Study Start Date: / Page:____ of ____
Protocol Title:
/ PI:
Sponsor:
Indicate delegated duties by checking the appropriate boxes
Research Personnel Printed Name/ Signature & Initials / Role in Study / Dates of Study Involvement / Consent / Study Oversight / CRFs / Study Co-ordination / Study Assess-ments / Study Inter- vention / *Other: Specify
Start / End
I verify the delegation of duties listed above / I verify that this log is complete and accurate
Principal Investigator Signature/Date:______/ Principal Investigator Signature/Date:______
(Signature at beginning of study) / (Signature at study close-out)
PLEASE MAINTAIN THIS LIST WITH YOUR STUDY FILES (see reverse side for instruction on document completion) Version 3/8/2006
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STAFF SIGNATURE SHEET AND DELEGATION OF RESPONSIBILITIES LOGDocument Completion Instruction
Personnel listed on this log should include those who are involved with the study such as Investigators, Study Coordinators, Research Assistants, study Counselors/Supervisors and any other individuals directly involved in the conduct of study. This log should also include any contracted specialists performing protocol-required examinations (e.g. physical exams). Changes in delegated duties should be reflected on Log including the addition of new or replacement staff with the PI initialing and dating any changes. Please complete page numbers. The PI must sign and date each page of this log at the beginning of the study verifying the delegation of duties listed, initial and date changes occurring during the study, and subsequently sign and date the document at end of study verifying that log is complete.
Definition of Terms
Study Start Date: / The date the study starts.
Principal Investigator / Name of Principal Investigator on record with the IRB
Role in Study: / Role of the Individual on the protocol.
Dates of Study Involvement: / Start date is the date the individual began working on the study. This may be the same as the Study Start Date or a later date. End date is the date the individual finished the study. This may be the date of the study close out or an earlier date. If newly delegated duties are added, PI checks appropriate boxes, initials and dates changes. If delegated duties are removed for an individual, note end date under "Dates of Study Involvement" and re-list the individual indicating the Start date of current duties".
Consent: / IRB approved to obtain informed consent for the study
Study Oversight: / Study/Staff supervision, Data/CRF Review and Approval
CRF's: / Completion/Correction of CRF's, Queries/data clarifications
Study Coordination: / Recruitment, Coordinating visit/staff/assessments
Study Assessments: / Completion of Safety and/or Outcome Assessments, i.e. Physical Exams, etc.
Study Intervention: / Med. Preparation/Titration/Compliance/Dispensing; Device; or for Behavioral trials Counseling/Therapy
Other: / Specify protocol duties not included elsewhere
Start of Study Protocol PI Signature: / Signature of Principal Investigator at study start verifying delegation of duties as listed
End Of Study Protocol PI Signature: / Signature of Principal Investigator upon study close-out verifying that the Log is complete and accurate
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