Appendix - Clinical Annotations

This appendix outlines all the clinical annotations found under the participant hook entity.

This appendix includes the following topics.

1 Data Entry for Clinical Information Annotation
- 1.1 Lab Annotation
  - 1.1.1 Known Issue with LabAnnotation.result Data Type
- 1.2 Family History Annotation
- 1.3 Treatment Annotation
- 1.4 Rad RX Annotation
- 1.5 Chemo RX Annotation
2 Treatment Regimen
3 Pathology-Specimen Collection Group Clinical Annotation
4 Pathology-Specimen Clinical Annotation

Data Entry for Clinical Information Annotation

This section outlines the following annotations found under the participant hook entity:

Lab Annotation
Family History Annotation
Treatment Annotation
Rad RX Annotation
Chemo RX Annotation

Lab Annotation

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

The following table lists the attributes of the lab annotation.

Attribute and Sub-Form Name	Action

Attribute and Sub-Form Name	Action
Lab Test Name	Select the appropriate laboratory test name from the drop-down list.
Other Lab Test Name	Enter the lab test name if same is not available in the Lab Test Name drop-down list. This field can be left blank.
Test date	Enter the date laboratory test was conducted. To do this, use the calendar.
Result	Enter the result of the test conducted. This data field can store alphanumeric values, which means you can add numeric values and values like positive and negative.
Result Units	Enter the measurement units for quantitative result. You can enter the units as abbreviations, for example: gm, ml; or enter the unit name, for example: gram, milliliter.

Known Issue with LabAnnotation.result Data Type

You cannot query on a result attribute in a LabAnnotation class using enumerated conditions. The result attribute in a LabAnnotation class has a data type ofString in the database. While querying, the conditions displayed for the attribute result in the entity LabAnnotation which is non-numeric. For many LabAnnotation Tests, the result values are numeric. If the data type in the database is String for result, you cannot query the numeric values using numeric operators like <, >, <=, >=, but you can query using the non-numeric operators.

Family History Annotation

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

The following table lists the at tributes for the Family History Annotation.

Attribute and Sub-Form Name	Action

Attribute and Sub-Form Name	Action
Relation	Select the appropriate relation name from the drop-down list.
Other Lab Test Name	Enter the relation name if the same is not available in the previous attribute's (Relation) drop-down list. Data entry in this field is optional.
General Health Diagnosis	To enter information about the General Health Diagnosis, click the Add More button.
Clinical Diagnosis	Select the appropriate Clinical Diagnosis from the drop-down list.
Other Clinical Diagnosis	Enter the clinical diagnosis value if the same is not available in the previous attribute's (Clinical Diagnosis) drop-down list. Data entry in this field is optional.
Age at Diagnosis	Enter the Age at Diagnosis. This field accepts integer (whole number) values only. If you enter a decimal value, the value is rounded off.

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

Treatment Annotation

This annotation tracks the general treatments that a participant has undergone or is undergoing.

The following table lists the attributes of the Treatment Annotation.

Attribute and Sub-Form Name	Action

Attribute and Sub-Form Name	Action
Agent	Select the appropriate Agent name from the drop-down list.
Other Agent	Enter the agent name if it is not available in the previous attribute's (Agent) drop-down list. Data entry in this field is optional.
Dose	Enter the amount or dose of radiation administered to the patient. This field accepts numerical value with decimal.
Dose Unit	Enter the measurement unit for the dose of radiation.
Duration	To enter information about the Duration of the treatment, click the Add More button.
Start Date	Enter the date treatment began using the calendar.
End Date	Enter the date treatment ended using the calendar.
Duration In Days	Enter the number of days the treatment lasted. This field accepts integer values only. If you enter a decimal value, the value is rounded off.

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.

The following table lists the attributes of the Rad RX Annotation.

Attribute and Sub-Form Name	Action

Attribute and Sub-Form Name	Action
Agent	Select the appropriate radiation therapy agent name from the drop-down list.
Other Agent	Enter the radiation therapy agent name if it is not available in the previous attribute's (Agent) drop-down list. Data entry in this field is optional.
Dose	Enter the amount or dose of radiation administered to the patient. This field accepts a numerical value with decimal.
Dose Unit	Enter the measurement unit for the dose of radiation.
Duration	To enter information about the Duration of the treatment, click the Add More button.
Start Date	Enter the date treatment began using the calendar.
End Date	Enter the date treatment ended using the calendar.
Duration In Days	Enter the number of days the treatment lasted. This field accepts integer values only. If you enter a decimal value, the value is rounded off.

