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The Standard for Exchange of Nonclinical Data (SEND) is an implementation of the CDISC Standard Data Tabulation Model (SDTM) for nonclinical studies, which specifies a way to present nonclinical data in a consistent format. These types of studies are related to animal testing conducted during drug development.
The data management plan describes the activities to be conducted in the course of processing data. Key topics to cover include the SOPs to be followed, the clinical data management system (CDMS) to be used, description of data sources, data handling processes, data transfer formats and process, and quality control procedure
The sponsor is responsible for designing a CRF that accurately represents the protocol of the clinical trial, as well as managing its production, monitoring the data collection and auditing the content of the filled-in CRFs. Case report forms contain data obtained during the patient's participation in the clinical trial.
Progress Note - This template represents a patient's clinical status during a hospitalization, outpatient visit, treatment with a LTPAC provider, or other healthcare encounter. [ 14 ] Transfer Summary - The Transfer Summary standardizes critical information for exchange of information between providers of care when a patient moves between ...
Pituitary gland tumors are very common in the canine. A productive form arising from the anterior pituitary is the primary cause of Cushing's disease of dogs. This tumor causes excessive production of cortisol from the adrenal cortex which leads to the classic signs of alopecia (hair loss), polyuria (excessive urination), polydipsia (excessive water drinking), and a pot-bellied appearance of ...
1.2.2 Angiocentric glioma 1.2.3 Polymorphous low-grade neuroepithelial tumor of the young (PLNTY) 1.2.4 Diffuse low-grade glioma, MAPK pathway-altered 1.3 Pediatric-type diffuse high-grade gliomas 1.3.1 Diffuse midline glioma, H3 K27-altered 1.3.2 Diffuse hemispheric glioma, H3 G34-mutant
The Common Technical Document is divided into five modules: [4] Administrative and prescribing information; Overview and summary of modules 3 to 5; Quality (pharmaceutical documentation)
The CCD specification is a constraint on the HL7 Clinical Document Architecture (CDA) standard. The CDA specifies that the content of the document consists of a mandatory textual part (which ensures human interpretation of the document contents) and optional structured parts (for software processing).