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Office of the Medical Director Mission Statement
In order to ensure optimum patient safety and compliance among investigators, postdoctoral fellows and research personnel of the General Clinical Research Center (GCRC) staff, the Office of the Medical Director (OMD) has been formed (hereafter referred to as the committee). The committee is comprised of two physicians, a biomedical ethicist, the GCRC Administrative Manager, the GCRC Nurse Manager, and the pediatric study coordinator. The Chairperson of the committee shall report directly to the GCRC Program Director. The committee meets at least twice per month and on an ad hoc basis. The mission of the committee is as follows:
- To review the safety monitoring plan for each new protocol before the protocol is presented to the GCRC Scientific Advisory Committee (GAC). Feedback is provided to the Investigator and changes made as needed prior to being reviewed by the GAC.
- To review all Serious Adverse Events (SAE's) in a timely manner. Recommendations are presented to the Investigator as needed.
- To receive, and evaluate promptly, reports from external or internal DSMB's for all GCRC protocols at least annually and more often for certain high risk protocols.
- To ensure that all current protocols have current Institutional Review Board (IRB) annual renewal forms.
- To review and implement governmental regulations as appropriate.
- To follow up any patient complaints or concerns as needed.
- To ensure that adequate training and education is provided to all GCRC research staff and Investigators.
- To serve as a resource for investigators who need assistance with safety plan formulation.
A summary of all OMD activities will be presented to the GAC on a monthly basis. Minutes of all meetings will be considered confidential and will be kept in a secure location in the GCRC Administrative Manager's office.
OMD mission statement
1/06
- The goals of a Data Safety Monitoring Plan should help us protect research subjects. To do this you first need to estimate the level of risk associated with your protocols because that will drive the level of oversight.
- Note well that your Data Safety Monitoring Plan must be approved by the IRB .
- Low - innocuous procedures e.g. phlebotomy; no therapeutic agent.
- Medium - "safe" therapeutic agent.
- High - Includes vulnerable subjects, along with therapy with chemo, gene, antibody, or toxic drug and risky procedures.
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- For Low-risk studies, the PI is usually sufficient.
- For Medium risk, at least one qualified monitor who is not associated with the protocol is necessary.
- If the study is High risk then you will need to organize a three-member Data Safety Monitoring Board (DSMB), and we will need to know who they are. For studies that already have a DSMB, their full names and contact information must be provided.
- (Note that under some conditions the GCRC/OMB could be asked to act as the DSMB for your protocol - contact Michael Barany at 724-0921 for details.)
- Serious adverse events/effects include death, disability, hospitalization (if outside the hospital), extension of an existing hospitalization, threat to life or limb, or anything the study director thinks is a serious adverse effect.
- The NIH Web site detailing serious adverse events/effects is at http://www.ncrr.nih.gov/clinical/gcrcpatientsafety20010622.html .
- In addition to reporting adverse events to the IRB, FDA and the NIH, serious adverse events associated with GCRC protocols MUST be reported orally and in writing immediately by the PI (or monitor in his/her absence) to the OMD Chairman.
Clinical Practice and Expertise
- All key personnel involved in this study must have completed the Human Subject Training that is now required by the NIH for everyone working on federal grants involving clinical research. This training is required not only for investigators but also for nurses and study coordinators as well.
- You can complete this training on the Web: http://www.stanford.edu/dept/DoR/MedHS/ under "required training." At the end of the training session you log in with your Stanford SUNet ID and a record is kept by the Stanford IRB.
