Approved Informed Consents
New Electronic Stamps
Coming July 9, 2015
KC IRB* Electronic Stamp
• Beginning July 9, 2015, the IU HSO will no longer
manually apply an IRB Approval stamp to Informed
Consent documents
• It will be replaced with an electronic stamp generated
automatically from KC IRB
Example:
* KC IRB, or Kuali Coeus Institutional Review Board, is IU's online system for tracking human subject research protocols
What is the KC IRB Electronic Stamp?
•
•
•
Institution-defined text that is applied to UNSECURED PDF* protocol
attachments
The text of the electronic stamp indicates the status of the protocol
The stamp appears on every page of an UNSECURED PDF
attachments when viewed, downloaded, or printed from Notes &
Attachments tab or from Protocol Actions tab - Print panel within a KC
IRB Protocol
o
o
o
As long as you do not secure your PDF documents, an electronic stamp
will appear
You should not secure your PDF consent document(s) so that the stamp
will appear
You should secure any other PDF documents if they should not receive
the electronic stamp, e.g. drug brochure, sponsor protocol
PDF (Portable Document Format) is a file format that has captured all the elements of a printed document as an electronic image that
you can view, navigate, print, or forward to someone else. PDF files are created using Adobe Acrobat.
KC IRB Electronic Stamp
• Since the stamp will no longer include approval or
expiration dates, it is very important for study
teams to utilize version dates and/or version
numbers. A few tips to remember:
o Be consistent. Develop a naming and versioning
convention to be used by all members of the study
team. Document your naming convention in your
study files where all team members, monitors, and
auditors can reference it.
o Abbreviate standard document types to reduce the
length of file names (e.g. Protocol = PRO, informed
consent statement = ICS; assent = AST)
KC IRB Electronic Stamp
Tips to remember cont’d:
o Include version dates/numbers in document footers
and document file names.
o Format dates consistently and choose a clear
standard. Always include the year.
o Be sure to update version dates/numbers in document
footers each time the document is revised.
KC IRB Electronic Stamp
• Information about this change will be shared in the
Research Compliance Quarterly newsletters in
May, June, and July
• Information will be provided to Sponsors via our
Sponsor website
• Guidance pertaining to Informed Consent
documents will be revised to clarify this change
KC IRB Electronic Stamp
• The electronic stamp is applied to ALL unsecured PDF
protocol attachments with the following protocol statuses:
o Approved
o Active – Open or Closed to Enrollment
o Active – Data Analysis Only
o Disapproved
o Expired
o Closed
o Attachment downloaded/viewed/printed from an
Amendment or Renewal that is NOT being amended
Sample Stamps
• Approved
Protocol XXXXXXXXXX IRB Approved
Sample Stamps
• Active
Open to Enrollment
Closed to Enrollment
Data Analysis Only
Protocol XXXXXXXXXX IRB
Approved
Protocol XXXXXXXXXX IRB
Approved – For Re-consent Only
Protocol XXXXXXXXXX IRB
Approved – Do Not Enroll Subjects
Sample Stamps
• Disapproved
Protocol XXXXXXXXXX
Disapproved
Expired
IRB Approval of Protocol
XXXXXXXXXX Expired 21-Apr-2015
Closed
Protocol XXXXXXXXXX Closed
Sample Stamps
• Attachment viewed/downloaded from Amendment
or Renewal that is
NOT being amended
Invalid copy – not being
modified with this
Amendment or Renewal
KC IRB Electronic Stamp
If you have any questions, please
contact the IU HSO at:
Indianapolis: (317) 274-8289
Bloomington: (812) 856-4242
Email: IRB@iu.edu