Study Staff Training and Delegation of Duty Log SOP

SCOPE: The PM&R Study Staff Training and Delegation of Duty Log should be created at study start-up and kept with your study records in the purple folder. All personnel that will be working on the study should be added to this form.
AIMS: The PM&R Study Staff Training and Delegation of Duty Log outlines the scope of each individual’s work on a given study. The Principal Investigator assigns all study personnel a number of duties or authorities. The PM&R Study Staff Training and Delegation of Duty Log serves as a consolidated, easily accessible list of these responsibilities.
RESPONSIBILITY: The PM&R Study Staff Training and Delegation of Duty Log should be maintained by the Principal Investigator, Project Coordinator, or Primary Contact. It is the responsibility of each individual added to the study to ensure they are listed on the document.
VERSION: 12/04/2017 EFFECTIVE DATE: 12/04/2017
APPROVED BY: M. Mealer-Russ
APPROVAL DATE: 12/04/2017

The form can be found here:

S:\REHAB\RSEC\Study Startup - Electronic Binder Template\11. Regulatory\6. Personnel

  1. When you have a new study starting, please make sure you complete the PM&R Study Staff Training and Delegation of Duty Log to be included with your study records.
  1. Fill in the Principal Investigator’s name, the Institution, Project Title, COMIRB Project #, and Study Site in the appropriate boxes.
  1. For each individual that will assist with the study, add her/his full name and title in the first column. Do this for all personnel, regardless of whether they are considered engaged in human subjects research. This form serves as a record of all individuals that have or will perform one or more services to the project. Please note that clinicians serving as non-key personnel for emergency purposes only do not need to be listed on this form.

[Note: this PM&R Study Staff Training and Delegation of Duty Log should provide a comprehensive list of study personnel and should be more exhaustive than the personnel form approved by COMIRB]

  1. Each individual listed must identify their study role and sign and initial the log, acknowledging their assignment to the study and that they have received the appropriate study-specific training.
  1. List all agreed upon delegated study tasks in the “Key Delegated Study Task(s)” column. Examples of key delegated tasks are provided at the bottom of the form; however, you can modify the tasks based on the individual study by deleting one of the examples and replacing with a study specific task. Ensure that all possible tasks an individual may be responsible for are listed appropriately.
  1. Assign start dates for each individual listed. Remember to update the “to” date any time this field changes (i.e. someone no longer works on the study).
  1. Once completed, give the log to the Principal Investigator for review and signatures. The PI should review and sign for each individual’s record.
  1. When a new individual is added to the study, remember to add her/him to the Delegation of Duty log, following steps 3-7 outlined above. When the log is full, add and complete a second page and save it within your regulatory binder.

Do not remove individuals from the log, even if they are no longer working on your study. The “To” date in the “Duration” column should reflect personnel end dates; the log should provide a comprehensive record of all personnel that have worked on the study at any given time.

Helpful tips:

  • If you are unsure of what authorities you have for a given project, consult the PM&R Study Staff Training and Delegation of Duty Log for your study prior to performing any tasks or procedures to ensure that you have been given the proper permissions.
  • You may update the log at any time. When updates are made, be sure to obtain an updated signature from the PI.
  • It may be helpful to check the log periodically to ensure all dates and delegated study tasks are current.

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Effective Date: 12/04/2017