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Lay language summaries are a mandated requirement of the EU-CTR

On 31 January 2022, the way clinical trials are conducted in the European Union (EU) will undergo a major change through the EU Clinical Trial Regulation 534/2014 (EU-CTR). The new regulation aims to standardize and harmonize interventional clinical trials, with legally binding rules on requirements and increased transparency. This includes the mandate of published study results in lay language on the Clinical Trial Information System (CTIS).

In this video, Parexel's Paul Bridges, EVP of Regulatory & Access, speaks with our experts about some of the requirements that need to be adhered to for compliance with the EU-CTR and considerations for creating more patient-friendly lay summaries.

Watch the full discussion >

See more insights below

 

Expert insights on the EU-CTR

If you currently operate or plan to operate clinical trials in Europe, you will be impacted by the EU-CTR. To prepare for the changes, companies will need to mobilize all stakeholders, analyze current business processes, upgrade information technology systems, and restructure operations to avoid disruptions to ongoing and new clinical trials. As we help to mobilize client operations, we've collated some of the most commonly asked questions and provided useful insights from our experts.

The deadline to add a new EEA country to an ongoing clinical trial in line with the former EU CT Directive is 30-January-2023

The deadline to add a new EEA country to an ongoing clinical trial in line with the former EU CT Directive is 30-January-2023

Submission of new clinical trial applications will no longer be possible after...

Submission of new clinical trial applications will no longer be possible after 31 January 2023 under the EU CT Directive for any EEA country

This means:

  • For an ongoing clinical trial under the EU CT Directive, new requests for clinical trial authorizations to include further EEA countries are not possible after 30-January-2023
  • To add new EEA countries to an ongoing clinical trial under EU Directive after this date, you must first transition the trial to the EU CTR and then submit additional EEA countries following the EU CTR procedure

What does this mean for you?

Ongoing trials transitioned to the EU CTR will require IMP labeling in line with the EU-CTR legal requirements

Ongoing trials transitioned to the EU CTR will require IMP labeling in line with the EU-CTR legal requirements

Investigational medicinal product (IMP) labels may need to be updated...

IMP labels may need to be updated to display “period of use” on any immediate packaging without exceptions

This means:

  • Updates to IMP labels require to happen only to batches that are labeled (or relabeled) after the authorization of the trial under the EU CTR, while not for those batches already released.

What does this mean for you?

All study drug supplies used in EEA countries will need to display “period of use” (expiry or retest date) without any exceptions

All study drug supplies used in EEA countries will need to display “period of use” (expiry or retest date) without any exceptions

Applicable to all clinical trials submitted under EU-CTR or ongoing trials when transitioned to the EU CTR...

Applicable to all clinical trials submitted under EU-CTR or ongoing trials when transitioned to the EU CTR. Label updates are needed for all IMPs and AxMPs.

This means:

  • Assess your current label set-up for alignment with EU-CTR requirements for any trials you intend to run under EU-CTR

What does this mean for you?

The deadline to submit a new clinical trial in line with the former EU Clinical Trial Directive is January 30, 2023?

The deadline to submit a new clinical trial in line with the former EU Clinical Trial Directive is January 30, 2023?

The option to start a new clinical trial under the EU Clinical Trial Directive rules is...

The option to start a new clinical trial under the EU Clinical Trial Directive rules is only permitted in the first year of the transition period.

This means:

  • The initial request for clinical trial authorization for all participating EEA countries must be submitted latest on 30 January 2023, whilst the authorization may be received after this date.
  • If such trial continues to be conducted in the European Union from 31 January 2025 onwards, all EEA countries with active sites must be transitioned to the EU CT Regulation latest by 30 January 2025 (authorization date).

What does this mean for you?

A joint Scientific and Ethics Committee evaluation is an integral component of CTIS applications

A joint Scientific and Ethics Committee evaluation is an integral component of CTIS applications

There are no separate regulatory or ethics committee (EC) application submissions under the EU-CTR...

There are no separate regulatory or ethics committee (EC) application submissions under the EU-CTR.

This means:

  • This could potentially result in more queries to be addressed within the stringent response times.
  • There will be aligned considerations between ECs and National Competent Authorities.

What does this mean for you?

There is only a one-year transition period for new trial applications

There is only a one-year transition period for new trial applications

While this may seem a long time, it really isn’t if you haven’t started aligning your internal structure to the required changes, including people, processes, and technology...

While this may seem a long time, it really isn’t if you haven’t started aligning your internal structure to the required changes, including people, processes, and technology.

This means:

  • If you want to add further countries to ongoing trial under the EU Directive after the first year, this trial will need to be transitioned to the EU-CTR
  • Determine a transition plan for both new and existing trials

What does this mean for you?

There is a requirement for a holistic collaborative approach for trial modification planning at trial and country/site level

There is a requirement for a holistic collaborative approach for trial modification planning at trial and country/site level

There are strict rules for modifications under EU-CTR...

There are strict rules for modifications under EU-CTR.

This means:

  • All substantial modifications (on studies and individual country/site level) will have to be reviewed and evaluated, and even approved in their entirety.
  • If adding unrelated changes to a substantial modification the unacceptability of one component will risk the approval of the entire dossier change.
  • Synchronize your operations and regulatory strategy.

What does this mean for you?

Lay summaries will be mandated as part of the EU-CTR

Lay summaries will be mandated as part of the EU-CTR

As part of the new regulation it is a mandated requirement that plain language lay summaries are to be published on the Clinical Trial Information System (CTIS) no later than 12 months after clinical study close...

As part of the new regulation it is a mandated requirement that plain language lay summaries are to be published on the Clinical Trial Information System (CTIS) no later than 12 months after clinical study close. The CTIS is expected to go live in January 2022.

This means:

  • Be prepared in advance of the go-live date.
  • Define your lay summary development process including review and approvals.
  • Develop your lay summary template, applying careful consideration to the content and visual requirements of lay audiences as well as the technical requirements.

What does this mean for you?

Query responses will only have a maximum 12-day turnaround window

Query responses will only have a maximum 12-day turnaround window

This is the maximum time for query response or request for information (RFI) otherwise an application lapses by default...

This is the maximum time for query response or request for information (RFI) otherwise an application lapses by default. An RFI window is not flexible, so this means that it will need to be addressed if you have multiple countries and languages.

This means:

  • Document revisions including any potential translations and redaction needs will need be available as they need to be included in the response submissions.
  • The response time may also be shorter if required.
  • An efficient, rapid response RFI response process will be required with simple and easy-to-use templates to allow for easy redaction.

What does this mean for you?

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