Collection Protocol (CP) Short Title

String

Yes

Protocol under which participants should be registered

Collection Protocol should exist within the system.

PPID

String

No

Participant Protocol ID

1. Blank - The New participant with auto-generated PPID is registered.

2. Existing - Specimens will get collected under participants of specified PPID.

3. New participant PPID - The

1. new participant with specified PPID will be registered.

Registration Date

Date

Depends

1. The visit date value is taken if the registration date is not specified and the visit date is specified.

2. The collection date value is taken if the registration date and the visit date are not specified.

3. From v10.3 if the registration date is mandatory if creating only new participants 

First Name

String

No

First Name of the participant

Last Name

String

No

Last Name of the participant

Middle Name

String

No

Middle Name of the participant

Date Of Birth

Date

No

Date of Birth of the participant

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

Death Date

Date

No

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

Gender

String

No

• Female

• Male

• Unknown

• Undifferentiated

Race#1

String

No

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

Vital Status

String

No

• Alive

• Dead

• Unknown

• Unspecified

Ethnicity

String

No

• Hispanic or Latino

• Not Hispanic or Latino

• Not Reported

• Unknown

SSN

Integer

No

Social Security Number for US locale.

National Identification Number for other countries.

It should be unique within OS.

eMPI

String

No

Enterprise Master Patient Index

It should be unique within OS.

PMI#1#Site Name

String

No

The site which issued the MRN

It should be an existing site within OS.

PMI#1#MRN

String

No

Medical Record Number (unique identification given by the site)

It should be unique within a site.

Event Label

String

Depends

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

If left blank, an unplanned visit is collected.

Visit Name

String

No

Auto-generated if left blank

It should be unique within OS.

Visit Date

String

No

If the visit date value is not specified, the system takes up the value of the collection date.

Collection Site

String

No

Maps to Visit site. It needs to be specified if no default is specified at the CP event level.

Visit Status

String

No

• Complete

• Pending

Default: 'Complete'

Clinical Diagnosis

String

No

Permissible Values File - SNOMED

Permissible Values File - ICD 10

Default: 'Not Specified'

Clinical Status

String

No

• 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'

Path. Number

String

No

Surgical Pathology Number

Default: 'Not Specified'

Visit Comments

String

No

Specimen Requirement Code

String

No

Code 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 Label

String

No

It needs to be specified when the auto label generation is OFF OR 'Manual Input' is set to 'Yes.'

It should be unique within the system

Barcode

String

No

It should be unique within the system

Class

String

Depends

Exception- conditional mandatory filed
If 'Not specified' is selected in the 'type' field, in that case, the class field is mandatory.

• Tissue

• Molecular

• Cell

• Fluid

Type

String

Depends

Permissible Values File

• From v10.3 mandatory only if creating specimens else optional

• Field not applicable to the aliquot as aliquot type would always be same as that of parent

Lineage

String

No

• New

• Derived

• Aliquot

Default: New

Parent Specimen Label

String

No

Required when creating child specimens

Anatomic Site

String

No

Permissible Values File

Default: 'Not Specified'

Laterality

String

No

• Left

• Right

• Not Applicable

• Not Specified

Default: 'Not Specified'

Pathological Status

String

No

• Non-Malignant

• Non-Malignant, Diseased

• Pre-Malignant

• Malignant, Pre-Invasive

• Malignant, Invasive

• Malignant

• Metastatic

• Not Specified

• Clinically normal

Default: 'Not Specified'

Initial Quantity

Numeric

No

Default units:

• Fluid: ml

• Tissue: gm

• Cell: cells

• Molecular: µg

It should be greater than zero ("0")

Available Quantity

Numeric

No

Default units:

• Fluid: ml

• Tissue: gm

• Cell: cells

• Molecular: µg

It should be greater than zero ("0")

Concentration

Numeric

No

Concentration units are

• Cells: cells,

• Tissue: µg/ml

• Molecular: µg/ml

It should be greater than zero ("0")

Freeze/Thaw Cycles

Numeric

No

The number of cycles carried out.

Created On

Date & Time

No

Mandatory for child specimens.

Comments

String

No

Collection Status

String

No

Status of the specimen to be collected

• Pending

• Complete

• Missed Collection

• Not Collected

Container

String

No

Name of the existing container.

1. The container specified should be existing.

2. Suitable to hold the specimen (based on type and protocol)

3. Should have available positions.

Row

String

No

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

If left blank, the system will allocate the next available position

Column

String

No

Position

Integer

No

Use this column if you do not use "row" and "column."

Collection Date

Date & Time

Depends

Required for primary specimens.

From V10.3 collection date is mandatory while creating specimens else optional

Collection Procedure

String

No

• Lavage Needle

• Aspirate

• Needle Core Biopsy

• Venipuncture

• Indwelling Catheter

• Surgical Resection

• Not Specified

Collection Container

String

No

Type 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

Collector

Email address

No

Valid user

Received Date

Date & Time

No

Date when specimens were received at the lab. If not specified, the current date/time is being used.

Received Quality

String

No

• Acceptable

• Thawed

• Frozen

• Quantity Not Sufficient

• Clotted

• Hemolyzed

• Lipemic

• Cauterized

• Hemorrhagic

• Damaged

• Unacceptable, Not Specified

• Not Specified

Receiver

Email address

No

Valid user