Altasciences Clinical Kansas, Inc.
The following detailed rules and guidelines are required to be followed during your stay at Altasciences.
Your cooperation is appreciated.
Admission time for your in-house stay will be communicated to you by Altasciences staff. You will not be allowed to admit early. If you are more than an hour late in arriving for your scheduled first admission of a study, you may not be allowed to admit. Late arrivals for other admissions may result in a deduction in your compensation beginning at $50 and increasing at the Investigator's discretion. Compensation will not be received if you do not admit.
Discharge time from your in-house stay will be communicated to you by Altasciences staff.
GENERAL INFORMATION
1. Outside Belongings Check: Upon admission, your belongings will be searched for prohibited items. All belongings must be in the two plastic bags issued at screening. No other bags will be permitted inside of the research facility. Any prohibited items will be locked in a designated area until you are discharged. Your belongings will also be searched upon discharge, to ensure that no company property leaves the facility. Designated site staff reserves the right to do a controlled body search by having you put on a gown in order to have your clothes and person checked for prohibited items that may have been brought into the research facility. This search involves removing all undergarments as well as putting on a gown so that there is no place that prohibited items could be kept. Your belongings could be searched at any other time during your stay, if suspicious behavior is suspected.
2. In-House Stay: You are not permitted to leave the facility, unless you are discharged from the study. All doors are alarmed within the unit. Visitors are not allowed at any time during your stay. Mail, shipped packages (incoming or outgoing) and dropped-off items are not allowed during your stay (this includes cigarettes, tobacco products, and toiletry items). You will not be allowed to receive or send any items/packages with a friend or family member during your stay. Your access to certain areas of the facility may be limited based on site staff discretion. You will be asked to refrain from talking or doing any other activities while the staff is conducting study procedures with you.
3. Food: Meals, snacks and drinks are provided during your stay. Meals are scheduled. Meals are to be consumed within 30 minutes unless the study specifies otherwise. You are expected to arrive to meals at least 5minutes prior like all other procedures. Arriving late to meals may result in a fine. No other food or drinks will be permitted (including gum, candy, etc.) during your stay. All meals and snacks must be consumed in the dining room. Food and drinks (except water) are not allowed outside the dining room. Food cannot be saved for later consumption. The menu provided for your study cannot be changed. Substitution or the exchanging of food between subjects is not permitted. Any incident of substituting or exchanging of food can result in an immediate fine or possible termination. One refillable bottle will be issued to you at admission that's permitted for use. Water is the only liquid allowed in your water bottle.
4. Prohibited Items/Contraband: No items that are prohibited or can be considered contraband will be allowed inside the research facility at any time, including any outside medications, illicit substances or narcotics. If you are found to be in possession of any prohibited items or contraband during your stay, the items will be immediately confiscated. Violators will be issued fines beginning at $50 and will increase at the discretion of the investigator depending upon the severity of the incident.
5. Incoming Phone Calls: Altasciences staff will not confirm or deny your presence at our facility for incoming callers. Incoming callers will be informed that a message can be taken. If the subject is present in our unit, the message will be given to them. Altasciences staff will not be responsible for relaying information from incoming callers.
6. Payment: If for any reason you leave prior to the scheduled discharge date you will not be compensated at time of discharge. If you leave prior to your discharge date, your payment can be received between 12:00PM-5:00PM on Monday-Thursday. If you discharge after 5:00PM, you will not receive your payment until 12:00PM the following day. On weekends, payments will not be received until 12:00PM Monday. If you’ve been in previous Altasciences studies and received a MasterCard ClinCard, please save your ClinCard. Your ClinCard will be reloaded when participating in other studies. If you misplace your ClinCard, let a site staff member know immediately upon check in. A replacement ClinCard can be purchased with two different options: 1) A ClinCard can be purchased and received by mail (which will take 7-10 days) for $7.00 2) A ClinCard can be purchased and received upon discharge from the facility for $15.00. There will be no money advances permitted during your participation in the study, for any reason.
7. Discharge: You must remain in your scrubs until all discharge procedures have been completed. Site staff will inform you when you can change into your personal clothing. Once changed you are required to stay in a designated area. Site staff will inform you when you are allowed to leave the facility.
BEHAVIOR GUIDE
1. Exercise/Activity: Strenuous exercise will not be allowed during your stay. For example, sit-ups, pushups, and yoga are not permitted. Sleeping during the day is not recommended.
2. Discussions with Other Subjects: You are not allowed to discuss your personal medical history, study information, or any medical issues you are experiencing with other subjects. This information should only be discussed with site staff. Viewing your chart can only be done with a site staff member present.
