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  Data and Safety Monitoring Plan (DSMP) Guidelines

These guidelines were developed to assist you in preparing a DSMP, and which can be incorporated into the Human Subjects section of your protocol in a narrative form.

 There are several steps to a DSMP plan, which include the following:

 Step 1 – Brief Description of the Study: May use protocol abstract

 Step 2 - Risk Assessment:  

Estimate risk level (low, medium, high) and briefly discuss risk consideration relevant to your protocol. For help in determining your protocols risk level click here.

·   Risk assessment should involve not only issues relating to potential risks and toxicities of study interventions, but also other risks, including risks   associated   with vulnerable populations (e.g., children, patients with dementia, UTMB employees), personal health information, privacy/confidentiality issues, problematic or difficult informed consent issues, and research in socially or politically sensitive areas (e.g., research involving minority populations, gene therapy research).

·   Other factors that might be considered in a risk assessment include: risk inherent in the study population or the number/frequency of clinically adverse events in the absence of study interventions (as, for example, in a very medically ill study population), risks associated with the study interventions, previous experience with the study intervention, previous experience of the study PI, anticipated difficulties in meeting study goals

(e.g., recruitment difficulties, drop outs from the study, noncompliance with the study protocol).

     Step 3 – Plan for Monitoring and Safety Review:

·       Specify the name and contact information of the individual responsible for monitoring the safety environment of the participants (i.e. PI only, or additional monitoring by a Medical Monitor, Safety Officer, Independent Committee, or DSMB).

·     Specify what you will monitor (i.e. subject eligibility, adherence to treatment plan, documentation of  dropouts, evaluation of primary and secondary endpoints, adverse events, and/or problems with informed consent).

·     If a DSMB is required, describe the composition of the board, what role the board will play, and the frequency of meetings.  Confirm that the PI, IRB, RSA, and other appropriate entities will receive all reports of DSMB meetings and other aggregate data analyses that may be indicated in evaluating subject safety.

For additional information on Data Safety Monitoring Boards  click here

Step 4 – Plan for Data Management:

·     Indicate who is responsible for collection and storage of data, where it will be stored. (i.e. Lab notebook, CRF, database) and any security measures needed to properly protect data from inadvertent loss or inappropriate use.

·     Include a description of how often interim data will be reviewed and by whom.

·     Specify any conditions that would necessitate early termination of the study (i.e. some clinical trails require documentation of stopping rules that might be used if the participants are found to be exposed to excessive risks in relation to anticipated benefits).

·     Indicate who will perform aggregate analysis of data and adverse events, if applicable

 Step 5 – Plan for Adverse Event Reporting:

·  Indicate the name and contact information of the individual responsible for monitoring and reporting the occurrence of adverse events throughout the study, whether they are anticipated, unanticipated, or serious, and the frequency of monitoring (annual, 6 months, other).

·  Describe the anticipated adverse events listed in the Consent Form for this protocol.  State your plan for how these will be reported and to whom (i.e. IRB, FDA, NIH).

·        Identify the scale that will be used to grade the severity attribution of adverse events.  to use the GCRC Adverse Event Scale or  the Common Toxicity Criteria (CTC) scale available at:  http://ctep.cancer.gov/. or another scale of your choice.

·        Indicate that you will follow the UTMB IRB Adverse Event Policy on mandatory reporting of Serious Adverse Events (SAEs), and also report them immediately both orally and in writing to the GCRC Program Director or RSA within 24 hours of occurrence or recognition.

·     For additional information on Adverse Events, Scales and Policies click here

 Step 6 – Protection of Human Research Participants-Computer Based Training:

·        Specify that all key research personnel have completed the NIH required training course: "Protection of Human Research Participants".   Key personnel include all individuals responsible for the design and conduct of the study.

·        To complete this training: UTMB Online Training

  Data and Safety Monitoring Plan: Example

Page updated: 01/28/05