The checklist also serves an important educational purpose. Protocols for studies funded by government agencies, private foundations,
and intra-institutional sources often lack the detailed DSMP descriptions characteristic of those developed by industry sponsors.
To help investigators prepare more comprehensive DSMPs or improve existing plans in ongoing studies, we have conducted educational
sessions to introduce the checklist. Investigators can use it as a template, supplemented by additional monitoring procedures
specific to their study. Also, IRBs may use the checklist as a basis for evaluating the adequacy of DSMPs in protocols submitted
for both initial review and continuing review. To standardize expectations for investigators or improve consistency in protocol
reviews, some IRBs may wish to incorporate such a tool into institution-specific guidance documents available to their members
as well as to the research communities they serve. Despite long-standing policies and available regulatory guidance, evidence found in FDA warning letters and reflected in our
own experience indicates a persistent gap between DSMP regulatory expectations and reality. The FDA citations discussed earlier,
illustrating that investigators commonly fail to follow the investigative plan, are just one example of this gap. Adequate
monitoring would likely have identified lapses in protocol adherence, prompting corrective responses. It may also be necessary
and appropriate for sites to exercise additional monitoring beyond that provided and/or required by the industry developed
protocol. Investigators should use their judgment to decide if the protocol's DSMP is not as well defined as it should be.
User-friendly tools are needed to help investigators, sponsors, IRBs, and quality assurance/improvement staff alike to translate
regulating requirements into practice. The DSMP checklist presented here offers concrete guidance to help users incorporate
all expected elements of data and safety monitoring into research protocols. It further provides a basis for evaluating regulatory
compliance and improving study site performance. To be effective, DSMPs must be developed and in place prior to the onset of the clinical trial and modified as needed as the
study progresses. Given the importance of DSMPs, tools such as the checklist described here can help to ensure regulatory
compliance while promoting subject safety and data accuracy/completeness. We believe that this tool responds to a significant
need for improved accountability as clinical trials come under closer scrutiny in both public and professional arenas. References 1. National Institutes of Health, NIH Policy for Data and Safety Monitoring (NIH, Bethesda, MD, 1998). 2. National Institutes of Health, Further Guidance on a Data and Safety Monitoring for Phase I and Phase II Trials, (NIH, Bethesda, MD, 2000). 3. Code of Federal Regulations, Title 21, Part 312, Sections 50, 60 (US Government Printing Office, Washington, DC). 4. Code of Federal Regulations, Title 21, Part 812, Sections 40, 100 (US Government Printing Office, Washington, DC). 5. International Conference on Harmonization, "Good Clinical Practice: Consolidated Guidance (ICH-E6)," April 1996. 6. N.T. Artinian, E.S. Froelicher, J.S. Vander Wal, "Data and Safety Monitoring During Randomized Controlled Trials of Nursing
Interventions," Nursing Research, 53 (3) 414–418 (2004). 7. L. Slimmer and B. Andersen, "Designing a Data and Safety Monitoring Plan," Western Journal of Nursing Research, 26 (7) 797–803 (2004). 8. M.L. Terrin, "Evaluating and Implementing Data and Safety Monitoring Plans," Journal of Investigative Medicine, 52 (7) 459–463 (2004). 9. NIH Guide for Grants and Contracts, Volume 8, No. 8 (1979). 10. Food and Drug Administration, Guideline for the Monitoring of Clinical Investigations (FDA, Rockville, MD, 1998). 11. U.S. Food and Drug Administration, FDA's Electronic Freedom of Information Reading Room—Warning Letters and Responses, http:// http://www.fda.gov/foi/warning.htm (Accessed January 2007).
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