pages per extended visit |
Applies
only to endpoint studies |
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Treatment tab or beyond |
$numCrfPagesPerExtendedVisitTreatmentE |
The
number of CRF pages per extended visit for treatment E |
Study |
integer |
Treatment
-> E -> Average CRF pages per extended visit |
Applies
only to endpoint studies |
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Treatment tab or beyond |
$numDaysActiveTreatment |
The
number of days between FSFT and LSLT |
Either |
integer |
-- |
"Either"
scope fields return a value appropriate to the scope in which it is used |
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Treatment tab or beyond |
$numDaysFromLslvToEndOfStudyDbLock |
The
number of days from LSLT/LSLV to End of Study Database Lock |
Study |
integer |
Data
-> Days from LSLV/LPLV until Database Lock (EOS) |
Applicable
when one or more treatments defines a follow-up and there will be a
supplemental CSR |
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Data tab or beyond |
$numDaysFromEosDbLockToEosStatReport |
The
number of days from End of Study Database Lock to delivery of End of Study
stat report |
Study |
integer |
Data
-> Days from Database Lock (EOS) until Statistical Report (EOS) |
Applicable
when one or more treatments defines a follow-up and there will be a
supplemental CSR |
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Data tab or beyond |
$numDaysFromEosDbLockToEosDraftReport |
The
number of days from End of Study Database Lock to delivery of End of Study
draft report |
Study |
integer |
Data
-> Days from Database Lock (EOS) until Draft Report (EOS) |
Applicable
when one or more treatments defines a follow-up and there will be a
supplemental CSR |
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Data tab or beyond |
$numDaysFromEosDbLockToEosFinalReport |
The
number of days from Database Lock to delivery of final report |
Study |
integer |
Data
-> Days from Database Lock (EOS) until Final Report (EOS) |
Applicable
when one or more treatments defines a follow-up and there will be a
supplemental CSR |
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Data tab or beyond |
$numDaysFromFirstSiteToLastSite |
The
number of days from FSA to LSA |
Either |
integer |
-- |
"Either"
scope fields return a value appropriate to the scope in which it is used |
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Site tab or beyond |
$numDaysForCost |
The
number of days during which this cost occurs |
Either |
integer |
-- |
This
variable is only available in the context of an indirect cost algorithm |
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Cost tab or beyond |
$numDaysForTask |
The
number of days during which the effort for this task occurs |
Either |
integer |
-- |
This
variable is only available in the context of a task/resource algorithm |
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Labor tab or beyond |
$numDaysFromFsftToEndpoint |
The
number of days from FSFT to Endpoint date |
Either |
integer |
Treatment
-> Weeks from FSI to endpoint |
"Either"
scope fields return a value appropriate to the scope in which it is used |
Should
not be used on tabs prior to the Treatment tab |
$numDaysFromFsftToFslt |
The
number of days from FSFT to FSLT |
Either |
integer |
Treatment
-> Treatment duration |
"Either"
scope fields return a value appropriate to the scope in which it is used |
Should
not be used on tabs prior to the Treatment tab |
$numDaysFromFsftToLsft |
The
number of days from FSFT to LSFT |
Either |
integer |
Treatment
-> Enrollment period |
"Either"
scope fields return a value appropriate to the scope in which it is used |
Should
not be used on tabs prior to the Subject tab |
$numDaysFromFsftToLslt |
The
number of days from FSFT to LSLT (the active treatment period) |
Either |
integer |
-- |
"Either"
scope fields return a value appropriate to the scope in which it is used |
Should
not be used on tabs prior to the Treatment tab |
$numDaysFromFsftToLslv |
The
number of days from FSFT to LSLV |
Either |
integer |
-- |
"Either"
scope fields return a value appropriate to the scope in which it is used |
Should
not be used on tabs prior to the Treatment tab |
$numDaysFromFsltToLsft |
The
number of days from FSLT to LSFT |
Either |
integer |
-- |
"Either"
scope fields return a value appropriate to the scope in which it is used |
Should
not be used on tabs prior to the Treatment tab |
$numDaysFromFsltToLslt |
The
number of days from FSLT to LSLT |
Either |
integer |
-- |
"Either"
scope fields return a value appropriate to the scope in which it is used |
Should
not be used on tabs prior to the Treatment tab |
$numDaysFromLsftToEndpoint |
