Registry Updates

March 2023: Health Canada Registry Update

On February 23, 2023, Health Canada posted a draft guidance document for the protocol registration of clinical trials and public disclosure of results, proposed a public search portal. This document provides guidance to sponsors of Health Canada-authorized clinical trials to support the registration and public disclosure of results using international registries that complies with World Health Organization (WHO) standards. Below are some of the key points from the draft guidance:

A Letter of Authorization is issued for the trials on medical devices, and a Notice of Authorization is issued for trials on natural health products (NHPs), a No Objection Letter (NOL) is issued for clinical trials investigating drugs if all regulatory requirements have been met in the trial application.
A trial would be “authorized” if the trial received: No Objection Letter or a Letter or Notice of Authorization or a clinical trial authorization for a COVID-19 related drug or medical device.
Health Canada recommends sponsors to register their Health Canada-authorized clinical trial prospectively (before recruitment of the first participant) in a clinical trial registry that complies with WHO standards. If a Health Canada-authorized study is already registered, sponsors should add all the Canadian sites to their existing registration record before recruitment begins at that site.
Health Canada recommends sponsors to submit the summary results of their Health Canada-authorized clinical trials within 12 months following primary study completion to the same registry where the clinical trial was registered.
Summary results information includes 4 areas: Participant flow, Demographics and baseline characteristics, Outcome Measures, and Adverse events. Draft guidance to be referred for the detailed information.
Health Canada mentioned two widely used registries that are publicly accessible and part of the WHO ICTRP Network which accepts clinical trials conducted in Canada: ISRCTN in the United Kingdom and ClinicalTrials.gov in the United States.
Not all registries and data providers that comply with WHO international standards will accept clinical trials conducted in Canada.
Health Canada’s proposed Clinical Trials Portal will display the information of all the authorized Canadian drug trials collected from data sources: Clinical trial applications submitted to Health Canada (after authorization), WHO ICTRP, and registries complying with WHO standards.
Subsequent releases of the portal under a phased implementation strategy are planned.

Please click here for the original update.

March 2023: CTIS Newsflash

On March 10, 2023, the latest CTIS Newsflash was made available in the What’s New section by the European Medicines Agency. All updates related to CTIS newsflash can be accessed from the Development of the Clinical Trials Information System page.

The information comprises essential data and patterns concerning CTA submissions, CTAs that received a decision, and CTAs with a decision per RMS for the week of February 28 to March 06, 2023, as compared to the previous week.

Below are the key updates from the newsflash:

Multi-factor (MFA) authentication strategy: From June 01, 2023, users for both Sponsor and Member State workspaces will need to log in to CTIS using an MFA along with their respective username and password. Users may choose their preferred second-factor method and amend their MFA options (a token in the Microsoft app, text to a mobile phone, or call on an office phone) at any time. Users can sign into the EMA ServiceNow portal to configure their MFA for EMA systems, which, once deployed and enabled, will also work for CTIS.
Submission of partial initial clinical trial application:

As per the requirements of Article 11 of the Clinical Trial Regulation (CTR), sponsors can submit partial initial clinical trial applications by submitting an application with Part I to all Member States Concerned (MSC) and part II to none or some MSC.
From the time Part I is submitted until a decision is issued by the Member State, the initial application will remain under evaluation for 2 years, after which the application will lapse.
The submission of further applications, such as substantial modifications and/or addition of an MSC, can only occur after all MSC have received both Part I and Part II of the dossier.
Any future changes to the partial initial application functionality in CTIS will be communicated to users in advance.

March 2023: What’s New on ClinicalTrials.gov

On March 09, 2023, an update was posted on ClinicalTrials.gov, What’s New section, as follows:

Virtual Webinar on ClinicalTrials.gov Modernization

On April 25, 2023, from 12:30 to 3:00 pm Eastern Time, a webinar will take place providing an extensive update on the current Beta website and progress updates. Attendees will have the opportunity to hear from and interact with members of the ClinicalTrials.gov modernization team and other stakeholders via chat.

To attend the webinar, registration in advance can be done through the webinar registration page. The meeting will be recorded and the recording as well as presentation slides will be available on the ClinicalTrials.gov Modernization webpage following the event.

March 2023: China/WHO Registry Update

On 3 March 2023, the International Traditional Medicine Clinical Trial Registry (ITMCTR) was added to the Primary Registries Network of the International Clinical Trials Registry Platform (ICTRP) by the World Health Organization (WHO). It is the first cross-regional clinical trial registry that targets traditional medicine, in the WHO ICTRP registry network.

The ITMCTR is a non-profit online registry that enables voluntary registration of clinical trials conducted in the field of traditional medicine, including but not limited to Chinese medicine, acupuncture, tuina massage, herbal medicine, ayurveda, homeopathy, and complementary and alternative medicine. The registry accepts global registrations, in addition to those conducted in China.

It is governed by the China Academy of Chinese Medical Sciences and The China Center for Evidence-Based Traditional Chinese Medicine.

March 2023: ClinicalTrials.gov Beta Website Update

On March 08, 2023, an update was posted on the Release notes section of the ClinicalTrials.gov Beta website, which reads as follows:

To enhance user-friendliness, the ClinicalTrials.gov Beta website has incorporated new features such as Table view, as well as improvements, and bug fixes.

