Author: digi

Transparency About Data Sharing With Regulators, Sponsors and Third Parties In the highly regulated landscape of clinical research, transparency about data sharing is not merely a best practice; it is an essential component of ethical conduct and compliance. Clinical trials involve multi-faceted collaborations among sponsors, regulators, and various third parties, requiring that all stakeholders fully…

Read More “Transparency About Data Sharing With Regulators, Sponsors and Third Parties” »

Anonymization vs Pseudonymization: Choosing Approaches for Global Programs Anonymization vs Pseudonymization: Choosing Approaches for Global Programs The management of sensitive personal data is a critical aspect of conducting clinical trials, especially in light of recent regulatory developments across the US, UK, and EU. The principles of privacy and confidentiality must be rigorously upheld, not only…

Read More “Anonymization vs Pseudonymization: Choosing Approaches for Global Programs” »

Ethics Committee Expectations on Privacy Risk Assessment and Mitigation Ethics Committee Expectations on Privacy Risk Assessment and Mitigation 1. Introduction to Privacy Risk in Clinical Trials Clinical trials, particularly those involving sensitive health data, necessitate rigorous evaluations of privacy risks. The integration of ethical considerations is essential to protect participants’ information and ensure compliance with…

Read More “Ethics Committee Expectations on Privacy Risk Assessment and Mitigation” »

Biobank Governance and Secondary Use of Stored Specimens Biobanks have become invaluable resources for advancing research, particularly in the context of clinical trials. As the use of stored specimens for secondary research purposes increases, so too does the need to address complex issues surrounding governance, privacy, and ethical considerations. This article delivers a comprehensive step-by-step…

Read More “Biobank Governance and Secondary Use of Stored Specimens” »

Public Registries, Data Repositories and Participant Expectations of Privacy In the domain of clinical trials, managing participant data with both efficacy and ethics is paramount. The advent of numerous public registries and data repositories has created new frameworks for how data is collected, stored, and utilized within clinical trial management. This article directs clinical operations,…

Read More “Public Registries, Data Repositories and Participant Expectations of Privacy” »

Creating Participant Information Sheets on Data Sharing and Future Research In the evolving landscape of clinical research, ethical considerations surrounding data sharing and future research are paramount. This article provides a comprehensive step-by-step guide for clinical trial investigators on developing Participant Information Sheets (PIS) that address privacy, confidentiality, and the secondary use of data. Understanding…

Read More “Participant Information Sheets on Data Sharing and Future Research” »

Data Access Committees and Governance for Secondary Use Requests Data Access Committees and Governance for Secondary Use Requests This article serves as a comprehensive guide for clinical operations, regulatory affairs, and medical affairs professionals engaged in clinical research in the US, UK, and EU. It offers an in-depth understanding of Data Access Committees (DACs) and…

Read More “Data Access Committees and Governance for Secondary Use Requests” »

Re-Consent and Broad Consent Models for Secondary Use of Data Re-Consent and Broad Consent Models for Secondary Use of Data In the world of clinical trials, the ethical management of patient data is of paramount importance. As clinical research continues to evolve, the need for robust consent models—especially regarding secondary use of data—becomes increasingly evident….

Read More “Re-Consent and Broad Consent Models for Secondary Use of Data” »