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Frequently Asked Questions


Table of Contents

 

GENERAL

PRE-STUDY

CLINIC ENVIRONMENT

STUDY CONDUCT

COMPENSATION & EXPENSES


 

GENERAL

 

What do you do at Lambda Therapeutic Research Inc.?

We conduct clinical trials for pharmaceutical companies at our facilities in Scarborough, Ontario. The majority of our studies compare the levels of an investigational generic (or “copy”) drug in your blood with that of a drug that is available on the market and allow us to gather information about the safety of the drug and how it affects people.  “Investigational” means that the study drug has not been approved by Health Canada for use outside of research studies.

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Is it safe to participate in a research study?

At Lambda Therapeutic Research Inc. your safety is of utmost importance.  Our eligibility assessment process is designed to ensure that your overall condition meets strict study criteria.  You will not be invited to participate in a study if there is concern that your participation could endanger your health.  However, there is always some risk associated with taking any medication, including those prescribed by your family doctor and over-the-counter medications that you buy at a pharmacy.  Before you participate in a research study, you will be fully informed of the risks associated with the study and provided with a list of the common side effects, procedures and purpose of the study in a written document called an “informed consent form” (ICF).  All research studies involving human volunteers and the informed consent forms must be reviewed and approved by an independent Research Ethics Board (REB), also known as an Institutional Review Board (IRB), before the studies begin. 

We encourage you to take the study ICF home after your screening appointment and consider the study requirements and expectations fully before joining the study.  Your participation must be voluntary and informed.  The informed consent is NOT a contract. You may leave the study at any time, for any reason.

As part of our commitment to volunteer safety, we also use the Clinical Research Subject Verification Program, Clinical RSVP (www.clinicalrsvp.com).  This system is a tool that allows Contract Research Organizations to share study dates, lockout dates and blood volumes for our volunteers, so that this information can be evaluated when you screen for a new study, and before you take study medication.  By ensuring that all study lockout / washout dates have been respected, we are able to better evaluate health risks to you, and avoid them.

You may or may not experience side effects during a study.  If you do experience side effects, our staff will assist you and provide medical care, if necessary.  As a clinical research participant, you will be providing important information about how the drug we are testing is absorbed by and eliminated from your body and how it makes you feel.  You will be expected to report all side effects or symptoms that you experience during the study to clinic staff even if they are mild or unrelated to the drug.  Communicating this information is important for your safety and it will give us a better understanding of how the drug affects people.

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What is an Institutional Review Board (IRB) or Research Ethics Board (REB)?

An IRB or REB (the Canadian term) is a group of scientists, non-scientists, and community members who review and approve clinic research involving human subjects in order to ensure the protection of the rights, safety and well-being of study volunteers.  An REB has the authority to approve, disapprove, propose modifications to, or terminate proposed or ongoing research involving human subjects. In Canada, at least 2 members must have broad expertise in the proposed research, at least 1 member must be knowledgeable in ethics, at least 1 member must be a community member with no affiliation with the institution conducting the research, at least 1 member must be knowledgeable in Canadian law regarding biomedical research and at least 1 member must have expertise in a non-scientific area.  In addition, REB membership should be broad enough to reflect the community or society in which the REB functions and from which research volunteers may be recruited.       

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What type of studies do you offer?

The majority of our research studies require healthy, non-smokers, age 18+ years who are not currently taking any medications, have no medical conditions (such as asthma, diabetes, high blood pressure, food allergies etc.), have no history of severe allergic reactions, and test negative for street drugs (such as cocaine, marijuana, opiates etc.) and alcohol.  Volunteers must also meet certain height and weight requirements to participate in studies.  The requirements for every study are not the same, and you may not always qualify for every study that we offer.   

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Where are you located?

460 Comstock Road
Toronto, Ontario
Canada, M1L 4S4

Please see the ‘Contact Us’ tab of our website for maps and directions.

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Is my participation in a research study confidential?

