Additional Information

The Additional Information section of the Protocol page allows for the entry, maintenance and viewing of non-required, general information about the protocol. Although optional, these are standard fields that most implementing institutions are likely to collect. They allow for specification of additional identifying information about the protocol and selection of applicable areas of research.

Figure 1106 Protocol Document, Protocol Page, Additional Information Section – All Subsections Example

Figure 1107 Protocol Document, Protocol Page, Additional Information Subsection Example

Table 322 Protocol Document, Protocol Page, Additional Information Section Field Descriptions

Field	Description
FDA IND or IDE #	Type to enter the U.S. Food and Drug Administration (FDA) Investigational New Drug (IND) application or Investigational Device Exemption (IDE) approval number when applicable.
Reference ID1	Type to enter an alphanumeric (spaces & special characters allowed) identification reference to track the protocol as defined by your institution or sponsor (field label may differ from example shown based on your institution’s unique implementation). This field is available as a search criterion on the Protocol Lookup screen.
Summary/Keywords	To briefly describe the research, click within the text box (or press the tab key from a previous field) to relocate the cursor to the field, and then type (or paste from virtual clipboard) to enter text in the box as necessary to provide the appropriate information.
Reference ID2	Type to enter an alphanumeric (spaces & special characters allowed) identification reference to track the protocol as defined by your institution or sponsor (field label may differ from example shown based on your institution’s unique implementation).

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