Frequently Asked Questions

A: The CRC is open to all UAMS faculty members, including those with adjunct appointments.  The CRC is open to Ph.D. investigators, but an M.D. co-investigator must be included on the protocol for contact in the event of illness.  Fellows, post-doctoral students, and pre-doctoral students are encouraged to use the CRC, but should identify a faculty mentor.  In addition, the CRC supports investigators at the Arkansas Children's Hospital and the John L. McClellan Veterans Hospital.

A: The CRC supports investigator - initiated, human - based research.  The protocols may be unfunded, pilot studies, NIH or VA funded studies, private foundation (American Heart Association, American Diabetes Association, etc) or pharmaceutical funded studies.   Investigators with NIH and VA funding have priority when requests for CRC use exceed available resources, but other projects may receive high priority to achieve a balance of interest areas and investigator demographics, or for investigators new to clinical research.  Pharmaceutical industry funded studies must demonstrate that they are investigator initiated.

A: The CRC is distinct from a clinical trials unit in that priority is given to investigator-initiated studies.  Other traditional pharmaceutical industry trials may use the CRC skilled nursing and beds on a space available basis.  However, in contrast to investigator - initiated studies, pharmaceutical trials are classified as "D" days by NIH, and must pay all the costs of CRC use.  Investigators who need the skilled nursing or kitchen support of the CRC are encouraged to contact Cindy Henrich or one of the Program Directors to inquire about the costs and support available.  D study budget agreements cannot be finalized until the protocol has been submitted to and approved by the CRC Scientific Advisory Committee (SAC).

A: If a protocol is substantially modified or updated after approval by the IRB, VA R & D, and CRC Scientific Advisory Committee, an amendment must be submitted and approved by the CRC Scientific Advisory Committee before subjects can be enrolled in the revised protocol. All revised consents and appropriate IRB approval letters must be forwarded to the CRC Administrator and Nurse Manager.

A: It is the responsibility of the principal investigator or appropriate designate to obtain informed consent from the subject/parents prior to the commencement of a study. The signed consent form must be on the subject's chart at the time of the inpatient admission or outpatient visit. The investigator is also required to retain the original signed copy and to give the study subject and the CRC a copy of the consent.

A: The physician investigator is responsible for the medical care of study subjects. Arrangements for emergency and night care must be formalized before study implementation.  In the event of an intercurrent illness, unrelated to the research protocol, care will be provided according to standard hospital practice. The subject may or may not remain in the CRC depending on both the needs of the subject and the bed space requirements of ongoing research studies. The investigator is responsible for reporting to the IRB and CRC Research Subject Advocate any and all Adverse Events or Serious Adverse Events.

A: The CRC medical record is to be kept in the same detail and with the same standards as that of any patient admitted to UAMS. This means that subjects admitted directly to the CRC must have a full medical history and physical in the record within 24 hours of admission and that subjects transferred from other services to the CRC must have appropriate transfer notes. Daily progress notes should include a description of the research procedures and their results, as well as current data obtained on the subjects. These notes will enable the CRC staff to follow the progress of the research project and subject.

If charts are needed for review or monitoring, they need to be requested in writing or via email by the investigator or a member of their staff.  Include the patient's full name, social security number, requestor's name, phone number or pager number, and date records are needed. The request should be sent to the Nurse Manager.

A: All orders must be in writing and have the name and pager number of a licensed VA privileged physician. A copy should be made available to the CRC staff prior to the scheduled in-service. Verbal orders may be accepted by the Nursing and Dietary staff, but must be signed by the investigator or physician member of his team within 12 hours after given verbally. A suggested outline for standing orders have been developed by the CRC staff for your convenience.

Orders should also include the name and pager # of a licensed VA privileged physician providing backup for the PI (if unavailable for any reason).  Special diets orders must be coordinated with the Research Dietitian, Traci Harmon, at 526-7670 at least 2 weeks prior to the initiation of the study.

If the physician will not be present at the time of discharge or prefers to write the order prior to discharge, the following statement must be included on Discharge Orders:   "May discharge patient at end of protocol, (date), if stable."

A: After receiving approval from the CRC Scientific Advisory Committee, you will be asked to meet with the CRC staff and introduce your protocol. This process is commonly referred to as the implementation meeting.  The implementation meeting is used to train and educate CRC staff on the specifics of your protocol, and will be videotaped for CRC staff to review.  Contact the Nurse Manager when you are ready to schedule your meeting.  For your convenience, a suggested implementation meeting outline has been developed that you might wish to use during your presentation.

A: The CRC Scientific Advisory Committee (SAC) approval is valid for six months from approval date.  If the protocol has not been activated on the unit within six months of the approval date, the PI must re-submit the protocol to the SAC for resource review to insure that necessary support is available on the CRC as additional protocols will have been approved and activated since initial submission.  Please contact Cindy Henrich for assistance with a resource review of a protocol that has not been activated within six months of approval date.  

Q:  I understand that the publications resulting from work completed on the CRC must cite the CRC.  How do I do that?