At Lambda Therapeutic Research Inc., the following precautions are taken in order to protect the privacy of our volunteers:

  1. You must prove your identity by verifying the 4 identifying pieces of information stored in our secure database (full name, phone number, address with postal code, and date of birth) before any personal information is discussed over the phone.
  2. Requested confidential volunteer information will only be released to you in person after your identity has been verified by comparing your government issued identification card with the information stored in our secured database, by mail or for sensitive information, by registered mail (requiring your signature upon receipt) to the address stored in our secure database.  
  3. Before medical or study information will be released to a third party, you are required to sign a consent form that authorizes Lambda Therapeutic Research Inc. to release specific information to a specific third party.  This does not apply to the release of positive infection disease results to Toronto Public Health as such reporting is required by law.  Lambda Therapeutic Research Inc. does not release confidential volunteer information or request such information from a third party without first being authorized by the volunteer personally.
  4. Your identity will be kept confidential at all times, except where disclosure is required by law. The Investigator (Study Doctor) will collect the results of your study-related tests and procedures and may also access your personal medical records at Lambda Therapeutic Research Inc. for health information such as past medical history and test results.  Any information obtained will be confidential and released only as part of the report to the sponsoring company, who will only provide it to the government drug regulatory authorities [e.g. Health Canada and/or the U.S. Food and Drug Administration (FDA)]. Records that are provided to the company sponsoring the research study will not contain your name.  If the results of the trial are published, your identity will remain confidential. 
  5. Study records, including confidential information about you, are stored in a secure location for a minimum of 25 years, as required by Canadian clinical trial regulations.

 

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PRE-STUDY

 

How do I enroll in a study at Lambda Therapeutic Research Inc.?

Please visit the ‘Current Studies’ section of our website (www.lambdacanada-cro.com/study-participants/participate-in-a-study.html) for information about available studies and hours of operation.  If you are interested in participating in one of the listed studies, call us at (416) 752-3333 or toll free at 1-866-207-3333, listen to the message and follow the prompts to speak with a Clinical Contact Centre Representative.  We will create an information profile for you in our database, which will allow us to match you with suitable studies.   Even though you may be matched to a study, you must provide informed consent and pass a medical screening exam to see if you qualify. 

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What does a screening session involve?

 

Identification Verification

When you arrive at the medical screening area, the receptionist will verify your photo identification (driver’s license, passport etc.).  If your identification does not include your Ontario address, you will be required to provide proof of residency in Ontario (e.g., mail that has your name and address from the government or a service provider such as your cable TV or telephone company).

You will be provided with an information package that will include documents such as Consent Forms (ICF – documents that outline the screening and study procedures, risks and benefits of the research, the purpose of the study, potential side effects of the drug etc.), a study schedule, examples of over-the-counter products you must avoid before and during the study, a map of clinic locations etc. 

 

Clinical RSVP
Using the Clinical Research Subject Verification Program, Clinical RSVP, is required for you to continue to screen.  You will be given a Clinical Research Subject Verification System Program (clinicalRSVP) Personal Health Information Authorization to review, and sign.  If you do not wish to participate in this system, you will not be screened for the study, and no further information will be collected from you.  

 

Informed Consent

You will be given time to read through all ICFs on your own before reviewing the details with a staff member.  You will be given the opportunity to have any and all questions you may have answered one-on-one with a staff member before signing the ICF.  You will be given a copy of all ICFs to bring home.  We encourage you to speak to your family, friends, or other individuals (such as your doctor) to help you decide if the study is right for you. 

 

Screening Tests & Medical Examination

After signing the ICF, you will complete a series of medical assessments including a physical examination similar to what you may experience during a visit to your family doctor.  The following assessments are commonly required during the screening process, not necessarily in this order:

  • Height and weight measurements
  • Blood pressure, heart rate, temperature, and respiration rate (vital signs measurements)
  • Electrocardiogram (ECG – a tracing of the heart’s electrical activity and rhythm)
  • Urine sample collection (standard panel of tests to determine health status and testing for nicotine and drugs of abuse)
  • Alcohol breathalyzer
  • Blood sample collection (standard panel of tests to determine health status and pregnancy test for females, if required for the study)
  • Medical history and medications
  • Physical examination
  • Study-specific tests (e.g. for tuberculosis)

 

Other tests may be required depending on the study.


