Below update was posted on ClinicalTrials.gov What’s New section on September 16, 2021:
Webinar on ClinicalTrials.gov Modernization: Join us on October 7, 2021, from 1:30 to 2:00 p.m. ET for an update on the ClinicalTrials.gov modernization effort. Please register via the ClinicalTrials.gov webinar registration page to learn more about the modernization efforts and information on the anticipated launch of beta ClinicalTrials.gov. A recording of the webinar and slides will be made available for those who cannot attend live.
Implementation of UK HRA’s New Reporting Standards for Clinical Research
As per the latest update from UK Health Research Authority, new reporting standards have been implemented to ensure that all researchers fulfill their responsibilities to make their research open and transparent. This is in line with the commitments set out in the Make it Public research transparency strategy.
From Wednesday 15 September health and social care researchers are expected to submit information at the end of their research study to the HRA online, explaining how they have fulfilled their transparency responsibilities. This is part of a set of changes which make it easy for researchers to be transparent and enable the HRA to know whether they are meeting the requirements.
This will also enable to see more clearly what proportion of studies are fulfilling transparency requirements, including information about study registration, publication of results, informing participants of the outcome of the study and the sharing of data and tissue (if applicable).
In order to standardize the information submission, a New Final Report Form had been published.
A notification (PRESS RELEASE No. 005-2021-OGITT/INS) dated September 09, 2021, was published on the Peruvian Registry of Clinical Trials (REPEC) website on September 13, 2021. In context of the same:
Due to preventive maintenance, services of the REPEC Version 2 System will be temporarily suspended as of Sunday, September 12, 2021. The services provided in the previous version of REPEC (REPEC Version 1) will continue as normal.
Note: As of September 15, 2021, the registry website (Version 2) is not yet working.
After the upgrade to Center for Drug Evaluation’s website on September 13, 2021, the “Applicant’s Window” login for the platform (also known as Drug Clinical Trial Registration and Information Disclosure Platform) is now available along with the old system account login.
As mentioned in the “Instructions for Drug Clinical Trial Registration and Information Disclosure Platform V2.0“, in order to ensure the authenticity of the applicant’s identity and the authenticity and validity of the registration information, the platform uses the real-name Ukey account in the “Applicant Window” column of the Drug Evaluation Center to log in, and supports account password login and certificate login at the same time. The platform supports the login of the “Applicant’s Window” account and the original platform (old system) account.
The user is required to link the old system account with the Applicant’s Window account (known as account docking), as per the given process. Once this process is complete, user can login only through the Applicant’s Window and the old system account will not support the login.
European Medicines Agency updated about the upcoming Clinical Trials Information System- Webinar for small and medium-sized enterprises (SMEs) and academia over the What’s New Section on September 10, 2021:
The webinar will be conducted on November 29, 2021, for the small and medium-sized enterprises (SMEs) and academic sponsors of clinical trials. The agenda of the event is uploaded on the event page along with the topics that will be covered during the webinar.
For more information, click here.
Upgrade of China’s Center for Drug Evaluation Website
The Center for Drug Evaluation’s website will be upgraded and deployed from 19:00 on September 10, 2021 to 7:00 on September 13, 2021. The clinical trial registration platform (also known as Drug Clinical Trial Registration and Information Disclosure Platform) will be temporarily closed, and the new version of the website will enter the trial operation stage after the deployment is completed.
This website upgrade has further expanded the scope of applicants’ online business processing, adding different columns like “eCTD Column”, “Guiding Principles”, “Information Disclosure” etc. The deployment structure has been further enhanced, and the electronic document submission of applicants has been encrypted and protected, and the overall security of the website has been improved with enhanced service capabilities.
European Medicines Agency updated the page Clinical trials information system (CTIS): online modular training programme by adding a PDF in Module 19: Quick guide – Introduction: CTIS for SMEs and Academia on September 07, 2021.
The document consists of a brief introduction to CTIS and its timeline. It also explains in detail about clinical trial life-cycle in CTIS, types of roles in CTIS, and interaction of CTIS with different database systems with diagrammatic represent and references links.
For more information, please click here.
European Medicines Agency updated the page name of Clinical Trials Information System: training programme to Clinical trials information system (CTIS): online modular training programme, on September 03, 2021. The below documents were also updated in CTIS Training Module 03 (User access management) and new versions of documents were added in Module 19 (CTIS for SMEs and academia):
- FAQs (v1.2): User access management – Module 03: It includes questions related to the processes of self-registration, login to CTIS, basic roles and permissions in CTIS, and user profile management with answers and diagrams.
