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During the Clinical Research Study

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Once you are in the study, you will be required to complete various procedures throughout the study. 

 

Normal Procedures:
Blood Collection	Your blood will be collected at various times during the study.  Most studies will have at least one day where you will have multiple blood collections.  Most times you will be stuck every time.  Some sponsors will allow heparin locks (hep-locks) but not always.  It is up to the study doctor and the sponsor to decide.  You cannot request them.  Most studies will have at least one day with multiple blood draws.  These are call PK days (Pharmacokinetics).  You may have between 10 to 20 sticks or more on each PK day.  It just depends on the study.  The total amount of expected blood draws will be disclosed on the informed consent form.  This does not factor in resticks which happens when they can't get a viable amount of blood on the first try.
Vital Signs	Your temperature, pulse-rate, blood pressure and respirations will be monitored at various times.
ECG (Electrocardiogram)	Most studies will have a few while other studies which are specifically monitoring the drug's effect on the heart, will have multiple ECG's.
Urine Sample	Most studies will have a sample taken at check in and check out.  The check in is also a drug screen while other parameters are also being checked.
Physicals	Some studies will have a brief physical midway or at various times.  Usually just a brief encounter.
Feel Checks	Feel checks are at various time throughout the study.  If you are having any problems or side-effects, they can be reported at feel checks.  However, if you are having problems or side-effects, you should and are required to contact appropriate staff (usually the paramedic on staff) at the onset of such problems or side-effect.
Monitored meals	Some studies are food dependent and will require you to eat all of your food, start and end at a specific time.
Additional Procedures for some studies:
Urine Collection (Common)	Some studies will monitor the volume and color of your urine at various times or for entire duration of study.  When you are on collection, you will be required to go to urine collection area every time you need to urinate and you will be given a container to go in.
Stool Collection (Common)	Some studies will monitor your stools for various reasons at various times or for entire duration of study.  Most common reasons are for Carbon 14 studies, IBS studies and others.  If you are required to give stool samples, you will be given a container to go in.
24 Hour Holter Monitor (Common)	Some studies will require continuous heart monitoring.  You will typically wear the device which is about the size of a portable cassette player for a period of 24 hours.  You won't be able to shower during that time.
Telemetry (Common)	Some studies will require live cardiac monitoring.  The difference between holter monitoring and telemetry is that with a holter monitor, the info is stored to a flash card whereas telemetry is transmitting the data to a computer wirelessly and technician or qualified person monitors everyone who is being monitored.  If there are any cardiac problems, abnormalities, it will be detected immediately and someone will come check on you to make sure your okay.  Again, the device is about the size of a portable cassette player.
Eye Exam (Less Common)	This is done if the drug may effect your vision as a precaution to make sure your vision doesn't change.
Adverse Events:	Each clinic may call it differently, but most refer to them as Adverse Events.  AE's are anything that is not normal for you.  Whether it be a headache, twitch in your eye or pain in your stomach, you must report it to the appropriate state, usually the paramedic on duty when the symptom occurs.  You must not share you issues with other study participants.  Contrary to rumor, reporting too many AE's WILL NOT get you banned from a clinic.  It is after all, the whole reason the study is being conducted.  To find how how how drugs react in different people.  Failure to report AE's can result in permanent injury or death to yourself.  AE's can turn serious if they are not properly handled at the onslaught.  So, the moment you think you have an AE, report it.  Your not a doctor so your opinion doesn't count.  Even if you are a doctor, it's the study doctor who makes the decisions.

Typically, you will be given a clipboard with all the procedures you have to do during the study.  A staff will initial as they complete each one. 

Every procedure will have a specific time that you have to be there.  You will be expected to be there 3 minutes early as the time listed is the time that the procedure has to be done, not the time you have to be there. 

Wonder what you can expect to do all day?  Check out a sample schedule!

Nearly all if not all Clinical Research Facilities use the 24-hour (Military) time format.  Having the correct time is very important, so every clock in the facility is synchronized or atomic.  Military time is formatted so there is no way to confuse 1 AM with 1 PM.  You will probably have to date and time many documents throughout the screening and study process.  Be sure to use the time provided and not your own watch.  

Military time should be written as 4 digits with no colon.  So for 7 AM, you should write 0700, not 07:00 or 7 AM.  And for pm just add 12 to the time.  So for 5 PM, you write 1700.  To figure out what time it is in the pm, just subtract 12. 

Every facility is different.  Many have dorm-style rooms with several beds or bunks.  Some have semi-private rooms with 2 to 4 people in each room.  Few have private rooms.  You will typically have enough room to store a standard sized suitcase and some small carry type bags.  Few clinics have lockers so if you bring valuables like a laptop, you need to keep a close eye on it.  Clinics will provide linens, blankets and towels. 

Some facilities have a separate room set aside for procedures while others perform the procedures at your bed. 

Some clinics have individual bedside TVs while other places have community TVs or a separate TV room.  Most places will provide movies, video games and internet access.  Board games, books, magazines and pool tables can also be found at many places.  

When a facility says they have computers with internet access, generally they mean 1 to 3 computers!  So you have to share with other people in your study and other studies.  Wi-fi access is fairly common in clinics though some still don't have it.  Even if a clinic has Wi-fi, don't expect it to be the best or be able to access high-bandwidth activities. 

Some clinics have structured activities like bingo, arts & crafts or tournaments. 

But for the most part, it is recommended that you bring your own stuff to keep you busy. 

Some studies will allow time for subjects to go outside for a walk.  If you are taking a drug that can make you sensitive to UV light, then you might not get a walk or it will be at dusk.  Shorter studies may not have walks.