After completion of the last activity, staff will verify that all documentation is complete before you leave.

 

Duration

We aim to complete screening visits within 1.5 hours; however, appointments may take longer depending on the length of the ICF and the tests required. 

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Can you guarantee me a spot in the study?

Acceptable results from medical screening tests alone do not guarantee participation in a study.  If you are selected for participation in a study, you will be given a pre-assigned subject number. To keep this number, you must follow all pre-study requirements and study restrictions and arrive on time for study check-in. 

 

Stand-by Participation:

If you are selected for stand-by participation, you will be required to follow the same study restrictions as volunteers with a pre-assigned subject number and arrive at the clinic prepared to stay for the entire study in the event that you are selected as a replacement subject.    

Some stand-by participants will remain at the clinic until check-in has been completed, and other stand-by participants will be asked to stay (generally overnight) until the study drug has been given to all subjects in the study.  You will receive compensation for your participation as a stand-by volunteer, which is specified in the study ICF.

 

Informed Not to Show:

If your participation is not required, you may be given the option to transfer to another suitable study, if one is available.  To transfer to another study, the results from your medical screening procedures must be valid on the day you will take the drug.  If you are transferred to another study, you may be required to have additional screening tests/procedures.

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What if I am running late or cannot make it to my screening appointment?

Running late:  If you are going to be more than 15 minutes late, please call us at (416) 752-3333 or toll free at 1-866-207-3333 and press ‘0’ for our screening receptionist.  The receptionist will indicate whether we will be able to accommodate you or if you will need to re-schedule your appointment.

 

Cancellations:  We require 24 hours notice when cancelling a screening appointment.  If you are unable to make your screening appointment, please call us at (416) 752-3333 or toll free at 1-866-207-3333, listen to the message and follow the prompts to speak with a Clinical Contact Centre Representative who will cancel or reschedule your appointment. When our call centre is closed, you may leave a voicemail message.  

 

Repeatedly failing to show up for appointments without giving 24 hours notice will be recorded in your file and will affect your future eligibility.

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Whom shall I contact to get my medical screening results?

You can contact us at (416) 752-3333 or toll free at 1-866-207-3333, listen to the message and follow the prompts to speak with a Volunteer Results Representative.  If repeat tests are required, a Volunteer Results Representative will contact you to book a time for your repeat test(s) generally before the day you are scheduled to obtain your results.

You will not be eligible to receive a pre-assigned subject number until you have met all screening requirements for the study.

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What happens if a study is delayed or cancelled?

We will notify you as soon as possible in the event of a study delay or cancellation.  You will be compensated a set amount if we delay or cancel a study within 48 hours of study check-in.

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Will my future study participation be affected if I attend medical screening at more than one facility in the same timeframe?

At Lambda Therapeutic Research Inc., volunteers who intentionally affect the integrity of a study by participating in overlapping studies or failing to respect study lockout periods will be found ineligible for future studies at Lambda Therapeutic Research Inc.  However, it is the dosing and blood collection in a study that generates a lockout period.  You will not be screened for a study, if your current ‘lockout’ period will still be in place when our new study will begin.

Volunteers who fabricate or falsify health information will also be rendered forever ineligible for future study participation.  Either of these acts poses a serious health/safety risk to the volunteer and jeopardizes the integrity of study data.

You will not be rendered forever ineligible solely for completing medical screening at two or more different facilities.

Canadian regulations and international guidelines require clinical researchers to adhere to study protocols. Deviating from protocol requirements (e.g. ignoring a post-study lockout period) would be in violation of these regulations and guidelines, which are in place to protect study volunteers.

 

Clinical RSVP

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CLINIC ENVIRONMENT

 

How should I prepare for study participation?

