Conduct of Studies within the CHRU - Expectations of Study Teams
The CHRU is designed to be a highly flexible unit, accommodating the needs of investigators with different levels of expertise and resources for the conduct of clinical and translational research. With this flexibility come clear expectations of all users (outlined below). Repeated failure to follow these unit policies will lead to termination of protocol execution in the CHRU.
It is expected that all users of the CHRU will follow unit policies, including:
- No studies will be conducted without IRB and CHRU-OC or CHRU-SRC approval.
- No studies will be conducted without a designated primary support physician.
- No studies of high risk (as defined by the Research Subject Advocate) in adult patients will be performed in the CHRU.
- All studies involving adult subjects (>21 yrs) should have a clearly defined adult medicine-trained team member.
- All scheduling will be initiated through the Scheduling Administrator of the CHRU.
- All study subjects will be logged in at the CHRU Administrative Desk by the investigative team, noting the date, the lead investigator, the protocol number, the visit number, and the service utilization (including period of unit use).
- All study personnel will follow infection control policies in-place for Children's of Alabama. Specifically, if patients are seen with infectious agents that can be potentially transmitted, appropriate infection control policies will be utilized.
- Study personnel will clean all hard surfaces within the examination rooms with sterilizing wipes when study subjects have completed their study visit.
- All non-biologic or non-sharps refuse should be bagged at the completion of the visit and placed in the hallway for removal by housekeeping.
- Use of CHRU equipment will only be permitted following orientation and demonstration of it's proper use and cleaning b y study personnel.
- All equipment will be left in a clean and working condition.
- All biohazards (sharps, biologic fluids, etc) will be properly disposed of in appropriate containers within the CHRU workspace.
- All specimens stored in the CHRU will be clearly labeled and maintained in their designated area.