The IEEE Standards Association (IEEE SA) and IEEE Engineering in Medicine and Biology Society/ Standards Committee invite you to participate in the working group for IEEE P2968.1™ – Trial Use Recommended Practice for Decentralized Clinical Trials Patient Safety and IEEE P2968.2™ – Trial Use Recommended Practice for Decentralized Clinical Trials Threat Modeling, Cybersecurity, and Data Privacy.
WHY GET INVOLVED
The adoption of technologies to help enable decentralized participation in clinical trials is changing how clinicians and patients interact from traditional face-to-face communication and assessments to more remote communication and assessments. Patient safety needs to remain central to clinical study design and execution, whether the patient is participating at a clinical site or remotely.
Digital health technologies are revolutionizing the ways we are able to interact, conduct clinical trials, and improve healthcare. Unfortunately, with the growth of internet/network-connected technology, the world has witnessed significant increases in data breaches and other cybersecurity events. Such threats not only put a patient’s personal information at risk, but they also expose industry sponsors to possible delays in approval or failure to capture information that would save a person’s life. Developing a recommended practice helps the industry better assess the threats, cybersecurity challenges, and data privacy needs that are associated with conducting decentralized clinical trials.
WHO SHOULD PARTICIPATE
- Clinical Trial Patients
- Clinical Site Investigators and Staff
- Biopharmaceutical and Medical Device Sponsors
- Contract Research Organizations
- Regulatory authorities
- Decentralized Trials Technology Companies
MEETING INFORMATION
Date: Friday, 09 April 2021
Time: 12:00 PM – 2:00 PM ET
HOW TO PARTICIPATE
- Log in to the myProject system to indicate interest in following or participating in this effort.
- Note: An IEEE SA account is needed to access the system – just click on ‘Create Account’ if you do not already have one.
- Click on the ‘Menu’ icon at the top of the page and go to the ‘Manage Profile and Interests’ page.
- Click on the ‘Interests’ tab, click on the ‘Add Groups’ and search for ‘2968.1’ and/or ‘2968.2.’ Click on the button in the ‘Groups I am Interested In’ column to indicate interest in the group.
- Indicate whether you want to follow or participate in the activity and declare your affiliation.
Need help? Click on the ‘Help’ icon at the top of the page for assistance.
For additional information, contact the Working Group Chair, Walter De Brouwer, at walter@doc.ai or the IEEE SA Program Manager, Tom Thompson, at thomas.thompson@ieee.org.