Mhra Legal Representative Clinical Trials

If one or more sponsors of a CTIMP are not located in the European Economic Area (EEA), it is required by law to appoint a legal representative based in the EEA for the purposes of the study. The contact details of the legal representative must be entered in the «Legal Representative» section of IRAS. All recognized EC RES must comply with the provisions of GAfREC, International Council for Harmonization for Good Clinical Practice Directive E6(R2) (GBR-113) and GBR-9. However, some COEs within RES are recognised or otherwise designated to review certain types of research proposals. In accordance with the MHCTR and MHCTR2006, the EC recognised for the conduct of investigational clinical trial reviews (CTIMP) are approved by the regulatory authority, UKECA, and are at the heart of this topic. More details on the RES and UKECA can be found in the topic Ethics Committee, sub-theme Licensing Authority. As described in RG-113, in the case of a multi-centre clinical trial, the sponsor must ensure that: As outlined in G-CTAuth, GBR-65 and GBR-9, the investigator and sponsor share responsibility for submitting progress reports on the progress of a clinical trial and submitting a final study report at the end of the study. These requirements are consistent with the progress and final reporting requirements outlined in the International Council of Harmony Good Clinical Practice Guideline E6(R2) (GBR-113). According to the MHCTR, GBR-3, GBR-4 and the International Council for Harmony Guideline E6(R2) (GBR-113), in all clinical trials in the UK, research participants selected from vulnerable populations should be given additional protection to protect their health and well-being during the consent process. GBR-3, GBR-4 and GBR-35 characterize vulnerable populations as those who depend on others and are unable to freely express their opinions or make their own decisions. They may be children, people with mental or physical disabilities, people with incurable diseases, people living in old people`s homes, the unemployed or the poor, emergency patients, ethnic minorities, the homeless, nomads, prisoners, prisoners, refugees, members of a hierarchical group such as students, subordinate personnel of hospitals and laboratories, employees of the pharmaceutical industry, members of the armed forces, and detainees. According to the G-CTApp, applicants must complete the IRAS Clinical Trial Application Form (GBR-78) and submit it via MHRA Submissions (GBR-13) with the remaining required documents.

GBR-17 notes that the MHRA continues to wait for a EudraCT number until further notice to provide a clear reference for clinical trials. The steps to access MHRA (GBR-13) submissions can be found in G-MHRASubmiss and GBR-11. The law requires that any clinical trial of an investigational drug (CTIMP) be sponsored. You can contact the MHRA Finance Department on 020 3080 6533 or sales.invoices@mhra.gov.uk email for more information on paying the fee. According to GBR-113, the Commission should approve any amendment to the ICF due to an amendment to the Protocol before such amendments are implemented. The participant and/or his/her legal guardian(s) must also re-sign the revised ICF and receive a copy of any amended documents. In addition, the G-ConsentPIS notes that the risk of harm caused during pregnancy is more likely when young people are recruited for an investigational clinical trial (CTIMP). In this case, the consent of a person over the age of 16 must be obtained, and the following must be done: As described in the G-MHRAFees, the MHRA charges the processing fee for the following clinical trials that remain in effect until 2022: For advice, you must send an email with «URGENT – FIH QUERY» as the title for clintrialhelpline@mhra.gov.uk, including: In accordance with the MHCTR and GBR-9, the sponsor or its designated representative should also notify the European Commission of significant changes to the protocol and provide all relevant documentation in support of those changes. These changes cannot be implemented without a favourable opinion from the European Commission (see Ethics Committee topic, Scope of Review and Clinical Trial Life Cycle sub-theme, Submission Content sub-theme for more details on the European Commission`s review and approval process). Whether it is the seat of the legal representative, the filing of applications with the competent regulatory authorities, pharmacovigilance obligations to ensure the safety of medicines or the supply of investigational medicinal products (PMI) to clinical sites: after Brexit, new procedures will have to be put in place to take all these aspects into account. There is a lot of pedagogical information.

The European Medicines Agency (EMA) and the UK Agency for Medicines and Healthcare Products Regulation (MHRA) continuously publish and update relevant information.2,3 In this article, we summarise the most important changes for sponsors outside the EU27 who wish to conduct clinical trials of medicinal products in the EU27 and the UK. See Figure 1 below for a visualization of these changes. If the legal representative is also a co-sponsor, this must be noted separately on the application form and the allocation of sponsorship responsibilities must be specified in detail. Insurance or liability coverage must be demonstrated. GBR-107 also provides the Non-Commercial Agreement (mNCA) template to meet the requirements of non-commercial sponsors and NHS/DHSC entities conducting research. This agreement has been developed as a unique UK-wide contract model, meaning it can be used regardless of where the sponsor and research site are located. It is designed to be used without modification or negotiation. The mNCA was developed for a range of intervention research scenarios, including clinical trials, medical device trials, patient data research, and human tissue research.

The conditions are appropriate for all of these scenarios, and only the completion of the highlighted sections, including the timelines of the agreement, differs according to the study. As described in EGR-9, EGR-66, RGS-111 and RGS-95, the type of EC responsible for approval (called a «positive opinion» in the UK) within the ESR depends on the type of research conducted. As explained in the previous sub-theme, works councils approved to conduct clinical trials reviews of investigational medicinal products (CTIMPs) must be approved by the UK Ethics Committee Authority (UKECA).