# Data Files

To enable the tool’s effective categorisation and visualisation of protocol deviations, data must be prepared using specific spreadsheets. This section provides guidelines for formatting data to ensure it is usable within the tool, allowing for accurate NLP-powered analysis and insight generation. By following these instructions, users can optimise data entry, minimise processing issues, and unlock the tool’s full potential for detecting patterns and recurring issues. Please refer to the steps below on how to format your data accordingly.



**Headers**

The spreadsheet headers are summarised below.

| **Variable Name** | **Variable Label**                  | **Comment**                                                                                                                                                                           |
| ----------------- | ----------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| SITEID            | Study Site Identifier               | Mandatory                                                                                                                                                                             |
| STUDYID           | Study Identifier                    | Mandatory                                                                                                                                                                             |
| DVSPONDES         | PD Descriptor Assigned by Sponsor   | Mandatory                                                                                                                                                                             |
| DVCAT             | Category for Protocol Deviation     | <p>Non-Mandatory</p><p>User can assign manually</p><p>If not assigned manually then this field supports mandatory fields as NLP will assign a defined DVCAT using the DVSPONDES</p>   |
| DVDECOD           | Protocol Deviation Coded Term       | <p>Non-Mandatory</p><p>User can assign manually</p><p>If not assigned manually then this field supports mandatory fields as NLP will assign a defined DVDECOD using the DVSPONDES</p> |
| DVTERM            | Protocol Deviation Term             | Auto-populated                                                                                                                                                                        |
| DVENTC            | Event Date                          | Non-mandatory                                                                                                                                                                         |
| DVENTCVIZ         | What Event Date, DVENTC, Represents | Non-mandatory                                                                                                                                                                         |

