August 2023 FDA Guidance – eICF Focus

On August 16, 2023, the Food and Drug Administration (“FDA”) announced that the final guidance for industry entitled “Informed Consent: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors” is now available. This Guidance was issued on August 15, 2023, and it aims to assist Institutional Review Boards (IRBs), clinical investigators, and Sponsors to comply with regulatory requirements for clinical investigations – FDA`s informed consent requirements.

EU – US Data Transfer: Adequacy Framework

The European Commission finally adopted its adequacy decision for the EU-U.S. Data Privacy Framework on July 10th, 2023. This decision concludes that the United States ensures an adequate level of protection for personal data transferred from the EU to US companies under the new framework. On this basis, personal data can flow safely from the […]

ICH Guidelines – Good Clinical Practice (GCP)

On 19 May 2023 the International Council for Harmonization (“ICH”) of technical requirements for pharmaceuticals for human use endorsed a draft version of Good Clinical Practice (“GCP”) Guidelines – E6(R3) – which is currently under public consultation.

New EDPB Guidelines on personal data breach notification under GDPR

On 28 March 2023, the European Data Protection Board (“EDPB”) published the newest Guidelines on personal data breach notification under General Data Protection Regulation (“GDPR”) version 2.0., following the targeted public consultation about data breach notification for controllers not established in the EEA.

The Site said NO

Site’s decision to cancel participation in a clinical trial is always frustrating news for the CROs/Sponsors. There are various reasons behind such decision: lack of resources, competitive studies, inability to meet the trial timelines, personal or external reasons etc.

European Data Protection Board („EDPB”) Guidelines on certification, data transfers and deceptive design patterns

The National Commission on Information and Liberties in France (Commission nationale de l'informatique et des libertés or „CNIL”) announces that EDPB recently adopted new guidelines regarding the certification, data transfers, deceptive design patterns. CNIL is a co-rapporteur institution with EDPB aiming for the optimal implementation of the regulations.

DELAYED CTA: ANOTHER CHALLENGE

Prolonged Clinical Trial Agreement (CTA) negotiation and late CTA execution is, unfortunately, quite common for the clinical research. That is why there is a specific focus on the CTA negotiation/execution process, as delayed CTA often means delayed clinical trial site initiation and start of patient recruitment. Not to mention, delayed CTA may cause site payment issues. Why is it so problematic to get the fully executed CTA on time?

Being New to CTA Negotiation – Is It That Scary?

Starting a career as clinical trial agreement negotiator is a very important decision. Joining clinical trial industry means becoming a part of a complex and multi-level mechanism that is ultimately designed for one purpose - to make the World healthier. Being new to clinical trials may seem scary, but it is actually not. Step by step, a professional becomes a great project assistant, coordinator, monitor, start-up specialist, lead or project manager etc.

EU – US Adequacy Decision: Site Contracts Impact

On 13 December 2022, the European Commission published its new draft adequacy decision for the United States which – if adopted – would make it easier for organisations to share personal data with recipients in the US. The draft decision reflects the assessment of the European Commission that the United States ensures an adequate level of data protection for personal data, paving the way for finalisation of the EU-US Data Privacy Framework ("DPF").

Data Protection Officer – notes for clinical research

A Data Protection Officer (DPO) is responsible to ensure that an organization processes the personal data of its staff, customers, providers or any other individuals (also referred to as ‘data subjects’) in compliance with the applicable data protection rules.