Clarifying Data Use in Pharma: Future Research in Clinical Trials vs. Further Processing of Personal Data
The evolving landscape of medical research and data privacy presents complex challenges, particularly for Data Protection Officers (DPOs) and researchers who navigate these waters. It’s crucial to understand the different regulatory frameworks that govern the use of personal data in clinical trials and its future uses. This article explores the key differences between future research […]
The Necessity of Drafting a Newborn ICF in Clinical Trials
In recent discussions within the biopharmaceutical industry, a critical question has emerged regarding the necessity of drafting a separate Informed Consent Form (ICF) for newborns when data collection extends beyond pregnancy outcomes in clinical trials. Typically, this arises when a female partner of a male research participant becomes pregnant, and the exposure of the fetus […]
Ethical and Legal Perspectives on Using Post-Mortem Data in Clinical Research
In the realm of medical research, clinical trials stand as critical conduits for advancing medical knowledge and improving patient care. However, an often-overlooked aspect of these studies is the handling of data from deceased participants, a topic that intertwines the complexities of legal requirements and ethical considerations. The Importance of Deceased Participants’ Data The data […]
Navigating the Future of Clinical Trials: Innovations and the Imperative for Privacy Protection
The field of clinical trials is rapidly evolving with several innovations that are shaping its future. Here are three significant advancements in clinical trials, each carrying substantial privacy implications. It’s essential for those involved in clinical trials to adhere to the pertinent legal and regulatory standards while also innovating in their approach to implementing privacy […]
Transfer Impact Assessment in the scope of clinical trials – who should do it?
What is a Transfer Impact Assessment? The requirement to perform a Transfer Impact Assessment (TIA) was introduced by the “Schrems II” ruling, where the Court of Justice of the European Union (CJEU) emphasized the responsibility of exporters and importers to ensure that personal data is processed, and continues to be processed, in compliance with the […]
Standard Contractual Clauses between Trial Sponsors and Hospitals
The reason why I’m writing this post is because I’ve seen multiple positions on the need or not to sign Standard Contractual Clauses (SCC’s) between Non-EU Trial Sponsors and EU Hospitals; but many do not align with what the competent authorities have said about the subject. I have seen Sponsors that are subject directly to […]
Clinical Trial Sponsors – Do you provide GDPR training to your employees?
privacy training a mandatory step to ensure GDPR compliance
Why RD Privacy?
RD PRIVACY was created to support pharmaceutical companies to ensure compliance with the GDPR and applicable privacy laws, when conducting clinical trials in EU countries. Why? Because after spending more than a decade in advising life science industries on GDPR compliance, I understand the challenges of the start-up phase of a clinical trial; I know […]
Data Protection & Investigator’s data
Clinical Trial Regulations and ICH-GCP’s have implemented privacy rules to the processing of research participants personal data, however there’s nothing on these regulations that rule the processing of personal information from Investigators and study staff; and even though we know that the processing of individual’s personal data involved in the conduct of the research is […]
CRO responsibilities on GDPR compliance – what Sponsors should know
Can a CRO act as Data Protection Officer (DPO) or as Data Protection Representative (DPR) for a clinical trial Sponsor? Should a Sponsor request the CRO to provide privacy advice? Is the CRO responsible to negotiate privacy clauses and agreements on behalf of a trial Sponsor? These are the most frequent asked questions, by clinical […]