The
number of days from LSFT to Endpoint date |
Either |
integer |
-- |
"Either"
scope fields return a value appropriate to the scope in which it is used |
Should
not be used on tabs prior to the Treatment tab |
$numDaysFromLsftToLslt |
The
number of days from LSFT to LSLT |
Either |
integer |
-- |
"Either"
scope fields return a value appropriate to the scope in which it is used |
Should
not be used on tabs prior to the Treatment tab |
$numDaysFromLsltToDbLock |
The
number of days from LSLT/LSLV to Database Lock |
Either |
integer |
Data
-> Days from LSO/LPO until Database Lock |
"Either"
scope fields return a value appropriate to the scope in which it is used |
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Data tab or beyond |
$numDaysFromStartToFirstSite |
The
number of days from PASD to FSA |
Either |
integer |
-- |
"Either"
scope fields return a value appropriate to the scope in which it is used |
Should
not be used on tabs prior to the Site tab |
$numDaysFromStartToFsft |
The
number of days from PASD to FSFT |
Either |
integer |
-- |
"Either"
scope fields return a value appropriate to the scope in which it is used |
Should
not be used on tabs prior to the Subject tab |
$numDaysFromStartToLastSite |
The
number of days from PASD to LSA |
Either |
integer |
-- |
"Either"
scope fields return a value appropriate to the scope in which it is used |
Should
not be used on tabs prior to the Site tab |
$numDaysFromStartToLsft |
The
number of days from PASD to LSFT |
Either |
integer |
-- |
"Either"
scope fields return a value appropriate to the scope in which it is used |
Should
not be used on tabs prior to the Subject tab |
$numDaysFromStartToLslt |
The
number of days from PASD to LSLT/LSLV |
Either |
integer |
-- |
"Either"
scope fields return a value appropriate to the scope in which it is used |
Should
not be used on tabs prior to the Treatment tab |
$numDiaryPagesPerExtendedVisitTreatmentA |
The
number of subject diary pages per extended visit for treatment A |
Study |
integer |
Treatment
-> A -> Subject diary pages per extended visit |
Applies
only to endpoint studies |
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Treatment tab or beyond |
$numDiaryPagesPerExtendedVisitTreatmentB |
The
number of subject diary pages per extended visit for treatment B |
Study |
integer |
Treatment
-> B -> Subject diary pages per extended visit |
Applies
only to endpoint studies |
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Treatment tab or beyond |
$numDiaryPagesPerExtendedVisitTreatmentC |
The
number of subject diary pages per extended visit for treatment C |
Study |
integer |
Treatment
-> C -> Subject diary pages per extended visit |
Applies
only to endpoint studies |
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Treatment tab or beyond |
$numDiaryPagesPerExtendedVisitTreatmentD |
The
number of subject diary pages per extended visit for treatment D |
Study |
integer |
Treatment
-> D -> Subject diary pages per extended visit |
Applies
only to endpoint studies |
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Treatment tab or beyond |
$numDiaryPagesPerExtendedVisitTreatmentE |
The
number of subject diary pages per extended visit for treatment E |
Study |
integer |
Treatment
-> E -> Subject diary pages per extended visit |
Applies
only to endpoint studies |
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Treatment tab or beyond |
$numDrugShipments |
The
total number of drug or device shipments |
Either |
integer |
-- |
Total
across (scope) |
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Site tab or beyond |
$numDsmbReports |
The
number of DSMB reports expected |
Study |
integer |
-- |
Based
on frequency chosen for the Data Tab field "Provide data to the
DSMB" |
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Data tab or beyond |
$numExpeditedSAEs |
The
number of SAE reports expedited to regulatory agencies and ethics committees |
Either |
integer |
-- |
Based
on the Data Tab field "Expected percent of SAE Reports to be
expedited" |
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Data tab or beyond |
$numFollowUpVisits |
The
number of follow-up visits for all subjects |
Either |
integer |
-- |
"Either"
scope fields return a value appropriate to the scope in which it is used |
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Treatment tab or beyond |
$numInvestigatorMeetings |
The
number of investigator meetings planned |
Location**
/ Either |
integer |
-- |
Returns
the number of meetings planned to take place in the specified location or the
total number of Inv Meetings |
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Meetings tab or beyond |
