|
As a Volunteer, what can I
expect?
Who May
Participate
Each pharmaceutical study has a
set of guidelines that may be based
on:
- Age
- Gender
- Type of disease or condition
- Previous treatment and other
medical considerations
For your safety, our Study
Doctors and Coordinators are trained
to look for patients that meet the
specific requirements.
Informed Consent
Informed Consent is a process
based upon a document that explains:
- Why the study is being done
- What you may expect during
participation
- Risks and benefits of
participation
- Any alternative therapies
that may be available for your
condition
- How your information will be
kept confidential
- Voluntary nature of research
– you may end your participation
at any time
At your first visit to the
clinic, a Remington-Davis Study
Coordinator will review the consent
form with you and explain the study.
By signing the document, you agree
to take part in the study.
Participation is completely
voluntary and you may choose to
withdraw from the study at any time.
You will be given information as to
who may see your medical information
and how your confidentiality will be
maintained.
Standard of Care
As a study participant, you will
be under the care of a Study Doctor
(also called the Principal
Investigator), who will be assisted
by the Study Coordinator. You may
experience more tests and clinic
visits than you normally would for
your condition under study.
Benefits
Some, but not all pharmaceutical
studies provide free therapies for
patients participating in clinical
trials. There is no guarantee that
participation will benefit you
directly.
Risks
The nature and
purpose of clinical research is to
determine effectiveness, side
effects and safety of the
investigational medication or
device. Every clinical study
conducted in the US is approved and
monitored by an independent
committee of physicians,
statisticians, community advocates
and others that ensure a clinical
study is ethical and that the
participants’ rights are protected.
Participation in a clinical trial
has inherent risks. Ask a
Remington-Davis Study Coordinator
for more information about a
particular study.
|
