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OP RSH PRO00037694 ALLIANCE A012103 - JAIN ARM 2 OBSERVATION	

Types:      Research Oncology Treatment
Synonyms:  PRO00037694, A012103, TNBC, CHECK POINT INHIBITOR, ALLIANCE

C1 D1	Repeat 1 time	Cycle length: 84 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   A012103 - Jain
		  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Dose Modifications and Management for PEMBROLIZUMAB Treatment : Refer to Section 8.1
Protocol Access Hyperlink:  A012103 - Jain
			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	History and physical

Physical examinations are required every 6 months (+/- 2 months) for 5 years after registration or recurrence. Thereafter, patients will be followed annually (+/- 3 months) for overall survival for a total of 10 years after registration. Clinical follow-up visits may be done outside of the registering institution if patient records are available. See also Section 12.0.
			Nursing Orders
  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse Event Assessment  - CTCAE
			Nursing Orders
  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse Event Assessment  - PRO-CTCAE 

Optional. Please refer to the CTSU website for PRO-CTCAE items.
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		  	T4, FREE	Interval: --	Occurrences: --			Labs
  	CORTISOL LEVEL, RANDOM	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	QOL/Value of Care 

See Section 14.1. FACT-B , WPAI:SHP,FACIT-COST, CoPaQ
		  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Health Care Utilization CRFs
					
C2 D1	Repeat 1 time	Cycle length: 84 days	Day 1	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	History and physical

Physical examinations are required every 6 months (+/- 2 months) for 5 years after registration or recurrence. Thereafter, patients will be followed annually (+/- 3 months) for overall survival for a total of 10 years after registration. Clinical follow-up visits may be done outside of the registering institution if patient records are available. See also Section 12.0.
			Nursing Orders
  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse Event Assessment  - CTCAE
			Nursing Orders
  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse Event Assessment  - PRO-CTCAE 

Optional. Please refer to the CTSU website for PRO-CTCAE items.
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	QOL/Value of Care 

See Section 14.1. FACT-B , WPAI:SHP,FACIT-COST, CoPaQ
		  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Health Care Utilization CRFs
					
End of Treatment (EOT)	Repeat 1 time	Cycle length: 1 day	EOT= Within 3-9 weeks after last cycle of treatment (week 27)	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	History and physical

Physical examinations are required every 6 months (+/- 2 months) for 5 years after registration or recurrence. Thereafter, patients will be followed annually (+/- 3 months) for overall survival for a total of 10 years after registration. Clinical follow-up visits may be done outside of the registering institution if patient records are available. See also Section 12.0.
			Nursing Orders
  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse Event Assessment  - CTCAE
			Nursing Orders
  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Adverse Event Assessment  - PRO-CTCAE 

Optional. Please refer to the CTSU website for PRO-CTCAE items.
			Nursing Orders
  	ONC NURSING COMMUNICATION 102	Interval: --	Occurrences: --	Comments:	Whole blood in EDTA tubes, Tissue and optional biobanking
			Provider Communication
  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	QOL/Value of Care 

See Section 14.1. FACT-B , WPAI:SHP,FACIT-COST, CoPaQ
		  	ONC PROVIDER COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Health Care Utilization CRFs
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		  	T4, FREE	Interval: --	Occurrences: --			Labs
  	CORTISOL LEVEL, RANDOM	Interval: --	Occurrences: --					
Follow Up	Repeat 1 time	Cycle length: 1 day	FU	Perform every 1 day x1		Appointment Requests
  	INFUSION APPOINTMENT REQUEST	Interval: --	Occurrences: --			Provider Communication
  	ONC PROVIDER COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	FUP= Patients will be followed every 6 months (+/- 2 months) for 5 years after registration or recurrence. Thereafter, patients will be followed annually (+/- 3 months) for overall survival for a total of 10 years after registration
			Nursing Orders
  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	History and physical

Physical examinations are required every 6 months (+/- 2 months) for 5 years after registration or recurrence. Thereafter, patients will be followed annually (+/- 3 months) for overall survival for a total of 10 years after registration. Clinical follow-up visits may be done outside of the registering institution if patient records are available. See also Section 12.0.
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --			Nursing Orders
  	RESEARCH - MEASURE WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 102	Interval: --	Occurrences: --	Comments:	Whole blood in EDTA tubes, Tissue and optional biobanking
			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --	Comments:	as clinically indicated
		  	T4, FREE	Interval: --	Occurrences: --	Comments:	as clinically indicated
			Labs
  	CORTISOL LEVEL, RANDOM	Interval: --	Occurrences: --	Comments:	As clinically indicated
			Imaging
◉	MAMMO BREAST SCREEN TOMOSYNTHESIS BILATERAL	Interval: --	Occurrences: --	Comments:	Mammogram, breast ultrasound, or MRI is required annually (+/- 60 days) during clinical follow-up, unless the patient had bilateral mastectomies
		◯	MRI BREAST WO CONTRAST BILATERAL	Interval: --	Occurrences: --	Comments:	Mammogram, breast ultrasound, or MRI is required annually (+/- 60 days) during clinical follow-up, unless the patient had bilateral mastectomies
		◯	US BREAST COMPLETE BILATERAL	Interval: --	Occurrences: --	Comments:	Mammogram, breast ultrasound, or MRI is required annually (+/- 60 days) during clinical follow-up, unless the patient had bilateral mastectomies