Protocol Review Committee Amendment Log Directions
One hard copy of the amendment log indicating the history of all amendments made to the study following initial HIC approval must
be submitted with the PRC Amendment Request Form.
DIRECTIONS:
1. The HIC Number, Study Title, Initial HIC Approval Date and Version Number at the Time of Initial Approval must be typed into
this section.
2. Amendments originating from the Yale PI are assigned an amendment number which starts at 1 and ascends with each successive
amendment. (Industry and cooperative sponsored amendments must also be assigned a Yale amendment number that starts with
the number 1 in addition to the industry/cooperative group assigned number.)
3. List the amendment number provided by the industry/cooperative group sponsor.
4. All YCC protocols and consent forms must have a protocol version number and version date. Indicate the version date of the
amendment.
5. Provide a brief description of the amendment request.
6. Indicate if there is a change to the informed consent document.
7. Provide a brief description of the changes to the informed consent document.
8. List the sponsor approval date of the amendment.
9. List the PRC approval date of the amendment.
10. List the HIC (IRB) approval date of the amendment.
DMM/06/01/07
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