November 2022: CTIS Update

European Medicines Agency updated the event page, Clinical Trials Information System (CTIS) bitesize talk: Notifications – Part 2 over the What’s New Section on November 23, 2022:

The presentation for the CTIS bitesize talk held on November 23, 2022, is now available on the event page. It explains, in brief, different kinds of circumstantial events notifications, their timelines, and the publication of these notifications.

Also, CTIS Sandbox survey 4.0 is now open. New potential users of CTIS can
express interest to access the CTIS training environment (CTIS Sandbox).

November 2022: What’s New on ClinicalTrials.gov

On November 17, 2022, the below update was posted on ClinicalTrials.gov, What’s New section:

ClinicalTrials.gov Beta Website:

New search features, Improvements and bug fixes are added to make the  ClinicalTrials.gov Beta website more user-friendly.

The key features include:

    • In addition to expanded tabular view of search results, the card view of search results is also added.
    • Users can also select and reorder the columns displayed onscreen.
    • Printer-friendly layouts for selected study records have  been included
    • Navigation and accessibility for both the desktop and mobile versions of the website have been enhanced

Moreover, the feature for ‘Study record history’ will be coming soon.

Detailed information on the updates can be found at Release Notes | Beta ClinicalTrials.gov.

October 2022: What’s New on Austrian BASG (NIS)

The below update was posted on October 11, 2022, on the What’s new section of the Austrian Federal Office of Safety and Healthcare (BASG), Non-Interventional studies (NIS):

On October 7, 2022, the ordinance on the obligation to report non-interventional studies was repealed as per the Federal Gazette for the Republic of Austria 374/2022. A notice about the same is available in German here.

Submission of the ongoing or completed non-interventional studies including changes to ongoing non-interventional studies, end-of-study notifications and final reports is no longer an obligation. Moreover, the public registry for non-interventional studies has been discontinued with immediate effect.

Currently, there is no notification about channeling existing studies to EU PAS or EU CTIS.

More information can be found here.

September 2022: What’s New on ClinicalTrials.gov

On September 26, 2022, the following update was posted on the  ClinicalTrials.gov What’s New section:

A Plain Language checklist for Lay Brief Summaries was added to the support materials under Data Element Definitions, Templates, and Checklists section. This checklist identifies plain language best practices to help investigators write brief summaries that can be easily understood by the general public.

August 2022: What’s New on ClinicalTrials.gov

On August 23, 2022, the below update was posted on ClinicalTrials.gov What’s New section, regarding the updates made to the ClinicalTrials.gov Beta website and clarification on the FAQ related to the requirement on submitting results for a Non-applicable Clinical Trial.

ClinicalTrials.gov Beta Website:

  • In addition to improved search for clinical studies and a tabular view of search results, new features, improvements and bug fixes are added to the ClinicalTrials.gov Beta website.

Moreover, the feature for ‘Table view of the study record’ will be coming soon. Detailed information on the updates can be found at Release Notes | Beta ClinicalTrials.gov.

FAQ Update

  • Under FDAAA 801,  results submission is not required for a non Applicable Clinical Trial (for example, a phase 1 trial studying an FDA-regulated investigational new drug). If a responsible party chooses to submit results for such a trial voluntarily, the Voluntary Submissions (PDF) provision of FDAAA 801 may apply.

Additionally, under the Voluntary Submissions (PDF) provision, a responsible party who submits results for such non-applicable clinical trial must submit complete clinical trial results information and must also submit results for each Applicable Clinical Trial that is required to be submitted to FDA for the same use studied.

More information on the FAQ can be found here.

July 2022: China Registry Update

Suspension of Supplementary Registration

From July 05, 2022, the Chinese Clinical Trial Registry (ChiCTR) has suspended supplementary registration of Clinical Trials.

Supplementary registration is defined as the registration done after the first case of candidate is recruited.

There have been no other changes made to the information available for supplementary registrations on the ChiCTR website.

