Appendix 2-1.doc

From Tissue/Biospecimen Banking and Technology Tools

Appendix 2: Clinical Annotations

This section outlines all the clinical annotations available in caTissue Suite.

Data Entry for Clinical Information Annotation

This section outlines the various annotations found under the participant hook entity.

Lab Annotation

This annotation helps you to capture information on the clinical and laboratory tests that the participant has undergone or is undergoing.

Table 30: Lab Annotation

Family History Annotation

This annotation helps you to capture the data related to the family medical history of the participant for family members. For each family member, you can capture details of one or more clinical diagnosis.

Table 31: Family History Annotation

	To delete a General Health Diagnosis record, select the check box next to that record and click Delete.

Treatment Annotation

This annotation keeps a track of the general treatments that a participant has undergone or is undergoing.

Table 32: Treatment Annotation

	To delete a row that contains data about the duration of treatment, select the check box next to the row and click Delete.

Rad RX Annotation

This annotation allows you to enter the details about the radiation therapy that the participant is undergoing or has undergone.

Table 33: Rad RX Annotation

Chemo RX Annotation

This annotation allows you to enter details about the chemotherapy that the participant is undergoing or has undergone.

Table 34: Chemo RX Annotation

Treatment Regimen

This annotation helps you to capture any treatment as a part of a well-defined treatment regimen. A treatment regimen may involve one or more chemotherapy or radiation therapy or a combination of both.

Table 35: Treatment Regimen

	Once you add the Chemotherapy or Radiation Therapy information, enter data for each row as described above for Chemo RX Annotation and RAD RX Annotation respectively.

Environmental Exposure Health Annotation

This annotation helps in capturing information about the environmental hazards or agents to which the participant is subjected to and the duration of the exposure.

Table 36: Environmental Exposure Health Annotation

Alcohol Health Annotation

This annotation captures the data about the alcohol consumption history of the participant.

Table 37: Alcohol Health Annotation

Smoking Health Annotation

This annotation captures information about the smoking history of the participant.

Table 38: Smoking Health Annotation

Health Examination Annotation

This annotation covers the participant’s health by providing information on various procedures for making a medical diagnosis.

Table 39: Health Examination Annotation

New Diagnosis Health Annotation

This annotation helps you to capture information about any new disease’s diagnosed in a participant.

Table 40: New Diagnosis Health Annotation

No Evident Disease Health Annotation

This annotation helps you to capture information about the procedures, which confirms that the participant has no evident disease.

Table 41: No Evident Disease Health Annotation

Recurrence Health Examination Annotation

This annotation captures information about the procedures and diagnosis of recurrence of a disease diagnosed in the participant earlier.

Table 42: Recurrence Health Examination Annotation

Local Recurrence Health Examination Annotation

This annotation captures information about the procedures used to diagnose recurrence of a disease diagnosed in the participant within the local anatomic site (same site where the disease was diagnosed earlier) in the body.

Table 43: Local Recurrence Health Examination Annotation

Distant Recurrence Health Examination Annotation

This annotation captures information about the procedures used to diagnose recurrence of a disease diagnosed in the participant at a distant anatomic site (site other than where the disease was diagnosed earlier) in the body.

Table 44: Distant Recurrence Health Examination Annotation

Pathology-Specimen Collection Group Clinical Annotation

This section outlines the various annotations found under Specimen Collection Group.

Base Solid Tissue Pathology Annotation

This generic annotation captures the pathological details about a group of specimens collected from any organ in the body by a particular procedure.

