Standard Operation Procedures
GA 104: Study Team Training
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SOP No.: 104     STUDY TEAM TRAINING
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:  :  This SOP pertains to:  All faculty and staff who are involved in supervising, managing, or conducting 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)

 

1. PURPOSE

This procedure describes the process for conducting and documenting training of the Investigators and other designated individuals who participate in the conduct of FDA-regulated human subject research.

2. GENERAL INSTRUCTIONS

  1. The Investigator at each site assumes the responsibility for the conduct of a clinical study and the protection of human subjects and has the authority to delegate portions of that responsibility to other key personnel. He/She is responsible for ensuring that key personnel to whom those responsibilities are delegated also are qualified by training and experience to perform their study-related duties.
  2. All personnel are responsible for taking the appropriate training to conduct study-related duties, to document training, and to demonstrate they can apply training in the conduct of their duties.

3. SPECIFIC PROCEDURES

3.1 Investigator's Employee Training Plan
  1. Thomas Jefferson University complies with federal directives to educate key research personnel by requiring those personnel complete a formal program of training on University policies and procedures.
  2. The Investigator's key personnel who are working on or overseeing human subject research programs should receive initial and ongoing training regarding the ethically and scientifically sound conduct of human subject research.
  3. Training key personnel will be supervised by the Investigator and/or his/her designee.
  4. The Investigator will ensure that all key personnel attend mandatory training programs offered through OHR and ORA.
3.2 Site Team Training
  1. Participating Investigators and all key personnel who are working on or overseeing research on human subjects should receive initial and ongoing training regarding the responsible conduct of research and SOPs.
  2. All personnel will support required training activities by taking an active part in their own professional development in relevant content areas.
  3. The Investigator must ensure that all key personnel are knowledgeable about all protocol-specific regulatory requirements for ongoing study protocols, study procedures and investigational products.
  4. Investigators and other key personnel should attend periodic workshops and seminars to acquire timely information about topics germane to the field of human subject investigations.

4. ATTACHMENTS


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