Chemo RX Annotation

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

The following table lists the attributes of the Chemo RX Annotation.

Attribute and Sub-Form Name	Action

Attribute and Sub-Form Name	Action
Agent	Select the appropriate chemotherapy agent name from the drop-down list.
Other Agent	Enter the chemotherapy agent name if it is not available in the previous attribute's (Agent) drop-down list. This field can be left blank.
Dose	Enter the amount or dose of chemical agent administered to the patient. This field accepts a numerical value with decimal.
Dose Unit	Enter the measurement unit for the dose of chemical agent.
Duration	To enter information about the Duration of the treatment, click the Add More button.
Start Date	Enter the date treatment began using the calendar.
End Date	Enter the date treatment ended using the calendar.
Duration In Days	Enter the number of days the treatment lasted. This field accepts integer values only. If you enter a decimal value, the value is rounded off.

Treatment Regimen

This section outlines the following annotations found under the participant hook entity:

Environmental Exposure Health Annotation
Alcohol Health Annotation
Smoking Health Annotation
Health Examination Annotation
New Diagnosis Health Annotation
No Evident Disease Health Annotation
Recurrence Health Examination Annotation
Local Recurrence Health Examination Annotation
Distant Recurrence Health Examination Annotation

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.

The following table lists the attributes of the Treatment Regimen Annotation

Attribute and Sub-Form Name	Action

Attribute and Sub-Form Name	Action
Treatment Regimen	Enter the name of the treatment regimen.
Treatment Order	To enter information about the Treatment Order, click the Add More button.
Cycle	Enter the sequence or cycle number of the treatment regimen.
Chemotherapy	To enter information about the Chemotherapy, click the Details link. Then, click the Add More button to add records for the same.
Radiation Therapy	To enter information about the Radiation Therapy, click the Details link. Then, click the Add More button to add records for the same.

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.

The following table lists the attributes of the Environmental Exposure Health Annotation

Attribute and Sub-Form Name	Action

Attribute and Sub-Form Name	Action
Agent	Select the appropriate environmental agent from the drop-down list.
Other Agent	Enter the name of environmental agent if it is not available in the previous attribute's (Agent) drop-down list. Data entry in this field is optional.
Years Agent Free	Enter the number of years the participant was Not subjected to the environmental agent. This field accepts numerical value with decimal.
Duration	To enter information about the Duration, click the Add More button.
Start Date	Enter the date the environmental exposure started using the calendar.
End Date	Enter the date the environmental exposure ended using the calendar.
Duration In Days	Enter the number of days the environmental exposure lasted. This field accepts integer values only. If you enter a decimal value, the value is rounded off.

Alcohol Health Annotation

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

The following table lists the attributes Alcohol Health Annotation.

Attribute/Sub-Form Name	Action

Attribute/Sub-Form Name	Action
Agent	Select the agent as Ethanol from the drop-down list.
Other Agent	Enter the name of agent if you need to specify a particular alcoholic beverage. Data entry in this field is optional.
Years Agent Free	Enter the number of years participant did Not consume Alcohol. This field accepts numerical value with decimal.
Duration	To enter information about the Duration, click the Add More button.
Start Date	Enter the date when alcohol consumption started using the calendar.
End Date	Enter the date when alcohol consumption ended using the calendar.
Duration In Days	Enter the number of days the participant consumed alcohol. This field accepts integer values only. If you enter a decimal value, the value is rounded off.
Drinks Per Week	Enter the number of alcoholic drinks consumed in a week. This field accepts integer values only. If you enter a decimal value, the value is rounded off.

Smoking Health Annotation

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

The following table lists the attributes Smoking Health Annotation.

