If this file opens in Compatibility Mode using Microsoft Word, convert to the latest document format to avoid potential formatting issues.	

OP RSH PRO00044071 EA8231 PRATH SCREENING	

Types:      Research Oncology Treatment
Synonyms:  PRO00044071 EA8231 PRATH, SACITUZUMAB GOVITECAN, PEMBROLIZUMAB, CARBOPLATIN, CISPLATIN, GEMCITABINE, PACLITAXEL

Screening (-35 to -1 Day)	Repeat 1 time	Cycle length: 7 days	Day -35	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: 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:    EA8231_Prath
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for all medications: Refer to Section 5.4. Protocol Access Hyperlink:   EA8231_Prath
			Imaging
  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	CT OR MRI. Chest, abdomen, and pelvis within 35 days prior to randomization. If bone scan shows disease at baseline, it should be followed with the same frequency as the other imaging scans for assessment
					
Screening ( -28 to -1 Day)	Repeat 1 time	Cycle length: 14 days	Day -28	Perform every 1 day x1			Research tolerance: -0/+0 days	Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Nursing Communication: 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:    EA8231_Prath
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for all medications: Refer to Section 5.4. Protocol Access Hyperlink:   EA8231_Prath
			Nursing Orders
  	ONC NURSING COMMUNICATION 75	Interval: --	Occurrences: --	Comments:	Informed consent
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Demographics
		  	ONC NURSING COMMUNICATION 35	Interval: --	Occurrences: --	Comments:	Relevant Medical and Surgical History
		  	ONC NURSING COMMUNICATION 34	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNICATION 37	Interval: --	Occurrences: --	Comments:	Bellmunt Score
		  	ONC NURSING COMMUNICATION 36	Interval: --	Occurrences: --	Comments:	Physical Exam
		  	ONC NURSING COMMUNICATION 52	Interval: --	Occurrences: --	Comments:	Concomitant medications
		  	ONC NURSING COMMUNICATION 53	Interval: --	Occurrences: --	Comments:	Adverse Event assessment
		  	ONC NURSING COMMUNICATION 54	Interval: --	Occurrences: --	Comments:	Health Related Quality of Life Assessment. FBISI-18, FACIT-Fatigue, EQ-5D-5L. Perform any time after consent, prior to C1D1 of treatment
			Nursing Orders
  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	Collect PT/INR and PTT per physician discretion
					
Screening (-14 to -1 Day)	Repeat 1 time	Cycle length: 14 days	Day -14	Perform every 1 day x1			Research tolerance: -0/+0 days	Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --					
Baseline (following randomization)	Repeat 1 time	Cycle length: 1 day	Baseline (following randomization)	Perform every 1 day x1			Research tolerance: -0/+0 days	Labs
  	TSH AND FREE T4	Interval: --	Occurrences: --	Comments:	For Arm B patients: 
It is strongly recommended that TSH and free T4 should be done at baseline (after randomization)
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	FFPE Tumor Tissue. Representative tumor tissue and related pathology are to be submitted within one (1) month following randomization.