There are specific requirements for each study.  Typically, you must not eat or drink specific foods and beverages (e.g. poppy seeds, regular or decaffeinated coffee, tea, products containing chocolate or cola, products containing grapefruit), prescription medications, over-the-counter medications including herbal/natural supplements, homeopathic remedies and vitamins, alcohol or street drugs for a specified period of time before your study participation.

 

What should I bring with me to the clinic when I check-in for an overnight stay?

  • Identification (the government-issued photo ID presented during medical screening)
  • Personal toiletries [soap, shampoo (non-medicated and not enriched with vitamins), toothpaste (non-whitening) etc.—we provide each volunteer with a small clean towel]
  • Pillow/blanket (we provide clean bed linens, a pillow and a blanket, but you may bring your own pillow and blanket for added comfort)
  • Loose, comfortable clothing
  • Rubber-soled non-slip shoes or slippers
  • A change of clothing for each day of your clinic stay if it is 96 hours or less
  • Laundry service will be provided during long-term studies (clinic stay of over 96 hours)
  • Long-distance calling card, if you wish to make calls outside the local calling area
  • A lock if you wish to use a clinic locker (available to every volunteer in our Warden clinic and on a first come, first serve basis in our Comstock clinics)
  • Do not bring valuables (i.e. jewelry etc.)

 

Bag Limit

You will be limited to one bag and one personal item (i.e. purse, briefcase, backpack, computer, etc.) for up to a 2 night clinic stay.  Additional bags may be brought in depending on the length of your stay in the clinic.  For long-term studies (>96 hour clinic stay), volunteers should not exceed a maximum of 3 bags and 1 personal item during check-in.

Print our Packing List to help you pack.

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Is there anything I should NOT bring to the clinic?

We strongly recommend that you do not bring any valuable items to our clinics.  However, if you choose to do so you will be solely responsible for them throughout your clinic stay.

For your privacy and that of your fellow volunteers, electronic devices with cameras (e.g., cell phones and laptops) are not permitted in the clinics. You will have access to a telephone for local calls while in the clinic, shared desktop computers with internet, and wireless internet throughout all of our clinics.

In compliance with study requirements, the following items are not permitted in the clinic:

  • Outside food or drinks, including candies, chocolates, gum, juice or water
  • Medications (prescription and over-the-counter)
  • Herbal remedies or supplements
  • Medicated products (e.g., Head & Shoulders®, Nizoral®, Selsun Blue®, Blistex®, Visine®, medicated skin creams)
  • Alcohol
  • Street drugs
  • Cigars or cigarettes (for studies requiring non-smokers)

 

To ensure a safe and respectful environment for all volunteers and staff, the following items are not permitted in the clinic:

  • Pornographic material of any kind.
  • Lighters, matches, etc.
  • Knives, guns or other weapons

 

Any unapproved items surrendered at check-in will be secured during your stay and returned to you after the study.  Print our Packing List to help you pack.

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Where will I store my valuables during my stay in the clinic?

We strongly recommend that you do not bring any valuable items to our clinics.  However, if you choose to do so you will be responsible for them throughout your clinic stay.  We do not advise leaving small items (wallets, watches, mp3 players etc.) on your bed.  Please bring a lock with you if you wish to secure your personal items (purse, wallet etc.) in a locker. There are enough lockers for each volunteer staying in our Warden clinic where the majority of our long-term studies are held. Lockers in our larger Comstock clinics are available on a first come, first serve basis.   

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What will I eat?

We will provide all of your meals and snacks during your stay in the clinic. Some of your meals may include meat, eggs, wheat or dairy products.  Meals will generally be identical in both/all study periods and must be consumed at scheduled times, which will be specific to your study. You will not be permitted to consume additional foods or drinks and some studies require fasting for a specific period of time before and after you take the drug.  Sharing food of any kind is not permitted during studies.  

Studies referred to as ‘fed’ studies include a meal that must be consumed completely within a specific time period—typically no more than 30 minutes—before taking the drug.  A high fat, high calorie breakfast or a low fat breakfast are the most common of these meals.

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How do I voice my opinion about food served in the clinic?

