House Rules

 

 

 

 

 

Pfizer New Haven Clinical Research Unit House Rules

The Pfizer New Haven CRU is a camera/video monitored facility. You will be required to present a valid government-issued photo ID and valid Social Security Card for all screening visits and check-ins at our research clinic.

Study requirements and facility rules

Violation of any of the following may result in financial penalty, which would be deducted from your participant compensation and can delay release of your payment check. Any serious violations may result in your dismissal from the study and your exclusion from participation in Pfizer New Haven Clinical Research Unit (Unit) studies in the future.

  1. Timeliness: You must report to procedures 5 minutes before the procedure’s scheduled time. For outpatient visits, please arrive 10 minutes before scheduled time. Please contact a member of the study staff at the Unit if you have any questions. Failure to report to in-house procedures on time will result in a fine of $50.00. Tardiness up to 1 hour at study check-in or during scheduled follow-up visits will result in a fine of $50.00. Tardiness in arrival of greater than 1 hour at study check-in or during scheduled visits will result in a fine of $150.00. If you miss a follow-up visit you will not be compensated for that visit and may also forfeit your completion bonus, as defined in the study Informed Consent Document. Tardiness to any study check-in may result in a change to order of volunteer participation at the discretion of the staff. To ensure your safety and the integrity of the study, it is very important that you complete all your follow-up visits (and extra visits if needed) and that you respond to all phone calls and emails. If you miss follow-up visits, or aren’t available for extra visits that are needed for your safety or the integrity of the study, or we can’t reach you by phone or email, you may be permanently banned from future studies. Please contact the Unit as soon as possible if you anticipate being late. Appointment no shows could result in a permanent ban from our facility.
  2. Identification: You will be given an electronic data capture management system (EDCMS) identification badge at check-in. You must wear this at all times while at the Unit.
  3. Bedrooms and Beds: For studies requiring overnight stays you will be assigned a bed. Do not enter any other bedroom. You must sleep in your assigned bed. A Unit staff member must authorize any room changes. For your safety, other than times when you are getting dressed, bedroom doors and/or interior window and door blinds and bed curtains will be kept
    open during the day and there may be times they are kept open during the night. Staff members may enter your room at various times throughout the day or night.
  4. Food: You are not allowed to bring any food, drinks (including water), candy, gum, or mints into the Unit. You must eat meals provided to you by the Unit cafeteria and adhere to the menu and diet outlined by the study requirements. These requirements may require you to eat all food served to you, including condiments, while participating in a study. All food must be eaten in the cafeteria unless otherwise directed by staff. Failure to do so may result in a warning, docking, or disqualification from a study. Unit staff must check your food tray upon completion of your meal. Volunteers who require special diets may not be eligible to participate in certain studies. You must not share your food with anyone else and may not remove any food from the cafeteria.
  5. Visitors: You will not be allowed any visitors during your stay at the Unit. If you need family or friends to bring you something that you forgot to pack, they may drop it off at the security desk at the main entrance to the building. All articles will be searched before being brought to you. You will not be allowed to exit the second floor (the in-house floor) without prior approval and escort during your stay at the Unit.
  6. Quiet hours/Lights Out: Quiet hours will commence at 10:00 pm. TV and radio volumes will need to be adjusted accordingly and volunteers will be required to refrain from playing pool. Lights out will be at midnight (the only exceptions would be for study-related procedures).
  7. Attire: You are required to wear the study T-shirt provided by the Unit and wear your own pants or shorts. You are required to wear the study T-shirt over any additional clothing you choose to wear while in the Unit (e.g., sweaters, personal clothing, etc.). Scrub bottoms may be provided. You must be dressed appropriately at all times (shirt, pants, and shoes) and pants must be pulled up with underwear NOT exposed. While sleeping you must wear study T-shirt and scrubs at a minimum. Except when in bed, footwear must be worn at all times while on the Unit premises. You must return your study T-shirt(s) and scrub bottoms (and any other Pfizer property) upon discharge from the Unit before compensation for study participation can be processed.
  8. Laptop Computers, Tablets, and Cellular Telephones: You are allowed to bring your own laptop computer, tablet, and/or cellular telephone into the Unit. The staff may check your hard drive(s) for inappropriate material, such as pornography. Cameras will be temporarily disabled and covered with tamper-proof security stickers at check-in. The security stickers must not be removed or tampered with in any way while in the Unit. You are not allowed to bring in DVDs, video games, CDs, etc. unless they are labeled, legal commercial originals. Anyone found with unauthorized recording devices or pornography in any form will be penalized (see section VII). Laptop computers may only be connected to a designated network port in the cafeteria. All other network ports are off limits. You will be penalized for bringing laptops, tablets, and/or cell phones to procedures or for not turning them off during procedures, including meals. Staff may check the content of your laptop, tablet, and/or cell phone to ensure that neither Pfizer’s interests nor the privacy and confidentiality of our volunteers have been compromised. Additionally, we provide courtesy landline phones free of charge for calls to the United States and Canada. Please limit phone conversations to 10 minutes to be fair to all volunteers. No telephone calls should be made or received after lights out. Subjects are not permitted to use their phones after lights out with the exception of alarms set for study procedure reminders. We will provide you a phone number to be used by anyone needing to contact you in an emergency. Your presence in the Unit will not be confirmed for privacy and confidentiality reasons. The staff will take the name and phone number of the caller and pass the message to you.
  9. Search: Prior to being brought to the second floor of the Unit for your in-house stay, your belongings will be thoroughly searched. You will be asked to empty your bags and set all of your belongings on the table so the staff can go through them. You will be asked to empty your pockets, remove your shoes and hat if you are wearing one and you will receive a pat down. You will be scanned with a metal detector wand. You and/or your possessions may
    be searched at any time during the study. Items not allowed will be held and labeled. These items will be stored in a secure location at the Unit. You will not have access to these items during your stay at the Unit. Items that are not claimed within 30 days of discharge from the study may be discarded. Your belongings will be searched again before you leave the Unit.

