Introduction to Clinical Research Studies - Overview Informed Consent:

Types of Studies

Laboratory Screening:

The Phone Screening

Physical Screening:

The Clinic Screening

24 hr Heart Monitor:

Checking In Repeats:
During The Study Disqualification:
After The Study Payment for Screening:
Doing Studies For A Living Selection Process:

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Informed Consent:      (Top)

1 - 2 weeks before Check-In day.

The first task at hand will be reading and signing the rather lengthy "Informed Consent" form.  Read this carefully!!!  At this point, they will disclose everything they know about the drug or drugs you will be testing.  They will also tell you what side effects were seen in lab animals and humans, if human trials have been done already.  You will sign two copies, one for the clinic and one for your records.  The informed consent also outlines what you will be doing during the study as far as procedures, time-points for blood collections and meal requirements.  The clinic's payment policy for stipends will be explained which will include how much your getting paid, when and if the clinic has a policy for fining you if your late to procures.  You will also read and sign a Clinic Rules document which will outline the rules and regulations of the clinic.  By signing both the informed consent and the Clinic Rules documents, you are agreeing to follow them.  Failure to comply with the rules and study requirements may result in being removed from the study with reduced payment.  If you feel that you cannot comply with the rules and study requirements, it is in your best interest not to do the study.  If you will not be able to make all of the study dates and outpatient visits, it is in your best interest not to do the study.  

 

Laboratory Screening:       (Top)

1 - 2 weeks before Check-In day.

Typically, you will have to "fast"  (not eat) for 8 to 10 hours before going in for the screening.  You may also be required to stop consuming caffeine products, foods containing poppy seeds, grapefruit products including grapefruit juice and to stop strenuous exercising.  Also, you should not have done any illicit drugs recently or consumed alcohol.  

 

Next, although not in this order:

 

Most Screenings

Height and Weight will be taken to determine BMI or IBW

Must be within predetermined range

A urine sample will be collected

Click here for more info on urine values

To test for drugs, alcohol and other parameters

Vital signs (temperature/blood pressure/respirations/pulse rate)

All must be within predetermined range

ECG (Electrocardiogram)

Must be within predetermined range

Blood collection and vein assessment

Click here for more info on blood values

All lab values must be within predetermined ranges

To access veins, a tourniquet will be tied on each forearm (not at same time).  You must have at least 1 major vein and 1 secondary vein in each arm for most clinics. 

Additional procedures for some studies

Breathalyzer to test for alcohol consumption (More common)

Must be negative

Occult fecal sample to test for blood in your stools (Rare)

Must be negative

Semen Collection (sperm count) (Rare)

Must be within a certain range

EEG Electroencephalography used to detect if your prone to epileptic seizures.  (Rare)

Must be within normal ranges

ERG Electroretinography used to detect various retinal diseases (Rare)

Must be within normal ranges

Tuberculin skin test to detect possible tuberculosis infection (Rare) Must be negative.  You may also have to have a chest X-Ray which also has to be negative
Elbow Breadth, a measurement to classify your body frame size.  (Common) Must be within a certain range

 

The screening visit will typically last 2 to 4 hours depending on how many people are screening.  If you do have to fast, it is recommended that you bring a few snacks with.  The staff will advise you when you can eat.  Typically you cannot eat until you have done both your urine and blood samples.  Some facilities will provide snacks.

 

Physical Screening:      (Top)

1 - 2 weeks before Check-In day. 

This may be done at the first screening, or may be done after the lab results are completed and on a different day.

 

Most times, this is just simple open your mouth and say ahhh type stuff.  No turn and cough type stuff.  Although this can very depending on the requirements of the study.  Expect basic stuff like listening to your heart, checking eyes, ears and throat.  Doctor will usually check reflexes and hand eye coordination

 

The doctor will confirm the medical history you gave over the phone and may ask some simple questions from the "Informed Consent" form like the name of the drug company or the name of the drug you will be testing.  This doesn't happen always, but it's nice to know this information.  Doctors are looking for serious people who are going to be reliable during the study.  

 

24 hr Heart Monitor:     (Top)

1 - 2 weeks before Check-In day.

This is not done for every study.  In fact it is pretty rare to be part of the screening process but sometimes, it is done during the study.  If you do have to have this done, you will wear a heart monitor for 24 hours while you go about your normal activities.  Yes, you have to take it home with you!  You will generally have 7 leads attached to your chest and a recorder, which is about the size of a portable cassette player.  During this time, you cannot take a shower, exercise, have sex or anything else that is strenuous.  You also will have to keep a log of what your are doing throughout the day to help the doctors determine if you have a normal heart rhythm.  Click here for picture.  Be aware that when heart monitoring is part of the screening, this will usually delay the invite to check-in to the day before check-in as the information has to be sent to an outside firm for analysis. 
 
Repeats:     (Top)

Certain procedures are allowed to be repeated if out of range. 

Your height and weight are pretty much set in stone, so if your BMI is out of range, then your out of luck.

Vitals are repeated on the spot using the machine and if still out of range, may be redone by a paramedic.  If out of range after that, then you'll be disqualified. 

Certain urine values can be repeated.  If blood is found in the urine or the urine PH level is too low, then you may get a repeat. 

Drugs and alcohol are zero tolerance, therefore no repeats as you will usually be banned from returning to the clinic.  You will have to come in at a later time to do this. 

Certain blood values may be repeated..  You will have to come in at a later time to do this. 

ECG's are typically set in stone unless there was too much artifact which should have been caught while the ECG was being done. 

 
Disqualification:     (Top)

There will be times when you don't qualify for a study after screening.  The recruiter will call you or if it was for vitals or BMI, you may be told at the screening. Unless the reason you were disqualified was deemed medically significant, you should be able to screen for another study.  Sometimes you will be referred to an outside doctor (at your expense) before they will allow you to screen again.  This will be explained to you if necessary. 

 
Payment for Screening:      (Top)

There is no payment for screening.  A few clinics will give you a stipend to assist with travel expenses (mainly on east coast).  This will usually be between $20 and $50.  No guarantees! 

Under very special circumstances, you may be paid for the screening.  This usually is because you may be required to stay a night or two as part of the screening process or do other unusual procedures. 

 

Selection Process:     (Top)

The clinic will first determine who qualifies for the study based on the screening results.  If more people qualify than spaces are available, then subjects are usually enrolled on a first screened, first qualified basis. 

 
Introduction to Clinical Research Studies - Overview Informed Consent:

Types of Studies

Laboratory Screening:

The Phone Screening

Physical Screening:

The Clinic Screening

24 hr Heart Monitor:

Checking In Repeats:
During The Study Disqualification:
After The Study Payment for Screening:
Doing Studies For A Living Selection Process:
 

 

Updated on 9/5/08

 

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