We are in constant communication with our caterer to ensure improvement of our services. While it may be impossible to appeal to all personal preferences, our kitchen staff and caterer strive to satisfy as many of our study participants by providing a variety of meals. We make improvements based on the feedback from our volunteers (which can be provided verbally to kitchen staff or the study Clinical Research Coordinator, by suggestion card or by phone call/e-mail to the Volunteer Services Coordinator).

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Does food preparation meet food safety regulations?

The facilities at Lambda Therapeutic Research Inc. and that of our caterer are inspected regularly. Our caterer must meet the requirements of our Quality Assurance program which includes review of inspection reports, such as that from the Regional Municipality of York, which concluded that the caterer is in compliance with food safety regulations.

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Where will I sleep?

You will sleep in a shared dormitory style sleeping area on a bunk bed if your study is held in our Warden clinic or any of our larger Comstock clinics.  During mixed gender studies, volunteers will sleep in gender-specific dormitories.  

Our Phase I clinic at our Comstock location is primarily used for Phase I studies, which involve testing a drug for the first time in a small number of human subjects.  If you are staying in the Phase I clinic, you will sleep in a hospital style bed.

Clean bed linens, a pillow and a blanket are provided in all of our clinics.

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Are there showers?

Yes, there are showers with curtain dividers for privacy in all of our clinics at our Comstock and Warden locations. You must bring your own personal toiletries (soap, shampoo, toothpaste etc.) and shower daily.  We provide a small clean towel for each volunteer.  Please note that medicated products (e.g., Head & Shoulders®, Nizoral®, Selsun Blue®, Blistex®, Visine®, medicated skin creams) may not be used for a set period of time before the start of the study and throughout the study. Medicated products found during the bag search must be surrendered and stored by staff for the duration of your stay in the clinic.  

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Is smoking allowed?

Smoking is not allowed in our buildings.  In studies that allow smokers, smoke breaks will occur only at scheduled times.

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Can I have visitors?

Visitors are not permitted during screening visits, a clinic stay of 96 hours or less, or return visits after a clinic stay.

During long-term studies (clinic stay of over 96 hours), you will be permitted to have supervised visits during your clinic stay.  Clinic staff will inspect all items that visitors bring for volunteers and all visitors will undergo a bag search.  The scheduled times for these visits will be posted and we request that you communicate these times to your visitors.  You will be limited to 1 visit per day with a maximum of 2 visitors per visit.  A sign-up sheet may be posted to permit visitation in manageable sessions.

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How will I pass my free time in the clinic?

Each of our clinics has a big screen television and access to a selection of movies and books. Our Warden clinic and our 2 largest Comstock clinics also have a computer with internet access for checking e-mail and a selection of board games.  Many volunteers bring laptops and take advantage of the complementary wireless broadband internet access provided throughout all of our clinics; however, laptops with cameras are not permitted in the clinics (to protect the privacy of fellow volunteers) and electrical outlets are limited.  We are also in the process of expanding our book and DVD movie collection to make long-term studies more enjoyable. 

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Are clinic staff equipped to deal with emergency situations?

Our clinic staff members are provided with Basic Life Saving training [which includes Cardiopulmonary Resuscitation (CPR)] annually. Our Nurses also receive Advanced Cardiac Life Support (ACLS) training and our Nurses and Medical Screeners are provided with Automated External Defibrillator (AED) training. Our clinic staff members have also received Crisis Intervention training.

In addition, we have Standard Operating Procedures in place to protect the health and well-being of our study volunteers by ensuring a quick and efficient response in emergency situations.

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How often is shared clinic space cleaned during a study?

Cleaning staff are scheduled to complete a full cleaning of clinic washrooms, dormitories and common areas at the beginning of each full clinic day and return 2 more times to collect garbage while volunteers are on-study. Additional cleaning will be conducted as needed or upon request. The cleaning staff sign a cleaning log after each cleaning which allows management to track adherence to
cleaning schedules and identify areas that may need additional cleaning. Non-adherence to cleaning schedules brought to the attention of management will be addressed immediately with cleaning staff.