3. Other Subjects’ and Staff's Property: Do not touch or use any other study subject’s or staff's personal property without their permission, i.e. cell phones or laptops.
4. Furniture and Altasciences Property: Please respect our furniture and do not place your feet on any furniture. Intentional damage or destruction of site property or of the research facility will result in a large fine and/or your immediate termination from participating further in the study.
5. Interaction with Other Subjects and Site Staff: Profanity swearing, racism, disrespect, physical contact, harassment or unprofessional behavior of any kind will not be tolerated. Please be courteous of others and make sure the content of your conversations is appropriate. Any direct profanity towards a staff member can result in a fine.
6. Security: An off duty police officer is on campus at all times.
7. Smoking: Smoking is only permitted in certain studies. You must be designated as a current smoker at your screening visit in order to smoke while in house, if the study permits. Chewing tobacco is not allowed in any study. Only unopened cigarette packs are allowed into the research facility. All opened packs will be collected upon admission and returned to you at discharge. Cigarettes may be ordered for $6.50/pack after your first night’s stay, with the amount being subtracted from your study compensation. Ordered cigarettes will be picked up no earlier than 0900, Monday-Friday. Smokers will be given a separate ID wristband upon admission, if permitted to smoke. You will only be allowed to smoke at times that do not interfere with study procedures and during the smoking room hours. Smoking is not allowed at nighttime between the hours of 11PM to 7AM (Unless deemed study specific). Site staff will let you into the smoking room at designated times. The smoking room may be closed for cleaning or clinic purposes. Cigarettes and E-cigarettes must be kept in the Smoking Station when not in use. You will be asked to show your wristband every time you get your cigarette/E-Cigarette from the Smoking Station. You are not allowed to save a partially smoked cigarette for future use. All used cigarettes must be discarded in the containers provided by the end of your smoke break. Smoking inside the building is strictly prohibited (except in designated smoking room) and will result in termination from the study. It may affect your participation in future studies.
STUDY-RELATED GUIDE
1. Wristbands: You will be required to wear an identification wristband on your arm at all times during your stay. Please do not remove this wristband for any reason. You will be required to show this wristband for every procedure. You may be issued an additional wristband if applicable to designate items such as allergies and/or smoking status.
2. Procedure Schedule: You will be given a study procedure schedule upon admission to the facility. Please be aware of what time your procedures are each day. You must be in your suite 5 minutes prior to the start of your procedures. You must remain in bed for one hour, or longer depending on the study, after each dose of study medication for your safety. During this time, you will not be allowed to go to the bathroom or have your face or eyes covered. Being late for a procedure is not allowed and may result in a fine.
3. Procedures: Please be quiet during dosing, and keep a low voice when procedures are being performed in the room/suite. When you are asked to sit, stand, or lay flat- please remain silent. This helps ensure all procedures are accurate and consistent. Electronics and cell phones are not allowed during procedures. Entertainment systems need to be turned off and stored in the original position against the wall during your procedures. Subjects may be required to end phone calls if loud and disruptive in the suite.
4. Continuous Pulse Oximetry, Telemetry, and ECGs: If you are in a study that requires telemetry, showering is not allowed while hooked up to equipment. Please do not remove the telemetry system on your own. Please get a site staff member to assist you in the removal of this equipment. ECG electrodes are not to be stuck on the nightstands, the bathroom mirrors, or the shower walls. Please take ECG electrodes off and throw them away in the trashcan before showering.
5. Blood Draws: Most studies require blood draws during your stay, and they are required for your participation. Drink plenty of water prior to blood draws (unless water is restricted). If a study allows for the placement of an IV for blood draws (not all do), site staff may insert one (depending on Investigator Approval). IVs may fail during the course of drawing blood, which can result in needle sticks for the remaining blood draws. You do not get to choose which site staff draws your blood or what location they draw blood from (right arm versus left arm). After a blood draw, please keep your arm elevated, straight, and hold pressure for 2-3 minutes before removing the gauze. Please make sure that your blood draw site has clotted before leaving your bed.
6. Urine Collection: Some studies require you to be on urine collection for certain periods of time during your stay. During this time, you will be asked to wear a yellow vest to clearly identify that you are on urine collection. This vest cannot be removed unless the site staff instructs you to do so. Removing the vest while on urine collection may result in a fine. You will need to ask a staff member to obtain a urinal before being allowed into the restroom. You must take a urinal into the restroom with you every time you want to use the restroom, even if you state that you are only going to take a shower. It is very important for the study that we collect all urine during the defined time periods of the study. All bathrooms will be locked whenever any study in the research facility is on urine collection. Supervised urine drug screen may be performed per investigator discretion.
