The purposes of the CCTSI Study Monitoring Committee (SMC) include
- oversee the safety of studies conducted within the Clinical and Translational Research Centers (CTRC). The SMC is charged to prospectively review the Data and Safety Monitoring Plans (DSMP) of all studies conducted on a CTRC and review studies that are active.
- oversee the recruitment and retention plan for all clinical research studies conducted at the University of Colorado Denver with COMIRB oversight.
CCTSI SMC Committee
The CCTSI SMC consists of SARC members as follows: (1) CCTSI Research Subject Advocate, (2) biostatistician, (3) physicians, and (4) senior research scientists.
The goals of the CCTSI SMC include:
independent monitoring to assure study safety and study integrity of
active studies on a CTRC
and support investigators to develop detailed and effective data and
safety monitoring plans for their study
that there is appropriate oversight for significant risk studies (in
conformity with NIH guidelines)
SARC with updates on the progress of current studies on a CTRC as needed
that new literature or research information is considered by on-going
studies and revised appropriately
safety reports from other safety bodies and ensure that recommendations
have been appropriately addressed
and liaise with safety officers
- Act as
a resource for DSMBs, safety officers, investigators, SARC, COMIRB, and
Active studies on the CTRC shall undergo at least annual
review by the SMC for safety based on risk assessment.
Study monitoring requirements will vary depending on the
nature and structure of the study to be undertaken. Minimal or low risk studies
can be monitored appropriately for safety by the investigator. Moderate and high risk studies require a
level of oversight other than can be provided by the investigator. These
studies will utilize, in addition to the investigator, additional monitoring such
as a safety officer or DSMB.
The extent of SMC safety monitoring for CCTSI studies will be based upon a risk assessment. Factors to be taken into account include the
Multicenter vs single site investigator
Inclusion of normal, healthy subjects
Inclusion of special populations
Continued oversight of DSMB
Continued SAE and AE monitoring
Delays in recruiting participants to clinical studies are a major barrier to progress in clinical research. Initially, it is important to develop realistic recruitment goals and have a means of tracking enrollment. Recruitment milestones are expected to be met by the investigators at specific time periods. It will be the responsibility of the CCTSI SMC to ensure the timely assessment of recruitment milestones. If, at any time, recruitment falls significantly below the milestones projected by the principal investigator, the CCTSI will consider taking one or more actions, depending on the severity and duration of the recruitment shortfall. The CCTSI SMC generally will work with the investigtor to correct the deficiencies before taking action.