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DSM Reporting Flowsheet

DSM Reporting Flowsheet. Start. UMCCC PRC provides peer review of the scientific merit of all clinical trial research to be conducted at the UMCCC. Administrative review is performed on NCI-recognized Cooperative Group Trials or studies peer-reviewed by the NCI (CTEP or DCPC).

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DSM Reporting Flowsheet

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  1. DSM Reporting Flowsheet

  2. Start UMCCC PRC provides peer review of the scientific merit of all clinical trial research to be conducted at the UMCCC. Administrative review is performed on NCI-recognized Cooperative Group Trials or studies peer-reviewed by the NCI (CTEP or DCPC). Is the study subject to review by the UMCCC Protocol Review Committee (PRC)? No Yes Independent External DSMB? Yes No

  3. Tissue repository Processed through the PRC to have a UMCC number assigned for tracking purposes END Correlative without therapeutic intent No DSMR No

  4. Start UMCCC PRC provides peer review of the scientific merit of all clinical trial research to be conducted at the UMCCC. Administrative review is performed on NCI-recognized Cooperative Group Trials or studies peer-reviewed by the NCI (CTEP or DCPC). Is the study subject to review by the UMCCC Protocol Review Committee (PRC)? No Yes Independent External DSMB? Yes No

  5. Only ACOSOG, ACRIN, CALGB, COG, ECOG, EORTC, GOG, NCCTG, NCIC, NSABP, RTOG, SWOG. These are the NCI cooperative groups. Emphasis is on randomized Phase III studies (large-scale trials in a multi-institutional setting). NCI Clinical Trials Cooperative Group END No DSMR Industry Sponsored Industry trials have established oversight committees END No DSMR Yes Lists of example consortia, networks, alliances, and coalitions are not complete and may not be processed as shown Other Multi-institutional, where UM is not coordinating center Default Path AlternatePath EDRN, MMRC, NABTC, PCCTC, SARC, University of Chicago Phase II Consortium (examples) BMT-CTN, NANT, TACL SUBMISSION OF DSMRBegin submitting to DSMB as soon as study is Open to Accrual. Therapeutic Phase I monthly or per protocol; or per DSMB ruling Therapeutic Phase II quarterly or per protocol; or per DSMB rulingTherapeutic Phase III. For non-cooperative group, limited-institution therapeutic Phase III studies without NCI / NIH monitoring, the PI at the lead institution will be responsible for monitoring the study and establishing an independent trial-specific DSMB.Non-therapeutic every 6 months or per protocol or DSMB ruling. Submit DSMR, or as specified by protocol, tothe DSMB specified by protocol Submit DSMR for all internal subjects for review by the UMCCC DSMB Wait for evidence of review Wait for evidence of review Study team passes on evidence of review to coordinating center and UM IRBMED Study team passes on evidence of review to UM IRBMED END END

  6. Start UMCCC PRC provides peer review of the scientific merit of all clinical trial research to be conducted at the UMCCC. Administrative review is performed on NCI-recognized Cooperative Group Trials or studies peer-reviewed by the NCI (CTEP or DCPC). Is the study subject to review by the UMCCC Protocol Review Committee (PRC)? No Yes Independent External DSMB? Yes No

  7. P01 Program Project Grant NCI $ for PI for exploratory or developmental studies or for UMCC program support R01 Research Project Grant No R21 or R21 Quick-Trial Grant Investigator-initiated multi-institutional, where UM is coordinating center Investigator-Initiated, local Submit DSMR for all internal subjects and DSMRs for all external subjects for review by the UMCCC DSMB; include a summary DSMR for all subjects together. Submit DSMR for all internal subjects for review by the UMCCC DSMB Wait for evidence of review Wait for evidence of review Study team passes on evidence of review to UM IRBMED and participating sites Study team passes on evidence of review to UM IRBMED END END

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