$numLabDiagnosticTestsPerSubjectTreatmentB |
The
number of diagnostic tests per subject for treatment B |
Study |
integer |
Treatment
-> B -> Lab and diagnostic tests per subject |
|
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Treatment tab or beyond |
$numLabDiagnosticTestsPerSubjectTreatmentC |
The
number of diagnostic tests per subject for treatment C |
Study |
integer |
Treatment
-> C -> Lab and diagnostic tests per subject |
|
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Treatment tab or beyond |
$numLabDiagnosticTestsPerSubjectTreatmentD |
The
number of diagnostic tests per subject for treatment D |
Study |
integer |
Treatment
-> D -> Lab and diagnostic tests per subject |
|
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Treatment tab or beyond |
$numLabDiagnosticTestsPerSubjectTreatmentE |
The
number of diagnostic tests per subject for treatment E |
Study |
integer |
Treatment
-> E -> Lab and diagnostic tests per subject |
|
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Treatment tab or beyond |
$numLocations |
The
number of locations |
Either |
integer |
Locations |
For
each specific location, just returns '1' |
Can
be used on any tab, but probably doesn't make sense on the Overview tab |
$numMinutesCrfDataCoordination |
The
number of minutes (per page) for data coordination |
Study |
floating-point
number |
Data
-> Minutes for Data Coordination per CRF page |
|
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Data tab or beyond |
$numMinutesCrfDataEntry |
The
number of minutes (per page) for data entry |
Study |
floating-point
number |
Data
-> Minutes for Data Entry per CRF page |
|
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Data tab or beyond |
$numMinutesQueryReview |
The
number of minutes to re-review queries/CRF data from a previous visit |
Either |
floating-point
number |
Time
to review queries from previous visit (minutes) |
|
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Monitoring tab or beyond |
$numMonitoringDays |
The
number of monitoring days expected |
Either |
integer |
Monitoring
-> (table of values) |
|
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Monitoring tab or beyond |
$numMonitoringMinutesPerCrfPageTreatmentA |
The
number of minutes to monitor each page for treatment A |
Study |
integer |
Treatment
-> A -> Monitoring minutes per CRF page |
|
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Treatment tab or beyond |
$numMonitoringMinutesPerCrfPageTreatmentB |
The
number of minutes to monitor each page for treatment B |
Study |
integer |
Treatment
-> B -> Monitoring minutes per CRF page |
|
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Treatment tab or beyond |
$numMonitoringMinutesPerCrfPageTreatmentC |
The
number of minutes to monitor each page for treatment C |
Study |
integer |
Treatment
-> C -> Monitoring minutes per CRF page |
|
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Treatment tab or beyond |
$numMonitoringMinutesPerCrfPageTreatmentD |
The
number of minutes to monitor each page for treatment D |
Study |
integer |
Treatment
-> D -> Monitoring minutes per CRF page |
|
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Treatment tab or beyond |
$numMonitoringMinutesPerCrfPageTreatmentE |
The
number of minutes to monitor each page for treatment E |
Study |
integer |
Treatment
-> E -> Monitoring minutes per CRF page |
|
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Treatment tab or beyond |
$numMonitoringVisits |
The
number of monitoring visits expected |
Either |
integer |
Monitoring
-> Total visits |
|
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Treatment tab or beyond |
$numMonths |
The
number of months between the study start date and the study end date |
Study |
integer |
-- |
|
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Data or Monitoring tab or
beyond |
$numMonthsForTask |
The
number of months during which the effort for this task occurs |
Either |
integer |
-- |
This
variable is only available in the context of a task/resource algorithm |
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Labor tab or beyond |
$numOneAndOneHalfDayMonitoringTrips |
The
number of one and one half day monitoring visits expected |
Either |
integer |
Monitoring
-> (table of values) |
|
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Monitoring tab or beyond |
$numOneDayMonitoringTrips |
The
number of one day monitoring visits expected |
Either |
integer |
Monitoring
-> (table of values) |
|
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Monitoring tab or beyond |
$numPharmacoEconomicPagesPerExtendedVisitTreatmentA |
The
number of pharmacoeconomic pages/extended visit for treatment A |
