It is the goal of the CHRU to provide a flexible means for investigators to conduct clinical research protocols, maintaining the highest level of safety for all study participants.  In general, studies that do not have direct physician oversight (ie: a physician on the CHRU premises) should only include 'well' patients (ie: patients without acute medical or surgical conditions).  Study-drug dosing should only be performed when the study physician is immediately available and can assess the subject should symptoms occur.  All protocols should have a study-specific medical management kit available on the CHRU for patient signs/symptoms that develop while on the CHRU.  These will be developed on a study-specific basis and will be filled by the outpatient pharmacy.  Examples of agents that could be included in these kits are listed below:

  • Tylenol or ibuprofen tablets/syrup
  • Albuterol for nebulization
  • Racemic epinephrine for nebulization
  • Benadryl tablets/syrup
  • Epi-pen
  • Prednisone tablets/orapred syrup


Medical management kits can be maintained on the CHRU for actively enrolling protocols, and reconciliation will be performed on a monthly basis.  All medical management kit costs will be the responsibility of the investigator.

Pediatric study subjects (age birth - 21 yrs):

  • For study subjects that develop new symptoms, or changes in vital signs that require non-emergent but urgent assessment:
  • Inform the primary support physician for the protocol, and place the subject on appropriate cardiopulmonary monitoring.
  • If resolution is not obtained rapidly, contact CHAT (Children's Hospital Assessment Team).
  • For study subjects that develop new symptoms, or changes in vital signs that require emergent assessment and intervention:
  • Call 638-9288 to activate the Pediatric Code Response.
  • Inform the primary support physician for the protocol.


Adult subjects (age > 21 yrs):

The CHRU understands that many studies of children's health and disease begin in adults, particularly for early phase clinical trials of new therapeutic strategies.  Thus, the CHRU is available to investigators who are conducting research of childhood diseases that continue to be manifest in adulthood and enroll adult study subjects.  As the Children's Hospital facility does not admit patients > 21 years of age and does not provide an adult code response team, it is extremely important that investigators who enroll adult subjects comply with specific issues to ensure the safe conduct of research on the unit.  These are listed in bullet form below:

  • All adult subjects evaluated in the CHRU must be in stable health without current acute medical conditions.
  • No research involving adult subjects will be conducted in the CHRU that is described as 'High Risk' by the CTSA Research Subject Advocate (part of the CHRU-SRC).
  • An adult-trained physician must be identified on the CHRU Utilization form, and must be available for study-related questions or concerns that arise.
  • A study-specific medical management kit must be developed and available on the CHRU that is appropriate for the study population and the therapeutic agent under investigation.
  • Any study enrolling adult subjects can be denied use of the CHRU at the discretion of the Medical Director.


For Adult (>21 yr old) study subjects that develop new symptoms, or changes in vital signs that require urgent or emergent assessment:

  • Inform the primary support physician for the protocol, and place the subject on appropriate cardiopulmonary monitoring.
  • If resolution is not obtained rapidly, contact Emergency Management Services.

Medically unstable adult study subjects should be transferred to the Adult Emergency Department at UAB for emergency care and management.  This transfer will be orchestrated by the primary support physician and the emergency response team (911).