Title:
Identification of Trial Subjects
1. PURPOSE
1.1 The purpose of this Standard Operating Procedure is to describe the
processes to be followed when identifying and approaching potential patients
for participation in a clinical trial. It also describes methods of estimating
patient numbers.
1.2 These procedures must be followed in order to comply with ICH-GCP
guidelines section 4.2.1 which states ‘The investigator should be able to
demonstrate a potential for recruiting the required number of suitable subjects
within the agreed recruitment period.’
1.3 Some sponsor companies and/or specific trials may require different
procedures as described in their clinical trial protocol or SOP. In these
instances their clinical trial protocol and/or SOP takes precedence (providing
they fully comply with ICH-GCP and that patient confidentiality is maintained)
2.
RESPONSIBILITIES
2.1 It is the responsibility of the investigator to
oversee all aspects of patient
identification.
Certain aspects may be delegated to an appropriately trained co-investigator or research nurse, in these
instances the investigator should ensure that a form ‘Delegation of trial
related duties is completed’. Most sponsor companies provide their own forms
for this purpose. When this form is not provided by the sponsor company then an
Ely Bridge Surgery version should be used.
3. PROCEDURE
3.1 Estimating patient numbers
Sponsor
companies often require investigators to provide written evidence of
potential
patient numbers. (Feasibility questionnaires) If the sponsor does not provide
instructions as to how this should be recorded the following format should be
used:
i.
the total number of patients with
indication to be studied, total number of patients meeting inclusion/exclusion
criteria and then an estimate (based on previous experience) of the number of
patients likely to enter the study.
ii. details of any inclusion/exclusion criteria
that exclude a large percentage
of
patients.
3.2 Identifying potential patients
Only staff
employed by the investigator or surgery should be permitted access to patient’s
medical records to identify potential trial patients. In order to respect
patient confidentiality representatives from sponsor companies should not be
allowed access to these records until the patient has given his/her consent.
Access to the computerised patient record system will be password protected
allowing restricted access only.
It is
important to invest time before starting a
trial to identify potential patients. This process can commence prior to
obtaining appropriate research ethics committee approval proving the patients
are not approached.
Methods for
identifying potential patients include but are not limited to:
a) Database search.
Computer
searches should be carried out using different disease headings or medication.
This will identify all patients who could be eligible under broad
inclusion/exclusion criteria.
b)
Manual filter.
A member of
the clinical trail team familiar with the protocol, using the exact
inclusion/exclusion criteria provided should filter the initial list obtained
from the database search. If one or more specific criteria preclude many of the
patients, the investigator should make a note for discussion with the sponsor
company as appropriate.
c)
Trial book
A trial book
containing separate pages for different disease areas may be used for
opportunistic tagging during routine surgeries. All patient details recorded
must be treated confidentially. Sponsor companies should not be given access to
this if it contains information that could directly identify patients.
d) Repeat
prescription monitoring.
Patients with
certain conditions will not visit the surgery frequently, however monitoring of
repeat prescription information will help identify these patients.
e) Increasing
awareness
It is
important to increase awareness of clinical trials amongst other staff and
patients. Basic details of forthcoming or on-going trials should be available
to other practice staff so they can refer patients to the clinical trial team
as appropriate.
Various
methods of communication may be used
including the surgery email system and the ‘Hook message’ system that provides
specific reminder messages to assigned Read Codes.
3.3 Approaching potential patients
Patients must
not be approached about a specific study until appropriate research ethics
committee approval has been obtained. The best way of approaching the patient
will depend upon the type of study and/or disease area (e.g. by letter,
telephone or direct approach during opportunistic visits). However the initial
approach to discuss potential involvement must be from a member of the practice
staff.
Approaches
made to patients and their response must be documented to ensure that they are
not approached for the same study more than once.