Using a Note to File (NTF)

Office for Human Subject Protection
4th Quarter 2013
Contact us:
Director OHSP:
Kelley O’Donoghue 273-4631
Executive Director RSRB:
Tiffany Gommel 273-4574
Director Research Education:
Bill Kelvie 275-5244
RSRB Specialists:
Emily Flagg, Sr. Specialist
Kathleen Buckwell, Sr. Specialist
Linda Palm-Montalbano
Vol. 2, No. 4
CITI Information: The transition to
CITI for initial certification for human
subject protection was initiated on
September 13, 2013. If you previously
recertified with CITI, ensure you use
your existing username and password
to be directed to the appropriate program. If you have forgotten your username or password, please follow the
instructions on the CITI login page. If
you have any questions about which
human subject protection program to
complete, please contact OHSP.
Igor Milosevic
Michelle Giglio
Kelly Unsworth
Assistant Specialists:
Jim Filingeri 273-4577
Nicole Mason 276-5544
Achieving High Quality Clinical
Research Seminar Series
November 19, 2013 “Review of the
Investigational Drug and Device
Regulations and Changes to the
RSRB Online Submission System
(ROSS) Application for Drugs and
Director Quality Assurance:
Kelley O'Donoghue and
Kathleen Wessman 273-2118
Tiffany Gommel
Quality Assurance Associate
For questions regarding ROSS
(RSRB Online Submission System) , please contact:
Sue Flanigan 275-3050
Upcoming Educational
Research Education News
Time: 12:15 p.m.-1:15p.m.
Place: Helen Wood Hall Auditorium
December 4-6, 2013
“Conducting Human Subject Research” 3-day Workshop on GCP
CLICK HERE: For more information and to register.
November 27th at 2pm
November 28th and 29th
December 24th at Noon
December 25th
December 31st at 2pm
January 1st
Office for Human Subject Protection
Quality Improvement News
Using a Note to File (NTF): Notes to file need to be well written, relevant, timely, and address the root
causes of the problem. It is important the NTF identify how the root cause of the problem will be corrected, not just document what occurred. Notes to file can help a study team to recognize a bad pattern or
trend, and lead to a change in policy and procedure, if necessary. Best practice is to include the NTF with
the document to which it refers (subject or regulatory file). Ensure a consistent and logical system for filing all notes to file.
Components of a NTF:
NTF should be printed on department letterhead.
Date: <When the NTF was written>
To: <Protocol number and documented related file ‘Regulatory Binder or Subject File #’>
From: <Name and title of person writing the NTF along with their signature>
Issue: <Describe the problem>
Root Cause: <Explain why the problem occurred>
Corrective/Preventative Action: <Describe how the problem was corrected, by whom, when it was corrected, and how the problem will be prevented in the future. If a problem cannot be corrected, explain why
it cannot be corrected, e.g. missing data. >
Additional Information: <comments or other relevant information>
NOW AVAILABLE!!!! Study Documentation Tool Box: OHSP-QI is pleased to announce a new resource for PIs and Study Coordinators! Research study forms and templates can be accessed here:
Research QI ‘Gold Star’ Award!!!!!
The QI division would like to recognize Dr. Jill Halterman and the Preventive Care
Program for Urban Children with Asthma Program members for their quality work on the ‘School-Based
Telemedicine Enhanced Asthma Management: A Randomized Control Trial Using Novel Technology to
Improve Preventive Asthma Care’ trial. This dynamic study team also includes Maria Fagnano and
Reynaldo Tajon, and is located in the Saunders Research Building.
They received the ‘Gold Star’ award for demonstrating attention to regulatory compliance, exceptional subject recruitment/retention practices, teamwork amongst site staff, and high quality, organized study-related documentation.
Office for Human Subject Protection
Research Subjects Review Board News
RSRB Submission During the Holidays
The holidays are fast approaching and we would like
to remind you of the importance of submitting continuing reviews a little earlier than usual to ensure
uninterrupted RSRB approval.
For those studies that require full board review, a list
of upcoming meeting dates is noted below. Keep in
mind that agendas fill up quickly especially at this
time of the year. Please contact your RSRB Specialist with any questions about submission requirements or timelines.
Board 01:
Board 02:
Board 03:
Board 04:
Board 05:
November 12th & 26th
November 19th
November 14th & 21st
November 13th
Board 01:
Board 02:
Board 03:
Board 04:
Board 05:
Investigators leaving the
University of Rochester
Principal Investigators (PI)
leaving the institution are responsible for notifying
the RSRB well in advance of their departure so
arrangements can be made to either close the study
or name another appropriately qualified individual
at the institution to serve as PI.
Keeping Your Email Address
Up to Date
It is critical that your email address and other contact information is UP-TO-DATE date
in the RSRB Online Submission System (ROSS).
If your email address is not accurate or you do not
frequently check your email, you may miss important email notifications, reminders, change requests, etc. Please contact the OHSP office to ensure that your contact information is accurate.
Study Personnel Amendments in ROSS
December 10
December 5th
December 3rd & 17th
December 5th, 12th, & 19th
December 11th (possibly move to
The name of the person who will be added, that
individuals certification and role on the study
MUST BE included in the amendment request
form when adding study personnel to your study.
In addition you MUST go into the “Amended Application” and add the person to the appropriate
section. This is routinely section 1.6 or 85.1. If
this is not done, the amendment request will be
returned to make these changes.