Most studies have specific dietary guidelines for the subjects to follow.  Typically, you will be receive three meals a day and a light snack.  Some studies may have reduced meals or even double meals.  Some studies may eliminate a meal (most commonly breakfast for morning doses).  It is important that you eat everything you are given and do not trade with others at the table.  Some studies will require that you eat all meals. 

Some studies may also require you to start eating at a particular time and to "save your last bite" until a particular time.  There are many variations to the diet and people on different studies will receive different meals.  It's kinda funny to see what everyone else is getting, except when your on a reduced diet and everyone else is on a double diet.

Most studies do not allow visitors while you are at the facility.  Some clinics will allow visitors during long stays but this will be outlined in the facility rules. 

Some times, the only studies you can find have multiple in-patient stays.  This could be bad depending on your schedule.  It is important that if you do this type of study that you remain "clean" during your off periods!  At every check-in, they will conduct drug and alcohol screenings!  Also, it is important to report back to the facility on time!

Many clinics institute a fine program intended to motivate subjects to follow rules by reducing their pay in small increments.  It is important to understand that you are being contracted by the clinic to follow the directions and procedures.  This include doing all procedures on time which insures that the study is being conducted properly.  Many clinics will fine you of you are late to procedures.  Any such fines are usually outlined in the informed consent.  The simplest way to avoid being fined is to follow all directions and be early to all procedures.  If you have any questions, be sure to ask staff.  Don't wait till it's too late to clarify something that results in a fine.  Some clinics also fine your for breaking any of the rules of the clinic, primarily major infractions.  See next section for more details. 

This is one of the major objectives of any study is to monitor the side-effects subjects have due to the medication.

Essentially, you need to report to appropriate staff (usually the paramedic on duty) anything that is not normal.  If you don't normally have a headache and all of a sudden you get one, then you need to report this.  Anytime you don't feel normal, this needs to be reported.  You should always report side-effects right when they start and when they end.  The study doctor will determine if the side-effect is study drug related.  You will not get in trouble for reporting side-effects.  It is also important NOT TO discuss your side-effects with other subjects or staff.  If a subject tells you that he/she is feeling strange, then you might somehow also feel the same way.  While your complaint may be valid, it is important that you tell the appropriate staff and they can determine what your side-effect may be.  Some clinics are becoming very strict and can remove you from the study if you are not reporting your side-effects or are discussing them with other subjects. 

It is important to note that not all side effects are bad.  If a drug that is developed to treat a condition but one of the major side effects is drowsiness, then this drug may be prescribed as a sleep-aid as well.  A well known erectile dysfunction drug was originally developed to treat high blood pressure.  So reporting all side-effects may lead to additional and better uses for drugs.

If you are removed from the study once it has started because the medication is causing serious side-effects or harm, you will typically be removed from the study and will receive the full compensation for the study as well as medical treatment provided at no cost (if necessary).  This is a decision made by the study doctor. 

Some studies have multiple stays and out-patients.  When you sign the informed consent form, you are agreeing to come to the clinic for all of these visits on time and on the day of the visit.  If you miss or are late enough to a second check-in or between in-patient stay out-patient visit, you can be removed from the study which will result in receiving less money. 

If you cannot finish the study for any reason not related to the study itself, you will only be compensated up to the point you leave. Before you sign up for a study, make sure you don't have any schedule conflicts, ie no job interviews, no court dates or anything else that would require you to appear in person.  Obviously there are times when you need to leave like family emergencies and the clinic will allow you to leave but again, they can only compensate you to that point. 

Additionally, you are not completely done with a study until your last labs (check-out) are cleared by the study doctor.  This usually takes 24 to 48 hours after your last visit.  If any of the values are out of range, you will be required to come back and provide additional samples.  Failure to do so will results in disqualification of the study and reduced payment as you will likely lose your completion bonus if applicable.  Also, you may not get your payment until the repeat is done. 

In the end, you will be compensated for your time and inconvenience.

Please note that some facilities compensate based on a completion program.  What this means is that part of your compensation is dependant on you completing the entire study including all In-Patient and Out-Patient visits.  Most call it a bonus or completion bonus.  Failure to complete all parts of the study may result in forfeiture of of the completion bonus. 

Depending on the clinic, you may have to wait for up to four weeks after you complete the study for compensation.  Be sure to check.  If the study is long and has multiple visits, you may get stipends at the end of each segment, although this is not guaranteed.    Again, be sure to ask before hand if this will be an issue.  There are no industry standards regarding the payment of stipends by clinics. 

If you earn more than $600 a year at any one clinic, you are liable for taxes.  All clinics are required to report to the IRS.  When you check in, you will fill out a W-9 and come tax time, you will get a 1099 misc income statement. 

If you are removed from the study once it has started because the medication is causing serious side-effects or harm, you will typically be removed from the study and will receive the full compensation for the study as well as medical treatment provided at no cost (if necessary).  This is a decision made by the study doctor. 

If you are removed because illicit drugs or unauthorized substances are found in your bloodstream or possessions, you may not receive any compensation at all!  Be sure not to bring in any contraband!  Also, follow all directions of the nurses and staff.  After all, you are being compensated to do so.  You can also be kicked off a study for any number of reasons including being disruptive, uncooperative and for fighting.  

If you decide that you cannot continue the study due to any reason, you will be allowed to quit, but you will only be compensated up to that point.  If you are not comfortable with the procedures, then you can quit at any time.  Most companies will compensate you on a pro-rated basis based on the number of nights you did complete.  If you quit voluntarily, you may not be eligible for the completion bonus if applicable.