DSMB Data Security

By Ethical 24 Nov, 2022

Preventing your trial data confidentiality breaches with eDSMB

With the management of a DSMB, DMC or Steering Committee comes the confidentiality risk, both in terms of document distribution and electronic data protection if you’ve opted for an online tool. Here’s why eDSMB® protects your team and your company from the data security risk inherent to external reviews.

New cases of data leak either accidental or malicious quite often capture the headlines. Any company or institution is potentially at risk and the downstream consequences can be severe: a data leak can reveal trade secrets but also jeopardize patient confidentiality, potentially harming a company’s reputation and even affecting stock price for those publicly listed on the stock exchange.

The limits of rules-based management

While trade secrets such as formulas or results of studies and experiments can be kept safe behind the company firewall and shared among a small number of individuals, as soon as one is out in the worldwide web using email communication, the protection becomes much more challenging. Rules-based management can help to some extent and companies have increasingly banned the use of email for exchanging any type of data even inside the company perimeter. However, it is difficult and risky to rely on rules in a setup involving external parties.

Securing access to documents used for external review

When external expert committees are hired to review clinical study data and material, the question of data safety and personal confidentiality naturally emerges. Protection from unauthorized access is needed at several levels. People external to the company or the committee should never have access to any of the material used for review, but even internal personnel may need to be blinded either because they do not work on the particular project or because there is a blinding of the results as part of the study design. 

Guaranteeing patient confidentiality

Patient identifying information must never reach anyone outside of the hospital or treating physician’s office and any system used to convey patient data must provide both secure role-based access and tools that allow the redaction of identifiers should they be accidentally left visible. 

Why eDSMB® is your best choice for data security

Clinical trial software vendors have an obligation to guarantee the security of the process itself as well as of all the data that is handled as part of their mission. eDSMB® is fitted with an array of data security features that guarantee the security of all data that transit from the tool:

  • Blinded/unblinded data segregation for specific role/user
  • Two-factor authentication (or SSO integration)
  • Strict role-based authorizations
  • Audit-trail
  • Regulatory compliance
  • Secure eSignature
  • AI redaction technology 
  • Encryption in transit
  • Encryption at rest

In conclusion, preventing data security risks is an important element to consider when setting up a clinical trial external committee such as a DSMB, DMC or Steering Committee. Ethical’s eDSMB® software has all the features needed to guarantee a secure and efficient committee operations management.


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