Table 45: Base Solid Tissue Pathology Annotation

Attribute and Sub Form Name	Action
Specimen Procedure	Select the appropriate Specimen Procedure from the drop-down list.
Other Specimen Procedure	Enter the name of Other Specimen Procedure if it is not available in the previous attribute’s (Specimen Procedure) drop-down list. Data entry in this field is optional.
Histologic Type	To enter information about the Histologic Type, click the Add More button.
Type	Select the appropriate Histologic Type from the drop-down list.
Histologic Variant Type	To enter information about the Histologic Variant Type, click the Details link. Click the Add More button to add a row.
Other Histologic Type	Enter the variant or other Histologic type. Click Submit to save data entered and to navigate back to the main form.
Additional Finding	To enter information about the Additional Finding, click the Add More button.
Pathologic finding	Select the appropriate Pathologic Finding from the drop-down list.
Details	To enter information about the Details, click the Details Link. Click Add More to add a row.
Details	Enter the details about the Additional Finding. Click Submit to save the data entered and to navigate back to the main form.
Comments	Enter any additional information about the specimen, site of specimen, or other basic details.
Histologic Grade	To enter information about the Histologic Grade, click the Add More button.
Grading System Name	Select the appropriate grading system name from the drop-down list.
Other Grading System Name	Enter the name of grading system if it is not available in the previous attribute’s (Grading System Name) drop-down list. Data entry in this field is optional.
Grade	Enter the Grade. This field accepts alphanumeric values.
Invasion
Lymphatic Invasion	Select the radio button for the appropriate value for Lymphatic Invasion.
Venous Invasion	Select the radio button for the appropriate value for Venous Invasion.
Perineural Invasion	Select the radio button for the appropriate value for Perineural Invasion.
Pathologic Staging
Primary Tumor Stage	To enter information about the Primary Tumor Stage, click the Enter Details Link.
Primary Tumor Stage	Select the appropriate Primary Tumor Stage from the drop-down list.
Regional Lymph Node	To enter information about the Regional Lymph Node, click the Enter Details link.
Lymph Node Stage	Select the appropriate Lymph Node Stage from the drop-down list.
Number Examined	Enter the number of lymph nodes examined. This field accepts integer values only. If you enter a decimal value, the value is rounded off.
Number Involved	Enter the number of lymph nodes involved. This field accepts integer values only. If you enter a decimal value, the value is rounded off.
Number Positive	Enter the number of lymph nodes macroscopically found. This field accepts integer values only. If you enter a decimal value, the value is rounded off.
Macroscopically
Number Positive	Enter the number of lymph nodes microscopically found. This field accepts integer values only. If you enter a decimal value, the value is rounded off.
Microscopically
Matted Nodes	Select the radio button for the appropriate value for Matted Nodes.
Distant Metastasis	To enter information about the Distant Metastasis, click the Enter Details link.
Metastasis Stage	Select the appropriate Metastasis Stage from the drop-down list.
Metastasis Tissue Site	To enter information about the Metastasis Tissue Site, click the Enter Details link. Click Add More to add a row.
Tissue Site	Select the appropriate Tissue Site from the drop-down list.
Other Tissue Site	Enter the name of tissue site if it is not available in the previous attribute’s (Tissue Site) drop-down list. Data entry in this field is optional.
Tumor Tissue Site	To enter information about the Tumor Tissue Site, click the Add More button.
Site Table45	Select the appropriate tissue site from the drop-down list.
Other Site	Enter the name of tissue site if it is not available in the previous attribute’s (Site) drop-down list. Data entry in this field is optional.
Tissue Side	To enter information about the Tissue Side, click the Details Link. Click Add More to add a row.
Side	Select the appropriate Side from the drop-down list. Click Submit to save the data entered and to navigate back to the main form.
Tumor Size
Greatest Dimension	Enter the Greatest Dimension of the tumor. This field accepts numerical values with decimal.
Additional Dimension One	Enter the first dimension of the tumor. This field accepts numerical values with decimal.
Additional Dimension Two	Enter the second dimension of the tumor. This field accepts numerical values with decimal.
Cannot Be Determined	Select the check box if the tumor size cannot be determined. If this check box is selected, do not enter data in the preceding three fields (Greatest Dimension, Additional Dimension One, and Additional Dimension Two).

Base Hematology Tissue Pathology Annotation

This annotation captures the pathological details about a group of specimens collected from blood by a particular procedure.

Table 46: Base Hematology Tissue Pathology Annotation

Attribute and Sub Form Name	Action
Specimen Procedure	Select the appropriate Specimen Procedure from the drop-down list.
Other Specimen Procedure	Enter the name of Other Specimen Procedure if it is not available in the previous attribute’s (Specimen Procedure) drop-down list. Data entry in this field is optional.
Histologic Type	To enter information about the Histologic Type, click the Add More button.
Type	Select the appropriate Histologic Type from the drop-down list.
Histologic Variant Type	To enter information about the Histologic Variant Type, click the Details link. Click the Add More button to add a row.
Other Histologic Type	Enter the variant or Other Histologic Type. Click Submit to save data entered and to navigate back to the main form.
Additional Finding	To enter information about the Additional Finding, click the Add More button.
Pathologic finding	Select the appropriate Pathologic Finding from the drop-down list.
Details	To enter information about the Details, click the Details link. Click Add More to add a row.
Details	Enter the details about the Additional Finding. Click Submit to save the data entered and to navigate back to the main form.
Comments	Enter any additional information about the specimen, site of specimen, or other basic details.
Biopsy or Aspirate Site	Select appropriate biopsy or aspirate site from the drop-down list.
Other Biopsy or Aspirate Site	Enter the name of Other Biopsy Or Aspirate Site if it is not available in the previous attributes (Biopsy or Aspirate Site) drop-down list. Data entry in this field is optional.
Adequacy of Specimen	Select the radio button for the appropriate value for Adequacy of Specimen.
Cytogenetics
Status	Select the radio button for the appropriate value for Cytogenetic study status.
Result	Enter the result of the Cytogenetic study in the edit box.
Immuno Phenotyping
Status	Select the radio button for the appropriate value for Immuno Phenotyping analysis status.
Method Used	Enter the name of the method used to carry out Immuno Phenotyping analysis in the edit box.
Result	Enter the result of the Immuno Phenotyping analysis in the edit box.

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