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Abbott Clinical Research

During the Clinical Research Study

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Procedures:

 

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!

 

Part 1 - Procedures

Part 2 - Time

Part 3 - Accommodations

Part 4 - Entertainment

Part 5 - Restrictions

Part 6 - Food

Part 7 - Visitors

Part 8 - Multiple In-Patient Stays

Part 9 - Fines

Part 10 - Completing The Study

Part 11 - Compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Abbott Clinical Research

 

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