Download Project Utilization of Pharmacy Resources for Clinical Research

Institutional Review Board Tallahassee Memorial HealthCare, Inc. IRB
Form 5a
Project Utilization of Hospital Resources for Research Protocol
Nursing Resources Utilization
Study Information
IRB #:
Study Title:
PI:
Phone:
Email:
Research Coordinator:
Phone:
Email:
Annual Approval Date:
Annual Study Expiration Date:
Proposed Number of Subjects in Study:
Where will subjects be seen? (Check Relevant Locations):
Inpatient Study. If yes, state location(s):
Outpatient Study. If yes, state location(s):
Study Sponsor (If applicable):
Name or Code # of Drug(s) or Device (If applicable):
Nursing Resources Utilization
Yes
N/A
What service will be required of the Nursing Staff?
Pretrial Staff Education
Yes
No
On-going Staff Education
Yes
No
Timed Lab Draws
Yes
No
Additional Vital Sign Assessments
Yes
No
Administration of Study Drug
Yes
No
Attention to Study Device
Yes
No
Study Procedure (i.e., IV’s)
Yes
No
Medical Record Documentation
Yes
No
Patient Education
Yes
No
Staff Consultation with Study Coordinator
Yes
No
Other:
Based on information above, estimate staff time allotment for protocol: _______
Comments:
Signature of Nursing Representative: ________________________________ Date:___________
Barbara Alford, RN, Chief Nursing Officer
Signature of Principal Investigator:___________________________________ Date:_____________
IRB Form 5a Rev. 8/15/13
-1-
Institutional Review Board Tallahassee Memorial HealthCare, Inc. IRB
Form 5a
Project Utilization of Hospital Resources for Research Protocol
Laboratory Resources Utilization
Study Information
IRB #:
Study Title:
PI:
Phone:
Email:
Research Coordinator:
Phone:
Email:
Annual Approval Date:
Annual Expiration Date:
Where will subjects be seen? (Check Relevant Locations):
Inpatient Study. If yes, state location(s):
Outpatient Study. If yes, state location(s):
Study Sponsor (If applicable):
Laboratory Resources Utilization
Yes
N/A
What service will be required of the Laboratory?
Pretrial Staff Education
Yes
No
Handling
Yes
No
On-going Staff Education
Yes
No
Repackaging
Yes
No
Storage*
Yes
No*
Labeling
Yes
No
Refrigeration*
Yes
No
Shipping
Yes
No
Freezer*
Yes
No
Record Keeping
Yes
No
Yes
No
Staff Consultation with Study Coordinator
Other:
*If YES, approximate size of the required storage/refrigeration/freezer area?
If YES, required storage temperature?
Based on information above, estimate resource cost:
Staff time allotment for protocol (per item/unit or procedure, specify):
Comments:
Signature of Laboratory Representative:______________________________
Date:__________
Janis Nall, Director, Lab Services
Signature of Principal Investigator:___________________________________ Date:__________
IRB Form 5a Rev. 8/15/13
-2-
Institutional Review Board Tallahassee Memorial HealthCare, Inc. IRB
Form 5a
Project Utilization of Hospital Resources for Research Protocol
Other TMH Resources Utilization
(Use One Form for Each Service Area Utilized)
Study Information
IRB #:
Study Title:
PI:
Phone:
Email:
Research Coordinator:
Phone:
Email:
Annual Approval Date:
Annual Expiration Date:
Proposed Number of Subjects in Study:
Where will subjects be seen? (Check Relevant Locations):
Inpatient Study. If yes, state location(s):
Outpatient Study. If yes, state location(s):
Study Sponsor (If applicable):
Other Resources Utilization
Yes
N/A
Indicate Resource or Service Area Used (i.e., IT services, Finance, Physical or Respiratory Therapy,
etc):________________
Pretrial Staff Education
Yes
No
On-going Staff Education
Yes
No
Other:
Based on information above, estimate resource cost:
Staff time allotment for protocol (per item/unit or procedure, specify):
Comments:
Signature of Authorized Representative: _____________________________ Date:_________
TMH Service Area (specify): _______________________________________________________________
Signature of Principal Investigator:________________________________
IRB Form 5a Rev. 8/15/13
-3-
Date:_____________