Study Implementation

Inservice
An inservice should be scheduled at least two weeks prior to first participant appointment.  To schedule inservice, contact Kawanee Shepherd, unit secretary, at kmshepherd@uabmc.edu or 934-7817.

Coordinator Tools

Inservice Guidelines

Coordinator Checklist 
     

Scheduling Participants

Bionutrition
To schedule a participant who requires only bionutrition services, please contact Betty Darnell at 975-8972 or bdarnell@uab.edu.

Bionutrition and Nursing
To schedule a participant who requires controlled feeding plus nursing services, the coordinator must consult with both Betty Darnell (to determine when feeding can start) and Jolene Lewis (to coordinate outpatient or inpatient visits).  In general, all admissions for participants on long-term feeding studies, that require multiple predetermined visits, are scheduled when the study begins. Times for food pick-up are coordinated between the investigator and bionutrition at the time of study initiation.

Nursing
Outpatient appointments on JT 15:
Please call 934-7817 to schedule outpatient appointments.  You may schedule appointments with Jolene Lewis, Nurse Manager, Angela Harkness, RN, Charge Nurse or Marsha Brand, RN.

Outpatient appointments at The Kirklin Clinic (TKC):
Please call 801-8740 and speak with Carolyn Cook, RN to schedule an appointment at TKC. 

Inpatient reservations:
To reserve an inpatient room, please call 934-7817 and ask to speak with  the nurse manager, Jolene Lewis.

Regulatory Requirements
It is the responsibility of the investigator to provide the following documents, within the specified time frame, to the PCIR Research Subject Advocate, Dr. Kathleen Powell at kpowell@uabmc.edu or via fax 5-6203.

--Original IRB approval and consent to be submitted at time of application or inservice
--Annual IRB approval documents to include IRB approval, IRB consent documents, and the Investigators Progress Report to be submitted at time of verification of IRB approval 
--Data safety monitoring reports to be submitted concurrently with IRB submission
--All amendments and/or protocols revisions to be submitted at time of IRB approval
--Any IRB problem report to be submitted at the time of IRB notification

Regulatory documents should be provided to the PCIR as long as the study is open to the PCIR.