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Sample Individual Delegation of Authority and Signature LogSponsor: Overall PI: IRB Protocol Number:Statement of the Overall PI: I am delegating the researchspecified tasks to starting on (date) and.

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FDA and ICH/GCP Guidelines call for investigators to ”maintain a list of appropriately qualified persons to whom the investigator has delegated significant trial-related duties.” This documentation can be called Delegation of Duties/Responsibilities Log or Delegation of Authority.

Delegations of Authority are important to the operation of the Agency. Delegations allow the FDA Commissioner and other officials to convey their authorities to subordinate officials so they may legally carry out the many activities of the Agency.

The IoR is responsible for the overall conduct of the trial. The IoR documents delegation of specific duties to site personnel using the DoD log. Any duties not delegated remain with the IoR; however, these duties do not need to be documented on the DoD log.

Prior to beginning research-specific tasks, the PI, with the assistance from the study team, will complete and keep current the Delegation of Authority (DOA) log.

The delegation of authority (DOA) log is a mechanism for tracking study team members over time. Those who are engaged in the research activity (including IRB approved study team members) need to be listed on the log.

Details: This log should provide a comprehensive list of study staff members and the duties that have been delegated to them by the Principal Investigator. It is required for both observational and interventional clinical research studies.

All Clinical Research Site (CRS) staff and other individuals who have been delegated significant study-related duties or tasks, which the Principal Investigator (PI)/Investigator of Record (IoR) would otherwise do, must be listed on the Delegation of Duties (DoD) log.

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© Copyright 1997-2025
airSlate Legal Forms, Inc.
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Form Packages
Adoption
Bankruptcy
Contractors
Divorce
Home Sales
Employment
Identity Theft
Incorporation
Landlord Tenant
Living Trust
Name Change
Personal Planning
Small Business
Wills & Estates
Packages A-Z
Form Categories
Affidavits
Bankruptcy
Bill of Sale
Corporate - LLC
Divorce
Employment
Identity Theft
Internet Technology
Landlord Tenant
Living Wills
Name Change
Power of Attorney
Real Estate
Small Estates
Wills
All Forms
Forms A-Z
Form Library
Customer Service
Terms of Service
DMCA Policy
About Us
Blog
Affiliates
Contact Us
Privacy Notice
Delete My Account
Site Map
All Forms
Search all Forms
Industries
Forms in Spanish
Localized Forms
Legal Guides
Real Estate Handbook
All Guides
Prepared for You
Notarize
Incorporation services
Our Customers
For Consumers
For Small Business
For Attorneys
Our Sites
US Legal Forms
USLegal
FormsPass
pdfFiller
signNow
airSlate workflows
DocHub
Instapage
Social Media
Call us now toll free:
1-877-389-0141
As seen in:
  • USA Today logo picture
  • CBC News logo picture
  • LA Times logo picture
  • The Washington Post logo picture
  • AP logo picture
  • Forbes logo picture
© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232