Linen/Laundry

  1. Towels, sheets, pillowcases, pillows, and blankets are provided for your use.
  2. To assist staff in coordinating outside laundry services, all study volunteers will be asked to strip their bed linen upon discharge from the Unit, or more frequently if participating in a long term study, and place it in an appropriate laundry receptacle.
  3. Laundry facilities will be available for long term study participants (volunteers inhouse more than 5 days). All items must be removed from the washer/dryer by the owner upon cycle completion.

Hygiene

  1. You are required to shower and brush your teeth at least once a day unless study requirements dictate otherwise. The staff will inform you of these instances.
  2. Toiletries will not be provided by the Unit, you are required to bring any and all necessities for your stay. Please see section VIII of this document for a list of allowable items.

Exercise

  1. You will not be allowed to engage in vigorous activities or exercise while in the Unit.
  2. Walking at a normal pace is allowed.
  3. Refer to your discharge instructions and Informed Consent Document for activity restrictions between study periods.

Entertainment

  1. The Unit provides access to televisions (both in your bedrooms and in certain public areas), video game consoles, wireless surround sound headphones for public televisions, a pool table, and internet access, as well as a movie and video game library. For videos and games you will have to sign these movies, games, and game controllers out each time at the nurse’s station. All signed out items must be returned by the end of the day before lights out. If they are not returned by the end of the day they were signed out, they will be considered stolen and you will be fined $150.00
  2. There is a quiet room for your use. No musical instruments, televisions, stereos, laptops, or video game devices are allowed in the quiet room. Electronic book readers, cell phones, and tablets with audio disabled are allowed.
  3. Be considerate of other study participants and do not monopolize equipment.

Conduct During Study

Use of degrading remarks with ethnic, racial, sexual, and/or religious undertones or making verbal or physical advances or threats toward staff members or other study volunteers will also be grounds for dismissal from the study and future studies. You may be removed from study participation and/or banned from participation in future studies if, in the judgment of staff members, your behavior is unacceptable at any time.

