Guidelines - data and safety monitoring plan in research protocol
All protocols should include information about a study's plan for monitoring the safety of the participants, the validity and integrity of the data, and the efficacy of the intervention under investigation.
Click here to download guideline checklist.
Samples of Data Safety Monitoring Plans
Sample A
(Low risk, investigator-initiated, single site study)
This study seeks to evaluate the effectiveness of nutritional counseling, vitamin supplementation or usual care on the quality of life and functional status of persons diagnosed with terminal cancer who are receiving supportive treatment for symptom management. The PI is a specialist in cancer treatment and the co-PI is a nutritionist who specializes in cancer therapy. They both have affiliation contracts with ----, the site from which subjects will be recruited and where the intervention activities will take place. Vitamin supplementation will be prescribed by the treating provider per direction of the PI; nutrition counseling will be provided by a specially prepared clinical nutritionist. All treating staff will complete education in the protection if human research subjects prior to study approval.
(Subject safety:) There is minimal risk associated with this study, and no serious adverse events are anticipated with the study activities. This is a high risk population, so mortality and morbidity associated with the diagnosis is anticipated. Any serious adverse events will be determined by the PI and reported to the IRB and the NCI (sponsor) within 24 hours, specifying the nature of the event and outcome, if related to the study and if anticipated or not. (Efficacy) Eighty subjects will be randomly assigned to each of three groups (N= 240). Ongoing monitoring of subject recruitment and eligibility, randomization, accrual and retention will be conducted by the PI and Co-PI.
(Data integrity:) Data collection will be conducted by trained research nurses, with inter-rater reliability of .90 established prior to data collection. Data will be entered by the project administrator and verified at 100%. Data will be password protected and subjects will be coded to assure confidentiality of information. Preliminary results of effectiveness measures among groups will be performed using correlation statistics at 6 month intervals for the three years of the study. If there are significant differences between intervention A and B after 50% of the subjects and 1 year of the intervention, the effective intervention will be continued and compared to usual care, the ineffective intervention will be discontinued. (Who:)The PI will assume primary responsibility for the ongoing monitoring of the data and safety of the study, and will provide report of this with annual renewal application to the IRB and annual progress report to the NCI.
Sample B.
(Phase 3, sponsored, multi-site clinical trial with moderate risk)
This is a three year multi-site S/K/F sponsored Phase 3 clinical trial to compare the efficacy and safety of -----------, the study drug, with -----------, the current treatment for symptoms of fatigue in persons with MS. This is a moderate risk study ad the safety of the side effects of the experimental drug are being studied. There is potential benefit, as the literature supports the symptom of fatigue is debilitating to MS patients and reduces the quality of life. Eligibility criteria are established by the sponsor and a checklist is included in the instruments attached. The PI and research team are on staff at the -----Center and have extensive clinical and research experience. Subjects will be recruited from the Center patient population by members of the research team and randomized to treatment arm according to the sponsor schedule. An Independent Data and Safety Monitoring Board (DSMB) has been created to have oversight of the study for safety and data integrity.
Subject safety will be monitored by monthly clinical visits and lab studies. Adverse events will be reported to research staff, with a 24/7 call hot line. Serious Adverse Events will be classified as related to the study/not, expected/not. They will be reported to the sponsor, FDA, and IRB within 48 hours of occurring, with a written report faxed and a paper copy mailed immediately. Subjects who miss a scheduled appointment will be contacted within 24 hours by the research co-ordinator to determine the reason. A designated contact person will be called if the subject is not reached.
Data Integrity: Data from lab tests, clinical visits and study instruments will be transposed to Contact Review Forms (CRFs) by the research associate. They will be verified by the research administrator. The sponsor also sends a Contract Research Organization (CRO) reviewer bi-annually to monitor the data, comparing the CRF to the source document, checking eligibility criteria, and reviewing intervention activities per protocol. The CRO report is sent to the PI, with any actions clearly specified. The PI will notify the sponsor and the IRB of the results and actions associated with CRO review.
Interim analyses are planned for 1 and 2 year data analysis. The DSMB will receive and review these analyses and determine if the trial should stop due to ineffectiveness or obvious superiority of the study drug, as determined by comparison of SAEs, lab tests, subject report data, (etc.)
NIH- Further Guidance On A Data and Safety Monitoring For Phase I and Phase II Investigations (Notice: OD-00-038, June 5, 2000) at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html
NIH- Policy for Data and Safety Monitoring (Notice: OD-98-084, June 10,1998) at http://grants.nih.gov/grants/guide/notice-files/not98-083.html
Recommendation ot General Clinical Research Centers (GCRCs) for Patient Clinical Research: http://www.ncrr.nih.gov/clinical/gcrcpatientsafety20010622.asp
Essential Elements of a Data and Safety Monitoring Plan for Clinical Investigators Funded by the National Cancer Institute at http://www.nci.nih.gov
NHLBI: Establishing Data and Safety Monitoring Boards (DSMBs) and Observational Study Monitoring Boards:http://rover2.nhlbi.nih.gov/funding/policies/dsmb_est.htm
NHLBI: Responsibility of Data and Safety Monitoring Boards (DSMBs) applied to Participating Institutions: http://rover2.nhlbi.nih.gov/funding/policies/dsmb_est.htm
Frederic C. Bartter General Clinical Research Center, Overview of the Requirement for a Research Subject Data Safety and Monitoring Plan (DSMP): http://gcrc.uthscsa.edu/dsmp/dsmpguidelines.htm
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