III. Study Initiation Meeting Checklist Completion Instructions Mark each item below as: item verified and/or discussed; unable to Yes, No, verify and/or discuss item; or, Provide comments for items marked or Not Applicable; Not Reviewed. No, whenever necessary or helpful. Review of Study RESPONSE COMMENTS ITEMS VERIFIED and/or DISCUSSED Background and Purpose of Study Study Objectives, Endpoints, and Design Clinical and Laboratory Evaluations Schedule of Evaluations, and Windows Enrollment RESPONSE COMMENTS ITEMS VERIFIED and/or DISCUSSED Informed Consent Process Screening/Pre-Entry Period No Exemptions Registration/Randomization Recruitment/Retention Anticipated Start of Enrollment Pharmacy RESPONSE COMMENTS ITEMS VERIFIED and/or DISCUSSED Study Drug Availability Study Drug Packaging and Labeling Study Drug Storage Study Drug Accountability and Use of DARF Staff Roles and Responsibilities
III. Study Initiation Meeting Checklist Completion Instructions Mark each item below as: Yes, item verified and/or discussed; No, unable to verify and/or discuss item; Not Applicable; or, Not Reviewed. Provide comments for items marked No, or whenever necessary or helpful. Review of Study ITEMS VERIFIED and/or DISCUSSED RESPONSE COMMENTS Background and Purpose of Study Study Objectives, Endpoints, and Design Clinical and Laboratory Evaluations Schedule of Evaluations, and Windows Enrollment ITEMS VERIFIED and/or DISCUSSED RESPONSE COMMENTS Informed Consent Process Screening/Pre-Entry Period No Exemptions Registration/Randomization Recruitment/Retention Anticipated Start of Enrollment Pharmacy ITEMS VERIFIED and/or DISCUSSED RESPONSE COMMENTS Study Drug Availability Study Drug Packaging and Labeling Study Drug Storage Study Drug Accountability and Use of DARF Staff Roles and Responsibilities
SOP2a-InitiationRptTmplt_01-06-2017.docx