SDTM Protocol Deviations (DV)

Description

An interventions domain that contains concomitant and prior medications used by the subject, such as those given on an as needed basis or condition-appropriate medications. A findings domain that contains the accountability of study product, such as information on the receipt, dispensing, return, and packaging. A special-purpose domain that includes a set of essential standard variables that describe each subject in study. One record will exist for each subject. An events domain that contains information encompassing and representing data related to subject disposition. An interventions domain that contains information about protocol-specified study product administrations, as collected. A findings domain that contains ECG data, including position of the subject, method of evaluation, all cycle measurements and all findings from the ECG including an overall interpretation if collected or derived. An interventions domain that contains the details of a subject's exposure to protocol-specified study products. A study product may be any intervention that is prospectively defined as a test material within a study, and is typically but not always supplied to the subject. A findings domain that contains the findings about an event or intervention that cannot be represented within an events or interventions domain record or as a supplemental qualifier. A findings domain that contains those criteria that cause the subject to be in violation of the inclusion/exclusion criteria. A findings domain that contains laboratory test data such as hematology, clinical chemistry and urinalysis. This domain does not include microbiology or pharmacokinetic data, which are stored in separate domains. An events domain that contains data that includes the subject's prior medical history at the start of the trial. A findings domain that contains concentrations of drugs or metabolites in fluids or tissues as a function of time. A findings domain that contains pharmacokinetic parameters derived from pharmacokinetic concentration-time (PC) data. A findings domain that contains physiological and morphological findings related to the respiratory system, including the organs that are involved in breathing such as the nose, throat, larynx, trachea, bronchi and lungs. A dataset used to describe relationships between records for a subject within or across domains, and relationships of records across datasets. A findings domain that contains subject-related data not collected in other domains. An interventions domain that contains information on the use of recreational products such as caffeine, alcohol, tobacco/nicotine, and other recreational drugs that may be of interest to the study. A relationship dataset used to describe nonstandard variables and their association to parent records in general-observation class datasets. A trial design domain that contains each planned arm in the trial. A trial design domain that contains the element code that is unique for each element, the element description, and the rules for starting and ending an element. A trial design domain that contains one record for each of the inclusion and exclusion criteria for the trial. This domain is not subject oriented. A trial design domain that contains one record for each trial summary characteristic. This domain is not subject oriented. A trial design domain that contains the planned order and number of visits in the study within each arm. A findings domain that contains measurements including but not limited to blood pressure, temperature, respiration, body surface area, body mass index, height and weight. An events domain for representing tobacco product device events, issues, and malfunctions that may occur during its use or testing. Since events may or may not be associated with a subject, USUBJID is a permissible variable. A study reference dataset that provides a mechanism for using multiple identifiers to create a single identifier for each device. A special-purpose domain that contains comments that may be collected alongside other data. A special-purpose domain that contains the actual order of elements followed by the subject, together with the start date/time and end date/time for each element. This domain captures body weights collected for subjects during the study and at the end of the study (terminal body weights). A findings domain that contains physiological and morphological findings related to the cardiovascular system, including the heart, blood vessels and lymphatic vessels. A findings domain that contains the diagnosis of the cause of death for a subject. The gross pathology findings recorded at necropsy. A findings domain that contains histopathology findings and microscopic evaluations. Findings from organ measurement evaluations. This domain captures information of any palpable masses examined during the experimental phase. A dataset that identifies individual subjects included in a pool of subjects for which a single observation record (pool level) is captured. This domain captures clinical sign information including ophthalmology, physical examination, and dermal examination collected in life while executing the study. This domain captures food/water consumption of animals in the study. The data in this domain is derived data. A special-purpose domain that includes a set of essential standard variables that describe each subject in a nonclinical study. One record will exist for each subject. A findings domain that contains ECG data, including position of the subject, method of evaluation, all cycle measurements and all findings from the ECG including an overall interpretation