Although different types of devices have widely varying data requirements, most Class II and III devices requiring regulatory data submissions share some fundamental characteristics.
How can you ensure you are submitting data in the proper format so that the FDA can process and review it?
The Medical Device Implementation Guide (IG) to the Study Data Tabulation Model (SDTM-MD) defines recommended standards for the submission of data from clinical trials in which medical devices were used.
It is intended to guide the organization, structure, and format of standard device clinical trial tabulation datasets submitted to regulatory authorities. The SDTM device domains are described in this guide, showing rules and examples of implementing these domains specifically for device-related data.
Data may be required to answer protocol questions, to address associated safety questions, or to associate specific devices with subjects. Some data are collected on Case Report Forms (CRF) that are completed by the investigative sites, whereas other data are usually derived by sponsors for the SDTM-based datasets.
The following seven SDTM-based domains are specific to devices, as described in this implementation guide:
1. Device Identifiers (DI)
This is a Study Reference 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 for linking data across Device domains. The information included in DI depends upon what is needed to identify the device uniquely within a submission and to meet analysis and regulatory requirements
2. Device-In-Use (DU)
DU 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. DU is distinct from Device Properties (DO), which describes static characteristics of the device. For example, DO would capture that an MRI machine’s field strength has a range from 0.2 to 3 Tesla, whereas the DU domain would capture that the field strength for the MRI scan for Subject 123 was 0.5 T.
3. Device Exposure (DX)
DX is an Interventions domain that records the details of a subject’s exposure to a medical device under study. This device is prospectively defined as a test article within a study and may be used by the subject, on the subject, or be implanted into the subject. Examples include but are not limited to stents, drug delivery systems, and any other item under study that is defined as a device in the applicable regulations. 2. The DX data may be captured on a CRF, downloaded from a device, or derived. The appropriate method is determined by the sponsor. In cases where a device-drug combination is being studied, the device exposure data would generally be submitted in DX and the drug exposure data would generally be submitted in EX, but each sponsor should confer with the appropriate regulatory authorities to determine the appropriate datasets.
4. Device Events (DE)
DE is an Events domain that contains information about various kinds of device-related events, such as device malfunctions. A device event may or may not be associated with a subject or a visit. If a device event, such as a malfunction, results in an adverse event, then this information should be recorded in the Adverse Events (AE) domain.
5. Device Tracking and Disposition (DT)
The DT domain is an Events domain that represents a record of tracking events for a given device (e.g., initial shipment, deployment, return, destruction). Different events would be relevant to different types of devices. The sponsor decides upon the level of detail that is appropriate for this domain based on the type of device and agreements with the regulatory agencies.
6. Device-Subject Relationships (DR)
The DR domain is a Relationships dataset structure that links each subject to devices to which they have been exposed. Information in this table may have been initially collected and submitted in other domains (e.g., Device Exposure, Device Tracking and Disposition, Device Events). This domain, however, provides a single, consistent location to find the relationship between a subject and a device, regardless of the device or the domain in which subject-related data may have been collected or submitted. This domain allows for many-to-many relationships such that a single subject may be associated with several devices (e.g., blood glucose test meters), a single device or class of devices may be associated with several subjects (e.g., an MRI machine), or several devices may be associated with several subjects.
7. Device Properties (DO)
The DO Findings domain is used to report characteristics of the device that are important to include in the submission and do not vary over the course of the study but are not used to identify the device. Examples include expiration date or shelf life. DO data would generally be assembled by a sponsor, rather than by an investigative site. The data can be captured using a CRF, assembled on a worksheet to support entry of the information into the clinical database, derived manually, or derived electronically from data in other domains or elsewhere.
How IMARC Research Can Help
As a full-service contract research organization, IMARC offers data management services that can help you submit study data in the proper format.
We can help you select the right electronic data capture system, build it according to your specifications, and work with site monitors to ensure data is entered accurately and in a timely manner. We can sort, clean, and analyze your clinical trial data and assist with database locking as your trial comes to a close.
Outsourcing your data and safety management to us eliminates silos so you can focus on bringing your device to market faster.
For practical tips on how to improve collaboration between data and safety management, download our latest whitepaper.
Study Data Tabulation Model Implementation Guide for Medical Devices (SDTMIG-MD)