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Checklist for Conducting Research in Clinical Areas

The Principal Investigator and Study Coordinator use this checklist to engage in a discussion with the Clinical Operations Directorin clinical areas where the research requires access to patients and support of nursing staff and resources.*

Pro ______Study Title ______

Question / No / Yes / Resolution with Clinical Operations Director
Are any study activities occurring on any hospital patient care unit, hospital procedural area, or hospital clinic?
Will there be any other work requiring staff support, including records review?
Hascontact with all involved unit/department Nurse Manager(s) been initiated?
Are there special concerns for the patient or care providers to address while the subject is enrolled? (e.g. infection, reactions)
Will you provide study ”Fast Facts” for staff use?
Will clinical staff be asked to participate in study related activities?
(include travel locations & frequency for staff) / Specific activities the clinical staff will be expected to do for this study:
Is there monitoring or treatment (studyinterventions) specific to the study which the nursing staff will be required to provide?
What will the research staff document regarding study activities in the clinical record (e.g., study drug administration)? These should be able to integrate within existing documentation system.
Do the PI and participating research staff have privileges at the study locations?
If study activities require a license, credential or competency check off to perform, the clinical staff can verify that the research staff member is approved to perform the specific study activities?
Will the study use any supplies or equipmentfor study purposes that are not standard of care or sponsor provided?
Has Procurement and Materials Management been engaged?
How are sponsor-provided supplies or materials stored, requested, and secured for use in clinical space?
Are there pharmacy and formulary discussions?
Have you addressed the training needs and associated expenses of clinic or hospital staff with the Nurse Manager(s)?
Does participation in the study change the patient’s care such that the amount of nursing care time may be increased or length of stay is increased?
Are there discharge planning needs that require the support of case management?

*Submit the completed checklist to your Research Practice Manager. Version 052713