STEPS TO STUDY ACTIVATION
Developing a Data & Safety Monitoring Plan
Investigators must ensure that investigator-initiated protocols have a Data & Safety Monitoring Plan (DSMP) sufficient to address the risks associated with their specific protocol.
Certain trials may necessitate enhanced monitoring based on NIH grant stipulations, institutional mandates, and Cancer Center involvement. For further information regarding institutional DSMP considerations, please refer to the IU HRPP Data and Safety Monitoring webpage.
The Indiana CTSI Bioethics and Subject Advocacy Program (BSAP) assists investigators in tailoring data and safety monitoring to their study’s complexity and risk. For a consultation or more information, visit here.
IU Simon Comprehensive Cancer Center (IUSCCC) Additional Information
For trials that operate under the scope of the IUSCCC, (refer to Cancer Center Scientific Review Committee to ensure study is within scope), there is an NCI-approved DSMP that provides defined data and safety monitoring oversights based on study risk. Cancer Center investigator-initiated studies require DSMP template language to be included in the protocol and these can be found in the appendices of the IUSCCC DSMP. PIs developing grant applications should consult IUSCCC Compliance Officer Amy Graf (agraf@iu.edu) to include this IUSCCC DSMP in their grant. Additional monitoring/auditing beyond the scope of the IUSCCC DSMP may be available as needed with pre-agreed percent effort.
Additional information about the IUSCCC DSMP can be found here.
Developing a Data and Safety Monitoring Plan is only one component of study activation. Additional requirements should be reviewed using Clinical Research Roadmap.