if collected or derived. A findings domain that contains concentrations of drugs or metabolites in fluids or tissues as a function of time. A findings domain that contains pharmacokinetic parameters derived from pharmacokinetic concentration-time (PC) data. An interventions domain that contains the details of a subject's exposure to protocol-specified study products. A study product may be any intervention that is prospectively defined as a test material within a study, and is typically but not always supplied to the subject. An events domain that contains information encompassing and representing data related to subject disposition. A findings domain that contains laboratory test data such as hematology, clinical chemistry and urinalysis. This domain does not include microbiology or pharmacokinetic data, which are stored in separate domains. A findings domain that contains physiological and morphological findings related to the respiratory system, including the organs that are involved in breathing such as the nose, throat, larynx, trachea, bronchi and lungs. A findings domain that contains subject-related data not collected in other domains. A findings domain that contains measurements including but not limited to blood pressure, temperature, respiration, body surface area, body mass index, height and weight. A dataset used to describe relationships between records for a subject within or across domains, and relationships of records across datasets. A relationship dataset used to describe nonstandard variables and their association to parent records in general-observation class datasets. A trial design domain that contains one record for each trial set characteristic including experimental factors, treatment factors, inherent characteristics, or distinct applicant designations. This domain is not subject oriented. A study reference dataset that provides a consistent identifier (SPTOBID) for the representation of a tobacco product. The dataset contains a list of the identifying and descriptive characteristics of the tobacco product. A study reference dataset that provides a consistent identifier (STOCONID) for the representation of a set of environmental conditions under which a test article is stored, and contains a list of those conditions. A special-purpose domain that lists the target, minimum, and maximum allowable values for design parameters of a product as allowed per manufacturer specifications. Therefore these data are not experimentally determined. A special-purpose domain that provides an identifier for each unique tobacco ingredient (IGDCMPID) in a tobacco product, and lists those tobacco ingredients and their attributes that contribute to their uniqueness. A special-purpose domain that provides an identifier for each unique non-tobacco ingredient (IGDCMPID) in a tobacco product, and lists those ingredients and their attributes that contribute to their uniqueness. A special purpose domain for representing the quantity of an ingredient/component of a product by the parent ingredient/component in which it occurs. A findings domain for representing results of testing performed on tobacco products or samples from tobacco products. PT is not a subject-level domain and is not used for results from testing products in human or animal subjects. A findings domain that contains in vitro genetic toxicology test results. A trial design domain that contains one record for each trial summary characteristic. This domain is not subject oriented. A trial design domain that contains each planned arm in the trial. A trial design domain that contains the element code that is unique for each element, the element description, and the rules for starting and ending an element. A study reference dataset that provides a mechanism for using multiple identifiers to create a single identifier for each device. A findings domain that contains the measurements and settings that are intentionally set on a device when it is in use. These are characteristics that exist for the device, and have a specific setting for a use instance. A findings domain that contains the measurements and settings that are intentionally set on a device when it is in use. These are characteristics that exist for the device, and have a specific setting for a use instance. An events domain used for data describing unintended signs, symptoms, or diseases temporally associated with the defined study period. A findings domain that contains data for named, stand-alone instruments designed to provide an assessment of a concept. Questionnaires have a defined standard structure, format, and content; consist of conceptually related items that are typically scored; and have documented methods for administration and analysis. A special-purpose domain that contains comments that may be collected alongside other data. An events domain that contains protocol violations and deviations during the course of the study. A relationship dataset used to describe how information is related to the design of the study and to other sources of information within the study. A special-purpose domain that contains the actual order of elements followed by the subject, together with the start date/time and end date/time for each element. A special-purpose domain that contains information for each subject's actual and planned visits and contact events. A findings domain that captures the post-mortem tumor findings of the study. Records in this domain are a subset of the records in the Microscopic Findings (MI) domain. A findings domain that contains the device characteristics that do not vary over the course of the study.

Specification

Assumptions

|