Site Signature and Delegation Of Responsibilities Log.
Study Sponsor: / Principal Investigator:
Protocol /Study Number: / Study site Number:
Country:
PLEASE REFER TO THE GUIDANCE DOCUMENT FOR INSTRUCTIONS ON THE COMPLETION OF THIS FORM.
THIS FORM IS TO BE COMPLETED BY SITE PERSONNEL INVOLVED IN THE STUDY TO WHOM THE INVESTIGATOR HAS DELEGATED SIGNIFICANT STUDY-RELATED DUTIES AND PRIOR TO CONDUCTING ANY STUDY RELATED ACTIVITIES.
THE PRINCIPAL INVESTIGATOR MUST ENSURE THAT PERSONNEL ONLY START THE DELEGATED STUDY-RELATED TASKS AFTER CONFIRMING THAT THEY HAVE RECEIVED STUDY RELATED TRAINING APPROPRIATE TO THE ROLE.
THE STUDY SITE IS REQUIRED TO MAINTAIN AN UP TO DATE ORIGINAL OF THIS FORM IN ACCORDANCE WITH SPONSOR REQUIREMENTS.
Name of Principal Investigator / Principal Investigator’s Signature* / Principal Investigators Initials / Start
(dd/mmm/yy) / End
(dd/mmm/yy)

*My signature confirms/acknowledgesthat the information contained here is accurateand that;

  • I will remain responsible for the overall study conduct and reported data.
  • I will ensure study oversight.
  • I will authorize the delegation of study-related tasks to each individual as listed.
  • The study tasks listed will only be delegated by me to skilled and qualified staff appropriately trained for the role.
  • I will ensure that all personnel assisting in the conduct of the study are informed about their obligations and will not have performed any delegated study-related tasks prior to appropriate delegation and completion of study training appropriate to the role.
  • I will ensure that site staff receives, in a timely manner, the appropriate information and training.
  • I will ensure that any and all changes in staff or delegated study-related task will be recorded in a timely manner.

Study Task Key:

  1. Coordinates IRB/EC communications
/
  1. Makes study related medical decisions
/
  1. Processes biologic sampleand shipssample
/
  1. Manages study drug/device accountability

  1. Screens/recruits study subjects
/
  1. Evaluates study related test results
/
  1. Uses IWRS/IVRS
/
  1. Activities related to Regulatory submissions

  1. Obtains Informed Consent
/
  1. Performs study-related assessments
/
  1. Makes entries/corrects e/CRFs
/
  1. Activities related to code break

  1. Confirms eligibility (Inclusion/Exclusion)
/
  1. Assesses AEs/SAEs
/
  1. Signs-off e/CRFs
/
  1. Other *......

  1. Obtains medical history
/
  1. Reports SAEs
/
  1. Resolves data queries
/
  1. Other *......

  1. Performs physical examination
/
  1. Stores study drug and/or monitors temperature
/
  1. Maintains essential documents
/
  1. Other*......

  1. Conducts study visit procedures
/
  1. Collects samples
/
  1. Prepares/dispenses study drug/device
/
  1. Other*......

(*)Other tasks may be those that are study specificor are local regulatory requirementsand have been identified by the Study Sponsor.

Name / Signature
My signature below indicates that I accept the study task. / Initials /

Study Role

/ Study Task(s)
(Select from key) / Start of task(s)
(dd/mmm/yy) /

PI Initials

/ End of task(s)
(dd/mmm/yy) /

PI Initials

Comments:Please check box if there are no comments

I confirm that the information contained in this document is accurate and complete. (To be completed by the Principal Investigator at the end of the study).

Principal Investigatorname:Signature:Date:

Site Signature and Delegation Of Responsibilities LogJune 2015

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