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OP PRO00038124 / SCREENING	

Types:      Research Oncology Treatment
Synonyms:  BASELINE, SCREENING, D926QC00001

Baseline/Screening( up to 28 days)	Repeat 1 time	Cycle length: 28 days	Day 1	Perform every 1 day x1		Nursing Orders
  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Informed Consent

Written (or electronic) informed consent and any locally required privacy act document authorization must be obtained prior to performing any protocol-specific procedures, including screening/baseline evaluations.
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Informed consent:genetic sample and analysis (optional).

Written (or electronic) informed consent and any locally required privacy act document authorization must be obtained prior to performing any protocol-specific procedures, including screening/baseline evaluations.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Inclusion/exclusion criteria.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Demographics
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Medical History and current medical conditions.
			Nursing Orders
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Full Physical Exam
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	AE review.
		  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Prior and concomitant medication review
			Nursing Orders
  	VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Blood pressure, body temperature, heart rate
		  	HEIGHT AND WEIGHT	Interval: --	Occurrences: --			Nursing Orders
  	PULSE OXIMETRY	Interval: --	Occurrences: --			Imaging
  	ECG 12-LEAD	Interval: --	Occurrences: --			Imaging
  	TTE COMPLETE, WO CONTRAST, WO DOPPLER	Interval: --	Occurrences: --		  	ZZ_HIST_NM CARDIAC BLOOD POOL MUGA (AT REST)	Interval: --	Occurrences: --			Imaging
  	CT CHEST W WO CONTRAST	Interval: --	Occurrences: --			Imaging
  	MAMMO BREAST SCREEN TOMOSYNTHESIS BILATERAL	Interval: --	Occurrences: --	Comments:	Performed at diagnosis.
		  	MRI BREAST WO CONTRAST BILATERAL	Interval: --	Occurrences: --	Comments:	Performed at diagnosis.
			Other
  	PULMONARY FUNCTION TEST	Interval: --	Occurrences: --			Ophthalmology
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	Ophthalmologic assessments including but not limited to visual acuity testing, slit lamp examination, intraocular pressure measurement, fundoscopy, and fluorescein staining will be performed by an ophthalmologist, or if unavailable, another licensed eye care provider. Please refer to the Dato-DXd Site Ophthalmologic Assessment Manual for further details.
		  	VISUAL ACUITY SCREENING	Interval: --	Occurrences: --		  	SLIT LAMP PHOTOGRAPHY - OU - BOTH EYES	Interval: --	Occurrences: --		  	FUNDUS PHOTOS - OU - BOTH EYES	Interval: --	Occurrences: --	Comments:	Fundoscopy
			Labs
  	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --			Labs
  	ONC NURSING COMMUNICATION	Interval: --	Occurrences: --	Comments:	A negative serum pregnancy test must be documented during screening for all FOCBP. If a serum pregnancy test is collected greater than 72 hours prior to randomization, perform a repeat pregnancy test (urine or serum per institutional guideline) within 72 hours before randomization. Perform repeat pregnancy tests (urine or serum per institutional guideline) within 72 hours before treatment at each cycle. A positive urine pregnancy test result mus
t immediately be confirmed using a serum test.
			Labs
  	HCG QUALITATIVE, SERUM SCREEN	Interval: --	Occurrences: --			Labs
  	HCG QUALITATIVE, URINE SCREEN	Interval: --	Occurrences: --			Labs
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Menopausal status Assessments (including FSH, LH, and estradiol);
Menstruation status
			Labs
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Prior HIV serology (anti-HIV with or without HIV RNA, as appropriate), hepatitis B serology (HBsAg, anti-HBs, and anti-HBc with or without HBV DNA, as appropriate), and hepatitis C serology (anti-HCV antibody with or without HCV RNA, as appropriate) testing results can be used if performed within 120 days before enrolment. In this case, there is no need for a repeat test during the 28-day screening period. If an HIV infection meets the criteria 
outlined in Section 5.2, monitoring of viral RNA load and CD4+ cell count is recommended and should be performed per local SoC (eg, every 3 months). Participants must be tested for HIV if acceptable by local regulations or an
IRB/EC.
			Labs
  	HIV 1/2 ANTIGEN/ANTIBODY, FOURTH GENERATION, WITH REFLEXES	Interval: --	Occurrences: --		  	HEPATITIS B SURFACE ANTIGEN	Interval: --	Occurrences: --		  	HEPATITIS C ANTIBODY	Interval: --	Occurrences: --			Labs
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Serum or plasma clinical chemistry (including liver function test monitoring) and hematology may be performed more frequently if clinically indicated. If TSH is measured
within 14 days prior to Day 1 (first infusion day), it does not need to be repeated on C1 Day 1. Free T3 or free T4 will only be measured if TSH is abnormal or if there is clinical suspicion of an AE related to the endocrine system. Clinical safety laboratory assessments (clinical chemistry and hematology) are required within 7 days prior to randomization. Table 8
			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		  	T3	Interval: --	Occurrences: --		  	T4, FREE	Interval: --	Occurrences: --			Labs
  	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --			Labs
  	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		  	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --			Labs
  	URINALYSIS, AUTOMATED WITH MICROSCOPY	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Research Labs
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --			Procedures
  	RESEARCH STUDY SPECIMEN	Interval: --	Occurrences: --	Comments:	All participants must have a FFPE tumor sample from primary invasive disease at time of diagnosis. Written confirmation of tumor sample needs to be available prior to
enrolment, and tumor samples should be available prior to randomization. Tumor samples should be taken within 12 weeks prior to randomization