|
|
|
|
Howard University General Clinical Research Center (GCRC) Data and Safety Monitoring Plan Template Instructions 1. Brief Description of Study Include a concise summary of the proposed research study (may use protocol abstract). 2. Training All research project personnel who work with study subjects and/or their samples or data must complete the NIH required training in the protection of research participants. The program, Human Participant Protections Education for Research Teams, is found at http://www.ci4.miami.edu/courses/irbtraining or you contact HU IRB office for details. It incorporates interactive modules, case studies, and exercises. Please submit a copy of the NIH completion certificate for every individual involved in your clinical study with the GCRC application. The GCRC application will not be considered complete until all certificates are received. 3. Risk Categorization Please use the appropriate risk profile outlined below to guide you in describing the risk categorization for your protocol. Minimal Risk – There are certain categories of low risk human subjects’ research, which have been designated as exempt from human subjects review. An Application for Exemption from Human Subjects Review must be completed and submitted to OPRS. The application lists the categories that qualify for the exemption status. (A more detailed description is available at Howard University the IRB site or contact Howard University IRB office at 202-806-7812). Research activities that present no more than minimal risk to human subjects, and involve only procedures listed in one or more of the following categories and, may be reviewed by the IRB through the expedited review procedure authorized by 45 CFR 46.110 and 21 CFR 56.110 may involve minimal risk. (For detailed information on Howard University IRB categorization of studies eligible for expedited review please reference Howard University IRB site or call the IRB office directly. For studies involving minimal risk, the investigator alone or individual not directly involved in the study may provide data and safety monitoring. This would include studies where participants are given questionnaires or where only blood is being drawn. Moderate Risk – Studies where procedures are being conducted on patients where the risk of complications is low, or where FDA approved medications are being given that have a low risk of complications. This also includes Low risk intervention in a population at risk for serious clinical events based on underlying disease; intervention of undefined risk or intervention with low frequency of serious adverse events. Low risk studies in vulnerable populations such as pregnant women, elderly, children or prisoners. These studies may require the oversight of a DSMC/DSMB. High Risk – Interventions associated with risk of serious adverse events at high or uncertain frequency; studies in populations associated with very high risk of serious adverse clinical events based on underlying disease or in whom assessment of treatment-associated adverse events may be difficult. This would include Phase I, II and III clinical trials. Study will require a DSMC/DSMB. 4. Monitoring and Safety Review Monitoring and safety review will continue throughout the progress of a study until all patients have completed their treatment and for an additional month after their last visit. a. Who will monitor? Data and Safety Monitoring may be accomplished by:
Not all clinical research projects need a committee or board to monitor safety and data. Under some circumstances, the PI alone or an individual independent of the PI can do this (see template instructions). The size of the committee and its composition are based on the complexity of the study and risk assessment. b. What will be monitored?
c. How frequently will data be monitored and reported? All PIs are required to report on the study status on an annual basis. The annual report will be submitted to the GCRC at the same time that IRB periodic review occurs. For low risk studies, a copy of the IRB annual renewal report may suffice. For moderate or high-risk protocols, a more frequent reporting schedule will be necessary as described in the DSMP. For high risk studies data reports may include, but should not be limited to, review of interim data analysis, cumulative adverse event summary, recruitment and retention summaries, analysis of data quality, and for studies with an external DSMB, a summary report or minutes of DSMB/DSMC meeting. Audits of research records may be performed, either on a random basis or as part of a planned audit, of moderate or high-risk protocols, by the RSA. d. What are the plans for interim analysis? If none, please state. For a study with an external sponsor (i.e., pharmaceutical company, NIH, foundation, etc.), please provide a summary of the DSMC/DSMB organization, responsibilities and operating procedures. Please include the following:
5. Plan for Adverse Event Reporting Describe the plan for reporting non-serious anticipated and unanticipated adverse events as well as serious adverse events to the IRB, GCRC, funding and regulatory agencies and any other appropriate body. The following are examples that can be used directly or modified as appropriate.
INFORMATION ABOUT REPORTING ADVERSE EVENTS TO THE IRB (AND GCRC)
OPRR and the FDA require investigators to report promptly and in writing to the Institutional Review Board any unanticipated problems involving risks to subjects. The adverse events should be submitted to the IRB via the Howard University-IRB Adverse Event Report Form. A copy of the current consent form should be attached to the Adverse Event Report Form.
GCRC Research Subject Advocate (RSA)Jane A. Otado, Ph.D. Tel: 202-865-7272 Fax: 202-865-1933 E-mail: j_otado@howard.edu Cc : Jaotado@att.net
|
| © Howard University, all rights reserved. General Clinical Research Center, Howard University Hospital, 4-West, 2041 Georgia Avenue NW, Washington, DC 20060 Phone: 202-865-GCRC, 202-806-4272- Contact Us - WWW Disclaimer |