COTC007B Data Inventory

COTC = Comparative Oncology Trials Consortium

Name of Data or Form	Description of Data	Source of Data	Example Data Received?	In What Format	Data Required for	Data Requested for	Data Received for	Data Acquisition on Track?	Data Destined for Use?	List of Key Fields Defined?
Enrollment	Demographics, diagnosis, study site, study arm/cohort	C3D export via Christina	Yes		3 canine patients	1 canine patient	1 canine patient	Yes	Yes	Yes
Baseline Medical Evaluation	Observations around 12 body systems during enrollment	C3D export via Christina	Yes		3 canine patients	1 canine patient	1 canine patient	Yes	Yes	N.A.
Prior Treatment Summary	Observations around 6 types of prior therapy	C3D export via Christina	Yes		3 canine patients	1 canine patient	1 canine patient	Yes	Yes	Yes
Prior Therapy Detail	Specific details concerning any given prior therapeutic intervention	C3D export via Christina	Yes		3 canine patients	1 canine patient	1 canine patient	Yes	Yes	Yes
Prior Surgery	Specific details concerning prior surgical interventions	C3D export via Christina	Yes		3 canine patients	1 canine patient	1 canine patient	Yes	Yes	Yes
Course Initiation	Records the date upon which a treatment cycle begins	C3D export via Christina	Yes		3 canine patients	1 canine patient	1 canine patient	Yes	Yes	Yes
Course Assessment	Summarizes outcome of treatment cycle wrt completion, response, adverse events, etc.	C3D export via Christina	Yes		3 canine patients	1 canine patient	1 canine patient	Yes	?
Study Medication	Records actual doses of therapeutic agent(s) administered	C3D export via Christina	Yes		3 canine patients	1 canine patient	1 canine patient	Yes	Yes	Yes
Concomittant Medications	Details concerning use of medications other than the test article(s)	C3D export via Christina	Yes		3 canine patients	1 canine patient	1 canine patient	Yes	No	N.A.
Follow Up	Records the dates of follow up visits after cycle, and any observations made	C3D export via Christina	Yes		3 canine patients	1 canine patient	1 canine patient	Yes	Yes	Not Yet
Off Medication	Records the date upon which treatment was suspended	C3D export via Christina							Yes	?
Off Study	Records the date upon which patient was taken off the study	C3D export via Christina	Yes		3 canine patients	1 canine patient	1 canine patient	Yes	Yes	?
Owner Assessments	Observations around the patient's general condition, as dindicated by the owner of the animal in question	C3D export via Christina	Yes		3 canine patients	1 canine patient	1 canine patient	Yes	No	N.A.
Sample Collection	Represents an inventory of what biospecimens were collected during the study, exactly when they were collected, and how/where they were subsequently stored	C3D export via Christina	Yes		3 canine patients	1 canine patient	1 canine patient	Yes	?
Procedures	Records medical procedures performed during the study (biopsy procedures, X-rays, surgical excisions)	C3D export via Christina	Yes		3 canine patients	1 canine patient	1 canine patient	Yes	?
PK	Records date and exact time of collection of samples for PK analysis, but contains no actual PK data	C3D export via Christina	Yes		3 canine patients	1 canine patient	1 canine patient	Yes	No	N.A.
PD	Records date and exact time of collection of samples for PD analysis, but contains no actual PD data	C3D export via Christina	Yes		3 canine patients	1 canine patient	1 canine patient	Yes	No	N.A.
Physical Exam + Vital Signs	Observations around 12 body systems during study visits	C3D export via Christina	Yes		3 canine patients	1 canine patient	1 canine patient	Yes	Yes	Yes
Extent of Disease	Detailed lesion measurements taken during study visits	C3D export via Christina	Yes		3 canine patients	1 canine patient	1 canine patient	Yes	Yes	Yes
Lab ALI	Detailed blood chemistry and UA measurements taken during study visits	C3D export via Christina	Yes		3 canine patients	1 canine patient	1 canine patient	Yes	Yes	?
Adverse Events	Details of adverse events noted during study visits	C3D export via Christina	Yes		3 canine patients	1 canine patient	1 canine patient	Yes	Yes	Not Yet
Pharmacokinetics	Plasma concentration of the test article(s) at numerous timepoints	Joe Covey	Yes		3 canine patients	3 canine patients	3 canine patients	Yes	Yes	Not Yet
Fields of Slides	Fields chosen from whole slides for analysis	Bob Kinders	No		3 canine patients	3 canine patients		No	Yes

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