Attribute and Sub-Form Name	Action

Attribute and Sub-Form Name	Action
Agent	Select the agent as Tobacco Smoking And Tobacco Smoke or Tobacco from the drop-down list.
Other Agent	Enter the name of agent if need to specify a particular value. Data entry in this field is optional.
Years Agent Free	Enter the number of years participant did Not smoke or consume tobacco. This field accepts numerical value with decimal.
Duration	To enter information about the Duration, click the Add More button.
Start Date	Enter the date when smoking started using the calendar.
End Date	Enter the date when smoking ended using the calendar.
Duration In Days	Enter the number of days the participant smoked. This field accepts integer values only. If you enter a decimal value, the value is rounded off.
Packs Per Day	Enter the number of packs of cigarettes consumed in a day. This field accepts integer values only. If you enter a decimal value, the value is rounded off.

Health Examination Annotation

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

The following table lists the attributes Health Examination Annotation.

Attribute and Sub-Form Name	Action

Attribute and Sub-Form Name	Action
Name of Procedure	Select the procedure from the drop-down list.
Other Procedure	Enter the name of procedure if it is not available in the previous attribute's (Name of Procedure) drop-down list. Data entry in this field is optional.
Date of Examination	Enter the date the procedure was carried out using the calendar.

New Diagnosis Health Annotation

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

The following table lists the attributes New Diagnosis Health Annotation.

Attribute and Sub-Form Name	Action

Attribute and Sub-Form Name	Action
Name of Procedure	Select the procedure from the drop-down list.
Other Procedure	Enter the name of procedure if it is not available in the previous attribute's (Name of Procedure) drop-down list. Data entry in this field is optional.
Date of Examination	Enter the date the procedure was carried out using the calendar.

No Evident Disease Health Annotation

This annotation captures information about the procedures that confirm that the participant has no evident disease.

The following table lists the attributes No Evident Disease Health Annotation.

Attribute and Sub-Form Name	Action

Attribute and Sub-Form Name	Action
Name of Procedure	Select the procedure from the drop-down list.
Other Procedure	Enter the name of procedure if it is not available in the previous attribute's (Name of Procedure) drop-down list. Data entry in this field is optional.
Date of Examination	Enter the date on which the procedure was carried out using the calendar.

Recurrence Health Examination Annotation

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

The following table lists the attributes Recurrence Health Examination Annotation.

Attribute and Sub-Form Name	Action

Attribute and Sub-Form Name	Action
Name of Procedure	Select the procedure from the drop-down list.
Other Procedure	Enter the name of procedure if it is not available in the previous attribute's (Name of Procedure) drop-down list. Data entry in this field is optional.
Date of Examination	Enter the date the procedure was carried out using the calendar.
Clinical Diagnosis	Select the appropriate Clinical Diagnosis from the drop-down list.
Other Clinical Diagnosis	Enter the clinical diagnosis value if it is not available in the previous attribute's (Clinical Diagnosis) drop-down list. Data entry in this field is optional.

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.

The following table lists the attributes Local Recurrence Health Examination Annotation.

Attribute and Sub-Form Name	Action

Attribute and Sub-Form Name	Action
Name of Procedure	Select the procedure from the drop-down list.
Other Procedure	Enter the name of procedure if it is not available in the previous attribute's (Name of Procedure) drop-down list. Data entry in this field is optional.
Date of Examination	Enter the date the procedure was carried out using the calendar.
Clinical Diagnosis	Select the appropriate Clinical Diagnosis from the drop-down list.
Other Clinical Diagnosis	Enter the clinical diagnosis value if it is not available in the previous attribute's (Clinical Diagnosis) drop-down list. Data entry in this field is optional.

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.

The following table lists the attributes Distant Recurrence Health Examination Annotation.

Attribute and Sub-Form Name	Action

Attribute and Sub-Form Name	Action
Name of Procedure	Select the procedure from the drop-down list.
Other Procedure	Enter the name of procedure if it is not available in the previous attribute's (Name of Procedure) drop-down list. Data entry in this field is optional.
Date of Examination	Enter the date the procedure was carried out using the calendar.
Clinical Diagnosis	Select the appropriate Clinical Diagnosis from the drop-down list.
Other Clinical Diagnosis	Enter the clinical diagnosis value if it is not available in the previous attribute's (Clinical Diagnosis) drop-down list. Data entry in this field is optional.
Tissue Site	Select the Tissue Site where the disease spread 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.

Pathology-Specimen Collection Group Clinical Annotation

This section outlines the following annotations found under Specimen Collection Group:

Base Solid Tissue Pathology Annotation
Base Hematology Tissue Pathology Annotation