NOTIFICATION OF CHANGES TO RESEARCH TEAM

Tufts Health Sciences Institutional Review Board (IRB)

800 Washington Street, Box 817
Boston, MA 02111

Principal Investigator: [Insert PI name]

IRB #: [Insert IRB number]

Study Title:[Insert study title]

[NOTE: This template cover letter should be used ONLYfor adding and/or removing research team members from the study. If study documents (for example: Protocol, ICF, recruitment materials, etc.) need to be revised to reflect this change, pleasesubmit tracked and clean copies of all revised documents with Amendment (Cover Letter) in place of this Change in Research Team (Cover Letter).]

[Include the following information, deleting any section that is not applicable]

I, the Principal Investigator, am notifying the IRB of changes to the research team.

1)[Change in PI: If this is a change in PI, submit the new PI’s COI form (regardless of responses on the COI form), and have both the former and new PI sign this letter.

  • Confirm the funding agency/sponsor has been informed of and accepts this change: ]

2)[Adding Research Team Member(s): To add research team member(s), complete the table below:

Addition of Research Team Member(s)
List newResearchTeam Member(s)
This includes those responsible for the design, conduct, or reporting of the research, such as the PI & Co-Is, research nurses and coordinators, project managers, etc. / Individual’s Role
For example: PI, Co-I,Research Coordinator.
Do not list any research team member as a “Co-PI;” only one person may be listed as PI for a study. / In a Training PositionFor example resident, fellow, student, etc. / Institutional Affiliation
For example Tufts MC, TUSM, HNRCA, etc. / Current CITI
Certification:
Indicate the expiration
date of each individual’s CITI certification. / Current GCP
Training1:
Indicate the expirationdate of each individual’s GCP Training
Check N/A if this does not apply to this study: N/A / Conflict of Interest (COI) FormCompleted:
If any “Yes” responses are indicated, submit the form to the IRB.
If there are only “No” responses indicated, retain in your study files only.
NOTE: IRB COI review is always required for change in PI.
1 GCP training is required for NIH funded clinical trials (NIH funded studies that meet the NIH definition of clinical trial).
As of 01 January 2018, GCP training will be required for allclinical trials, regardless of funding source.

3)[Removing Research Team Member(s): To remove research team member(s), list their names]

The current enrollment status of the study is [there has been no enrollment to date / enrolling subjects / closed to enrollment].

The total number of subjects enrolled to date is [insert # of subjects enrolled].

The total number of subjects being followed is [insert # of subjects being followed].

Please contact me at [telephone / e-mail] or the study coordinator, [name, telephone / e-mail] if you have any questions.

Sincerely,

Name of Principal Investigator (NOTE: If this is a change in Principal Investigator in which no study documents need to be updated to reflect this change, please have both the formerand new PI sign this letter)

Principal Investigator’s original ink signature