The key features include:

- The interventional and observational studies on ClinicalTrials.gov Beta now feature a new Table View that organizes study information in a way that caters to the needs of data researchers and journal editors.
- To provide more accurate search results, a new label has been added to study records in the Table View.
- Users can conveniently access studies by including study hyperlinks in CSV downloads.

Additionally, ClinicalTrials.gov Beta will soon introduce a feature that allows users to view record history and compare versions.

For more detailed information on these updates, please visit the Release Notes section of the Beta ClinicalTrials.gov website.

March 2023: Japan registry update

On March 06, 2023, a notice was released on the Japan Registry of Clinical Trials (jRCT) regarding the completion of data migration. As per the notice, users can now view and update the registered information of JapicCTI and Japan Medical Association Clinical Trial Registration System (JMACCT-CTR) on the jRCT system.

The jRCT system now allows users to view the data of JapicCTI and JMACCT-CTR, as well as register new trials as usual.
For guidance on login methods and migrating data for the first time, users can refer to the ‘Operation Manual’ and ‘Frequently Asked Questions’.
A list of study IDs before and after migration has been posted for reference.

Please click here to go to the original update.

March 2023: CTIS Newsflash

On March 03, 2023, the latest CTIS Newsflash was made available in the What’s New section by the European Medicines Agency. All updates related to CTIS newsflash can be accessed from the Development of the Clinical Trials Information System page.

The information comprises essential data and patterns concerning CTA submissions, CTAs that received a decision, and CTAs with a decision per RMS for the week of February 21 to 27, 2023, as compared to the previous week.

On March 01, 2023, a CTIS update was released, which introduced the following improvements:

Alerts will no longer be generated when an initial clinical trial application (CTA) is withdrawn across all Member States.
The search function has been enhanced to retrieve medicinal products with more than 35 substances and to add a product using the ATC code.
The issues related to duplication of IMP and auxiliary medicinal products (AxMP)-related documents have been resolved.

For more information, the current version of the release notes and lists of known issues and proposed workarounds can be accessed.

March 2023: Japan registry update

On March 02, 2023, the Japan Registry of Clinical Trials (jRCT) published a notice regarding the updated schedule for data migration. The registered data from two registries – the Japan Medical Association Clinical Trial Registry System (JMACCT-CTR) and the Japan Pharmaceutical Information Center Clinical Trial Information (JapicCTI) – will be migrated to the Clinical Research Submission and Disclosure System of jRCT.

The data migration will follow the schedule below:

– jRCT suspension period: March 02 to March 06, 2023

– JMACCT-CTR and JapicCTI data will be updated and viewable on jRCT after migration: March 06, 2023

The direct link URLs for JMACCT-CTR and JapicCTI will become invalid, and it is suggested to change them to the URLs for jRCT after migration.
The detailed transition rules will be posted on the jRCT page after the transition.
In terms of user ID, if the same email address is used in multiple databases, the order of priority will be jRCT > JMACCT-CTR > JapicCTI. After migration, lower priority IDs cannot be used.
JMACCT-CTR or JapicCTI login IDs can be used to log in to the jRCT registry, but a new password needs to be issued the first time. Detailed steps are outlined in the accompanying document.

Please click here to go to the original update.

February 2023: Clinical Trials Highlights

On February 20, 2023, EMA published the thirteenth issue of the Clinical Trials Highlights. All Clinical Trials Highlights updates are posted on the Development of the Clinical Trials Information System page.

Starting from January 31, 2023, sponsors are required to submit their initial clinical trial applications through CTIS. EMA has resolved a considerable number of issues, improving the user experience and providing system enhancements by strengthening the notices and alerts functionality, enhancing the creation and preparation of application documents and data, and enhancing the authorization and supervision of clinical trials.

The CTIS User Support Service has been strengthened to address user inquiries effectively, and the steps to raise a ticket are provided. Additionally, EMA issues a weekly CTIS Newsflash that includes significant updates on new releases and system developments, reminders about upcoming training and events, and links to helpful reference material.

The upcoming CTIS events include the sponsor end-user training programs scheduled on May 02 to 05, 2023, and June 27 to 30, 2023.

February 2023: CTIS Newsflash

On February 24, 2023, the European Medicines Agency released the most recent CTIS Newsflash via CTIS.communications. All CTIS newsflash updates are posted on the Development of the Clinical Trials Information System page.

This includes key data and trends about CTA submissions, CTAs with a decision, and CTAs with a decision per RMS for the week of February 14 to 20, 2023, as compared to the previous week.

On February 20, 2023, a CTIS “Hotfix” was implemented to enable a group of sponsors to modify an application in response to a Request for Information (RFI), by resolving database locks that had occurred in a limited number of trials. Due to the need for additional testing, the next CTIS release will take place the following week implementing all the improvements listed in the previous CTIS newsflash post. For more information, the current version of the release notes and lists of known issues and proposed workarounds can be accessed.

In addition, EMA has initiated the process of registering CTIS as a WHO data provider. Once registered, CTIS data will be accessible on the International Clinical Trials Registry Platform (ICTRP) Search Portal of the WHO.