June 2022: Netherlands Update

Netherlands Trial Register (NTR) No Longer Available

As per an update posted on Central Committee on Research Involving Human Subjects (CCMO) website on June 24, 2022, the NTR is no longer available. The National Trial Register, in which the CCMO register and the NTR will be merged, is not yet ready for use.

Guidelines provided to researchers for the time being are as below:

  • For ongoing investigations that were already reported to the NTR: The data as registered in NTR are automatically included in the International Clinical Trial Registry Platform (ICTRP) and can be consulted on the  ICTRP Search Portal. The researcher thus still meets the requirement of prospective registration as required by the International Committee of Medical Journal Editors (ICMJE) for publication in scientific journals. Unfortunately, the data can no longer be edited. If adjustment of the data is nevertheless necessary, the research will have to be registered again with another recognized register, see below. A reference to the trail ID of NTR must be included.
  • For registering new trials: New studies can be registered on any WHO recognized registers, such as  ClinicalTrials.gov. The full list of recognized registries can be found at Primary registries in the WHO registry network.

As soon as this situation changes, the CCMO will inform researchers. Click here for more information.

June 2022: What’s New on ClinicalTrials.gov

On June 09, 2022, the following updates were posted on the  Clinicaltrials.gov What’s New section.

The new FAQ for the deadline for submitting a good cause extension for prematurely terminated studies have been included and the information to be taken into consideration for registering expanded access records have been updated.

A responsible party must submit results information no later than one year after the primary completion date unless the responsible party has submitted a certification of delay, a request for an extension for good cause, or a request for a waiver of the requirements for submission of results information.

The standard results information submission deadline is one year after the actual Primary Completion Date. The termination date does not impact the actual Primary Completion Date or the standard results information submission deadline.

A good cause extension request submitted on or after the standard results information submission deadline date, would be late and would not be accepted, regardless of when the decision to terminate the trial was made.

More information can be found here: FAQ

Detailed considerations for registering expanded access records can be found here.

May 2022: Switzerland Update

An update posted on the Kofam portal on May 27, 2022, informs users of the most important new developments and changes relating to clinical trials with in-vitro diagnostic products (IVDs) which  are regulated by the Ordinance on Clinical Trials with Medical Devices (ClinO-MD) from May 26, 2022.

According to the update, in addition to the existing obligation to prospectively register clinical trials with IVDs, the results of trials with IVDs must now also be published in a trial registry. This also applies to clinical trials with IVDs already underway when the ClinO-MD entered into force on 26 May 2022. The updated ClinO-MD is also now available.

The update further informs users of the categorization of IVDs and classification of clinical trials regulated under ClinO-MD into clinical investigation and performance studies.

An online information event, to cover the new and changed requirements and clarify the specifications in Switzerland will be held on  3 November 2022. Participation is free of charge and individual presentations will be provided on the Swissmedic website in German, French, Italian, and English a few days before the event.  The presentations during the event will be given in German and will be interpreted simultaneously into French. The event will not be recorded. The presentations can not be viewed at a later date.

More information can be found here.

May 2022: Switzerland Update

An update posted on the SwissMedic portal on May 26, 2022, informs users of the change in legal requirements for clinical trials with in-vitro diagnostic products (IVDs) in Switzerland.

From 26 May 2022, at the same time as the application of the In Vitro Diagnostics Regulation (IVDR) in the EU, clinical trials with in vitro diagnostic medical devices will be regulated in the Ordinance on Clinical Trials with Medical Devices (CTO-MedD) and no longer in the Ordinance on Clinical Trials (ClinO).

These new transitional periods in the EU have also been taken into account accordingly in the Swiss Ordinance on In Vitro Diagnostic Medical Devices (IvDO). To avoid jeopardizing a sufficient supply of medical devices to Switzerland, the Federal Council has set lengthy transitional periods – over one year for most devices – for designating the CH-REP.

More information can be found here.