Study |
integer |
Treatment
-> A -> Pharmacoeconomic pages per extended visit |
Applies
only to endpoint studies |
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Treatment tab or beyond |
$numPharmacoEconomicPagesPerExtendedVisitTreatmentB |
The
number of pharmacoeconomic pages/extended visit for treatment B |
Study |
integer |
Treatment
-> B -> Pharmacoeconomic pages per extended visit |
Applies
only to endpoint studies |
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Treatment tab or beyond |
$numPharmacoEconomicPagesPerExtendedVisitTreatmentC |
The
number of pharmacoeconomic pages/extended visit for treatment C |
Study |
integer |
Treatment
-> C -> Pharmacoeconomic pages per extended visit |
Applies
only to endpoint studies |
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Treatment tab or beyond |
$numPharmacoEconomicPagesPerExtendedVisitTreatmentD |
The
number of pharmacoeconomic pages/extended visit for treatment D |
Study |
integer |
Treatment
-> D -> Pharmacoeconomic pages per extended visit |
Applies
only to endpoint studies |
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Treatment tab or beyond |
$numPharmacoEconomicPagesPerExtendedVisitTreatmentE |
The
number of pharmacoeconomic pages/extended visit for treatment E |
Study |
integer |
Treatment
-> E -> Pharmacoeconomic pages per extended visit |
Applies
only to endpoint studies |
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Treatment tab or beyond |
$numPharmacoEconomicPagesPerSubjectTreatmentB |
The
number of pharmacoeconomic pages/subject for treatment B |
Study |
integer |
Treatment
-> B -> Pharmacoeconomic pages |
|
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Treatment tab or beyond |
$numPharmacoEconomicPagesPerSubjectTreatmentC |
The
number of pharmacoeconomic pages/subject for treatment C |
Study |
integer |
Treatment
-> C -> Pharmacoeconomic pages |
|
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Treatment tab or beyond |
$numPharmacoEconomicPagesPerSubjectTreatmentD |
The
number of pharmacoeconomic pages/subject for treatment D |
Study |
integer |
Treatment
-> D -> Pharmacoeconomic pages |
|
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Treatment tab or beyond |
$numPharmacoEconomicPagesPerSubjectTreatmentE |
The
number of pharmacoeconomic pages/subject for treatment E |
Study |
integer |
Treatment
-> E -> Pharmacoeconomic pages |
|
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Treatment tab or beyond |
$numPhoneMonitoringVisits |
The
number of phone-based interim monitoring visits expected |
Either |
integer |
-- |
"Either"
scope fields return a value appropriate to the scope in which it is used |
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Monitoring tab or beyond |
$numPreStudySiteVisits |
The
number of pre-study site visits |
Either |
integer |
-- |
Based
on Site -> Percent of sites requiring a pre-study site visit (in-person) |
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Site tab or beyond |
$numProtocolAmendments |
The
number of protocol amendments expected |
Study |
integer |
-- |
Based
on Data Tab amendments; one per added amendment |
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Data tab or beyond |
$numQolPagesPerExtendedVisitTreatmentA |
The
number of Quality of Life pages per extended visit for treatment A |
Study |
integer |
Treatment
-> A -> QOL pages per extended visit |
Applies
only to endpoint studies |
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Treatment tab or beyond |
$numQolPagesPerExtendedVisitTreatmentB |
The
number of Quality of Life pages per extended visit for treatment B |
Study |
integer |
Treatment
-> B -> QOL pages per extended visit |
Applies
only to endpoint studies |
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Treatment tab or beyond |
$numQolPagesPerExtendedVisitTreatmentC |
The
number of Quality of Life pages per extended visit for treatment C |
Study |
integer |
Treatment
-> C -> QOL pages per extended visit |
Applies
only to endpoint studies |
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Treatment tab or beyond |
$numQolPagesPerExtendedVisitTreatmentD |
The
number of Quality of Life pages per extended visit for treatment D |
Study |
integer |
Treatment
-> D -> QOL pages per extended visit |
Applies
only to endpoint studies |
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Treatment tab or beyond |
$numQolPagesPerExtendedVisitTreatmentE |
The
number of Quality of Life pages per extended visit for treatment E |
Study |
integer |
Treatment
-> E -> QOL pages per extended visit |
Applies
only to endpoint studies |
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Treatment tab or beyond |
