DELEGATION OF RESPONSIBILITY LOG Protocol Number : Site Site Name : Number : Principal Investigator : Sponsor : Name Role Key Task(s) Initials Signature Start Date PI End Date PI (choose from list below) (dd/mmm/yyyy) Initial (dd/mmm/yyyy) (If prior to EOS) Principal Investigator Investigator Signature: Date: Comments: 16 = Make entries/corrections on CRFs Task Key: 5 = Perform physical exam 10 = Perform drug accountability 17 = Sign off CRF 1 = Obtain Informed Consent 6 = Conduct study visit procedure as 11 = Study drug storage and temperature outlined in the protocol monitoring 18 = Maintain essential documents 2 = Subject selection/recruitment 7 = Make study related medical decisions 12 = Sample collection 19 = Perform study related assessments as per protocol 3 = Confirm eligibility (review inclusion/exclusion criteria) 8 = Assess AEs/SAEs 13 = Sample processing and/or shipment 20 = Other (specify): 4 = Obtain medical history (source 9 = Dispense drug 14 = Evaluate study related test results 21 = Other (specify): documents) 15 = Use IWRS/IVRS Name Role Key Study Task(s) Initials Signature Start Date PI End Date PI (choose from list below) Initial (dd/mmm/yyyy) (dd/mmm/yyyy) (If to EOS)
DELEGATION OF RESPONSIBILITY LOG Protocol Number : Site Name : Site Number : Principal Investigator : Sponsor : Name Role Key Task(s) (choose from list below) Initials Signature Start Date (dd/mmm/yyyy) PI Initial End Date (dd/mmm/yyyy) (If prior to EOS) PI Principal Investigator Investigator Signature: Comments: Date: Task Key: 1 = Obtain Informed Consent 2 = Subject selection/recruitment 3 = Confirm eligibility (review inclusion/exclusion criteria) 4 = Obtain medical history (source documents) 5 = Perform physical exam 6 = Conduct study visit procedure as outlined in the protocol 7 = Make study related medical decisions 8 = Assess AEs/SAEs 9 = Dispense drug 10 = Perform drug accountability 11 = Study drug storage and temperature monitoring 12 = Sample collection 13 = Sample processing and/or shipment 14 = Evaluate study related test results 15 = Use IWRS/IVRS 16 = Make entries/corrections on CRFs 17 = Sign off CRF 18 = Maintain essential documents 19 = Perform study related assessments as per protocol 20 = Other (specify): 21 = Other (specify): Name Role Key Study Task(s) (choose from list below) Initials Signature Start Date (dd/mmm/yyyy) PI Initial End Date (dd/mmm/yyyy) (If to EOS) PI
DELEGATION-LOG-1.docx