To identify who (at a group level) will be responsible for each of the various tasks
associated with planning, executing, monitoring, analyzing, reporting, and
archiving a clinical research study
This document identifies which group will be conducting each of the various study
tasks but is not intended to be a legal transfer of sponsor obligations. As such,
when an IND/IDE is obtained, the IND/IDE sponsor retains overall regulatory
obligations for the study.
The objective of this document is to ensure that all potential study responsibilities
are considered and clearly assigned.
• This document should be prepared early in a study to ensure that all
responsibilities are clearly established.
• This tool can be edited to suit the needs and requirements of the study.
You can indicate “Not applicable” or remove rows at your discretion.
There are additional blank rows included for your convenience; add other
responsibilities that may be important and/or unique to your study in these
• All parties noted in the checklist should agree on the delineation of
responsibilities and receive a copy of the completed document.
• This is not intended to replace the Delegation of Responsibilities Log,
which differentiates site specific clinical responsibilities.
• Changes to the grid should be documented and the updated version
should be made available to all responsible parties.
• If you are not using the services of CROMS (Rho), you can replace that
column heading with the designation of the relevant Data Coordinating
• Below are suggestions for completing the tables. Use the strategy that
works best for your study.
Insert “X” into cells in a row when one group is solely responsible for a
task. In some cases, when multiple groups share some responsibilities, it
may be helpful to use “Lead” to indicate the group with primary
responsibility for the task and “X” for others who also play a role in that
task. You can use additional terms, if useful, to clarify the roles of other
groups. If the terms are necessarily abbreviated or not intuitive, add the
abbreviation to the “Abbreviations and Terms” table at the end of the
For documents being developed, use “Develop” for the initial author. If the
author is also the person making any updates to the master document,
then it is not necessary to have a separate “Update” delineation. It is
assumed that the authoring group and the approving group will also have