Our clinic chairs and couches are upholstered in healthcare fabric which has antimicrobial, anti-stain and anti-abrasion properties and allows for easy, thorough cleaning.

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How is clinic air quality and temperature controlled?

Our HVAC (heating, ventilation, air conditioning) system is assessed (filters changed etc.) quarterly (four times a year). The clinic temperature is adjusted when requested by volunteers and extra blankets are provided upon request.

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STUDY CONDUCT

 

What happens at study check-in?

Before you leave our facility during your initial stay in the clinic you will be provided with a wallet card that lists the phone number and extension for the Clinical Research Coordinator of your study for non-medical study questions (416-752-3636 ext. 200 for voicemail), the 24-hour number for all medical and safety related concerns (416-277-5470), and the number to call if you are going to be late for check-in or a return visit (416-752-3636 ext. 270 to reach the Comstock clinics or 416-752-3333 option #3 and follow the prompts to reach the Warden clinic).  Repeatedly arriving late or failing to show up for check-in or return visits will be recorded in your file and will affect your future eligibility.

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What if I am running late for check-in or a return visit?

Before you leave our facility during your initial stay in the clinic you will be provided with a wallet card that lists the phone number and extension for the Clinical Research Coordinator of your study for non-medical study questions (416-752-3636 ext. 200 for voicemail), the 24-hour number for all medical and safety related concerns (416-277-5470), and the number to call if you are going to be late for check-in or a return visit (416-752-3636 ext. 270 to reach the Comstock clinics or 416-752-3333 option #3 and follow the prompts to reach the Warden clinic).  Repeatedly arriving late or failing to show up for check-in or return visits will be recorded in your file and will affect your future eligibility.

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How will I know it is time for my study activities?

The specific study activities you will experience and the timing of these events are specific to each study and will be outlined in the study consent (ICF) and study schedule provided during your screening session.  Activities such as drug and fluid administration, meal distribution, blood draws, vital sign measurements (heart rate and blood pressure) and electrocardiograms are common timed study activities that are based on your drug administration time.  A list posted in the clinic will indicate the assigned times of each activity for each volunteer to help you keep track of when you must present yourself to the area where the clinic activity is being conducted.

Return visits to the clinic, if any, will be indicated on a take home document, which the Clinical Research Coordinator of the study will provide to you during the first period of the study.  You will be required to arrive at the clinic at least 15 minutes before your scheduled return blood draw time to allow sufficient time for ID verification and compliance questions before your scheduled activity (e.g. blood draw).

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Why is washroom and shower use monitored during clinical trials?

Our staff members are required to accompany volunteers to the washroom and remain in the outer doorway while volunteers use the facilities in the first hours after receiving drug to ensure volunteer safety. In the event of a drug related adverse event, staff would need to be present to immediately assist the volunteer.

Staff members also accompany volunteers to the washroom during water restrictions to ensure compliance with protocol requirements.

Our shower stalls have shower curtains for privacy, but they do not reach to the floor as staff must be able to monitor volunteers in order to take immediate action, if a volunteer were to slip and fall.

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How often can I participate in a study?

It is extremely important for your safety and the integrity of study data that you do not participate in overlapping studies at more than one facility.  Studies that involve taking a drug will have a minimum pre study lockout period of 30 days before study check-in.  Some studies have pre study lockout periods longer than the 30-day minimum based on the type of drug.  Studies that involve having more than 49 mL of blood/plasma collected require that you have not donated blood (e.g., to Canadian Blood Services or Red Cross) or had blood drawn while participating in a research study at any institution within 60 days before study check-in.

Studies that involve taking a drug and/or having more than 49 mL of blood/plasma collected will also have a post-study lockout period, which is the time you must wait after the study completion date before you may participate in another study at Lambda Therapeutic Research Inc. or at another clinical research facility.  The post-study lockout period is study-specific and based on the amount of blood collected and the type of drug.  Lockout periods are enforced to protect your health and safety.  Post-study lockout periods of 30, 45 or 60 days are common.  Studies that only involve providing a urine sample typically do not have a post-study lockout period.
 
