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OP PRO00038634  WO44263 / INDUCTION SCREENING	

Types:      Research Oncology Treatment
Synonyms:  BASELINE, SCREENING, WO44263

Induction Screening -28 to -1	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1			Research tolerance: -28/+0 days	Nursing Orders
  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Informed Consent.
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Demographics
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Medical history and baseline conditions
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Complete physical examination
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	ECOG PS
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Concomitant medications
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Adverse events
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Tumor assessment
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Blood pressure, body temperature, heart rate
		  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Vital signs will include height (at screening only), weight, temperature, pulse rate, pulse oximetry), respiratory rate, and blood pressure while the participant is in a seated position. 
Vital signs (to be taken before blood collection for laboratory tests) will consist of one pulse and three blood pressure measurements (three consecutive blood pressure readings will be recorded at intervals of at least 1 minute). The average of the three blood pressure readings will be recorded on the eCRF.
			Imaging
  	ECG 12-LEAD	Interval: --	Occurrences: --			Imaging
  	ECG 12-LEAD	Interval: --	Occurrences: --			Imaging
  	ECG 12-LEAD	Interval: --	Occurrences: --			Imaging
  	TTE COMPLETE, WO CONTRAST, WO DOPPLER	Interval: --	Occurrences: --			Labs
  	HEPATITIS B SURFACE ANTIGEN	Interval: --	Occurrences: --		  	HEPATITIS B SURFACE ANTIBODY	Interval: --	Occurrences: --		  	HEPATITIS C VIRUS (HCV), QUANTITATIVE PCR	Interval: --	Occurrences: --		  	HIV 1/2 ANTIGEN/ANTIBODY, FOURTH GENERATION, WITH REFLEXES	Interval: --	Occurrences: --		  	HUMAN IMMUNODEFICIENCY VIRUS 1 (HIV-1), QUANTITATIVE PCR	Interval: --	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --			Labs
  	LDH	Interval: --	Occurrences: --		  	MAGNESIUM LEVEL	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --			Labs
  	BILIRUBIN DIRECT	Interval: --	Occurrences: --			Labs
  	HEMOGLOBIN A1C	Interval: --	Occurrences: --			Labs
  	FASTING GLUCOSE LEVEL	Interval: --	Occurrences: --			Labs
  	FIBRINOGEN	Interval: --	Occurrences: --			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --