Title: Identification of Trial Subjects
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)
2.1 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.
3.1 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
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.