Study Management

After the setup of a study is complete, managing the study procedures involves a series of steps listed below.

Subject Recruitment and Enrollment

Please visit the Clinical Research Resource HUB for appropriate strategy of effectively enrolling subjects.

Scheduling and APeX Orders

Before scheduling can begin, please ensure that you have submitted the Full Study Application. Scheduling for use of each equipment is different.

If additional clinical services are required for research procedures (i.e. urinalysis, complete blood counts, etc.), an order must be placed in APeX. Please arrange with a study coordinator.

Consent Process

Only key personnel listed on the CHR protocol are able to obtain informed consent from research subjects. The subject and the consenter, prior to any research procedures, must sign the consent form, Permission to Use Personal Health Information for Research form, and Bill of Rights form.

Scanning-Day Operations

If you do not have a study coordinator present, a radiology research coordinator will be present with the research subject on the day of the exam for guidance through procedures on a recharge basis. The coordinator is responsible for the completion of any case report forms. 

Data Management and Transfers

All images are transmitted to PACS at the end of the scan. For sponsor-driven studies, data can be downloaded, de-identified, and transferred. The Quantitative Imaging Processing Center (QUIPC) provides post-processing and transferring services on a recharge basis.

Regulatory Compliance

A regulatory binder serves to organize and record keep regulatory documents to ensure compliance. All documents related to the quality and reproducibility of the study should be maintained in the regulatory binder and made readily available for inspections and audits. For more information, please visit the Clinical Research Resource HUB.