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Steps that Precede Clinical Study Initiation (DSMB)

Steps that Precede Clinical Study Initiation (DSMB). Review, finalize, and submit: Protocol Response to summary statement concerns Human Subjects Protection Plan/ Safety Monitoring Plan Target Enrollment Form Human Subjects Training Certification

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Steps that Precede Clinical Study Initiation (DSMB)

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  1. Steps that Precede Clinical Study Initiation (DSMB) • Review, finalize, and submit: • Protocol • Response to summary statement • concerns • Human Subjects Protection Plan/ • Safety Monitoring Plan • Target Enrollment Form • Human Subjects Training Certification • (delivered to Grants Management Brach) • Model Informed Consent Form IRB • Develop or revise study materials • and procedures: • Study organization • Manual of Operations • Study forms/CRFs • Safety monitoring processes/reports • DSMB report outline YES Protocol, Informed Consent, or other study materials require changes NO Changes suggested by NINDS/DSMB? YES NO DSMB recommends to NINDS that study can begin If NINDS agrees, schedule investigator meeting

  2. Steps that Precede Clinical Study Initiation (SMC/IMM) • Review, finalize, and submit: • Protocol • Response to summary statement • concerns • Human Subjects Protection Plan/ • Safety Monitoring Plan • Target Enrollment Form • Human Subjects Training Certification • (delivered to Grants Management Brach) • Model Informed Consent Form IRB YES • Develop or revise study materials • and procedures: • Study organization • Manual of Operations • Study forms/CRFs • Safety monitoring processes/reports Protocol, Informed Consent, or other study materials require changes NO Changes suggested by NINDS? YES NO NINDS states study can begin

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