7. Adverse Events: The medication or products you will be given may make you feel different than usual. Please report any unusual feelings to staff. Recording these effects is important and will not affect your continued participation.
FACILITY
1. Bed and Suite Assignment: Bed assignments are not to be changed. Please do not move beds out of their locked position. You are only allowed in your assigned research suite or in the common areas. You are not allowed in any other research suites. Do not remove blankets or pillows from empty beds in the suites. If you’d like to request an additional blanket, one can be requested at the Nurse’s Station, if available. Only one pillow per person is provided during your stay. You may be moved into a different suite/bed based on clinic needs.
2. Locker for Belongings: Upon request, you will be provided a locker and a lock to keep your personal belongings secure. Site staff is not responsible for any loss, theft, or damage of any personal items that you bring into the facility. Please keep your personal items locked in your locked locker to prevent theft or misplacement when they are not in use. We are not responsible for lost, damaged, or stolen property.
3. Nightstand: All personal items must be stored in your locker or nightstand drawer when they are not in use. Only water bottles, papers, pens, books, and cell phones/chargers may be kept on the top of your nightstand.
4. Personal Items: Shoes/slippers must be kept under your nightstand or bed when not in use. You must keep the area between beds clear of all personal belongings for staff and subject safety.
5. Linens: Scrubs, towels, and bed linens will be provided during your stay. Please place soiled scrubs and linens in the blue laundry bags located in each restroom. An additional blanket is available upon request from the Nurse’s Station. Blankets are not allowed outside of the research suites. You are not allowed to remove pillows from other beds in the suite.
6. Scrubs: While in house, you will wear scrubs. Scrub tops and bottoms must be worn during business hours, from 7AM to 11PM. Scrub jackets will be provided upon request. Pants must be worn around the waist (no sagging of pants is allowed). Personal pajamas may be worn instead of scrubs from 11PM to 7AM (when in your suite); undergarments must be covered. No personal clothing can be worn while in house other than your undergarments, socks, and personal pajamas. Scrubs must be worn during all procedures.
7. Lights: Research suite lights are to remain on between the hours of 7AM to 11PM. All overhead lights will be turned on at 7AM, dimmed at 9PM, and then shut off at 11PM. If procedures occur earlier than 7AM or later than 11PM, then all overhead lights will be turned on. Lights will be fully on for procedures but can be dimmed under discretion such as AEs or extended periods when no procedures are occurring. No personal lights permitted from 11 PM to 7 AM (such as reading lights, cell phone lights, or lighting from TV or small electronics).
8. Nighttime: You must remain in your bed between the hours of 11 PM to 6AM, unless you need to use the restroom. The dining room will open up at 6AM for those who would like to use it for quiet activities; scrub attire must be worn. Electronics cannot be used between the hours of 11PM to 7AM. This includes cell phones, personal computers, personal music players, and bedside entertainment systems. Cell phones are not allowed on ring/vibrate mode between the hours of 11 PM to 7AM (they must be on silent or shut off). The emergency number 913-696- 1601 is to be used by outside callers, in the event of a true emergency.
9. Chart Holders: Tables and chart holders at the end of each bed are for site staff use only. Please do not place any personal items on the tables or in the chart holders.
10. Outlets: Emergency power outlets are located by each bedside. These outlets are for site staff use only. Please plug any personal electronic items into the other outlets provided.
11. Room Temperature, Windows, Fans and Doors: Thermostats and blinds within each research suite are to be adjusted by site staff only. Doors will remain closed during lights out (11PM-7AM). Fans in each suite will always be on between the hours of 11 PM to 7AM. Fans may be on at other times during the day if needed.
12. Showers: You are required to shower daily during your stay. Please check your study schedule prior to showering to ensure that you do not have a scheduled procedure. Showers are to be taken between the hours of 10 AM and 10 PM. Please keep the area around the shower dry for your safety. Please limit showers to 20 minutes in length so other subjects have access to the restrooms/showers. The staff bathroom cannot be used by study subjects unless staff is collecting urine samples. The designated “Female Only” subject restroom cannot be used by male subjects.
13. Laundry: We will only wash socks and undergarments. We can launder these items after 4 consecutive days in- house. Please get a bag from the Nurses Station to put these items in when they need to be washed. No other clothing items will be washed. Please keep your used personal laundry items in your locker or nightstand drawer. Bags can be obtained from the Nurses Station to store your personal used laundry. Site staff is not responsible for any lost or stolen laundry items. Laundry will be done at night by site staff.
