Our Drug is not be affected · Upcoming Protocol

Our Clinical Research Organization (CRO) is
involved in a large global Phase III pivotal study, investigating the pain
management of osteoarthritis patients. The study is being conducted in 25
countries across 10 different time zones, and the current recruitment situation

On Monday at midday, our CRO receives
an official notification about a safety issue with a marketed medicine of the
same class as our investigational product. The study will continue without
affecting the recruitment schedule.

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The Sponsor decides to organize an
urgent call with all international team members. During this call, the Sponsor informs
about the issue and upcoming protocol and ICF amendment.

Due to safety reasons, patients will
need to re-consent orally in an expedite way immediately before the amendment
approval is obtained. A notification letter will be sent urgently to all
involved sites

 To ensure the continuity of the trial an ensure
transparency, our clinical team is going to develop a plan which includes
immediate, medium and long-term actions.

The aim of the team is to guarantee that the sites are immediately and
correctly informed about the safety issue and the urgent measures to be adopted

extraordinary meeting is arranged to plan immediate
actions and evaluate possible
risks, the results are:



Lack of confidence in the investigational


ICF withdrawn or loss of follow up of
enrolled subject

High number of early termination patients

New subjects deny participating in the study

Target number of enrolled patients will not
be reached or delayed


A communication plan is going to be
developed following this diagram:



The Sponsor
sends the notification letter to all involved sites explaining/informing:

issue occurred

that the Sponsor Drug is not be affected

Protocol and ICF amendment

instructions. Patients must re-consent orally and this will have to be registered
in the source data documentation,

will be scheduled with sponsor and Medical Monitor to resolve all the questions
of the sites and the actions needed to be carried out in detail, also a
re-training will be conducted first to CRO and sites on how to focus the safety
issue to sites/patients, to reinforce that the sponsor drug is safe.


Each country team will notify immediately the Competent
Authorities about the safety issue and actions taken. Local teams will contact
sites to confirm they have received the Sponsor notification and their
assistance to the Webex. It is crucial to ensure sites are informed properly
and feel comfortable with the actions taken and they can keep on enrolling

To increase safety and
maintain the recruitment our team will suggest the Sponsor:

design patient safety cards which contain a description of principal symptoms
and contact details in case of emergency.

local physician specialist should be available in each site for safety issues.

a lost follow up process focusing on patient retention and ensuring sites are
making all efforts to keep patients in the study.

site visits with the Medical Science Liaison to reinforce the sites reliability.

To ensure a
correct development of the action plan we design the following medium-term actions. A good
organization is crucial to verify the plan is executed in a good way:


visits will be planned to inform all the patients and perform the reconsenting

will be instructed to identify a local physician specialist which will be
assigned by each site to be available this case related safety issues.

site management calls with sites will be performed by each local clinical team
to follow up

Amendment will be submitted to each country Authorities

monitoring visits will be scheduled to ensure sites are complying with the

the loss of follow up process has been designed by the Sponsor, it will be
distributed and each local site team will be trained accordingly

the initial recruitment plan and re-formulate where applicable. For instance,
addition of new sites or advertisements (changes can be included in the

The main goal is to reach the
recruitment target, ensure patient safety, data reliability and quality. Therefore,
we develop the following long-term

Once amendment is approved, it will
be implemented in all sites and new documentation (ICF, protocol, safety cards
and new patient diaries) will be distributed. Sites must be trained during
either site management calls or monitoring visits to ensure all patients sign
the new ICF version and patient safety cards are provided during next study
visit, documenting the process on patient chart.


A new Monitoring Plan will be designed. This
updated version will include changes in monitoring visit frequency (based on
subjects recruited at site) to assure amendment and new safety measures are
properly implemented at sites.

The Sponsor will notify that an Interim
Analysis will be conducted to analyse safety data. Hence, each local clinical
team should design a monitoring plan to meet all the deadlines considering:

Data Cut Off/Interim Analysis, the Sponsor and the Pharmacovigilance Department
will send an official notification to involved sites to inform about results.
In addition, this information will be shared through a global Webex considering
the different times zones.

To sum up, this risk assessment and action plan
has been developed considering the standards of quality,
information´s transparency, continuous training and follow-up. Moreover, we
should not forget to keep sites motivated and to continue with the new adapted recruitment
strategies to achieve our patient goal.

project focus has been prevention and anticipating events to make sure that
excellence and success is guaranteed.

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