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OP RSH PRO00044358 J6M-MC-JSGD MAI SCREENING	

Types:      Research Oncology Treatment
Synonyms:  PRO00044052 NIRAVATH BC-IMT-04

Baseline/Screening	Repeat 1 time	Cycle length: 28 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:    J6M-MC-JSGD_Mai
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Nursing Communication: Dose Modifications and Management for Tersolisib/Placebo: Refer to Section 6.6. Protocol Access Hyperlink:   J6M-MC-JSGD_Mai
			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Informed consent. Up to 42 days prior to randomization
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Inclusion/Exclusion Criteria
		  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Demographics
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Preexisting conditions and medical history
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Prior cancer treatments
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Concomitant medications
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Adverse events
		  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Record ECGs before collecting blood
		  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --		  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Physical examination
		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	ECOG PS evaluation
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Register/Randomize with IWRS
		  	ONC NURSING COMMUNICATION 102	Interval: --	Occurrences: --	Comments:	Clinical Tumor Assessment- Visible tumor (such as skin lesions) should be documented by photography, and each photographic image of the tumor should include a ruler. If measurable, caliper measurements should be recorded.
			Labs
  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --	Comments:	Pregnancy (serum or urine). Test required for individuals of childbearing potential. Must collect a serum sample <=14 days prior to the start of study treatment.
		  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --	Comments:	Pregnancy (serum or urine). Test required for individuals of childbearing potential. Must collect a serum sample <=14 days prior to the start of study treatment.
			Labs
  	HEPATITIS B SURFACE ANTIGEN	Interval: --	Occurrences: --		  	HEPATITIS B SURFACE ANTIBODY	Interval: --	Occurrences: --		  	HEPATITIS B CORE ANTIBODY TOTAL	Interval: --	Occurrences: --		  	HEPATITIS C VIRUS (HCV), QUANTITATIVE PCR	Interval: --	Occurrences: --	Comments:	Qualitative HCV RNA (if HCV-Positive)
		  	HEPATITIS C VIRUS (HCV) ANTIBODY WITH REFLEX TO PCR	Interval: --	Occurrences: --			Labs
  	HIV 1/2 ANTIGEN/ANTIBODY, FOURTH GENERATION, WITH REFLEXES	Interval: --	Occurrences: --			Imaging
  	NM BONE SCAN LIMITED	Interval: --	Occurrences: --	Comments:	Testing up to 42 days prior to randomization may be used for baseline assessment
			Imaging
  	ONC NURSING COMMUNICATION 20	Interval: --	Occurrences: --	Comments:	X-ray or CT with bone windows or MRI. Required only for participants with RECIST v1.1 non-measurable evaluable bone disease, for any lesions identified on bone scintigraphy not visible on the chest, abdomen, and pelvis scans.
			Imaging
☑	CT CHEST W WO CONTRAST ABDOMEN W WO CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	CT or MRI
		☐	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	CT or MRI
		☐	CT CHEST WO CONTRAST ABDOMEN WO CONTRAST PELVIS WO CONTRAST	Interval: --	Occurrences: --	Comments:	CT or MRI
		☐	MRI CHEST W WO CONTRAST	Interval: --	Occurrences: --	Comments:	CT or MRI
		☐	MRI CHEST W CONTRAST	Interval: --	Occurrences: --	Comments:	CT or MRI
		☐	MRI CHEST WO CONTRAST	Interval: --	Occurrences: --	Comments:	CT or MRI
		☐	MRI ABDOMEN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	CT or MRI
		☐	MRI ABDOMEN WO CONTRAST	Interval: --	Occurrences: --	Comments:	CT or MRI
		☐	MRI PELVIS W WO CONTRAST	Interval: --	Occurrences: --	Comments:	CT or MRI
		☐	MRI PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	CT or MRI
		☐	MRI PELVIS WO CONTRAST	Interval: --	Occurrences: --	Comments:	CT or MRI
			Imaging
☑	ONC NURSING COMMUNICATION 33	Interval: --	Occurrences: --	Comments:	CT or MRI brain. Required only for participants with known CNS lesions identified at screening or if clinically indicated. Contrast-enhanced brain MRI is preferred. If MRI contrast is contraindicated, then MRI (without contrast) or CT (recommended with contrast) is acceptable.
		☑	MRI BRAIN W WO CONTRAST	Interval: --	Occurrences: --	Comments:	CT or MRI brain. Required at baseline for all participants, even without a history of brain metastases.For participants with treated brain metastases, contrast-enhanced brain MRI is preferred. If MRI contrast is contraindicated, then MRI (without contrast) or CT (recommended with contrast) is acceptable.
		☐	MRI BRAIN W CONTRAST	Interval: --	Occurrences: --	Comments:	CT or MRI brain. Required at baseline for all participants, even without a history of brain metastases.For participants with treated brain metastases, contrast-enhanced brain MRI is preferred. If MRI contrast is contraindicated, then MRI (without contrast) or CT (recommended with contrast) is acceptable.
		☐	MRI BRAIN WO CONTRAST	Interval: --	Occurrences: --	Comments:	CT or MRI brain. Required at baseline for all participants, even without a history of brain metastases.For participants with treated brain metastases, contrast-enhanced brain MRI is preferred. If MRI contrast is contraindicated, then MRI (without contrast) or CT (recommended with contrast) is acceptable.
		☐	CT HEAD W CONTRAST	Interval: --	Occurrences: --	Comments:	CT or MRI brain. Required at baseline for all participants, even without a history of brain metastases.For participants with treated brain metastases, contrast-enhanced brain MRI is preferred. If MRI contrast is contraindicated, then MRI (without contrast) or CT (recommended with contrast) is acceptable.
		☐	CT HEAD W WO CONTRAST	Interval: --	Occurrences: --	Comments:	CT or MRI brain. Required at baseline for all participants, even without a history of brain metastases.For participants with treated brain metastases, contrast-enhanced brain MRI is preferred. If MRI contrast is contraindicated, then MRI (without contrast) or CT (recommended with contrast) is acceptable.
		☐	CT HEAD WO CONTRAST	Interval: --	Occurrences: --	Comments:	CT or MRI brain. Required at baseline for all participants, even without a history of brain metastases.For participants with treated brain metastases, contrast-enhanced brain MRI is preferred. If MRI contrast is contraindicated, then MRI (without contrast) or CT (recommended with contrast) is acceptable.
			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Tumor tissue
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Biomarker blood
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Hematology
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Clinical Chemistry
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Coagulation
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Glucose Metabolism Markers
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Fasting Lipid Panel
		  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	Urinalysis