Module 4
Page 5 of 14

Adverse event reporting

Adverse events and incidents are unfavourable or harmful effects or problems that occur during the trial of a health product, service or drug.

This can be applied to all of our contact with research participants and should be outlined in the project design development plan. When related to pharmaceutical company work, the process of understanding and reporting adverse events is often also called PharmacoVigilance (PV).

We collect reports of adverse events and incidents in order to continually monitor the safety profile of Ctrl Group products and services. This safety record may form part of the contract between us and a client, and is also required by regulators.

Definitions in detail

Adverse event (AE): any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. (From Article 2(m) of European Directive 2001/20/EC)

Adverse incident (AI): an event that causes, or has the potential to cause, unexpected or unwanted effects involving the safety of device users (including patients) or other persons. (From MHRA Adverse incident reporting)

Two key points to remember from this definition are:

Untoward medical occurrence: the event does not necessarily have to be a negative consequence (e.g. an incidence of hair growth in a bald man taking an antidepressant is considered an AE, even though the hair growth may not be considered negative.

Causal relationship: the event may or may not be related in the opinion of the reporter but should still be reported.

Responsibilities in adverse event reporting

Everyone involved with activities related to your trial needs to know how to identify and report safety information to the relevant person

This information might come from:

  • Nurse visit records
  • Call centre records
  • Returns to Ctrl Group e.g. administration equipment
  • Open text fields in surveys, database fields, and other forms used
  • Survey questions potentially generating safety information
  • Social media formats - Twitter, Facebook, SMS text
  • Emails, letters and postcards
  • Mobile applications

Any AE or AI should be reported when it involves any of the following:

Worsening of the participant’s condition that occurred after the start of the relevant product or project, even if this is an expected consequence of their disease. e.g. A patient contacted the call centre to check if they should continue with their treatment as their blood tests had shown worsening of their renal function.

Special situations i.e. specific safety events in addition to adverse events such as inadvertent exposure, drug interactions, abuse and misuse, or maladministration.

Product complaints related to a relevant project product. Any written or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness or performance of a product / device after it’s released for distribution.

For example, these might include:

  • You visit a patient and they report feeling unwell
  • You call a patient and are told the patient has died, no other information is available
  • You call a patient and are told the patient is currently hospitalised, no other information is available
  • A patient or healthcare professional returned product or associated kits due to the death of a patient or discontinued use of the product due to another medical reason (e.g. hospitalisation, surgery or AE).
  • You are made aware that a patient has undergone surgery

At the start of a project, an internal project Pharmacovigilance (PV) capability is established to take responsibility for AE and AI report assessment, processing and decision-making.

Depending on the level of risk that a project involves, the PV capability must include the following expertise:

  • Clinical expertise
  • Medical regulations / ethics / legal expertise
  • Management expertise

There are three routes through which an AE or AI might be detected.

  • A researcher is made aware of an AE / AI through communication with the participant in the context of a project.
  • User directly contacts us to report an AE / AI in relation to our project.
  • User completes an MHRA Yellow Card in the context of a user identifying an AE / AI related to the use of your product, and reporting directly to the MHRA.

In each instance Ctrl Group would follow up with the participant or the MHRA. You should decide your own protocols for follow-up before you start a trial.

What information to gather for completing a report

When reporting an AE or AI there are key points of information that must be gathered. A report can be filed with the minimum of the following, even if you don’t have any other information:

  1. Awareness date (i.e. the date that an AE or AI is reported to any person working for, or on behalf of,your team or company, anywhere in the world).
  2. Relevant product (with batch number if available, and a drug or product version number if software)
  3. AE / AI / special situation / product complaint
  4. Identifiable reporter
  5. Patient name, contact details (their preferred mode of contact, within any data or privacy regulations)
  6. Reporter opinion of causality
Hidradenitis suppurativa logo
Case study

Ensuring adverse events (AEs) in patient-centred research can be managed with due care

Challenge

Each project where we carry out research with patients requires specific training around AE reporting. Each pharma company has its own training and processes to follow, and each team member who has contact with a patient needs to go through this training before any patient contact.

Approach
  • At the outset of any research project with patients, capture if and how AEs should be recorded and reported. The example below is specific to a research project to look at the use of online materials to inform decision making on the treatment of Hidradenitis suppurativa (HS) – a painful, long-term skin condition that causes abscesses and scarring on the skin.
  • First we worked with the project sponsor (a UK-based pharma company) to establish the risk profile of the research project. We used their procedure to review the research protocol to establish that it was a low risk, patient oriented programme. Even though this was a low risk programme, as it was pharma sponsored and some of the participants were currently on or had used the company’s treatments in the past, it was agreed that we should used the pharma company’s AE reporting process.
  • All team members went through the pharma company’s mediated pharmacovigilance (PV) training which included how to detect and report AEs.
  • All patient contact was initially assessed by the researcher as to whether any AEs should be reported or not. Open questions were flagged to management and decisions were made on what to report.
Results
  • The project was completed with only a single AE reported.
  • The AE was discussed between the researcher and the project research lead before reporting.
  • After discussing what action to take, our decision was to report the AE,to err on the side of caution. It was important to report within very specific timelines and to not delay it for any reason.
  • No further action was taken based on the report.