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Manage Delegation of Authority Log

Overview

  • Each site is equipped with only one Delegation of Authority (DoA) Log. Although there is just one log per site, it can encompass multiple versions over time.
  • The PI can initial the DoA Log only after all assigned members have signed off on their respective delegations.
  • A new version of the DoA Log can be created only after the PI has initialed the existing version. This ensures a controlled and orderly process for updating and maintaining the integrity and accuracy of the log.

New Delegation

Create a New Delegation of Authority (DoA) Log for a Site

Follow these simple steps to create a new DoA Log:

  1. Access the main menu and select Documents. From there, choose Delegation of Authority Log.
  2. Click on the Add New button. A prompt will appear for you to enter details.
  3. Enter the Required Information:
    • Select Site: Choose the relevant site from the dropdown menu.
    • Enter Protocol Version: Type in the specific protocol version you're working with.
    • Select Principal Investigator: Pick the Principal Investigator from the provided list.
  4. Once all the necessary information is filled in, click Save to finalize your new DoA Log.

And you're done! You've successfully created a new Delegation of Authority Log for your site.

Assign Delegation to Study Staff

Follow these steps to assign delegation roles and responsibilities to your study staff:

  1. Access the DoA Log:
    • Go to the Delegation of Authority (DoA) Log of a specific site.
    • Click on the Edit icon to open the details page.
  2. Add a New Delegation: In the "Delegated Roles & Responsibilities" section, click on the ADD DELEGATION button.
  3. Enter Staff Information:
    • Select Staff Name: Choose a staff member from the list. These are users in your T6 EDC system for the study at the corresponding site. 
    • If the delegate is not in the EDC system, check DELEGATE NOT IN THE SYSTEM, and manually enter their name and email.
  4. Define Role and Duration:
    • Select Role: Choose the specific role they will have in your study.
    • Start Date: Set the date when the delegation starts.
    • End Date (Optional): You can specify an end date, or leave it open-ended.
    • Responsibilities: Outline the specific responsibilities assigned to the staff member.
    • Notes (Optional): Add any additional notes if necessary.
  5. Save Your Entries: Once all information is filled out, click Save to complete the process.

Delegation Modifications

Edits to assigned delegations are permissible only if the log hasn't been approved by the Principal Investigator (PI). Should any changes be made, staff members who have signed must do so again to validate the updates. However, once the PI has signed off on the DoA, any alterations necessitate the creation of a new version of the log. Following such updates, both staff and the PI are required to sign and approve the document anew. 

Exception: if the modification is solely to extend or shorten the end date of a delegation, staff signatures are not needed, assuming that the staff member's involvement in the study has ceased. This policy ensures that the DoA Log remains a current and accurate record of delegated responsibilities within your study.

Edit a Delegation in the DoA Log

If you need to make changes to an existing delegation, follow these straightforward steps:

  1. Locate the Delegation Entry: Find the delegation entry you wish to edit in the Delegation of Authority (DoA) Log.
  2. Begin Editing: Click on the Edit icon (pencil) next to the delegation entry. This action will open the delegation details for editing.
  3. Make Necessary Changes: Update any details such as staff name, role, start/end dates, responsibilities, notes, or other relevant information.
  4. Save Your Changes: After making the desired edits, click Save to update the delegation entry.

Delete a Delegation Entry from the DoA Log

If you need to remove a delegation entry from your Delegation of Authority Log, please follow these steps:

  1. Find the Delegation Entry: Review the Delegated Roles & Responsibilities section to locate the entry you wish to delete.
  2. Click on the Trash Bin icon corresponding to the entry you intend to remove. This will prompt a deletion confirmation dialogue box to appear.
  3. Confirm Deletion: If you are certain you want to proceed, click OK. If you've changed your mind or clicked the icon by accident, select CANCEL.

 

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