Regulatory Focus™ > News Articles > 2020 > 11 > Euro Roundup: Swissmedic allows remote source data verification

Euro Roundup: Swissmedic allows remote source data verification

Posted 12 November 2020 | By Nick Paul Taylor 

Euro Roundup: Swissmedic allows remote source data verification

Pandemic-related remote source data verification for clinical trials should focus on critical data, such as the primary efficacy endpoint and key safety measures, according to updated guidance from the Swiss Agency for Therapeutic Products (Swissmedic).
 
Early in the pandemic, the European Commission began allowing clinical trials of COVID-19 products and pivotal studies of treatments for serious or life-threatening conditions to use remote source data verification (SDV) to spare monitors of the need to travel.
 
Under Swissmedic’s update guidance, monitors also can review secondary efficacy data at the same time provided the information is included in the documents shared to support verification of the critical data. The goal is to minimize the burden remote SDV places on site staff.
 
Swissmedic wants principal investigators to decide whether their sites can give monitors direct, controlled remote access to trial participants’ electronic medical records (EMRs) while preventing them from recording images, or can share coded copies of the source documents. Zoom, Skype and similar tools cannot be used in the video review of medical records.
 
Principal investigators should decide what, if any, of the options for remote SDV are suitable for their sites “without undue pressure” and confirm their consent in writing. Site staff and monitors must be trained in remote SDV.
 
Monitors can only remotely access source data while in Switzerland at a location that prevents the viewing of documents by unauthorized persons. The monitor must have a secure internet connection and a computer appropriately protected against unauthorised access to the data. Monitors need to sign written confidentiality agreements and commit to destroy redacted documents as soon as they have been used for SDV.
 
Swissmedic expects monitors to access EMRs via a virtual private network. Sites should provide read-only access to data on trial patients and establish an audit trail showing who accesses data and when. The monitor’s access should be revoked once the remote SDV is complete.
 
When remote SDV that is facilitated by the redaction of source documents by site staff, Swissmedic expects monitors to request access to a specific participant’s records in writing. That done, site staff should create copies of the requested documents and redact private information that is not needed. A second person should confirm all the information is redacted.
 
Swissmedic is only permitting remote SDV during the COVID-19 public health crisis. Considering its reservations about the approach, Swissmedic wants sponsors that use remote SDV during the pandemic to prepare to enact increased on-site monitoring and other robust follow-up measures once the situation normalizes.
 
Swissmedic Notice
 
MHRA advises on limiting clinical trial disruption
 
Clinical trial sponsors are advised to create “formalized, structured methods of conducting telemedicine” to support the collection of reliable data during the COVID-19 pandemic, according to updated guidance from the Medicines and Healthcare products Regulatory Agency (MHRA).
 
Early in the crisis, MHRA published guidance on managing clinical trials during the pandemics. The new document builds on the earlier text by sharing some recent lessons learned. 
 
MHRA noted the downside of prescriptive, highly complex as another lesson of the pandemic. Prescriptive protocols necessitate more substantial amendments when plans need to change. Complex protocols feature exploratory endpoints that may be hard to collect data for in a pandemic. MHRA sees value in simpler, more flexible protocols.
 
MHRA also details the actions sponsors can take to maintain study and data integrity. Drawing on a paper published by employees of leading pharma companies, MHRA lists steps sponsors can take to assess the impact of COVID-19 on trial integrity and define mitigation measures.
 
MHRA Guidance
 
Swissmedic extends deadline for evaluating nitrosamine risk again
 
Marketing authorization holders (MAHs) have until next year to assess whether chemically synthesized active substances may be contaminated with nitrosamines, under a deadline extension granted by Swissmedic.
 
One year ago, Swissmedic gave MAHs until mid-May to assess the risk of nitrosamine contamination. The pandemic prompted Swissmedic to push back that deadline to the start of October. Swissmedic assessed compliance with the revised deadline last month, revealing that “a large majority of the companies had not managed to complete” the work on time, and pushed the deadline to 31 March 2021. MAHs of biological medicines have until 1 July 2021.
 
The delay had knock-on effects on the timelines for confirmatory testing and authorization changes that MAHs will need to undertake if they discover a risk of nitrosamine formation. The deadline for biological medicines is now 1 July 2023, although Swissmedic stuck with its 1 October 2022 deadline for chemical medicines.
 
Swissmedic Notice
 
EMA calls for independent scientific experts to join PRAC
 
The European Medicines Agency (EMA) has called for independent scientific experts to join its Pharmacovigilance Risk Assessment Committee (PRAC).
 
EMA is seeking applications from pharmacovigilance specialists who want to support the supervision of medicines in the European Union. Successful applicants will join PRAC in July 2021 and serve for three years. Existing PRAC independent experts can reapply.
 
Six independent experts attend PRAC’s monthly meetings and are involved in the committee’s discussions and examinations of documents. The experts are expected to complement the expertise of the people appointed by member states and the representatives of healthcare professionals and patients.
 
Applications are being accepted until 20 November.
 
EMA Notice, EC Notice
 
MHRA seeks public views on psychiatric and sexual side effects of acne drug
 
MHRA is asking patients, healthcare professionals and other stakeholders to share their views on the risks and benefits of the acne medicine isotretinoin.
 
Isotretinoin, sold in the EU under the brand name Roaccutane, is an effective treatment for severe acne but is linked to severe side effects. Serious side effects, which happen in less than one in 1,000 people, include anxiety, aggression and violence, changes in mood or suicidal thoughts. In 2017, a routine EU review linked isotretinoin to sexual dysfunction adverse effects, including erectile dysfunction. Isotretinoin also is known to cause birth defects.
 
MHRA has asked an Expert Working Group to review the evidence and advise on the need for it to take additional regulatory action. In parallel, MHRA is seeking the views of patients and their families, healthcare professionals, researchers and organizations. MHRA wants to gather views on the role of isotretinoin, its risks and existing and potential measures to support safe use.
 
The comment period closes on 2 February.
 
MHRA Notice
 

 

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