Participant Policies for QPS INFORMATION YOU NEED TO KNOW 1 Be courteous and polite to all staff members and fellow participants. If you are in a disagreement with another participant, you should try to work it out amongst yourselves. If the disagreement cannot be resolved amongst yourselves, QPS staff will determine a resolution. Please remember the golden rule; “Treat others how you would like to be treated”. 2 Your call back sheet will list study specific information with regard to the restrictions for your study as well as check in information. Most studies will require participants to avoid alcohol, caffeine, unapproved medications, donation of blood or plasma, exercise or strenuous activity for a specific number of days prior to and throughout the study. There are typically restrictions prohibiting the consumption of alcohol, caffeine or grapefruit products. Any deviation from study restrictions should be reported immediately to the QPS staff. 3 No visitors are allowed. Items brought into the clinic for a participant by another person (e.g., movies, bathroom necessities, etc.) will be given to and searched by QPS staff prior to being released to a participant. Items can only be dropped off Monday through Friday, 7 am to 1 pm. 4 Be on time for all events, returns, blood draws, etc. Every study is conducted on a strict timeline to ensure that all the information collected about absorption and metabolism of a drug is accurate to the minute. You will be asked to line up early to ensure that everyone is in the correct order, identified by armband and on time for the scheduled procedure. Missed and/or late returns will result in a deduction of payment. It may also result in limiting the type of studies you can participate in and/or can result in a probationary period in which you will not be allowed to participate in any upcoming studies. Please contact a Recruiting Coordinator regarding questions on deduction amounts and our late/missed return policy. 5 QPS is generally a non-smoking clinic. If the study allows for smoking during confinement, participants who smoke will be escorted by QPS staff to a designated smoking area outside at specific time points during the study. Cigarettes and all tobacco products will still be removed at check in. 6 All luggage, pockets, purses and bags will be searched at each check-in. Any unapproved items such as medications, weapons (including pocket knives), products containing alcohol or herbals, food, gum, candy, etc., will be remove, placed in a labeled bag with your information and may be returned at check-out of the study. It is your responsibility to retrieve your items. 7 Allowed medications (e.g., birth control) must be turned in to QPS staff. Those medications will be provided to you during your stay at designated times by a QPS staff member. 8 All food and beverages given to participants must be consumed in full and during the allotted time. No additional portions of food or beverages will be served. The amount of food and beverage you consume may have a considerable effect on the absorption and metabolism of the drug being tested. Each participant is given a specific amount and must only consume that amount (no sharing or saving food or throwing it away without reporting to QPS staff). 9 Lights out typically occurs at 11:00 P.M., unless there is a blood draw/procedure scheduled after that time. In those cases, QPS staff will inform you when lights out will be for the evening. After lights out, it is prohibited to play video games, listen to music or CD’s (even with earbuds/headphones), watch TV, staying up to talk, etc. Bedrooms are a quiet area for participants. If participants do not adhere to the policy, QPS may remove such devices until morning. 10 You may be required to wear a “subject alert device” while confined to the clinic. These devices are to be used to alert staff of any safety related health concerns. The alert device is not a toy and is to be taken seriously. The device is very loud and is not to be triggered without cause. If this device is falsely triggered, you and/or the person that triggered the device will be asked to leave the clinic. 11 We expect you to follow an honor system and to provide accurate information with regard to your medical history, medication usage and any previous participation at any clinical research study site other than QPS. This information may have a direct impact on your safety and the data collected during the trial. If false information is provided or information is omitted, this will impact your ability to participate in future clinical studies. 12 QPS has a NO TOLERANCE policy regarding harassment of any kind, including sexual harassment. If you feel any staff member is harassing you, please contact us at 305-665-5151. If you feel a fellow participant is harassing you, please notify QPS staff. 13 QPS allows the use of cell phones and computers during confinement periods. There may be times that the use of these devices may be prohibited due to procedures or lights out. Pictures or videos of the facility, staff or other participants are strictly prohibited. Video sharing or posting of confidential information (including pictures/videos) on any social media outlet is a breach of HIPAA and this could affect your future participation. 14 Burned DVDs will NOT be played on QPS equipment. You will not be allowed to copy or download any illegal content including but not limited to videos or movies.. There is a PG-13 rating restriction on all QPS devices. We do monitor the WiFi activity and if you are downloading and/or watching any illegal or inappropriate content, (including X rated) it could affect your future participation with QPS. Please remember we follow strict HIPAA guidelines and we are only monitoring the WiFi for illegal activity. In efforts to not bother other subjects while confined, we do ask for you to use earbuds and keep the volume low enough to be able to hear when the QPS staff is calling for your number. 15 Our Referral Program works to ensure you reap the benefits of spreading the word about QPS. To ensure you receive Referral Bonuses: You must have completed a study (prior to your referral or on the same date as your referral). Your referral must put your name on their Participant Application (must be his/her first application) Your referral must submit a First clinical research study/Referral Card with his/her and your names on the Card to a Recruiting Coordinator. 16 QPS staff will enforce all policies in order to comply with the Sponsors’ protocol guidelines. Failure to comply with protocol restrictions, participant policies or QPS staff may result in dismissal from the study. QPS staff reserves the right to deny participation in future studies to those in violation of these policies. You are not considered an employee of QPS, the Sponsor or the FDA while participating in a study. Some of the restrictions and their consequences are listed below: A 24 hour notice of cancellation is required prior to physicals. Failure to do so may result in a probationary period in which you will not be allowed to participate in any upcoming studies. Cancellation from a study after completion of physical may result in a probationary period in which you will not be allowed to participate in any upcoming studies. A positive result in any drug screen may result in your dismissal from the study and/or a probationary period in which you will not be allowed to participate in any upcoming studies. Repeated tardiness or missing of any study procedures or deviations of blood draw or procedure times may result in dismissal from the study and/or a probationary period in which you will not be allowed to participate in any upcoming studies. Rude or disruptive behavior during the study may result in your dismissal from the study and/or a probationary period in which you will not be allowed to participate in any upcoming studies. Harassment or “bullying” of any QPS staff member or fellow participant will not be tolerated and may result in your dismissal from the study and/or a probationary period in which you will not be allowed to participate in any upcoming studies. You will be responsible for any damage you cause or vandalism you are a part of with regard to QPS property. QPS is NOT responsible for any personal property that you bring to the facility. ADDITIONAL QUESTIONS? You will find the answers to many (if not most) of the questions you may have about participation in a clinical research study here. If you have additional questions, please call us at 305-665-5151.