14. Footwear: You must wear shoes, slippers or slipper socks at all times when not in your bed. Each subject will be issued one pair of socks upon request at your initial admission to the facility. Shoes are not to be worn in bed.
15. Headwear: Sunglasses and headwear of any kind are not permitted.
16. Biohazard Containers: Biohazard containers are located on the wall by each bedside and are not to be used for trash.
ELECTRONICS
1. Bedside Entertainment Systems: Bedside entertainment systems are available in suites for study subjects to use between the hours of 7 AM to 11PM. Tablets/DVD players are available as well upon request. Do not use these systems until site staff has completed training with you. Use care when moving the unit away from the wall and when returning the system back to the wall after use. Entertainment systems are not to be used during study procedures. Do not make any adjustments to the programs on the systems. Please do not attempt to reset them at any time during your stay. Please ask site staff for assistance if you have any problems.
2. Headphones: Headphones must be used with all electronic devices at all times in all areas of the facility. Music is not to be played without the use of headphones.
3. Confidentiality: Video recording/video calling/taking pictures is not allowed in our facility. This is to maintain confidentiality of our subjects. If any of the above incidents occur the subject will receive an immediate fine.
4. Entertainment Check-Out: Movies, DVD players, PS4 and PS3 games and other games are available to be checked out from the Nurses Station between the hours of 7AM and 10PM. All checked out items must be returned to the Nurses Station by 10:30PM each day. There is a two-hour time limit on all PlayStation games. Gambling isn’t allowed. If need be the entertainment floor may be closed for clinic purposes.
5. Computer Room: You may have access to computers during your stay. Do not plug in other devices to these computers or disconnect any part of these computers. Only certain websites are enabled on these computers. Do not download other programs to these computers.
6. Telephones and Televisions: Phones are located in the dining area for subject use. Long distance calls are not allowed. A 10-minute time limit is allotted to allow other subjects access to these phones. Phones located in other areas throughout the facility, including in each suite, are for site staff use only. Dining room TV’s are controlled by site staff only. Please do not adjust these TV’s.
7. Wi-Fi: Altasciences provides wireless internet throughout the building. Personal hotspots are not allowed.
EMERGENCY GUIDE
Emergencies: Emergency exits are designated with signage above the door. There is an exit on the north end of the building, two on the south end, and one on the second floor. If a tornado warning does occur, staff will direct all subjects to the first floor stairwells. Emergency procedures will be reviewed with subjects at admission to the facility. Emergency buttons are located throughout the unit including in each restroom and at each bed. These emergency buttons are only to be pushed in case of a safety or medical emergency. These are not “call” buttons.
These rules and guidelines are designed to keep subjects and staff in a safe, courteous and respectful environment. These rules also meet the requirements that have been put in place by the Study Sponsors and the Food and Drug Administration.
You are required to be considerate and respectful to others – profanity, sexual comments, obscene gestures, viewing explicit materials, destruction of property, or other disruptive behavior will not be tolerated.
Violent or threatening behaviors or comments to staff members or other subjects will not be tolerated and will result in a fine or dismissal from the current study as well as potential ban from participation in future studies at Altasciences.
PLEASE NOTE: Altasciences reserves the right to issue a fine for violations of the subject rules. Fines may begin at $50 per incident and will increase at the Investigator’s discretion depending on the severity of the offense. Fines will automatically be deducted from study participation compensation. Appropriate fine amounts will be determined by the Investigator, or appropriate staff.
For repeated violations or serious offenses, a subject may be removed from the study and/or disqualified from participation in future studies at Altasciences.
When a subject breaks the rules, violates study procedures, is late for procedures, behaves inappropriately or is disrespectful toward staff or other subjects, or presents a safety risk of any kind, fines and/or removal from the study, including banning from future study participation at Altasciences will be enforced.
Adhering to the visit schedule is very important. The following restrictions may be placed at the Investigator’s discretion:
· If you miss a repeat lab or admission, there may be a 30-day waiting period to screen for another study.
· If you withdraw consent for any reason or miss a follow up visit, there may be a 30-day waiting period after the end of study visit to screen for another study.
· If you have a positive drug screen in a healthy volunteer study (at screening, admission or a follow up visit) then the following restrictions may be placed :
o The first offense may result in a 30-day waiting period to screen for another study.
o The second offense may result in a 60-day waiting period to screen for another study.
o The third offense may result in not being allowed to participate in future healthy volunteer studies.
By signing below, you acknowledge that you understand and agree to follow the above rules and guidelines during your stay at the facility. You also understand if you do not follow the above rules, fines may be deducted from your study compensation.