Certain behavior is expected of you during your stay at the CRU. Compliance with the policies and rules is essential. The following are some examples of behavior that will not be tolerated. Be aware that violation of any of the following may result in financial penalty which will be deducted from your study participation compensation and you may be removed from the study and banned from participation in future studies at the Unit at the discretion of the Unit staff:

  1. Use of abusive language
  2. Failure to comply with protocol requirements as written in your Informed Consent Document
  3. Use of illegal drugs or alcohol
  4. Smoking (unless allowed by the protocol)
  5. Gambling or Stealing
  6. Possession of weapons of any kind
  7. Unauthorized absence from the Unit (missed visits, arriving late to check-in or follow-up, etc.)
  8. Arguments or interactions with staff or other study volunteers or comments that may be perceived as unreasonable or disrespectful (including arguing about how/when/where to perform procedures, Unit House Rules or operations)
  9. Failure to comply with the study procedures and instructions
  10. Willful destruction of property or other malicious behavior
  11. Providing false information or withholding valid information (including not informing study staff of any side effects while participating in a study, or sharing side effect information with other volunteers)
  12. Sexual advances toward or activity with other volunteers or staff will also be grounds for dismissal from the study and future studies
  13. Improper disposal of waste (gauze, ECG tabs, tissues, bandages, etc.)
  14. Soliciting/conducting personal business, for profit, with other volunteers or staff
  15. Other activities/actions may be considered intolerable at the discretion of the Unit staff

Consequences of Inappropriate Behavior

To ensure a safe environment at the Unit and the need to obtain accurate study data behavioral issues may be grounds for termination of your participation in a study and/or may jeopardize your ability to participate in future studies.

At the discretion of Unit staff consequences of inappropriate behavior may consist of one or more of the following (actions may not be taken in order listed):

  1. An individual or group verbal warning
  2. Adjustment of overall study compensation
  3. Dismissal from the Unit and the loss of your study completion bonus
  4. Probation period from future study participation
  5. Ineligibility for future studies

Penalties for misconduct are as follows:

First Degree Offenses – $50.00 fine per violation

  1. Late for in-house study-related procedures (e.g., meals, ECGs, vital signs, etc.)
  2. Activated/turned ‘on’ electronic devices during procedures
  3. Unauthorized physical activities (e.g., games involving physical activities and/or any form of exercise)
  4. Protocol Violations (e.g., exercising, lying down during unauthorized times,
    consuming caffeine or herbal supplements, etc. during unauthorized times)
  5. Failure to consume meals over time frame specified by clinic staff and/or study protocol
  6. Profanity
  7. Non-compliance of facility rules (e.g., ignoring bedtime curfew, not wearing photo ID badge, not wearing pants, shoes, or study T-shirt, or use of laptop outside of permitted areas)

Second Degree Offense – $100.00 fine per violation

  1. Late for dosing, unrelated to preceding study procedures
  2. Entering unauthorized areas (e.g., elevators, another subject’s room,
    nursing observation area/bubble, dining room after lights out, any unauthorized area / storage room / closet)
  3. Tripping alarms (inappropriately)
  4. Possession of food outside of the dining area, hiding/trading food, bartering for additional food items.

Third Degree Offense – $150.00 fine per violation

Offense may lead to immediate discharge from a study and/or permanent exclusion/ineligibility for future NHCRU studies

  1. Arriving more than 1 hour late to study check-in or outpatient visit without prior authorization from Unit staff. You may be dropped from the study if arriving more than 1 hour late for check-in
  2. Refusal to complete meals as required by the protocol
  3. Stealing / Gambling
  4. Property destruction or malicious behavior
  5. Fighting / Physical contact with another subject and/or staff member
  6. Smoking (unless allowed by the protocol)
  7. Possession of any unauthorized device with camera, video, or other recording
    capability
  8. Removing or otherwise tampering with security stickers on laptop/tablet/phone cameras while admitted to the Unit
  9. Refusal to allow staff to check content of laptop, tablet, and/or cellular telephone
  10. Possession/use of tobacco/nicotine (unless allowed by protocol), illicit drugs,
    prescription or nonprescription (OTC) medications including vitamins or herbal supplements, or alcohol
  11. Possession of any kind of weapons (concealed or not concealed)
  12. Unauthorized absence from the Unit
  13. Providing false information or withholding valid information, for example, failure to report side effects, or sharing side effect information with other volunteers
  14. Use of abusive language including degrading remarks with ethnic, racial, sexual, and/or religious undertones or making verbal or physical advances or threats toward staff members or other study volunteers
  15. Arguments with staff or other study volunteers or comments that may be perceived as disrespectful, such as arguing about how/when/where to perform procedures
  16. Soliciting/conducting personal business, for profit, with other volunteers or staff
  17. Pornography in any form.

