CTSA Clinical Research Unit (CRU)

Cleveland Clinic
 
 
 
 
 
 

CRU

INVESTIGATOR

MANUAL
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Credit on Publications: All publications that result from utilization of any of the CRU resources should cite the grant as a contributing source of support and indicated the CRU grant number, “CTSA 1UL1RR024989”

INDEX

  Page Number
Mission Statement 3
Contact Information 3
CRU Operational Flow 4
Technical Resources 5
Administration  
          Application 7
          CRU Advisory Committee 7
          Resource Council 8
Subject Categories 9
Research Subject Advocate 10
CRU Resources  
          Nursing 12
          Core Laboratory 12
          Informatics Core 15
          Biostatistics 15
Services  
          Nutrition 16
Pharmacy 17
Study Initiation  
          Required Documents 18
          Study Execution 19
          Scheduling 20
          Medical Record Management 20
          Scheduling Request Form 21
          Admission Procedures 22
Annual Reporting 23
   

MISSION STATEMENT

The mission of the CTSA Clinical Research Unit (CRU) at CCF and the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University (CCLCM) is to facilitate and enhance the performance of clinical research so as to help understand human physiology, translate basic research into patient care, and develop new therapies.  This is done through the provision of core support for the design, implementation, and analysis of clinical studies.  This includes inpatient and outpatient research space, the expertise of research nurses, a laboratory core, informatics core & biostatistics core, Research Subject Advocate (RSA), and research subject support.  The CRU is also committed to providing an environment that ensures the training of the next generation of clinical investigators through support of young investigators and medical students.
 
 
 
 

CONTACT INFORMATION

Charlotte Bhasin, MOT, OTR/L

Administrator / M51

216/444-5113

Fax: 216/636-3367

bhasinc@ccf.org

Kay D. Stelmach, RN, RTT

Nurse Manager / M51 

216/444-3588 

Fax: 216-636-3367 

stelmak@ccf.org
 

Jackie Soos

Department Coordinator / M51

216/445-6018

Fax: 216/636-3367

soosj@ccf.org

CRU OPERATIONAL FLOW

Pre-application Assistance - Contact CRU at (216) 444-5113

Incomplete

PI submits completed application with protocol and budget to CRU Administration to be reviewed for completeness. There, a database log and project file will be created.

Complete

PI will be contacted by CRU administration for missing info.

Not approved

Copies of the application are distributed to RSA and Biostatistics for review.

CRU Workgroup Overview: RSA, Biostatistics, Core Lab, Nursing, Informatics. The WorkGroup will review the project, based on each respective WorkGroup member’s expertise, to identify any potential issues or problems with the project.

Not approved

Approved

Contact PI to answer questions or resolve issues.

The application is forwarded to the CRU Advisory Committee (GAC) Chairman who will assign two GAC members to review and score the project based on scientific merit. Once completed, the reviews are presented before the GAC for further consideration.

Comprised of hand-appointed CCF staff physicians of diverse specialties & expertise, the GAC considers the project’s scientific merits and assigns an overall score based on the reviews, scores, RSA and Biostatistics comments.

Unfavorable Score

Depending on the outcome, the PI will receive a formal letter requesting to either revise their project, or that the project has been rejected outright. All reviews (with the reviewer’s made anonymous) are forwarded to the PI. If a revision is requested, then a designated mentor may be assigned to assist. All re