ࡱ>  bjbj Ů`o``o` x yyyyy8,$0(===T0V0V0V0V0V0V0Q36V0y]]"V0yy== k0GGGdy=y=T0GT0GGZ'h*(@ KL'@0000'X6/ 6 *(*(6y(TGV0V0; 06 Y ?:  Principal Investigator _____________________________ Site Name/# ___________ Study Title IRB # ___________ Protocol Name/# ___________ Sponsor Date of Site Initiation Visit (SIV) _________ Date of Site Activation __________ Pre-Visit Preparations: Schedule the SIV with the study sponsor and all key research personnel. Schedule and document alternate training for individuals who cannot be present at the SIV. Compile available regulatory documents ahead of the SIV. Confirm all required agreements have been executed (e.g. Clinical Trial Agreement). Confirm all approvals have been obtained as applicable (IRB, IBC, Radiation Safety, TPRM). Conducting the SIV: The SIV is completed by the study sponsor, CRO, or sponsor-investigator if the study is investigator-initiated. If conducting an investigator-initiated SIV, utilize the below visit checklist: Opening meeting with introductions, objectives and visit agenda. Detailed protocol training: objectives, study design, participant population, eligibility, randomization procedures, visit schedule, safety monitoring, AE reporting. Review essential documents and regulatory files. Review informed consent process and documentation procedures. Review CRFs and data collection guidelines. Ensure all study supplies (e.g., lab kits, blood draw supplies, patient diaries) are available and facilities are adequate to conduct the study. Training: Complete any specialized protocol training, including but not limited to applicable drug or device training procedures, specialized training required by the sponsor/CRO, or training on the behavioral intervention/assessments. Review procedures for data management and safety reporting (sponsor and IRB requirements). Post-Visit Activities: File the SIV follow-up letter and accompanying documentation in the studys regulatory files. Ensure SIV records include a list of personnel who attended the SIV and details on the protocol training each received. Ensure follow-up items following the SIV are resolved, regulatory files are complete, supplies are available, and all applicable training has been completed. Ensure all applicable approvals have been obtained (e.g., IRB, EHS, TPRM) and official site activation has been granted by the sponsor/CRO. If any of the above items have not been completed or additional site initiation activities remain outstanding, e.g., receipt of supplies, training of additional personnel, document and notes and comments below with estimated completion dates. 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