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Health data ecosystems: Sharing health data to facilitate medical

Health data ecosystems hold many benefits, alsoin regard to clinical trials. Not only do they allow those running clinicaltrials to better find and match potential candidates who have the appropriateprofile, but health data ecosystems can also … See more

Actived: 3 days ago

URL: https://www.sctoplatforms.ch/en/publications/ra-watch/ra-watch-7-n-data-privacy-and-data-sharing/an-industry-view-interpharma-sharing-data-in-health-data-ecosystems-167.html

Guidance for Electronic Health Record (EHR) System Requirements …

WebWhen electronic health record (EHR) systems are used for source data in clinical trials, they must fulfil special regulatory requirements in order to be compliant with ICH-GCP, the …

Category:  Health Go Health

Guidance for Electronic Health Record (EHR) System …

WebHealth related data which are stored in EHR systems and retrieved from EHR systems have to be attributable to individual trial subjects. ICH GCP 2.10, 4.9.0 and EMA eSource …

Category:  Health Go Health

EHR Systems Study Site Assessment Template

WebEHR Systems Study Site Assessment Template More and more frequently, electronic health record (EHR) systems provide source data for case report forms (CRFs) in …

Category:  Health Go Health

Guidelines for Risk-Based Monitoring

WebThe Federal Office of Public Health (FOPH) provides, via its kofam portal, a standardised electronic risk-categorisation tool12. This categorisation may feed into the risk-based …

Category:  Health Go Health

Promoting inclusive, patient-oriented research: A rare disease …

WebPublic health research (Egger et al. 2021), by nature observational, focuses on the evaluation of population health and well-being and patient experiences (Moreau …

Category:  Health Go Health

An update on the national general informed consent: what is the …

WebThe general consent, what are we talking about? In personalised medicine, the use of health-related data and samples from large patient populations have become an …

Category:  Medicine Go Health

Towards a national strategy for registries and cohorts

Web1. Establish a national registry strategy. First of all, the Confederation needs to establish a national policy for registries, cohorts, and biobanks in the Swiss health system. Data …

Category:  Health Go Health

Position paper: Monitoring in Non-Interventional Human Research

WebThis position paper discusses and provides recommendations regarding the implementation of monitoring strategies for non-interventional human research projects. This includes …

Category:  Health Go Health

Tools for clinical research professionals

Websts_graph_landmark is a Stata programme for avoiding survival bias that creates landmark analysis Kaplan-Meier curves, complete with risk tables. Tools for clinical research …

Category:  Health Go Health

COVID: 1–9 work practices and lessons learnt at one CTU

WebOn 11 March 2020, the World Health Organization (WHO) declared the coronavirus situation a global pandemic – a crisis caused by the SARS-CoV-2 virus. The …

Category:  Coronavirus Go Health

Medical registries and their use for research projects

WebThe overarching aim of medical registries is to accurately and consistently collect high-quality, reliable data over a long period of time and then use this data to improve care …

Category:  Medical Go Health

Regulatory aspects of patient and public involvement in academic

WebLegal basis of PPI in Switzerland. In 2015, the Federal Council evaluated the participation rights of patient organisations and patient involvement in health policy …

Category:  Health Go Health

Central Data Monitoring in Clinical Trials

WebThis led to major challenges for quality assurance and control, in particular for multicentre trials. It became apparent that there is a need to complement conventional monitoring at …

Category:  Health Go Health

The evolving practice of patient and public involvement in Europe …

WebSimilar to health systems, the academic research environment was not originally planned around the patient. With the Declaration of Helsinki adopted only in …

Category:  Health Go Health

Patient input into medical device development: A missed …

WebMedical device users: An overlooked but valuable source of input. The World Health Organization (WHO) reports an estimated two million different kinds of medical devices …

Category:  Medical Go Health

Regulatory developments in the medical devices sector: A long …

WebEuropean law has evolved to guarantee greater safety for patients who receive or use medical devices (MDs).The new EU Medical Device Regulation (MDR), which governs …

Category:  Medical Go Health

Navigating the 2021 changes to the medical device regulatory …

WebHow time flies! In October 2019, we published our second issue of Regulatory Affairs Watch – dedicated to the new medical device (MD) regulatory environment – ahead of the …

Category:  Medical Go Health

Involving patients and consumers in Swissmedic’s regulatory …

WebA Google search for “patient and public involvement” or “patient engagement” results in over six million hits. This demonstrates that a widespread effort exists to …

Category:  Health Go Health

Data privacy and data sharing within the regulatory framework …

WebAnonymised health-related data means health-related data which cannot (without disproportionate effort) be traced to a specific person (Art. 3, let. i). Before being …

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Swissmedic’s experience with the regulatory changes for clinical

WebTherefore, in 2022 Swissmedic, swissethics, and the Federal Office of Public Health developed decision trees for applicants that are simple to use (see Figure 1 and Figure …

Category:  Health Go Health

Seminar series: Facts and pitfalls of observational studies

WebSeminar series: Facts and pitfalls of observational studies - How to plan and conduct HRO projects Human research is more than clinical trials. HRO projects are observational …

Category:  Health Go Health