Execution phase | Clinical operations services

Safety reporting

Your patient’s safety is of the utmost importance and needs to be monitored closely during your clinical trial. We can support you with our safety reporting services.

Safety reporting involves the monitoring, documenting and reporting of what’s happening with your patient during the trial, the (serious) adverse events.

The type of event required to be reported depends on the type of investigation. For IP trials, a pharmacovigilance department has to be involved. For MD trials, you need to work with a vigilance department. We can organise both.

(Serious) Adverse Events ((S)AE) are adjudicated by the Clinical Event Committee (CEC), we support you by coordinating this adjudication process. After adjudication, events are reviewed by the Data Safety Monitoring Board (DSMB), an independent committee formed to monitor the safety of the patients during a trial. We can assist with the DSMB formation and overseeing the process, including preparation of the DSMB charter, contracting, recruiting of members and organising meetings.

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Serious Adverse Event (SAE) reporting

A SAE is any undesired serious medical event involving a patient, not necessarily associated with the treatment. All SAEs need to be reported, individually or annually to the ethics committee if indicated in the study protocol.

We provide SAE reporting, including Serious Adverse Reaction (SAR), Suspected Unexpected Serious Adverse Reaction (SUSAR) and Serious Adverse Device Effect (SADE) reporting.

Classification

We use two types of coding for our safety reporting:

1. For events: ATC/DDD coding
   We use the Anatomical Therapeutic Chemical (ATC) as classification system and the Defined Daily Dose (DDD) as a unit of measure, endorsed by the World Heart Organisation (WHO).
   
   The ATC classification system categorises the active medical substances according to the organ/system on which they act and according to their therapeutical, pharmacological and chemical properties. The ATC/DDD coding facilitates standard presentation of events internationally.
   
   
2. For medication: MedDRA classification
   The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) developed Medical Dictionary for Regulatory Activities (MedDRA) almost three decades ago. MedDRA is a specific standardised medical terminology to facilitate sharing of regulatory information internationally for medical products used by patients in clinical trials.

Clinical Event Committee (CEC)

The CEC is an independent committee of medical experts formed to review events obtained from patients who are participating in a clinical trial. CEC members independently review events based on the CEC charter definitions. This centralised adjudication provides a standard, systematic and unbiased assessment of endpoints.

We support you by coordinating the entire adjudication process. We prepare the event dossiers and organise the CEC meetings. In addition, we can facilitate remote adjudication through our web-based eDREAM system, accessible 24/7.

Data Safety Monitoring Board (DSMB)

The DSMB is an independent committee of medical experts formed to monitor the safety of the patients during a trial.

We can assist with the DSMB formation and overseeing the process, including preparation of the DSMB charter, contracting, recruiting of members and organising meetings.