Via G-ConsentPIS, the Participant Information Sheet (PIS) supports the consent process to ensure that participants have been properly informed. In addition, the PIS is part of the transparency information that must be provided to participants under data protection laws for the use and processing of personal data. As described in the UK-GDPR and UK-DPAct, personal data includes genetic data and biological samples. G-GDPR points out that for the purposes of the UK GDPR, the legal basis for processing data for health and social research should not be consent. This means that the UK GDPR`s consent requirements do not apply to health and care research and therefore do not change the consent requirements to participate in a clinical trial and collect human tissue samples. For more information on the sponsor`s and auditor`s responsibilities for complying with data protection requirements (such as transparency, safeguards and data rights), see sponsorship. The information you provide in the submission package will be used to validate your application. Incomplete applications will be rejected. It`s important to name your files, and naming only the files in your submission reduces validation issues. According to the G-CTApp, applicants must complete the IRAS Clinical Trial Approval Application Form (GBR-78), create XML and PDF versions of the MHRA application form, store and sign electronically, and submit via MHRA submissions with the remaining required documents. The steps to access MHRA submissions can be found in G-MHRASubmiss and GBR-11. All documents must have a copy and paste function.
The MHRA does not currently accept password-protected documents. The information contained in the submission package will be used to validate the application and incomplete applications will be rejected. In addition, it is important to name files, and naming files uniquely reduces validation problems. For detailed IRAS instructions, see GBR-78. (See Clinical Trial Lifecycle, Submission Content sub-theme for documentation to be included in the application package.) According to the MHCTR and G-CTAuth, the sponsor must notify the Medicines and Healthcare Products Regulatory Agency (MHRA) and the European Commission in writing that a clinical trial has ended within 90 days of the end of the study. The G-CTAuth further states that a declaration of termination of a clinical trial must be sent to the MHRA within 90 days of the overall end of the trial and within 15 days of the early end of the trial overall. The submission must include a graduation form (included in G-CTAuth and GBR-24) and a cover letter. Note that only the global end-of-trial notification needs to be submitted.
However, an institution may notify the MHRA of the local (UK) termination of the study via the End-of-Study Notification form, but these local notifications are not officially confirmed and automatic email confirmation of MHRA submissions should be considered proof of submission. If a local termination of the study is submitted, we are still waiting for relevant safety updates and significant changes for the ongoing study until global notification of the end of the study is received. T. A waiver of this requirement must be requested for approval by means of a substantial amendment. The amendment must clearly indicate to which documents the proposal refers and contain a sound justification for the request. All safety documents must be submitted unless there are no other trials of the same product in the UK. All study activities (e.g., follow-ups, visits) must be completed prior to submitting the overall end-of-study declaration form. It is not possible to submit amendments to the study or the ESD once the overall end-of-study declaration form has been received by the MHRA. If the graduation declaration is received within a reporting period or within 60 days of the data blackout point, the corresponding DSA is not required.
Sponsors must submit end-of-trial declarations using MHRA (GBR-13) submissions. G-MHRASubmiss and GBR-11 describe the steps for accessing MHRA submissions. The MHCTR and G-ConsentPIS indicate that the researcher(s) must provide detailed information about the research study to the participant and/or his/her legal guardian(s). The MHCTR and G-ConsentPIS also state that oral and written information about the study, including ICF, must be easily understandable and submitted without coercion or undue influence to a potential subject to participate in the clinical trial. The participant and his or her legal representative or guardian should also be given sufficient time to consider whether or not to participate. Via G-ConsentPIS, the Participant Information Sheet (PIS) supports the consent process to ensure that participants have been properly informed. In addition, the PIS is part of the transparency information that must be provided to participants under data protection laws for the use and processing of personal data. According to the UK GPR, UK DPCA, and GDPR, consent to participate in research is not the same as consent as a legal basis for processing personal data under data protection laws. For more information on the sponsor`s and auditor`s responsibilities for complying with data protection requirements (such as transparency, safeguards and data rights), see sponsorship.
Physical media (CD/DVD) submissions for drug approval and clinical trial applications will no longer be accepted as of February 1, 2016. Under G-SubtlAmndmt, the UK requires the sponsor or legal representative of a clinical trial in the UK or a country to be on an approved list of countries initially comprising EU and EEA countries. A change of sponsor or legal representative for a UK study is a significant change that must be submitted to both the MHRA and the Ethics Committee. In accordance with the G-Import IMPs, the sponsor of a clinical trial in the United Kingdom using IPDs imported from countries on the G-CTApprovedCountries list must require the holder of the AMI(PMI) to establish a guarantee system to verify that these IMPs have been certified by a qualified person in a listed country before being released for review. A sponsor can self-check QP certification in a listed country if they have a UK MIA (IMP). Alternatively, they may outsource this verification to a third party who owns a UK MIA (IMP). A one-year transition period will apply to the implementation of these guidelines from 1 January 2021. IPs arriving in the UK from Northern Ireland do not need this additional monitoring. PIs arriving in the UK directly from third countries that are not on the list of approved countries will still need to obtain UK import and PQ certification by the MIA holder (IMP) in accordance with existing requirements. According to the G-SubtlAmndmt, for any change in the manufacture, import or certification of IP relevant to the delivery of IP in an ongoing trial in the UK, a material change must be submitted to the MHRA. However, if the sponsor chooses to maintain an existing UK release site for the ongoing UK study, but includes an additional EU/EEA release site only for the EU/EEA studies, no substantial modification of the MHRA is required.