Clinical Research Unit Services (CRUS)
DATA AND SAFETY MONITORING PLAN
What is a Data and Safety Monitoring Plan (DSMP)?
The Cleveland Clinic Clinical Research Unit (CRU) of the Clinical and Translational Science
Collaborative (CTSC) of CWRU are funded by the National Institutes of Health (NIH). The NIH
requires oversight and monitoring of all clinical trials to ensure participants’ safety and data
validity and integrity. All protocols conducted in the Clinical Research Unit (CRU) must have a
DSMP—even protocols involving only residual biological specimens. The following steps will
guide you in the design a DSMP and assist you in completing the DSMP section of the
“Application for Clinical Research Unit Services”
In order to develop a DSMP, a PI must identify protocol risk level, identify who is responsible to
monitor the safety risk, assessing and reporting, and if necessary, decide whether or not to
modify a protocol and/or the informed consent.
The plan specifics depend on the nature, size, complexity and risk of the research study. Risk
associated with participation in research must be minimized as much as is practical.
Determining risk level will help determine who is needed for safety monitoring and what safety
parameters should be in place. All monitoring plans must include a description of the
mechanisms for reporting adverse events and unanticipated problems to the IRB and NIH, FDA,
Sponsors, if needed. The required method and amount of monitoring depends upon the degree
of risk involved.
In studies of small numbers of subjects, toxicity may more readily become apparent through
close monitoring of individual patients, whereas in larger studies risk may be better assessed by
statistically comparing treatment groups. A Data and Safety Monitoring BOARD (DSMB) is
required for all multi-center trials, all gene transfer studies and all NIH-funded Phase III trials. In
phase I and II trials, several factors influence risk. For many phase I and phase II trials,
independent DSMBs may not be necessary or appropriate if the intervention is of low risk. But, if
a phase I or II trial has multiple clinical sites, is blinded or uses particularly high-risk
interventions or involves vulnerable populations, a DSMB may be appropriate.
In some instances, the PI or IRB may determine that monitoring does not require a DSMB but
should not be done by the PI and choose an independent medical monitor for the study.
DSMP or DSMB Questions? Please contact the CRU Research Subject Advocate:
Dr. Sumita Khatri, (216) 445-1701; pager 14-83257, or RSACRU@ccf.org
Revised 12/30/13
PROTOCOL RISK LEVEL
Check all applicable study procedures—this does not mean procedures done as part of
routine care.
Data Collection
LEVEL I RISK: minimal and low risk studies
Procedures (CONT)
Chart review, interview, questionnaire
Pathology slide review
Anthropomorphic evaluations
Observational studies
Procedures
Electrocardiograms (EKGs)
Echocardiograms (Non-TEE)
Urine Collection, simple
Urine Collection, 24-hr
Intravenous glucose tolerance tests
Magnetic resonance imaging (MRI) without
contrast
MRI with Contrast
DEXA scans
CT with contrast
CT without contrast
Exercise testing
Intravenous catheter insertion
Venipuncture
Oral glucose tolerance tests
Special/prescribed diets
PET scans
Other low (Level I) risk non-therapeutic tests
or studies (list):
LEVEL II RISK: moderate risk studies
Study Population
New Drug/Device
Child population
Elderly population
Pregnant population
Normal population (Healthy Volunteers)
Psychologically or neurologically
impaired population
Other vulnerable population
Agent under early evaluation, Phase III
Phase IV Post marketing study
Moderate Risk Procedures
Endoscopy
Insulin clamp
Muscle biopsy
LEVEL III RISK: high risk studies
Invasive Diagnostic Maneuvers
Internal organ biopsy
Invasive diagnostic maneuvers (list):
Other high risk non-therapeutic tests or studies
(list):
New Drug/Device
Gene transfer study
Pharmaceutical agent(s) never used
before or investigator-initiated IND(s)
Product manufactured in CCF lab
Phase I and II protocols (with substantial
subject risk) or phase III
Pilot clinical studies
Investigator initiated IND
Rank level of risk (select one - the highest level checked above will determine risk level
for entire protocol)
LEVEL OF RISK
Level I / Level II Risk
Appropriate category if all identified procedures were
selected from the Level I risk and/or Level II risk sections
above.
Level III Risk
Appropriate category if any of the identified procedures
were selected from the Level III risk section.
Revised 12/30/13
SAFETY CONTACT MONITORING
Who shall be contacted and available on-call, including after-hours, in the event of an
unexpected event, or research subject safety concerns?


This study involves only residual biological specimens (this means specimens that are
left over from routine clinical care or research other than this study). The Principal
Investigator is solely responsible for safety, adverse events and progress reporting as
appropriate.
The study involves low study numbers or level I risk and the PI will be solely responsible
for all safety, adverse events and progress reporting
No additional information is needed

This study is a Level I or II risk but there is a need for additional monitoring by other
physicians and/or other staff are listed in the protocol/consent form as safety contact
Complete this section on the application
Name
Admitting
Privileges?
Role on Project
Contact Information
(telephone, pager, e-mail)
Yes
No



There is monitoring required in addition to the PI and the other physician listed
The study has an independent medical monitor
The study is level III risk and/or a phase III trial and requires a DSMB
Complete this section on the application
Name
Revised 12/30/13
Title
Affiliation
Contact Information
ASSESSMENT OF PATIENT SAFETY
What findings or events would require a research subject to be removed from the study?


What type of study parameters will be monitored and/or evaluated and by whom?
Will there be certain clinical testing required for safety and by whom?
Are there defined stopping rules in the protocol?
Explain them.
Yes
No
Describe any anticipated Adverse Events.
 Include anticipated adverse events and any potential unanticipated problems if known
 All adverse events and unanticipated problems need to be reported to the CRU
Research Subject Advocate (RSA) in conjunction with the requirements by the IRB
 Please list all other institutes that adverse events will also be reported to (NIH, FDA,
DSMB, sponsor, Drug/device manufacturer, etc.)
Please provide any other information relevant to the Data and Safety Monitoring Plan,
including any information pertaining to the data confidentiality if necessary.
DATA CONFIDENTIALITY




Will study data be disclosed or shared with persons outside of the institution?
Does the consent form make these disclosures clear to the research subject?
Does the protocol describe clearly how data is being protected?
Is data being stored in REDCAP? Another electronic database?
Revised 12/30/13