| Invite to Check-In: | |
| Types of Studies | Packing for the Study: |
| The Phone Screening | Check-In: |
| The Clinic Screening | The Dosing: |
| Checking In | - |
| During The Study | - |
| After The Study | - |
| - |
The call may be anywhere from a week to the night before the Check-In.
When you screen, you should be given a list of stuff you can and can't bring. The following pretty much applies to all clinics unless noted.
|
Allowed |
NOT Allowed |
|
Toiletries |
Medicated lotions, shampoos, anything with vitamins, aloe vera, cocoa butter, peroxide, whitening toothpastes |
|
Cell phones |
Cameras, cell phones with cameras, laptops with cameras |
|
Laptop computers |
Food, beverages, snacks, gum, candy, bottled water |
|
Games, books, magazines, homework |
Explicit material such as movies, magazines, pictures |
|
Movies, VHS, DVD |
Large TVs (pretty much anything non LCD) |
|
Portable TVs, DVD players, 15" or smaller LCD TVs |
Weapons or anything that could be perceived as a weapon |
|
Video game consoles, alarm clocks |
Electronics without headphones |
|
CD players, MP3 players |
Alcohol, drugs (seems to go without saying but...) |
|
Guitars (though you shouldn't play in the dorms or sleeping areas) |
Anything large and bulky |
| Recommended Items to Bring | |
| Animal Slippers (okay, any slippers will do) | Shower shoes/flip-flops |
| Power strip if you have more than 2 electronic devices | Blanket |
| Hoodie |
Headphones (even if you don't have a laptop) |
| Earplugs (some clinic provide them but better to be sure) | Skin Lotion (can be dry in the clinic) |
|
Deodorant (please bring some!) |
LAN cable (if you have a laptop) |
Most places have little if any room for storage. You will be expected to bring as little as possible, but enough to keep you busy and entertained. Most places do not provide lockers for storing valuables. It is recommended that you do not bring valuables and if you do, to keep them with you at all times to prevent damage or theft.
Payphones are usually provided. Bring your own change or bring a cell phone or phone card.
You will be provided with linen, pillows and blankets. Laundry service varies from facility to facility. It will depend on the length of the study. You may wish to bring an extra blanket and or pillow as clinics keep the air conditioning on year round in order to maintain a sterile environment. Some clinics are freezing cold!
At most clinics, you will need to bring your own clothes. Bring enough for 6 to 7 days. You will be lounging around most of the day so bring comfortable clothes like sweat shirts and sweat pants. You will probably want to bring a hoodie. Some clinics provide scrubs to wear, but you'll still need to bring lots of socks and undies. You should also bring comfortable shoes or animal slippers. You are not allowed to walk around bare-foot or in sock as there could be sharp objects or needles on the floor.
Be sure to search your bag for stuff that is not allowed. Do not bring any medications or items with banned substances. You can be removed from the study if you have a medication because they don't know if you've used it or not.
Some clinics strip search you down to your underwear. So be sure to wear underwear!
Make sure that you arrive to check-in at least 30 minutes early. If you arrive late, you can be removed from the study or bumped to the back of the order. The clinic brings in backup volunteers to take the place of volunteers who arrive late or get disqualified during check-in.
When you arrive for Check-In, you will be given one of two classifications:
|
Primary Subject: This means that barring any major changes in your health between the screening visits and Check-In, you will more than likely be on the study.
|
|
Backup Subject: This means that you are here in case one or more of the primary subjects do not show up and or are disqualified before the first dosing. Most backups will stay until the first dosing but one or two may be sent home on the day of check-in. |
It is very important to keep in mind that ALL subjects are backups until the first dosing! No one is guaranteed a spot on the study until after the first dosing. Even people using priority cards can be disqualified if you fail to meet the study requirements at check-in.
Let's say that the study you are trying to get on has 10 spots available. More than likely, 12 to 15 people will be called in for Check-In. Sometimes more.
Between Check-In and the first dosing, most if not all screening procedures will be repeated. You will have to submit a urine sample, blood samples, vitals and ECG. The tests are done again because values often change between the screening and Check-In. Results from the screening and the Check-In are compared for inconsistencies. Also, you are being tested for illegal drugs and alcohol, which are not permitted at anytime throughout the study.
If any of your tests come back out of range, you may be pulled from the study. Most times it is simply that your lab values were out of the range that the Sponsor was looking for. As long as nothing medically abnormal is found in your lab values or drugs or alcohol were found in your system, you will be able to screen for another study right away. If you are pulled from the study, you will probably not receive any compensation for your time as you will likely be dismissed before staying the night.
If you are a backup subject, you may stay at the facility for one or more nights, up until the first dosing. Some drugs are dosed the day after Check-In, while others dose two or more days after. If you are a backup subject and do not make it on the study, you will typically receive some compensation. This will be outlined in the informed consent. There may also be backups who do not stay the night. As long as you are still qualified, you may still get a small payment and a priority card for another study.
Don't get discourage if you check in and are a backup. I've been in studies where every backup was used and of course studies where no backups were used and everything in between. You never know what will happen between check in and the first dose.
Some facilities do not operate in this manner. I have seen dozens of different scenarios. But this seems to be the most common. Again, it is important to remember that nobody is guaranteed a spot on the study until the first dosing.
If drugs or alcohol are detected, you will not be in the study and you will likely be barred from participating in future studies. It's not worth the risk.
Once the sponsor makes the final decision of who to allow on the study, you will be dosed. Once you are dosed, you are on the study.
A representative from the sponsor is often present during the first dosing.
A backup could be used right up to the last minute. Once everyone who is going to dose has dosed, then any backups will be sent home.
| Invite to Check-In: | |
| Types of Studies | Packing for the Study: |
| The Phone Screening | Check-In: |
| The Clinic Screening | The Dosing: |
| Checking In | - |
| During The Study | - |
| After The Study | - |
| - |
|
Updated on 2/28/09
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