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Additional Information

 

The Additional Information section of the Protocol page collects FDA-related information.

 

Figure 635 Protocol Document, Protocol Page, Additional Information Section – All Subsections Example

 

Table 272 Protocol Document, Protocol Page, Additional Information Section Field Descriptions

Field

Description

FDA IND or IDE #

Enter the Investigational New Drug (IND) or Investigational Device Exemption (IDE) number, when applicable.

IU or Investigator held IND/IDE? Y/N

Type either “Y” or “N” to indicate if the IND or IDE is held by Indiana University or an IU investigator.

Summary/Keywords

Optional. Click within the text box (or press the tab key from a previous field) to type (or paste from virtual clipboard) text as necessary to provide a brief summary of the research. Click the add note icon to view/edit/paste text in a larger browser window, then click the continue button to return to the text entry field in the document.

Reference ID2

DO NOT USE

For protocols that existed prior to the implementation of KC IRB, this field identifies the Grant or Sponsor # associated with the protocol. This information will eventually be removed and housed solely in the Funding Sources panel.