If you are found knowingly and intentionally hiding prohibited items during search or on the second floor, or if you are found to be in violation of New Haven CRU House Rules, you may be penalized and/or immediately discharged from this study and you may also be permanently banned from participating in future studies at the New Haven CRU. You may be fined for other reasonable offenses not listed above at the discretion of the study staff and/or management.

If docking on any one study (from first check-in through final visit) equals or exceeds $300.00 you may be permanently excluded from future studies.

Allowable Items (Includes, but may not be limited to):

  1. Alcohol-free, non-medicated mouthwash (e.g., Alcohol Free Scope®, Plax®)
  2. Small electronic devices (i.e., CD/DVD player, mp3 player, electronic reader)
  3. Books and magazines (non-pornographic/sexually explicit)
  4. Board games and playing cards (note: gambling is not allowed)
  5. Hairdryer
  6. Non-medicated lip balm (e.g., Chapstick®, Vaseline® Lip Therapy)
  7. Toothbrush and toothpaste
  8. Nail clippers
  9. Blunt scissors/manicure sets (less than 4 inches)
  10. Deodorant
  11. Video/cassette tapes and DVDs (legal, commercial originals only)
  12. CDs (legal, commercial originals only)
  13. Video game systems and video games
  14. Pillow/blanket/towel if desired (all these items will be furnished by the Unit)
  15. Non-medicated skin lotion
  16. Laptop computers, tablets, and cellular telephones (cameras will be temporarily disabled and covered at check-in with tamper-proof security stickers)
  17. Electronic keyboards/pads (headphones required), and guitar, if in-house period exceeds 5 consecutive days
  18. All toiletries (e.g., soap, shampoo, mouthwash) must be in its original packaging with ingredients listed in English and must not contain anything considered medicated

Prohibited Items (Includes, but may not be limited to):

  1. Medicated toothpaste, medicated shampoos, medicated body creams or medicated lotions, herbal/homeopathic chewing sticks, etc.
  2. Cologne/perfume/scented body sprays
  3. Medicated mouthwash (e.g., Listerine®) or mouthwash that contains alcohol
  4. Herbal supplements or vitamins
  5. Over-the-counter (OTC), or prescription medication items (e.g., creams, powders, cough drops, treatment shampoos, acne medications, aspirin, antacids, etc.)
  6. Food or beverages (including water, candy, and/or chewing gum)
  7. Unlabeled items (items in plastic containers or bags, “generic” or copies of CDs/DVDs or DVDs that are X-Rated or have not been rated)
  8. Knives, firearms, sharp objects, weapons of any kind
  9. Sexually explicit materials (books, magazines, videos, DVDs, drawings, sketches, photos, illustrations, etc.)
  10. Glue or white out
  11. Medicated lip balms (e.g., Carmex®)
  12. Matches or lighters
  13. Nicotine containing products (cigarettes, cigars, chewing tobacco, electronic
    cigarettes), unless use on study or in-house is required/allowed by protocol
  14. Amplifiers
  15. Drums
  16. Cameras in laptops, tablets, or phones not otherwise disclosed to staff
  17. Stereos
  18. Any unauthorized recording devices (audio and/or video)
  19. Ethernet cables
  20. Wireless routers

NOTES:

Due to limited storage space within the CRU, you are restricted to no more than two
small pieces of luggage. Please do not bring any valuables or large amounts of cash into the Unit. Volunteers are encouraged to bring shower shoes and light outerwear (i.e., sweatshirt/long-sleeved T-shirt) to accommodate any temperature variations within the facility. As well, it is recommended volunteers check with staff regarding acceptability of questionable personal items in advance of reporting to the CRU.

Pfizer is not responsible for any lost, stolen, or damaged items. If you are concerned about any materials becoming misplaced, you must personally secure it, or do not bring it with you.