Consent by zhangyun


									                                                Consent: Example of
                                                Expiration Label Use
                                                        See how to document in the label click here.

                                                     Change in
                                                     Research did                          Change in                                   Study has been approved
                                                     not affect the                        Research did not                            for continuation.
                                                     consent form.                         affect the consent                          Certificate of Approval
                  Change in Research did not         The consent                           form. The                                   arrives without a consent
                  affect the consent from.           form retains the                      consent form                                document. Consent
                  Consent original date still        approval date                         retains the                                 retains the approval date
                  valid. No change to the            from CIR#2.                           approval date                               from CIR#2.
                  master consent copy.                                                     from CIR#2.

    Initial Approval        CIR #1      CIR #2        CIR #3            Annual Review #1     CIR#4              Annual Review #2        Annual Review #3

Consent master copy
receives label with                                                                                        Study has been approved
                                Change in Research affected         Study has been approved                for continuation.
original approval date.
There will not be an            consent language. Original          for continuation.                      Certificate of Approval
expiration date assigned.       consent document has                Certificate of Approval                arrives without a consent
                                expiration placed on label;         arrives without a consent              document. Consent
                                unused copies of document are       document. Consent                      retains the approval date
                                destroyed, original master          retains the approval date              from CIR#2.
                                stored with study. Modified         from CIR#2.
                                consent master prepared with
                                label exhibiting the new
                                approval date for the consent.

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