IRB Continuing Review Application Policy
regulations require that primary investigators, or other principal parties, must
file either a Continuing Review Application (CRA) or a Closeout Report prior to
the 365-day IRB approval expiration date (indicated on the approval letter).
The IRB does not have the authority to extend the approval period without a
CRA. If approval expires, all research activities must cease and any data
collected without IRB approval must be destroyed.
for Continuing Review
Investigator must submit a Continuing Review Application (CRA) for IRB approval
if any of the following applies:
The PI will or may continue to
interact or intervene with subject participants for the purposes of research
data collection for the current approved study.
The PI will or may continue to
enroll subjects in the current approved research study.
The PI has completed data collection
with subjects but will or may continue to work with data samples that can be
IRB approval must be obtained annually as long as the possibility exists
of any future identification of subjects by code or otherwise.
Minor Modification Requests
A PI may request any or all of the
following three changes on the Continuing Review form:
New study title
Removal of key personnel. (Follow
instructions on the application form for listing names and reasons.)
Correction of typos on the informed
consent form(s). (Attach corrected form with application.)
all other changes, you must submit a separate Modification
Request Form with the CRA.
Continuing Review Application (CRA) Instructions
the CRA using MS Word or similar word-processing software (no handwritten
w Respond to all items as applicable,
and attach explanations as necessary, or the CRA may be returned to you for
additional information, thereby causing a delay in processing your application
and potentially creating a lapse in approval.
your CRA, you may request: a title change, removal of personnel, or correction
of typos on the informed consent form(s). Any modifications that do not fall
into one of these 3 categories require the submission of a separate Adverse
w Obtain all necessary signatures
before submitting your CRA: PI, Faculty Advisor (if not the PI), and
w Submit all forms as 1) hard copy in
a sealed envelope to:
IRB, Office of Research Services
& Sponsored Projects, University Services Building #203.
(After business hours, place materials in mail slot.) OR 2)
scanned and signed PDF documents sent to: email@example.com
are approved for 365 days only (see expiration date on the
approval letter or contact the IRB to verify your expiration date). Prior to
study expiration, the PI must submit to the IRB either a CRA or a Closeout
to leaving SU, the PI must submit to the IRB either an Adverse
Effects–Modification Form to request changing PIs or a
in IRB approval are considered by SU policy to represent non-compliance with
the Federal regulations and the requirements of the IRB, and are handled
according to SU IRB policy and procedures.
As a courtesy, the PI will be sent a reminder email approximately one month
before IRB approval expiration. The responsibility lies with the PI to submit
forms accordingly so that no lapse in IRB approval occurs.
Please direct all questions to: firstname.lastname@example.org or (206) 296-2585