• Provide assurance to the CTRC Principal Investigator that appropriate efforts are being made to ensure that subject safety receives the highest priority.
• Act as liaison with the institutional Office of Human Protections, including the IRB.
• Develop and guide implementation of policies and procedures for:
• Timely and appropriate reporting of adverse events
  
• Development and adherence to the data and safety monitoring plan
• Approval and recording of all protocol amendments and changes in informed consent documents
  
• Performance of regulatory responsibilities in a complete and timely manner
• Conduct of the research as written in the most recently approved protocol.
• Receive copies of all correspondence to and from the IRB, FDA, and the sponsor related to conduct, safety, clinical holds, removal of holds, changes, and other relevant information concerning protocol on the CTRC's.
• Provide educational and training opportunities for investigators, coordinators and CTRC staff on human subject protection.
• Reflect the views of research participants to CTRC staff when appropriate.
• Assist research participants in understanding clinical research and what role they play.

What is a data and safety monitoring plan (DSMP)?

A DSMP is a prospective plan for periodically assessing a study by:

• Verifying assumptions made during study design
• Maximizing the yield from the study
• Protecting human subjects

• Who will be responsible for the monitoring
• How frequently monitoring occurs
• How the results of monitoring will be reported
• What is being monitored and why

Data should be monitored:

• To confirm demographic and covariate assumptions
• To assess accrual and withdrawal rates
• To determine effect size
• To rule out early study termination
• To ensure integrity of the protocol and the collected data.

Safety should be monitored:

• To detect study-related adverse events
• To ensure privacy and confidentiality
• To respond to new information that may affect study
• To assess a change to the risk/benefit ratio
• To respond to futility of a study arm or entire protocol.

Who is responsible for monitoring?

For many of the DSMP activities, the immediate study staff will be responsible for monitoring. Examples include site-specific issues that must be handled immediately, such as:

• Adverse event reporting
• Breaches of confidentiality
• Accrual or retention problems.

Other monitoring depends on the criteria for DSMBs and investigator conflict of interest.

Protocols which are being conducted at the University of Pittsburgh/UPMC and which require a local DSMB can request assistance from the Office of Clinical Research. This office has created an Institutional DSMB (IDSMB), which has a pool of clinicians, researchers and statisticians from which a DSMB with the required expertise can be formed.

For more information on the IDSMB, please go to http://www.clinicalresearch.pitt.edu/ and select “Services” under the heading “Investigators & Staff.”

Regulatory Update:

Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject Protection DHHS released its final guidance on conflict of interest on May 12, 2004. The document outlines suggestions for how an institution can best monitor potential and real conflicts of interest of its investigators as well as of itself. One of the suggestions for investigators is to declare any potential conflict of interest within the consent form. See the guideline in the Federal Register, 69(92) at: http://ohrp.osophs.dhhs.gov/humansubjects/finreltn/finalguid.pdf.

References:
“Protecting Study Volunteers in Research”
Cynthia Dunn, MD and Gary Chadwick, PharmD, MPH Thomson Publishing, www.centerwatch.com
“Integrity in Scientific Research: Creating an Environment That Promotes Responsible Conduct”
Institute of Medicine National Research Council National Academies Press, 2002, www.nap.edu
“Responsible Research: A Systems Approach to Protecting Research Participants” Institute of Medicine National Academies Press, 2003, www.nap.edu
“Patient Safety: Achieving a New Standard of Care” Institute of Medicine, Board on Health Care Practices National Academies Press, 2004, www.nap.edu
“Ethics and Regulation of Clinical Research” Robert Levine Urban & Schwarzenberg, 1986; Yale University Press, 1988
“Beyond Regulations: Ethics in Human Subject Research” King, Henderson & Stein University of North Carolina Press, Chapel Hill, 1999
“The Ethics of Medical Research on Humans” Claire Foster Cambridge University Press, 2001