many studies require both males and females, some studies will
be gender specific i.e. males used for a male enhancement drug
and females used for a birth control drug.
Also, depending on where the clinic is at the time of
screening, they may only need a certain gender. Some
studies require an even split.
study will be targeted towards a specific age group.
Example: 18 to 55 is common. May be you'll see 25
to 45 or 65 to 80 or even 6 to 18.
The main age cut-offs are:
45 for most studies
55 for many studies
65 for some studies
After 65, healthy
Phase I studies will be limited but they do
occur! These are usually the hardest to
fill so compensation tends to be higher and referral bonuses
are often offered.
Studies for those 17 and under require
Body Mass Index (BMI)
height and weight are used to determine your BMI. Many
studies recruit participants with a BMI between 18 to 30, but
this figure can vary widely. BMI is your body fat.
here to use a BMI calculator.
Ideal Body Weight
studies require you to be within a certain percentage.
15% is common.
here to use a Ideal Body Weight Calculator. A study
will use either the BMI or IBW but usually not
the ideal body weight by 15%. Then subtract your body
weight from the ideal body weight. As long as your
weight is equal to or less than 15% or what ever percentage
the clinic is looking for, then you should be okay. Note
that this is not a standard test and many clinics may use a
studies require participants who do not consume alcohol in
excess. Many studies will have "cut-off
periods" of 24 to 72 hours before screening and check in
and do not allow the consumption of alcohol during the study
period. This includes the actual study as well as
between multiple periods and out patient visits.
Do not show up at a
clinic with a SCRAM ankle bracelet. Nothing says "I
don't have issues with alcohol" like showing up to a clinic with
Secure Continuous Remote Alcohol Monitoring device on your
ankle. I have heard clinics banning volunteers who do
this so don't do it!
View my blog entry about
SCRAM ankle bracelets
studies require participants who do not use tobacco products
including chewing tobacco and cigarettes. Some studies
do allow light users, but typically will ban the use of tobacco
products during the length of the study. Note that some
studies have "cut-off periods" of varying
length. Many clinics are now doing blood tests for
cotinine which is a byproduct of nicotine so it
is best to be honest about whether or not you
have smoked recently. Cut-off periods may
range from a few days to a year or more.
If you are exposed to heavy second hand smoke, you might
test positive for cotinine and would be excluded.
Illicit Drug Use
healthy volunteer studies require participants who do not use
illicit drugs including but not limited to: crack, marijuana,
cocaine, heroin and ecstasy. If you have put drugs
behind you, be aware that most drugs can be traced in your
system up to 90 days after cessation.
Clinical Research Facilities are implementing "Zero Tolerance"
policies which allow them to bar you from participating in
future studies if any illicit drugs are found in your system
at any time during the study. This includes during the
screening process, during the study and after the study until
you have been "cleared" from the study.
is necessary for the clinic to know if you are allergic to any
drugs, foods or anything else. Having an allergy doesn't
necessarily exclude you from a study, but it is for your
safety and health that you report any allergies you may
have. Most studies have a study specific diet and cannot
be altered due to food allergies. As for drug allergies,
it is important that you don't do studies with
drugs that may cause an allergic reaction.
Prescription And Or Over-The-Counter Drug Use
studies require participants to not be taking prescription
drugs or OTC drugs. Most studies will have "cut-off
periods" of around 30 days. It is best to be honest
if you have taken anything during the "cut-off
period." Anything found in your system that cannot
be accounted for will most likely excluded you from the
This also includes herbal and nutrition supplements as well
as energy drinks which can throw off your labs.
Recent And Past Medical History
Clinical Research Facilities will ask information regarding
your recent history. This can include any
hospitalizations due to sickness or physical conditions,
surgeries, mental conditions or medical procedures.
Most surgeries will not disqualify you but it's
important for the clinic to know your history.
This is generally collected at your first screening and
updated as needed if you participate in additional studies.
studies require a certain ethnic population. Pretty
unseal for Phase I but they occur.
Some studies will require
subjects with no family history of certain
Recent Blood Or Plasma Donations
on how often you donate blood or plasma, you may be asked to
wait a period of time before participating in a study.
You will not be allowed to donate blood or plasma during a
study and usually for a period of 30 days after you complete a
study. Participating in a clinical research study counts
as blood donation.
Recent Involvement In A Clinical Research Study
volunteers find that they've enjoyed the experience of
participating in a study so much that they want to join
another study. Most studies have a "wash-out"
of at least 30 days. That means that once you've
completed your last dose in a study, you must wait at least 30
days before participating in another study at any clinic. Some studies
will require a longer "wash-out" period.
Many clinics are now using verification systems
to check if you have been in another study recently.
explanation of washouts
Many studies will have
restrictions against people who have
traveled outside the US or country that the
study is being conducted in. This is due
to unknown health conditions in foreign
countries and especially if you had to have any
vaccinations or immunizations.
Some studies will require
surgically sterile or post menopausal
Also, females cannot be pregnant during a
clinical research and should not conceive a
child for a period of 3 months post study.
1st in man studies will generally require
non-childbearing females or may not require females at all
due to the unknown effects on pregnancy.
must be available for all visits including staying at
overnight for one or more consecutive or non-consecutive
stays. You must be available for any and all out-patient
visits. Dates are predetermined and are not negotiable.
If you think you will not be able to make a visit, it is wise
not to apply for that study. Failure to be on time and
present for your visits can result in financial penalties.
It is wise to also have a day or two on the tail
end free. On rare occasions, studies may be delayed by
a day or even postponed.
Part 1 - General
Part 2 - In-Depth
Look at Qualifications
Part 3 - Additional