Protocol Amendments

CAPNET requires that an amendment be submitted for review and approval of approved projects if minor changes are requested. Examples of minor changes include:

  • Addition of a new paper topic or aim that is substantially within the approved project topic area and scope
  • Addition of a significant, new methodologic approach (i.e., using natural language processing, or using recursive partitioning to derive a clinical decision rule)

If you wish to address a new topic, make significant changes to your aims, or if you need a significant amount of new data or a new data set from the Data Coordinating Center (DCC), please start a new CAPNET submission. The DCC has the discretion to require a new submission for proposals with changes to the requested data set.

Once the amendment is approved, it is the responsibility of the lead investigator to update any involved IRBs if indicated. Changes to the project may not be implemented at an institution without approval of the CAPNET Writing and Publications Committee and the CAPNET DCC.

Amendment Instructions

  1. Complete the CAPNET Project Amendment Request Form
  2. Attach the revised project proposal. Project amendments must be written in the same format as the original project proposal, highlighting the new/changed elements.
  3. Email the completed CAPNET Project Amendment Request Form and revised project proposal to the CAPNET W & P Committee Chair (megan.letson@nationwidechildrens.org) and DCC Director (WOODJO@chop.edu).
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