PEDIATRIC CLINICAL AND TRANSLATIONAL RESEARCH CENTER (PCTRC)
CHILDREN’S HOSPITAL OF PITTSBURGH
New Application Instructions:
OSIRIS

All new PCTRC protocols must be submitted using OSIRIS, the IRB electronic
submission application.

It is required that all protocols must have final IRB approval before review by
the PCTRC advisory committee.

At the time of your initial submission in OSIRIS you must select the following
choices if your protocol utilizes resources of the PCTRC:
CS7.0 Will this research study use any Clinical and Translational Research Center
(CTRC) resources?
Answer:
YES
CS7.1 Please select the CTRC you intend to use:
PCTRC
CS7.2 Click the link below to access the CTRC Portal page and to complete an
application for CTRC services.
CTRC Portal: http://ctrc.upmc.edu/
* Upload CTRC Services Request Form
(You must upload the PCTRC new application, 2- PCTRC budget sheet(s) and
the .pdf portal form that you create in the Portal page)

By following these steps in OSIRIS you will grant the PCTRC the ability to follow
and view your study in OSIRIS.

Once final IRB approval has been obtained, your protocol will be assigned
for review at the next PCTRC advisory committee meeting. The deadline for
review is the first business day of the month. If the PCTRC has any questions
PCTRC New application instructions: November 2008
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or requires additional information to review your study, you will be contacted
directly by the PCTRC.
OTHER SOURCES OF FUNDING

If your study has federal or foundation funding, you must submit a copy of the grant
budget and the NGA to the PCTRC. All documents should be emailed to the
department mailbox: PCTRC@chp.edu
Investigator initiated or Pilot Studies

If your study is an Investigator-initiated study or a Pilot study, you must submit
a protocol summary in addition to the application form.

The PCTRC advisory committee requires a 5 page protocol summary in
addition to OSIRIS. This will enable the reviewers to comprehensively
evaluate your proposal (something that is difficult to accomplish with OSIRIS)
and will facilitate the approval process. The guidelines for submission are
attached. Please contact the PCTRC advisory committee for the guidelines.
The PCTRC Scientific Advisory Committee

The committee meets once a month, on the third or fourth Monday of each
month. Typically the meetings are held in the B-level conference center.

The committee reviews protocols for scientific merit, patient safety, feasibility
and utilization of resources.

We request the attendance of the Principal Investigator at the Advisory
committee meeting.
a) The PCTRC advisory committee requests that the PI or a co-investigator
be available to address reviewer and committee concerns in real time
at the advisory committee meeting.
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b) This will allow reviewers and discussants assigned to your application to
discuss the strengths and weaknesses that have been identified and
provide the opportunity for questions to be answered by the
investigator during the meeting.
c) The week before the advisory committee meeting you will receive an
email identifying your time frame for review (a ten minute window) and
the location; typically meetings are held in the CHP B-level conference
center.
d) You will be asked to wait outside of the meeting until your presence is
requested.

After your study has been reviewed, you will receive a letter summarizing
the review of your study.

You must respond to any comments or contingencies within 60 days in
writing to the PCTRC. Your response must contain a copy of all related
documents; you must print all related documents from OSIRIS to include
with your response.

Please insure that each response is:
1) Point-by-point, numerically matching the order on this letter
2) All changes (revisions, additions or deletions) must be clearly
delineated, indicating the source (e.g., Consent or Protocol,
OSIRIS section, Page No. and Paragraph) and the text should be
highlighted.

If the requested changes require IRB approval, please send the
approved, modified documents, along with the IRB approval letter, to the
PCTRC. Upon receipt of your response, it will be reviewed and, if
acceptable, a final approval letter will be issued.

If we do not receive your response within 60 days, this protocol will be
suspended from enrollment and activity on the PCTRC until your response
is received and approved.
You are encouraged to contact the PCTRC if you have any questions or require
assistance:
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Director: Silva Arslanian, M.D.
Associate Director: Patrick M. Kochanek, M.D.
Associate Director: P. David Adelson, M.D.
Chairperson, Advisory Committee: Ellen M. Mandel, M.D.
Administrative Director: Lynnette Orlansky
Nurse Manager: Janet Bell, R.N.
Research Participant Advocate: Michael Green, M.D.
PCTRC New application instructions: November 2008
692-6565
383-1901
692-6347
692-6214
692-5573
692-6327
692-6111
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