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Home / eDSMB Blog

Ethical’s BLOG

Stay connected to eDSMB® and Data Safety
Monitoring Boards news in the eClinical World

Ethical’s Director Mimmo Garibbo and colleagues in Clinical Committee Management,  
Software Engineering and Security bring you news and insight on issues, trends,
technology, developments and noteworthy events in the world of Data Safety Monitoring Boards.

Manageability DSMB

By Ethical 29 May, 2023

Manageability and communication in DSMB

Let’s start with the simplest of questions: how many parties do you expect to be involved in the DSMB process of your clinical trial? If your answer is “two, me and the DSMB chairperson” then you don’t need to read the rest of this article. You may just as well pick up your phone, call the chairperson and start the negotiati...

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DSMB Data Security

By Ethical 18 May, 2023

Security in DSMB management: why use a validated software?

Double-blind randomized clinical trials are the cornerstone of modern clinical development and have proven their utility times and again in various settings (active treatment versus placebo, new compound versus established treatment and so on). Blinding of patients, investigators and sponsor staffs is essential to the unbiased comparison and is usu...

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DSMB Compliance

By Ethical 18 Apr, 2023

GCP Compliance for DSMBs and DMCs: How to ensure?

Good clinical practice (GCP) is an international ethical and scientific quality standard for designing, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and wellbeing of trial subjects are protected and that clinical-trial data are credib...

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audit trail clinical trial committees

By Ethical 21 Feb, 2023

Audit trail of a clinical committee process: the invisible string to compliance

An audit trail is the part of metadata allowing to track the key parameters of a digital record: when the record was created, in which environment or system, by whom, who reviewed it and when, who approved it, and so on. If metadata such as dates of issuance, dates of validity or all other important information allowing to identify digital records...

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