SUNY Downstate Health Sciences University
Clinical and Translational Science Center
CTSC Policies and Procedures
1. Hours of CTSC operation and access of authorized personnel
The CTSC is open for use by principal investigators (PIs) and authorized personnel Monday-Friday, 9:00 AM - 5:00 PM (except for official holidays). During these hours, CTSC entry doors are unlocked and staff are present at the reception desk. Please inform phlebotomist and pharmacist by 4:30pm if you will need their services after 5pm. Additional hours, such as some evening sessions, will be considered on an as needed basis and as per study protocols. Authorized personnel (PIs and their staff) may access the CTSC at other times by using ID cards programmed to open the locked entry door (swipe card access). Note that swipe card access will expire when the term of your authorized use of the facility ends.
2. Access to phones and computer equipment
CTSC subject rooms are not equipped with phones and computers. Wifi and cell phone service are available in all subject rooms. PIs are required to carry their cell phones when using the CTSC facility so they can be contacted about subject arrival. We suggest that you also bring a laptop computer to facilitate data collection, etc. Land line phones and a small number of sharable computers are located in the CTSC reception area and other strategic locations. Sharable CTSC computers may be used on a first come-first served basis.
3. Equipment: storing, sharing, training
The CTSC is intended to be a facility where equipment can be shared among investigators. A Core Laboratory is under development and will have a refrigerated centrifuge, vortex, water bath, microscopes, and other equipment. Once the Core Lab is fully operational, CTSC members wishing to use the equipment MUST BE TRAINED BEFORE USING IT. If your study requires access to specific equipment on site and it can be moved to the CTSC (at the PI's expense), you may request that we house the equipment in a specific subject room to which you will be assigned for the duration of the study. Note that PI-owned equipment housed in the CTSC is considered sharable equipment. For example, if your study requires that you have access to a centrifuge within the CTSC and one is available due to a study being carried out by another investigator who is temporarily housing his/her centrifuge in the CTSC, we will assign you the room that has that equipment if at all possible. In many cases, use of PI-owned equipment that is being shared requires special instructions and training. We will arrange for the PI that owns the equipment to do the necessary training or, in some cases, training will be carried out by the CTSC staff. A record of whom received the training and who did the training will be kept. Responsible use of all equipment is paramount.
4. Storing supplies and data
Each subject room has an unlocked storage closet that may be used by PIs assigned to that room. Storage of small items used when working with human subjects is allowable (e.g. paper rolls for exam tables). PIs are urged to clearly label stored items with their names. Do not store anything of significant value as these closets are not locked. Moreover, DO NOT store research data or personal laptops in these closets. All records associated with human subject research should be entered into laboratory books or computer files on laptops and any rating forms or consents with subject information, should be removed from the facility when you have completed work on every and any given day.
Equipment and facilities needed for processing of biospecimens (e.g. blood, urine) collected from human subjects as part of an IRB-approved may be available in the CTSC Core Laboratory (see 3 above). No biospecimens may be stored overnight within the CTSC. All biospeciments must be removed following use of the facility on any given day. All PIs and their staff must adhere to OSHA guidelines and Downstate's Institutional Biosafety Committee's policies for handling, transporting and disposing of biospecimens.
In the event of an emergency, please call the appropriate number listed below or ask the staff at the CTSC reception desk to make the call for you. Note that all PI's are expected to carry cell phones as subject rooms are not equipped with phones.
Cardiac Arrest (Adult)
Cardiac Arrest (Child)
Other Medical Emergencies
To Summon Security
NUMBER TO CALL
7. Responsibilities of CTSC staff at reception desk
Staff at the CTSC reception desk are responsible for routine duties (answering phones, greeting faculty, staff, visitors, etc.). They are also responsible for research subject check-in and check-out requirements. When subjects arrive at the CTSC reception area, the receptionist will log them in and notify the PI or their staff. Research subjects will then be asked to wait in the waiting room until the PI or their staff arrive to greet them (also see Policy 9 below for related information). CTSC staff are not responsible for communicating instructions or PI printed material concerning research activities to subjects. PIs and their staff should provide research subject with this material.
When research subjects' visits are completed, the receptionist will log them out of the CTSC. PIs and their staff should ensure that subjects stop by the receptionist's desk to check them out of the facility when they are leaving.
8. Responsibilities of PIs and their staff
PIs granted CTSC membership who will be performing research with human subjects within CTSC space are expected to ensure that participating staff are listed on their CTSC application and that they have all required training related to (a) the responsible conduct of research including research involving human subjects; (b) HIPAA; (c) working with bloodborne pathogens, etc.
PIs and their staff should ensure that subject rooms are kept clean.
Restrooms located in subject rooms MAY NOT BE USED. (Some exceptions may be made when specimen collection, such as urine collection, might be required in the study protocol.) General use of restrooms is restricted to those located in CTSC North and South corridors.
Storage closets located in subject rooms may only be used to store small items such as paper supplies needed for the specific day(s) of study.(see Policy 4 for additional information).
Prior to subjects' arrival (minimum of 24 hours before scheduled visit, if at all possible), PIs or their staff are required to inform the receptionist of the names of subjects who are scheduled to visit the CTSA. Subjects will be logged-in at the desk to record their arrival time. The receptionist will then escort them to the CTSC waiting room. The receptionist will also log-out subjects once they have completed their visit.
PIs and their staff should ensure that subjects stop by the receptionist's desk to check them out of the facility when they are leaving.
9. CTSC Waiting Room Guidelines
Research subjects should be as quiet as possible while sitting in the CTSC waiting room. We ask that they refrain from eating and cell phone use in this area. PIs should ask research subjects to arrive approximately ten minutes before their scheduled visit to minimize waiting time.
PIs should not carry out interviews or research-related conversations with subjects in the CTSC waiting room. Assigned subject rooms should be used for this purpose.
10. CTSC kitchen area
The kitchen adjacent to the CTSA waiting room is not to be used by visitors. If a given study requires the use of the kitchen, this must be indicated on the PI's application to use CTSC space. Currently, the kitchen does not have a refrigerator. We hope to make one available in the near future so that PIs can store bottled water or juices in the event that they anticipate that some subjects may require hydration during or after their participation in a research study within the CTSC.