Amendments – Summary Table of Changes



Protocol Amendment – Summary Table of Changes with Rationale Table

[A summary table of changes as described in the sample below is a helpful way to outline changes between versions of the study protocol. Include all proposed changes, including typographical changes. The notes in red are instructional and should be deleted before submitting to the Sunnybrook Research Ethics Board (REB).]

REB PIN/Full Study Title

Summary Table of Changes from Protocol Version 1 dated Month day, year.

to Protocol Version 2 dated Month day, year.

Sample

|Protocol Version 1 |Protocol Version 2 |Rationale |

|dated Month day, year |dated Month day, year | |

|1 Hypothesis and Objectives, page 4 |1 Hypothesis and Objectives, page 4 |We plan to stratify subjects who are enrolled based|

|This randomized, double-blind, placebo-controlled |This randomized, double-blind, placebo-controlled |on this revised BMD inclusion criteria (protocol |

|trial will determine the efficacy of Risedronate 35|trial will determine the efficacy of Risedronate 35|version 1.1 dated March xx, 200x) versus the |

|mg weekly versus placebo with standard care for |mg weekly versus placebo with standard care for |inclusion criteria of protocol version 1.0 dated |

|eighteen months, on changes in BMD of the distal |eighteen months, on changes in BMD of the distal |July x, 200x. We have elevated our sample size by |

|femur in 44 subjects with SCI and osteopenia of the|femur in 46 subjects with SCI and osteopenia of the|two subjects (n=46) to allow for an additional |

|hip region. |hip region. |degree of freedom in our statistical analysis. |

|16 Randomization, page 10 |16 Randomization, page 10 |Correction of typing error. |

|This will enable the subject’s trial physician to |This will enable the subject’s treating physician | |

|obtain access to the subjects’ intervention |to obtain access to the subjects’ intervention | |

|allocation from the pharmacy binder 24 hours per |allocation from the pharmacy binder 24 hours per | |

|day in the event of an emergency. |day in the event of an emergency. | |

 

REB PIN/Full Study Title

Summary Table of Changes from Protocol Version 1 dated Month day, year.

to Protocol Version 2 dated Month day, year.

|Protocol Version No. |Protocol Version No. |Rationale |

|Date |Date | |

| | | |

| | | |

| | | |

| | | |

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