You will be informed of the pre- and post-study lockout periods when you call our Clinical Contact Centre to discuss available studies. 

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Should I continue to see my family doctor?

You should continue to see your regular physician.  Participation in clinical studies does not replace normal health care.  We encourage you to discuss your study participation with your family doctor.

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What if I do not want to participate in studies anymore?

Please call us at (416) 752-3333 or toll free at 1-866-207-3333, listen to the message and follow the prompts to speak with a Clinical Contact Centre Representative who will inactivate your file.  We will no longer contact you about upcoming studies after your file has been inactivated. Your information will remain in the system, so if you choose to reactive your file you may do so by calling the Clinical Contact Centre.

Once you have completed the telephone screening, any portion of medical screening procedures or a study, we cannot delete your personal or health information from our files or database.

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COMPENSATION & EXPENSES

 

Will I receive compensation for completing a screening session?

You will not receive any compensation for routine medical screening procedures or repeat tests that may be required, as we do not provide compensation for medical screening.  Volunteers bear the burden of qualifying for a study.  The industry standard is to compensate volunteers for inconveniences incurred after a volunteer has qualified for and agreed to participate in a study.  Providing compensation from the point of study check-in onward should reduce the number of failed medicals due to volunteer non-compliance (failure to adhere to restrictions requirements).      

At Lambda Therapeutic Research Inc., you will receive compensation for screening visits that take place at other facilities, if so required, or special tests that require volunteers to return for multiple screening visits (e.g. tuberculin skin test, Holter monitoring (ambulatory ECG)].

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Will I receive compensation for my participation in a research study and is the amount standardized?

Our compensation policy describes how study compensation is calculated based on predefined inconveniences and occurrences experienced by volunteers when participating in clinical trials.  Compensated inconveniences include but are not limited to confinement to the clinic, remaining in a particular position after receiving drug, being awakened for nighttime blood draws and returning to the clinic after exiting.  

The compensation policy at Lambda Therapeutic Research Inc. is reviewed and approved for use by a Research Ethics Board (Institutional Review Board) annually to ensure that study compensation and payment method do not unduly influence a volunteer’s decision to participate in a study by compromising the voluntary nature of that decision or a volunteer’s willingness to explore the risks and benefits of the study.  

You will be compensated on a prorated basis according to a compensation disbursement schedule in which a percentage of the total study compensation is provided to you after each study period. Prorated compensation is less likely to pressure a volunteer into completing a study or concealing information in order to receive money, which simultaneously protects the safety of human study participants and the integrity of the scientific data.

You will not be compensated for potential adverse events associated with the study drug, the risk or mode of investigational drug administration (e.g. oral, intramuscular, patch, or intravenous), or incurred expenses (e.g. travel, babysitters, parking costs etc).

 

Deductions

If you do not show up for a return visit or you are late for a return visit, a set amount will be deducted from the overall compensation you receive for each late or missed return visit.  

Please note that while you may choose to leave a study at any time, repeated study withdrawals, missed and late return visits, and late check-in will be recorded in your file and will affect your future eligibility.  If too many volunteers withdraw from a study, the validity of the study can be jeopardized, thereby potentially necessitating a repeat of the same study and unduly exposing more individuals to the investigational drug.

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Will I incur any expenses by participating in a research study?

All medical screening and study tests, examinations, and medical care required as part of a study are provided at no cost to you, the public health plan, or your private medical insurance.  Study medication will be provided free of charge for the duration of the study.  The sponsor of a study will cover any costs not covered by the provincial health plan or your private medical insurance, if you require medical treatment due to illness or injury as a result of study participation.  

We do not provide additional compensation for travel (i.e. from your place of residence to the clinic) or other expenses (e.g. babysitters, parking tickets, etc.).

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Where can I learn more about clinical research in general?

www.ciscrp.org

www.irbservices.com/irbservices/Subjects.html



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