Study Guidelines

Confirmation of selection tests results

Once your results are available, an employee will contact you. Please make sure your phone number and e-mail address are valid.

STUDY RESTRICTIONS

Please refer to your Informed Consent Form / Calendar.

If you are assigned as a stand-by you are expected to present yourself at check-in and follow all study restrictions described in the informed consent form. If you are an extra you are expected to follow all prestudy procedures and be available should you be needed for check-in.

Eating before arrival

No food will be allowed inside the establishment, it is strongly recommended that you eat before arriving at the clinical site.

IDENTIFICATION

Upon arrival at the clinic, you will be identified with a wrist band and a bed will be assigned to you. Once you have been checked in you will not be permitted to leave the clinic until the end of each housing period.

locker

A locker will be available for you during your stay. You must leave all personal belongings, not required on site, in your locker. You will not have access to this locker until the end of the housing period.

Warning

Bring you own lock.

We are not responsible for forgotten, lost or stolen items.

personal items

Upon arrival, all personal belongings will be checked according the following criteria:

  1. The product has to have an ingredients list
  2. The garment cannot conceal your face and/or head
  3. The product cannot be ingestible or the material made of non-plastic or non-transparent color (eg accessories; casing)

The following items are not allowed in the clinics: food, cigarettes, matches, lighters, mouthwash, chewing gum, medication, etc. They should be left in your locker or will be confiscated and returned to you upon your departure. We recommend you bring only a minimum of items in soft-shell luggage so that it can fit in your locker (e.g. knapsack, duffle bag, sports bag, hand bag). Hard-shell baggage will not be accepted.

Your personal care items must fit in a bag measuring approximately 37x30cm whereas your personal effects (clothes, books, magazines, slippers, undergarments, etc.) must fit in a bag measuring 60x56cm. These bags will be supplied at check-in. Any cases for laptops, CD, DVD, etc… will not be allowed in the clinic and will be placed with the other items in your locker.

respect and behavior

As you will be part of a group of people participating in a clinical trial, during the clinical housing period we ask that you behave accordingly to maintain a friendly and pleasant environment.

When in the dormitories please speak quietly to avoid disturbing those sleeping; the common areas are more suitable for conversations and games.

Inappropriate or aggressive behaviour towards other participants or staff will not be tolerated and may result in current or future study participation being suspended.

We always encourage your feedback and we appreciate any suggestions or comments that you would like to contribute.

Suggestion boxes are available in each of the clinics.

smoking

If smoking is permitted for the study, you will be able to smoke only at specific hours according to the clinical activities and up to one cigarette per hour. Only cigarettes coming from sealed packs will be allowed. Cigarettes will be removed upon arrival.

 

electronic devices

The use of Ipods, MP3’s or personal computers is permitted only with earphones or headphones.

Warning

You may be asked to turn off all music, movies, games, etc., at critical moments in order not to disturb the clinical procedures.

The use of the camera on your device is not permitted to respect the privacy of your fellow participants.

bedding / clothing

Bedding (sheets, pillow, and blanket) as well as a towel and facecloth will be provided. Each volunteer is required to bring the toiletries needed for the length of the housing period at the clinical site.

Bring comfortable clothes for the length of the housing period. For a 24 or 48 hour stay, it is recommended to bring the following clothes: 2 T-shirts, 1 long-sleeved sweater, 1 set of pyjamas and one pair of pants as well as your undergarments, socks and slippers. Laundry facilities are not available.

For stays of at least 84 hours, clothing will be supplied and washed and you only need to bring your undergarments, socks and slippers. If you are a light sleeper, bring your earplugs because you will be sleeping in a dormitory. Remember all your items must fit in the bags provided so that you can store them in the dormitories.

Warning

You must wear shoes (or slippers) at all time in the clinic. You must also wear appropriate clothing. No circulation in undergarments is permitted outside the dormitory.

meals and snacks

All meals and snacks are standardized; you cannot bring your own food. During critical meals you will be encouraged to eat the entire meal; this is not the case for non-critical meals. Critical meals are designed as part of the purpose of the study to ensure that all participants have a standardized food intake before taking the medication to measure the effect of being fed on the behavior of the medication.

water restriction

Hand washing and showers will not be allowed during the water restriction period. You will also not be allowed to brush your teeth during this time.

departure

At the end of the study, please leave the premises in good condition. Make sure that no personal belongings are forgotten. Luggage will be checked at random before departure.

Following the last blood draw please keep pressure on the puncture site for about 2 minutes until the bleeding has stopped to reduce the chances of bruising and dispose the cotton ball in the yellow containers before your departure.

payments / pro rated for dropouts

A cash amount is given before your departure at the end of each period. You must leave with the amount given on the selected day.

You will be compensated for your time and inconvenience related to your participation in the study. During each period of the study you will receive a sum of money at predetermined moments during your visits to the clinical site (including returns, if applicable) and the balance will be given to you upon discharge from the clinic after your last study stay. If you do not complete the entire study, the amount you will receive will depend on the portion of the study you completed, even if the study is cancelled or stopped by the sponsor or Algorithme Pharma.

If you complete the entire study, you will receive an additional amount after the end of the study. Completion of the study means that you have completed all study activities and have provided any requested samples and attended any return/follow-up visits. If you miss an appointment of if you do not stay until the end, we will consider you have not completed the study.

The final balance is given by cheque at the end of the study.

Warning

For all subjects withdrawing before the end of the study, a cheque will only be provided at the scheduled post-study date of the project.

However, for administrative reasons, an additional 10-day delay may be applied before receiving your cheque.

emergency / FOR MEDICAL EMERGENCIES

Dial 9-1-1 or go immediately to the nearest hospital.

As soon as you can, dial the 24-hour emergency phone number (514) 774-2402 (a nurse will call you back as soon as possible) to inform us of your health status.