$numQolPagesPerSubjectTreatmentB |
The
number of Quality of Life pages per subject for treatment B |
Study |
integer |
Treatment
-> B -> QOL pages |
|
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Treatment tab or beyond |
$numQolPagesPerSubjectTreatmentC |
The
number of Quality of Life pages per subject for treatment C |
Study |
integer |
Treatment
-> C -> QOL pages |
|
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Treatment tab or beyond |
$numQolPagesPerSubjectTreatmentD |
The
number of Quality of Life pages per subject for treatment D |
Study |
integer |
Treatment
-> D -> QOL pages |
|
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Treatment tab or beyond |
$numQolPagesPerSubjectTreatmentE |
The
number of Quality of Life pages per subject for treatment E |
Study |
integer |
Treatment
-> E -> QOL pages |
|
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Treatment tab or beyond |
$numQuartersForCost |
The
number of quarters during which this cost occurs |
Either |
integer |
-- |
This
variable is only available in the context of an indirect cost algorithm |
|
$numQuartersForTask |
The
number of quarters during which the effort for this task occurs |
Either |
integer |
-- |
This
variable is only available in the context of a task/resource algorithm |
|
$numRepeatDataFigures |
The
number of repeat/copy data figures/graphs expected |
Study |
integer |
Data
-> Number of Repeat Figures and Graphs |
|
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Data tab or beyond |
$numRepeatDataListings |
The
number of repeat/copy data listings expected |
Study |
integer |
Data
-> Number of Repeat Data Listings |
|
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Data tab or beyond |
$numRepeatDataTables |
The
number of repeat/copy data tables expected |
Study |
integer |
Data
-> Number of Repeat Data Tables |
|
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Data tab or beyond |
$numRepeatPkPdDataFigures |
The
number of repeat/copy data PK/PD figures/graphs (*Phase 1 HV only*) |
Study |
integer |
Data
-> Number of Repeat Pk/Pd Figures and Graphs |
Applies
only to Phase 1 (HV) trials |
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Data tab or beyond |
$numRepeatPkPdDataListings |
The
number of repeat/copy PK/PD data listings (*Phase 1 HV only*) |
Study |
integer |
Data
-> Number of Repeat Pk/Pd Data Listings |
Applies
only to Phase 1 (HV) trials |
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Data tab or beyond |
$numRepeatPkPdDataTables |
The
number of repeat/copy PK/PD data tables (*Phase 1 HV only*) |
Study |
integer |
Data
-> Number of Repeat Pk/Pd Data Tables |
Applies
only to Phase 1 (HV) trials |
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Data tab or beyond |
$numSAEs |
The
number of Serious Adverse Events expected |
Either |
integer |
-- |
Based
on Data -> SAE rate as a percent of randomized subjects |
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Data tab or beyond |
$numScreenFailsPaid |
The
number of screen failures for which the sponsor will pay |
Either |
integer |
-- |
Based
on Treatment -> Percent of screen failures paid for |
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Site tab or beyond |
$numScreeningVisits |
The
number of screening visits for all subjects |
Either |
integer |
-- |
"Either"
scope fields return a value appropriate to the scope in which it is used |
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Treatment tab or beyond |
$numScreensPerCrfBook |
The
number of screens to be designed for the CRF book |
Study |
integer |
-- |
Based
on Number of screens per CRF page and number of books |
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Data tab or beyond |
$numSiteCloseoutVisits |
The
number of site closeout visits |
Either |
integer |
-- |
Based
on Site -> Percent of onsite close-out visits |
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Site tab or beyond |
$numSiteInitiationVisits |
The
number of site initiation visits |
Either |
integer |
-- |
Based
on Site -> Percent of sites requiring site initiation visits (in-person) |
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Site tab or beyond |
$numSitesIdentifiedBySponsor |
The
number of sites to be identified by the Sponsor |
Either |
integer |
-- |
Based
on Site -> Percent of sites identified by sponsor |
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Site tab or beyond |
$numSitesIdentifiedByVendor |
The
number of sites to be identified by the vendor |
Either |
integer |
-- |
Based
on Site -> Percent of sites identified by sponsor |
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Site tab or beyond |
