Versions Compared

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

Table of Contents

...

Added inColumn nameData type

Mandatory

(Create)?

DescriptionPermissible ValuesValidations

Collection Protocol(CP) Short TitleStringYesProtocol under which participants should be registered

Collection Protocol should be existing within the system


PPIDStringNo
  1. Blank - the New participant with auto-generated PPID is registered
  2. Existing - Specimens will get collected under participant of specified PPID
  3. New participant PPID - the New participant with specified PPID is registered


Registration Date

DateYes



v3.4

First Name

StringNo


v3.4

Last Name

StringNo


v3.4

Middle Name

StringNo


v3.4

Date Of Birth

DateNo



v3.4

Death Date

DateNo



v3.4

Gender

StringNo
  • Female
  • Male
  • Unknown
  • Undifferentiated

v3.4Race#1StringNo

Add an extra column for the participant with multiple races. E.g.

Race#1, Race#2, etc.

  • American Indian or Alaska Native
  • Asian
  • Black or African American
  • Native Hawaiian or other Pacific Islander
  • Not Reported
  • Unknown
  • White

v3.4

Vital Status

StringNo
  • Alive
  • Dead
  • Unknown
  • Unspecified

v3.4

Ethnicity

StringNo
  • Hispanic or Latino
  • Not Hispanic or Latino
  • Not Reported
  • Unknown

v3.4SSNIntegerNo

Social Security Number for US locale

National Identification Number for other countries


Should be unique within OS
v3.4eMPIStringNoEnterprise Master Patient Index
Should be unique within OS
v3.4

PMI#1#Site Name

StringNoThe site which issued the MRN
Should be an existing site within OS
v3.4

PMI#1#MRN

StringNoMedical Record Number (unique identification given by the site)
Should be unique within a site
v3.4

Event Label

StringNoEvent Point Label from the protocol for which this event corresponds. E.g. baseline, surgery, etc.

v3.4

Visit Name

StringNoAuto-generated if left blank
Should be unique within OS
v3.4Visit DateStringNo

Select the correct date format from UI based on the data in the file


Collection SiteStringNoMaps to Visit site. Needs to be specified if no default is specified at CP event level.

v3.4Visit StatusStringNo
  • Complete
  • Pending
Default: 'Complete'
v3.4

Clinical Diagnosis

StringNo

Permissible Values File - SNOMED

Permissible Values File - ICD 10

Default: 'Not Specified'
v3.4

Clinical Status

StringNo
  • No Diagnosis / Control
  • New Diagnosis
  • Pre-Therapy
  • Post-Therapy
  • Pre-Operative
  • Operative
  • Post-Operative
  • Remission
  • Relapse, Primary Site
  • Relapse, Distant Site
  • Relapse, Not Specified
  • Not Specified
Default: 'Not Specified'
v3.4

Path. Number

StringNoSurgical Pathology Number
Default: 'Not Specified'
v3.4

Visit Comments

StringNo


v3.4

Specimen Requirement Code

StringNoCode defined in collection protocol for the corresponding specimen requirement

If this is not specified, specimens are created as unplanned specimens.

For enabling CP encoding please refer to the wiki page


Specimen LabelStringNoNeeds to be specified when the auto label generation is OFF OR 'Manual Input' is set to 'Yes'
Should be unique within the system

BarcodeStringNo

Should be unique within the system

ClassStringDependsException- conditional mandatory filed
If 'Not specified' is selected in the 'type' field, in that case, the class field is mandatory.
  • Tissue
  • Molecular
  • Cell
  • Fluid


TypeStringYes
Permissible Values File

LineageStringNo
  • New
  • Derived
  • Aliquot
Default: New

Parent Specimen LabelStringNoRequired when creating child specimens


Anatomic SiteStringNo
Permissible Values FileDefault: 'Not Specified'

LateralityStringNo
  • Left
  • Right
  • Not Applicable
  • Not Specified
Default: 'Not Specified'

Pathological StatusStringNo
  • Non-Malignant
  • Non-Malignant, Diseased
  • Pre-Malignant
  • Malignant, Pre-Invasive
  • Malignant, Invasive
  • Malignant
  • Metastatic
  • Not Specified
  • Clinically normal

Default: 'Not Specified'


QuantityNumericYes

Default units:

  • Fluid: ml
  • Tissue: gm
  • Cell: cells
  • Molecular: µg

Should be greater than zero ("0")


ConcentrationNumericNo

Concentration units are

  • Cells: cells,
  • Tissue: µg/ml
  • Molecular: µg/ml

Should be greater than zero ("0")



Freeze/Thaw Cycles


NumericNoThe number of cycles carried out.


Created OnDate & TimeNo

Mandatory for child specimens.




CommentsStringNo




Collection Status


StringNoStatus of the specimen to be collected




ContainerStringNoName of the existing container.
  1. Container specified should be existing
  2. Suitable to hold the specimen (based on type and protocol)
  3. Should have available positions.

RowStringNo

Position within the container at which the specimen is to be stored.

If left blank, the system will allocate next available position


ColumnStringNo


PositionIntegerNoUse this column if you do not use "row" and "column"

Collection DateDate & TimeYes

Required for primary specimens.





Collection ProcedureStringNo
  • Lavage Needle
  • Aspirate
  • Needle Core Biopsy
  • Venipuncture
  • Indwelling Catheter
  • Surgical Resection
  • Not Specified


Collection ContainerStringNoType of container used for specimen collection
  • ACD Vacutainer
  • Citrate Vacutainer
  • CPT
  • EDTA Vacutainer
  • Heparin Vacutainer
  • No Additive Vacutainer
  • Paxgene
  • Serum Separator Vacutainer
  • Sterile Specimen Container
  • Streck
  • Not Specified


CollectorEmail addressNo

Valid user

Received DateDate & TimeNoDate when specimens were received at the lab. If not specified, current date/time is being used.




Received QualityStringNo
  • Acceptable
  • Thawed
  • Frozen
  • Quantity Not Sufficient
  • Clotted
  • Hemolyzed
  • Lipemic
  • Cauterized
  • Hemorrhagic
  • Damaged
  • Unacceptable, Not Specified
  • Not Specified


ReceiverEmail addressNo

Valid user

...