The annual GCP Symposium was held by the MHRA on 11 September 2019 in Manchester. The symposium focused on non-commercial organisations (Trusts/Health Boards/University sponsors, Charities and investigator sites) and covered a variety of topics.
On 28 October 2019 the GCP inspectorate will be holding a roundtable discussion aimed at suppliers of electronic health records in both primary and secondary care (including commercial and non-commercial developers). This post details how to register your attendance for this event.
A look at the hot topics relevant to non-commercial sponsors and investigator sites on the agenda for this event on 11 September in Manchester
Whether investigator site or sponsor, what can be done to ensure EHRs are fit for purpose to make clinical trials the best they can be.
All early phase clinical trials have risks associated with them that require mitigation. Following not just the legislation but also all the associated guidance will help in maintaining public safety and the credibility of data.
Dose escalation practices should be the same regardless of whether a clinical trial involves healthy volunteers or patients. Good quality data and sound procedures are vital to ensure the safety of all trial subjects.
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This blog shares the work of the Medicines and Healthcare products Regulatory Agency (MHRA) Inspectorate, by inspectors and those the Inspectorate works with.