$numSitesRequiringAudit |
The
number of sites requiring a QA audit |
Either |
integer |
-- |
Based
on Site -> Percent of sites requiring a QA audit |
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Site tab or beyond |
$numSitesUsingCentralIRB |
The
number of sites using a Central IRB/EC |
Either |
integer |
-- |
Based
on Site -> Percent of sites using ONLY a central IRB/EC + Percent of sites
using BOTH a central and a local IRB/EC |
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Site tab or beyond |
$numSitesUsingLocalIRB |
The
number of sites using a local IRB/EC |
Either |
integer |
-- |
Based
on Site -> Percent of sites using ONLY a local IRB/EC + Percent of sites
using BOTH a central and a local IRB/EC |
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Site tab or beyond |
$numSitesUsingBothLocalAndCentralIRB |
The
number of sites using BOTH a local and a central IRB/EC |
Either |
integer |
-- |
Based
on Site -> Percent of sites using BOTH a central and local IRB/EC |
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Site tab or beyond |
$numSitesUsingLocalMonitoring |
The
number of sites using local monitoring |
Either |
integer |
-- |
Based
on Site -> Percent of sites using local monitoring |
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Site tab or beyond |
$numSitesWithOnsiteCOV |
The
number of sites requiring onsite close-out visits |
Either |
integer |
-- |
Based
on Site -> Percent of onsite close-out visits |
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Site tab or beyond |
$numSitesWithOnsiteSIV |
The
number of sites requiring site initiation visits (in-person) |
Either |
integer |
-- |
Based
on Site -> Percent of sites requiring site initiation visits (in-person) |
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Site tab or beyond |
$numSitesWithOverhead |
The
number of sites requiring overhead |
Either |
integer |
-- |
Based
on Site -> Percent of sites requiring overhead |
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Site tab or beyond |
$numSitesWithPhoneCOV |
The
number of sites requiring only phone-based close-out |
Either |
integer |
-- |
Based
on Site -> Percent of sites requiring only phone-based close-outs |
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Site tab or beyond |
$numSitesWithPhonePSSV |
The
number of sites requiring a phone-based prestudy site visit |
Either |
integer |
-- |
Based
on Site -> Percent of sites requiring a phone-based pre-study site visit |
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Site tab or beyond |
$numSitesWithPhoneSIV |
The
number of sites requiring only phone-based site initiation |
Either |
integer |
-- |
Based
on Site -> Percent of sites requiring only phone-based site initiation |
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Site tab or beyond |
$numSubjectsDropped |
The
number of subjected expected to drop out prior to completing the standard
treatment |
Either |
integer |
Site
-> Drop Rate |
|
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Site tab or beyond |
$numSubjectsFailScreen |
The
number of potential subjects that will fail screening |
Either |
integer |
-- |
Based
on Treatment -> Screen failure rate |
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Site tab or beyond |
$numSubjectsPerSitePerMonth |
The
expected enrollment rate (subjects per site per month) |
Either |
floating-point
number |
-- |
Calculated |
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Subject tab or beyond |
$numSubjectsToScreen |
The
number of potential subjects to be screened |
Either |
integer |
Site
-> Number of subjects to screen |
Based
on Treatment -> Screen failure rate |
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Site tab or beyond |
$numSubjectsTreatmentB |
The
number of subjects randomized to Treatment B |
Either |
integer |
Treatment
-> B -> Number of subjects |
|
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Treatment tab or beyond |
$numSubjectsTreatmentC |
The
number of subjects randomized to Treatment C |
Either |
integer |
Treatment
-> C -> Number of subjects |
|
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Treatment tab or beyond |
$numSubjectsTreatmentD |
The
number of subjects randomized to Treatment D |
Either |
integer |
Treatment
-> D -> Number of subjects |
|
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Treatment tab or beyond |
$numSubjectsTreatmentE |
The
number of subjects randomized to Treatment E |
Either |
integer |
Treatment
-> E -> Number of subjects |
|
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Treatment tab or beyond |
$numSubjectsWillComplete |
The
number of subjected expected to complete all visits |
