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Standard operating procedure
Family recruitment No 011D
All potential subjects for the study will be recruited from
Medical Research Council (MRC) General Practitioner (GP) framework
practices where possible. It is important to get as much information
as possible from prospective subjects from the posted questionnaire
and subsequent follow up telephone calls, so that visit appointments
are made only for suitable candidates. In order to obtain the
maximum and most reliable information it is necessary that all
nurses follow the same screening procedure and ask all the same
open and non-leading questions documented in the screening questionnaire
Research nurses trained in the method are responsible for recruiting
suitable families and ensuring subject documentation is completed
thoroughly. It is the responsibility of the Nurse Co-ordinator
to ensure that all research nurses are familiar with the study
procedures and equipment, and adhere to the guidelines set out
in the standard operating procedures.
It is the
responsibility of each nurse to ensure that they always have
the relevant paperwork and equipment available at all times
nurses involved with the study should be familiar with the study
protocol and should be aware of the inclusion/exclusion criteria
before attempting to recruit potential subjects.
monitor should have the charged batteries already installed;
the guidelines for this procedure can be observed in the Omron
manual. Additional batteries should also be available to protect
against battery failure. The monitor should also be programmed
with the correct date & time and printer paper. Any alterations
required with the monitor's set up can be achieved by reading
the guidelines from the manufacturer.
Return of initial questionnaire
the return of a questionnaire the guidelines laid down in
SOP 013 should be followed.
should only be recruited to the study if they fit the inclusion/exclusion
that the subject understands the study and what will be required
the subject's family details and ensure that they correspond
with the study protocol.
that there is a sibling pair willing to take part.
a visit time suitable to the subject.
the subject with further information about the study, pitched
at their level of understanding.
phenotypic data and ensure that they correspond with the inclusion/exclusion
a family meets all the inclusion criteria, place the subject's
documentation details in the appropriate family file. The
family file will be the only documentation by which a subject
can be traced, all further details will use a unique identification
number. Only staff directly involved with the study may consult
the family file.
the family a unique identification number. The first two letters
should represent your centre name, e.g. LN for London. The
following five numbers will be unique to the family and your
centre number allocation, e.g. 00001 to 00200 for London.
The final numbers will depict which member of the family the
subject represents, e.g. 001 for father and 002 for mother.
subject's identity is maintained by the allocation of the
unique identification number, it is completely unrelated to
their name. This ID number will be the only reference used
for the subject after they are entered into the study. All
subject details stored on the computer database will use this
the subject's details into the study database.
the bloods and urine are sent to the appropriate laboratories
(guidelines in SOP 009).
a follow up visit or phone call for any missing details, if
the subject's GP with the medical results obtained. However,
due to ethical constraints, genetic details will not be issued
to either the GP or the subject. If several subjects are seen
at the same practice, several results can be issued together.
details in the correct files for subjects not meeting all
the study requirements and those withdrawing from the study
due to personal/health reasons,
the subject(s) for their time and assistance with the study.
Subjects requesting results should be encouraged to visit
their surgery after the results have been sent to their GP.
- It is
essential that subject confidentiality is maintained at all
times. Families may be unaware of their relatives' medical
history and so individual subject confidentiality should be
- It is
vital that subjects are fully aware of all aspects of the
study. A written consent should be signed by the subject before
any phenotypic, medical or personal details are taken.