STUDY SUMMARY Full of protocol Title Short Title Shortened trial (match this to title used it ClinicalTrials.gov) Version Include date & amendment number. Study phase & design attributes such as single blind, double blind or Study Design open label; randomized, placebo or active placebo control; cross-over design, Simon two-stage, etc. If list all projected centers to be involved & indicate who the Study Center(s) lead site will be. At a minimum list all primary & secondary objectives (can refer to body of Objectives protocol for any exploratory objectives). Number of subjects projected for the entire trial (may specify by phase if Sample Size phase I/II trial). Diagnosis & Key Note the main clinical disease state under study and some of the Eligibility Criteria significant inclusion or exclusion criteria (do not list all criteria here) Brief overview of treatment plan including study intervention(s) and dose/route/regimen or other description of therapy (for non-drug or biologic). Also state overall treatment/intervention timeframe. NOTE: If Treatment Plan name-brand agent is used in the study, may reference the marketed name in background or drug info section, but should use generic name throughout majority of the protocol.
STUDY SUMMARY Title Full of protocol Short Title Shortened (match this to title used it ClinicalTrials.gov) Version Include date & amendment number. Study Design Study phase & design attributes such as single blind, double blind or open label; randomized, placebo or active placebo control; cross-over design, Simon two-stage, etc. Study Center(s) If list all projected centers to be involved & indicate who the lead site will be. Objectives At a minimum list all primary & secondary objectives (can refer to body of protocol for any exploratory objectives). Sample Size Number of subjects projected for the entire (may specify by phase if phase I/II trial). Diagnosis & Key Eligibility Criteria Note the main clinical disease state under study and some of the significant inclusion or exclusion criteria (do not list all criteria here) Treatment Plan Brief overview of treatment plan including study intervention(s) and dose/route/regimen or other description of therapy (for non-drug or biologic). Also state overall treatment/intervention timeframe. NOTE: If name-brand agent is used in the study, may reference the marketed name in background or drug info section, but should use generic name throughout majority of the protocol. trial trial
interventional-protocol.docx