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Study Data Tabulation ModelCDISC Device Draft Standard for Public Review and Comment Period - Comments Due Tuesday, 21 February 2012
This draft Devices Supplement to the Study Data Tabulation Model Implementation Guide (SDTMIG) defines recommended standards for the submission of data from clinical trials in which medical devices were used. These domains cover both studies where the device is under study and where approved devices are used to generate study measurements but the device is not under study.
This is the first attempt by CDISC to develop submission standards for device trials, so it is expected that there will be gaps and areas for further development. To this end the CDISC Device team requests that the clinical research community review these proposed standards and submit comments for further improvement and development. Reviewers are encouraged to model these standards with test data and provide detailed feedback on what did and did not work.
This draft document contains seven proposed new SDTM domains that are designed to capture basic information about medical devices. These domains have been modeled on, and work in concert with, existing SDTM constructs:
1. Device Identifiers (DI): This is a special-purpose domain designed for the submission of information that identifies a specific device unit. The primary purpose of this domain is to provide a consistent sponsor-defined variable (UDEVID) for linking data across Device domains.
2. Device Properties (DO): The Device Properties special-purpose domain is used to report characteristics of the device that are important to include in the submission, do not vary over the course of the study, but are not used to identify the device. Examples include expiration date or shelf life.
3. Device-In-Use (DU): Device in Use is a Findings domain that contains the values of measurements and settings that are intentionally set on a device when it is used and may vary from subject to subject or other target. These are characteristics that exist for the device, and have a specific setting for a use instance.
4. Device Exposure (DX): Device Exposure is an Interventions domain records the details of a subject’s exposure to a medical device under study. Examples include but are not limited to stents and drug delivery systems
5. Device Events (DE): Device Events is an Events domain that contains information about various kinds of device-related events, such as malfunctions. A device event may or may not be associated with a subject or a visit, and device malfunctions may or may not be associated with adverse events.
6. Tracking and Disposition (DT): The Device Tracking and Disposition domain is an Events domain that represents records of tracking events for a given device. These could include initial shipment, deployment, return, and destruction.
7. Device-Subject Relationship (DR): The Device-Subject Relationship domain is a special-purpose domain that links each subject to device(s) to which they may have been exposed. This domain provides a single, consistent location to find the relationship between a subject and a device.
Once this initial device document is published the team will focus on the following next steps:
• CDASH data-collection field gap analysis. Based on this analysis, the needed CDASH collection fields will be developed to support the SDTM submission fields.
• Controlled Terminology gap analysis. Based on this analysis, the needed device-specific terminology will be developed and these new terms will be requested according the terminology change control process located on the NCI-EVS website.
These new domains are intended to support regulatory submissions in the following device categories:
FOR REVIEWERS:
Items listed below require specific input from reviewers. Please pay special attention and provide your feedback.
1. The former Device Malfunctions domain has been generalized and renamed to be Device Events, which will allow for its use in a wider variety of situations. The team would like reviewers to submit use cases (i.e., events of interest occurring with devices that are not malfunctions).
2. Does your organization require a free text and a controlled terminology field for tracking devices? For example, if device is shipped from sponsor to site is it sufficient to have field containing SHIPPED or is a free text field required as well?
Follow the link to access Draft Document as well as the Comments Spreadsheet.
PUBLIC REVIEW COMMENTS ARE DUE TUESDAY, 21 FEBRUARY 2012.
Please send comment spreadsheet to rfacile@cdisc.org.
Amendment 1 Now Available!
CDISC is pleased to announce the posting of 'Amendment 1 to the Study Data Tabulation Model (SDTM) v1.2 and the SDTM Implementation Guide: Human Clinical Trials V3.1.2.' Amendment 1 contains new variables for certain domains as well as instructions and clarifications. This was a collaborative effort between CDISC and FDA and is a companion document to the 'CDER Common Data Standards Issues Document Version 1.1.'
Public Review: SDTM Virology Draft Domains
FDA's CDER has recognized a critical need for the development of standards to accommodate the virology data accompanying submissions in multiple therapeutic areas. To address this need, CDER has worked with CDISC to develop a possible solution. Two new SDTM domains to house virologic genotypic (VG) and phenotypic (VP) are proposed. The VG and VP domains are structured as Findings domains that can stand alone or be folded into the constellation of domains called PGx that are currently being drafted. While PGx is designed to house subject-level data, VP and VG are intended to house pathogen-level data.
The material in this posting consists of:
Comments for this domain ended on 4 Oct 2011.
SDTM v1.2, SDTMIG: Human Clinical Trials v3.1.2 Comment Period ClosedThe comment period for the Amendment 1 to the Study Data Tabulation Model (SDTM) v1.2 and the SDTM Implementation Guide: Human Clinical Trials v3.1.2 has closed. Comments are being addressed in order to finalize the amendment. To get a copy of this draft, click here.
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