Either |
integer |
-- |
|
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Site tab or beyond |
$numSubjectVisits |
The
number of treatment visits per subject, not including screening or follow-up
visits |
Either |
integer |
-- |
|
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Treatment tab or beyond |
$numThirdPartyDataVendors |
The
number of third party data vendors or sources expected |
Study |
integer |
Data
-> Number of 3rd party vendors/data sources |
|
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Data tab or beyond |
$numThreeAndOneHalfDayMonitoringTrips |
The
number of three and one half day monitoring visits expected |
Either |
integer |
Monitoring
-> (table of values) |
|
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Monitoring tab or beyond |
$numThreeDayMonitoringTrips |
The
number of three day monitoring visits expected |
Either |
integer |
Monitoring
-> (table of values) |
|
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Monitoring tab or beyond |
$numTranslations |
The
number of languages into which documents must be translated |
Study |
integer |
Locations
-> Number of Translations/Dialects |
|
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Site tab or beyond |
$numTreatmentArms |
The
number of treatment arms |
Study |
integer |
Treatment
-> Count (Treatments A - Z defined) |
Number
of treatment arms added on the Treatment tab. Min = 1; Max = 26 |
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Treatment tab or beyond |
$numTwoDayMonitoringTrips |
The
number of two day monitoring visits expected |
Either |
integer |
Monitoring
-> (table of values) |
|
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Monitoring tab or beyond |
$numUniqueDataFigures |
The
number of unique data figures/graphs expected |
Study |
integer |
Data
-> Number of Repeat Figures and Graphs |
|
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Data tab or beyond |
$numUniqueDataListings |
The
number of unique data listings expected |
Study |
integer |
Data
-> Number of Repeat Data Listings |
|
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Data tab or beyond |
$numUniqueDataTables |
The
number of unique data tables expected |
Study |
integer |
Data
-> Number of Repeat Data Tables |
|
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Data tab or beyond |
$numUniquePages |
The
number of unique CRF pages to be designed |
Study |
integer |
Data
-> Number of Unique Pages |
|
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Data tab or beyond |
$numUniquePkPdDataFigures |
The
number of unique PK/PD data figures/graphs (*Phase 1 HV only*) |
Study |
integer |
Data
-> Number of Repeat Pk/Pd Figures and Graphs |
Applies
only to Phase 1 (HV) trials |
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Data tab or beyond |
$numUniquePkPdDataListings |
The
number of unique PK/PD data listings (*Phase 1 HV only*) |
Study |
integer |
Data
-> Number of Repeat Pk/Pd Data Listings |
Applies
only to Phase 1 (HV) trials |
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Data tab or beyond |
$numUniquePkPdDataTables |
The
number of unique PK/PD data tables (*Phase 1 HV only*) |
Study |
integer |
Data
-> Number of Repeat Pk/Pd Data Tables |
Applies
only to Phase 1 (HV) trials |
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Data tab or beyond |
$numVisitsTreatmentB |
The
number of weeks (or days) in which a subject visit occurs for treatment B |
Study |
integer |
Treatment
-> B -> Visits per subject |
|
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Treatment tab or beyond |
$numVisitsTreatmentC |
The
number of weeks (or days) in which a subject visit occurs for treatment C |
Study |
integer |
Treatment
-> C -> Visits per subject |
|
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Treatment tab or beyond |
$numVisitsTreatmentD |
The
number of weeks (or days) in which a subject visit occurs for treatment D |
Study |
integer |
Treatment
-> D -> Visits per subject |
|
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Treatment tab or beyond |
$numVisitsTreatmentE |
The
number of weeks (or days) in which a subject visit occurs for treatment E |
Study |
integer |
Treatment
-> E -> Visits per subject |
|
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Treatment tab or beyond |
$numWeeks |
The
number of weeks between the study start date and the study end date |
Study |
integer |
-- |
|
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Data tab or beyond |
$numWeeksFollowup |
The
number of weeks expected for subject followup |
Study |
integer |
Treatment
-> Follow subjects for |
5.8
and previous endpoint-defined cost model plans will display this value as