- Quick guide (v1.2): User access management – Module 03: It guides on the process of self-registration, steps to log in to CTIS, understand the roles and permission and in brief about user profile management.
- Step-by-step guide 1 (v1.0): User access management and user administration- Module 19: It provides step by step guide for registration on CTIS, viewing roles and managing user profiles. It also explains briefly about CT-centric and Organisation-centric approaches, respectively.
- Step-by-step guide 2 (v1.0): CTIS workload functionalities for the sponsor workspace – Module 19: It provides step-by-step guidance on how to use the workload functionalities- notices and alert tab, request for information (RFI) list tab and timetable tab along with screenshots for every step.
- Step-by-step guide 3 (v1.0): Search, view and download a CT and a CTA in the sponsor workspace – Module 19: It provides steps for searching, viewing, and downloading CT and/or CTA along with detailed screenshots.
- Step-by-step guide 4 (v1.0): Create, submit and withdraw a clinical trial application and nonsubstantial modifications – CTIS Training Programme – Module 19: It provides steps to create and submit different types of CTs (mono-national and multi-national) with screenshots for better understanding.
- Step-by-step guide 5 (v1.0): Create and submit an RFI response, including changes to an existing application – CTIS Training Programme – Module 19 It provides steps to view and access RFIs raised by the Member States Concerned (MSCs) during the validation and assessment phases of the evaluation of a CTA, as well as on how to create and submit the responses, and how to modify an existing CTA as part of the response.
- Step-by-step guide 6 (v1.0): How to manage a clinical trial – CTIS Training Programme – Module 19 It provides steps for creating different types of notification, responds to RFIs in context with ad hoc assessment, request for corrective measures and steps to submit trial results and lay summary of results.
- Step-by-step guide 7 (v1.0): Submit an Annual Safety Report (ASR) and how to respond to related RFIs – Module 19 It provides steps to create and submit ASR submission form, access and respond to RFIs in the context of ASR assessment.
FDA Takes Action For Failure to Submit Required Clinical Trial Results Information to ClinicalTrials.gov
The FDA issued a Notice of Noncompliance on August 31, 2021, to Andrey Petrikovets, M.D. (responsible party) affiliated to University Hospitals Cleveland Medical Center, for failing to submit required summary results information to ClinicalTrials.gov. The company failed to update the study results for their applicable clinical trial (ACT) within 30 days after the first notice was issued. The company’s applicable clinical trial compared ICE-T postoperative multimodal pain regimen to the Standard regimen in patients undergoing same day vaginal pelvic reconstructive surgery.
The prenotice was issued on July 20, 2020, alerting Andrey Petrikovets to potential noncompliance with the requirement to submit clinical trial results. Although the trial’s results were made public in a medical journal, journal publication does not satisfy ClinicalTrials.gov disclosure requirements. On November 30, 2020, Andrey Petrikovets responded, stating that they were very busy with the “Covid surge” and were short staffed. FDA recognizes the unique circumstances that the pandemic presents, and believes they have provided ample opportunity to submit the required results information. The Notice of Noncompliance gives Andrey Petrikovets 30 days to submit the required summary results information. The FDA is authorized to seek civil monetary penalties for Andrey Pretrikovets’s violation, including additional civil money penalties if Andrey Petrikovets fails to submit the required information within the 30-day period.
The Notice of Noncompliance has been posted to the FDA’s website and information about the noncompliance has also been posted on the study record on ClinicalTrials.gov by NIH. NIH will continue to update the ClinicalTrials.gov records for applicable clinical trials that are the subject of a Notice of Noncompliance with information regarding whether the noncompliance has been corrected and the amount of civil money penalties assessed if any.
For more information, please refer to the Letter of noncompliance on the FDA Website: Non-compliance letter
On August 31, 2021, MHRA launched new systems functionality to support the combined review of Clinical Trials of Investigational Medicinal Products (CTIMPs). The combined review service (previously known as ‘combined ways of working’) offers a single application submission route and a coordinated review for CTIMPs, resulting in a combined regulatory and ethics decision on a clinical trial.
The trial sponsors can now manage their complete trial lifecycle via combined review using the Integrated Research Application System (IRAS) – from initial application through to amendments, safety reporting, end of trial notification and submission of summary results. From January 01, 2022, the combined review will become the only way to apply for CTIMP approvals.