Office of Human Research
Page Title

SOP No.: 500         PROJECT MANAGEMENT

Author:    Office of Human Research

Effective Date:  October 1, 2007

Supercedes document dated:              N/A

Last Reviewed on:     N/A                                 

Results of Review:               N/A

This SOP pertains to:  all Investigators involved in the conduct of FDA-regulated human subject research within Thomas Jefferson University

Responsibility for executing this SOP:  Investigator and Designated Research Personnel

Approved By:

 

J. Bruce Smith, MD

 

Associate Vice President for Research

 

(signature on file at OHR)

Approved By:

 

Steven E. McKenzie, MD, Ph.D.

 

Vice President for Research

 

(signature on file at OHR)

 

SOP No. 501: Communication

This procedure describes the process for documenting all clinical study communications that are required during the conduct of FDA-regulated human subject research.

SOP No. 502: Investigational Product Inventory Management

This procedure describes the methods to be used for the labeling, distribution, receipt, dispensation, accounting, and return of investigational products used for FDA-regulated human subject research. While some Good Manufacturing Practice (GMP) issues are addressed, this procedure does not address GMP regulations for the manufacture of investigational products.

SOP No. 503: Documentation and Records Retention

This procedure describes the processes followed by the Investigator and all participating Investigators for the creation, management, review and maintenance of files pertaining to the conduct of FDA-regulated human subject research.

SOP No. 504: Routine Monitoring Visits

This procedure describes the activities performed during the monitoring of clinical study investigative sites.

SOP No. 505: Study Closeout

This procedure describes the activities performed to close out a study at an investigative site.

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