Clinical Trial Structured Risk Assessment
University of Cape Town
Clinical Research Centre
Title
Risk assessment Form
Number
QA02.4
Version
1
Author
Reviewer
Authoriser*
Name
Delva Shamley
Greg Hussey
Tania Douglas
CRC SOP QA02 Appendix
Title
Signature
CRC Deputy Director
CRC Director
Deputy
Dean
for
Research
Date
1 Introduction, Background and Purpose
Prior to UCT agreeing to sponsor a trial the clinical trial will need to undergo a risk assessment and this
Guidance Document describes how to do this. Risk assessment must be carried out as early as
possible to ensure measures are taken to minimise the risks. Potential hazards should be identified
for every clinical trial and the risk of harm assessed. This Guidance Document is based on two
Clinical Trial Risk Assessment documents :
http://www.ct-toolkit.ac.uk/_db/_documents/MPTrials2.pdf
http://www.ct-toolkit.ac.uk/_db/_documents/Trial_RA.pdf
2 When this Guidance Document Should be Used
This Guidance Document should be referred to when you are requesting sponsorship by UCT or
you are designing a clinical trial. A risk assessment must be submitted to the CRC Steering
Committee.
3 Identify Hazards and Assess Risk
In order to identify hazards and assess risk:
•
•
Create a list of potential hazards (anything that could cause harm) for the trial and identify or
specify how they will be minimised
Assess the risk (probability that harm will be caused by the hazard) of each hazard and set out
your plan for controlling the risks.
Clinical Trial Structured Risk Assessment
To do this you must complete the risk assessment form in section 4 below.
Tables 3.1-3.4 below are examples of the categories that may present hazards for your clinical trial. It
is recommended that you look through each of these whilst completing the form.
3.1 Identify the Potential Hazards for the Trial Participants’ Rights
Hazard
Participants entering the clinical trial
without fully informed consent (the
participant or their legally acceptable
representative must always give consent,
except in very exceptional circumstances
where prior consent is not possible)
Points to consider
•
•
•
•
the vulnerability of the patient/study group
and capacity to give consent, e.g. children,
incapacitated adults
consent process, e.g. timing relative to
diagnosis, time to consider, signature
participant information provided – clarity,
appropriateness, different languages
training of those providing
participant information and
obtaining consent
Failing to act on the participant’s request to •
withdraw from the trial
your communication and recording
systems
Failing to protect the privacy of the
participants
your data protection and security systems
anonymisation
•
•
Clinical Trial Structured Risk Assessment
3.2 Identify the Potential Hazards for the Trial Participants’ Safety
Hazard
The intervention, e.g. expected adverse
effects, unexpected adverse effects,
clinical management of adverse effects,
clinical management of patients’
underlying medical condition
Points to consider
• The nature of the intervention
• The treating clinician’s previous experience of
the intervention
• If a medicinal product trial development phase,
licensing status, indications, clinical experience,
pharmacology, pharmacy/drug handling
requirements, training and competence, suitability
of location proposed for study activity, access to
emergency treatment facilities
• Staff training
• Susceptibility of the population – disease, genetic,
age, sex
• Systems to monitor and review adverse effects
• Systems to maintain awareness of and to act on
new knowledge
• Systems on wards, etc for notifying trial
personnel of unexpected admissions of trial
subjects
• Ability of participants to report adverse events
and study outcomes reliably
The assessment methods
• Increased radiological exposure
• Additional invasive tests
Indemnity
•
•
Determine if non-negligent harm indemnity
insurance is required
Ensuring HPC membership for staff involved in the
trial
3.3. Identify the Potential Hazards to the Completion of the Trial in
Relation to Recruitment and Follow-up
Hazard
Points to consider
Non-completion of the trial in relation
to recruitment and follow-up
• Feasibility, study population, numbers of
subjects required
• Time scale of the trial
• Researcher time allocated to the trial
• Staff competence and experience at sites
• Having adequate study management
• Defining roles and responsibilities
• Length of follow-up
• Frequency of follow-up
• Alternative means of follow-up, e.g. GP, relatives.
Clinical Trial Structured Risk Assessment
3.4.
Identify the Potential Hazards to the Reliability of the Results
Hazard
Lack of study power
Setting the wrong eligibility criteria
Points to consider
• Plausible treatment effects
• Patient numbers
Statistical support
Statistical
• UndulySupport
restrictive/prescriptive eligibility
criteria
• Appropriate access to clinical trials to patients
of both sexes, all ages, ethnic backgrounds, etc
Major violation of eligibility criteria
• Need for checking/procedures to verify
eligibility of participants
Fraud
• Incentives – financial and non- financial
• Consequences – size and severity of threat to
trial results
• Options for checking
Randomisation procedure
• Robustness of the procedure
• Potential for loss of allocation
concealment/unblinding
Outcome assessment
•
•
•
•
•
Data being incomplete and inaccurate
• Data type and complexity (case report form
design)
• Collection method (paper, electronic)
• Data entry method
• Key data items
• Staff training
• Need for and options for data
verification
Non-adherence to the protocol
• Complexity
• Staff training and trials experience
• Barriers
to compliance
with
intervention (for trial personnel
participants)
Blinding (single, double)
Objectivity of the measure
Standardisation of assessment methods
Potential for independent review
Potential for simple external verification, e.g.
death certificate, laboratory investigation
result
the
and
Clinical Trial Structured Risk Assessment
4 Clinical Trial Structured Risk Assessment Form
Chief Investigator
(if applicable):
Project Title:
Hazard
Category
(see Guidance
Document 8,
for
examples)
Rights
Safety
Completion
Reliability
Other
Hazard Description
(Add more rows if
more hazards
identified)
Impact if it
Happens
1 – Low
2 – Moderate
3 – Significant
4 – Severe
5 – Catastrophic
Likelihood
of it
Occurring
1 – Remote
2 – Unlikely
3 – Possible
4 – Likely
5 - Certain
Risk
(= Impact x
Likelihood)
IF THE POINTS TO CONSIDER AS STATED ABOVE ARE NOT COVERED IN EITHER
THE PROTOCOL OR THE ETHICS SUBMISSION THEN PLEASE describe what
control measures will be put in place to reduce the risk(s)
to the lowest possible level.