Task Delegation Log

REB NUMBER: / QUALIFIED INVESTIGATOR (QI): / SITE NUMBER:
FULL STUDY TITLE: / INSTITUTION: / SPONSOR NAME:
NAME
(Print Clearly) / STUDY ROLE
(Print Clearly) / FULL SIGNATURE /

INITIALS

/ DELEGATED TASKS
Write Numbers
(see list)[SH1] / QI SIGNATURE
to authorize delegation and affirmation of qualifications / DATE OF SIGNATURE
(yyyy-mmm-dd)[SH2] / QI SIGNATURE
for End of Study or End of Study Role / DATE OF SIGNATURE
(yyyy-mmm-dd)
Qualified Investigator (QI) / ALL

Instructions:

Identification of study role includes but is not limited to sub-investigators, study nurses, clinical nurses, study coordinators, pharmacist (when appropriate, technicians, nurse practitioners, physician assistants, residents, and data recorders). List individual’s delegated study-related tasks (ICH GCP 4.1.5) as described in the Task Delegation/Responsibility List. Signatures/Initials are required for all persons authorized to make entries and/or corrections to Case Report Forms (ICH GCP 8.3.24). When tasks are delegated by the QI, the QI is responsible for providing adequate training and supervision of those to whom tasks are delegated. QI affirmation and delegation, by means of signature and date above, must occur after individual has completed all required training and prior to conducting any study-related tasks. If any of the tasks listed below do not apply, remove from the list. If there are other tasks required, add to the ‘Other’ section. Note: If a research team members’ role changes, reassign remaining study-related tasks from the Task Delegation/Responsibility List to a qualified site research team member by creating a new line and include the new start date.

Task Delegation/Responsibility List:

  1. Participant Identification/ Recruitment
/
  1. Obtain Informed Consent
/
  1. Collection of Eligibility Criteria
/
  1. Affirmation of Eligibility Criteria (QI/Sub-I)

  1. Randomization
/
  1. Un-blinding
/
  1. Medical Oversight
/
  1. Medical History

  1. Physical Exam (medically qualified personnel)
/
  1. Trial Measurements (eg. BP, HR, Temp, Wt)
/
  1. Interpretation of Lab Data
/
  1. Obtain Biological Samples

  1. Process Biological Samples
/
  1. Ship Biological Samples
/
  1. Instruction on Investigational Product (IP) Administration
/
  1. IP Shipping and Handling

  1. IP Dispensing
/
  1. IP Accountability/Reconciliation
/
  1. Administration of Questionnaires
/
  1. Collect AEs/SAEs

  1. Review/Assessment of AE/SAE criteria (QI/Sub-I)
/
  1. Reporting SAEs
/
  1. CRF Completion
/
  1. CRF Sign-off (QI)

  1. Essential Document Management
/
  1. Filing/Archiving Data
/
  1. Regulatory/REB Submissions
/
  1. Training Staff

  1. Trial Monitoring
/
  1. Other
/
  1. Other
/
  1. Other

Version 6Page ___ of ___

[SH1]Instructions:

  • Ensure Task Delegation/Responsibility List is reviewed and revised to reflect tasks associated with the identified study. Note: the QI is responsible for all study related tasks and may delegate individual tasks as deemed appropriate.
  • In the Task Delegation/Responsibility List, remember to include all service departments as indicated on the Study Impact Approval Form (SIAF). The department manager/delegated signatory must sign the study TDL. Example: Clinical Pathology, Anatomic Pathology, Medical Imaging.
  • As indicated, assessment of an AE/SAE can only be assigned to the Qualified Investigator and Sub-Investigator.

[SH2]Instruction:

  • QI must sign and date only after all applicable training has been completed with respect to the delegated tasks for the specified individual.