read-only for backwards compatibility |
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Treatment tab or beyond |
$numWeeksForTask |
The
number of weeks during which the effort for this task occurs |
Either |
integer |
-- |
This
variable is only available in the context of a task/resource algorithm |
|
$numWeeksProjectManagement |
The
number of weeks of Project Management expected |
Either |
integer |
-- |
|
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Data tab or beyond |
$numWeeksScreening |
The
number of weeks expected for subject screening |
Either |
integer |
-- |
"Either"
scope fields return a value appropriate to the scope in which it is used |
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Treatment tab or beyond |
$numWeeksTreatmentB |
The
duration of treatment B (in weeks) |
Study |
integer |
Treatment
-> B -> Treatment duration |
|
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Treatment tab or beyond |
$numWeeksTreatmentC |
The
duration of treatment C (in weeks) |
Study |
integer |
Treatment
-> C -> Treatment duration |
|
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Treatment tab or beyond |
$numWeeksTreatmentD |
The
duration of treatment D (in weeks) |
Study |
integer |
Treatment
-> D -> Treatment duration |
|
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Treatment tab or beyond |
$numWeeksTreatmentE |
The
duration of treatment E (in weeks) |
Study |
integer |
Treatment
-> E -> Treatment duration |
|
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Treatment tab or beyond |
$numYears |
The
number of years between the study start date and the date the final report is
due |
Study |
integer |
-- |
|
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Monitor or Data tab or beyond |
$numYearsForTask |
The
number of years during which the effort for this task occurs |
Either |
integer |
-- |
This
variable is only available in the context of a task/resource algorithm |
Can
be used on any tab |
$otherOnsiteHoursPerVisit |
Other
onsite hours expected per Visit |
Study |
integer |
Monitoring
-> Other (Non-SDV) hours onsite per visit |
Applicable
from 5.7 Cost Model |
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Monitoring tab or beyond |
$pctRegulatoryDocsCollected |
The
percent of regulatory documents to be collected |
Location |
floating-point
number |
Site
-> Percent of regulatory documents collected |
|
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Site tab or beyond |
$pctSAEs |
The
percent of the total subject population expected to generate SAEs |
Study |
floating-point
number |
Data
-> SAE rate as a percent of randomized subjects |
|
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Data tab or beyond |
$pctSiteOverhead |
The
average percent overhead for sites requiring overhead |
Location |
floating-point
number |
Site
-> Percent of sites requiring overhead |
|
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Site tab or beyond |
$pctSitesWithOnsitePSSV |
The
percent of sites requiring an onsite prestudy site visit |
Location |
floating-point
number |
Site
-> Percent of sites requiring a pre-study site visit (in-person) |
|
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Site tab or beyond |
$pctSubjectsFailScreen |
The
percent of potential subjects that will fail screening |
Location |
floating-point
number |
Treatment
-> Screen failure rate |
|
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Site tab or beyond |
$queryRate |
The
percent of pages expected to generate queries |
Study |
floating-point
number |
Data
-> Query Rate |
|
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Data tab or beyond |
$therapeuticAreaID |
Numeric
identifier of the Therapeutic Area |
Study |
integer
(identifier) |
-- |
|
Can
be used on any tab |
$transportFactor |
Location-specific
transportation factor |
Location |
floating-point
number |
-- |
|
Can
be used on any tab past the Locations tab |
$washoutDays |
Length
of washout period in days |
Study |
integer |
Treatment
-> Washout period duration |
Applies
only to crossover trials |
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Treatment tab or beyond |
$washoutPeriodDuration |
Length
of washout period, in weeks for late stage trials and days for Phase I trials |
Study |
integer |
Treatment
-> Washout period duration |
Applies
only to crossover trials |
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Treatment tab or beyond |
$washoutWeeks |
Length
of washout period in weeks |
Either |
integer |
-- |
Applies
only to crossover trials |
Can
be used in a field on any tab, but may not return the correct value unless it
is on the Treatment tab or beyond |
|
|
|
|
|
|
|