The Global Protocol Deviation Assessment Plan (Global PDAP) provides a central standard or guideline for organizing Protocol Deviations (PDs) across all studies, streamlining the process of PD review and identifying trends to reduce the number of deviations within a clinical trial overall.

The Study Protocol Deviation Assessment Plan (Study PDAP) provides the standard or guidelines for organizing and managing PDs for a specific study. The Study PDAP can inherit standards from the Global PDAP to ensure consistency across studies, and have additional standards added that are unique to the study.

Permissions: Users must have the Global PDAP Configure system privilege to access and configure the Global PDAP. 
Users must have the Data Central and Study Configure privileges to configure Study PDAPs in Data Central Configuration.

Tip: Best practice is to create a Global PDAP and rarely, if ever, edit existing entries, as the goal is to establish a standard across all studies. If users need to modify a Global PDAP for a specific study, it is recommended to add it as a new Study PDAP entry rather than editing the Global PDAP entry.

PDAP Standard Values:

• Global: Indicates whether the standard is inherited from the Global PDAP. [Study PDAP only]
• Level: The level in the organizational hierarchy to which the PD belongs. For example, Organizational (Global) or Intermediate (Therapeutic Area, Compound, Program, Study (i.e., Protocol Specific), etc.).
• Standard Category (Required): The organizational category of the PD. For example, Safety, Regulatory, Data Integrity, etc. This category is used for metric reporting in the Protocol Deviation Dashboard.
• Standard Description (Required): The description for the category of the PD. For example, AE Reporting, Failure to Report SAE, IC Violation, etc.
• Code: Internally defined code or identifiers for the PD standard.
• Protocol Version: The specific version of the study or protocol the PD is assigned to or associated with. [Study PDAP only]
• Identification Method: The methodology used to identify or find the PD. For example, if it should be found Manually or in the Site Monitoring or Data Review Plan. The drop-down options are based on industry standard models for PD management.
• Role Responsible: The role responsible for identifying and / or managing the PD.
• Impacts Key Data: Indicates if the PD impacts completeness, accuracy, or reliability of key data or processes.
• Impacts Subjects Safety: Indicates if the PD impacts a subject’s rights, safety, or well-being.
• Importance Classification: Indicates whether the PD is important, which reflects whether it causes danger to the overall health of the trial. Typically used as a summarization of the other two Impact columns.
• Importance Threshold: Provides additional clarification on the Importance Classification. For example, the number of acceptable instances of the PD expected.

Access the Global PDAP

1. Click the 9-dot icon to open the Platform Menu. 
2. Click Protocol Deviation Assessment Plan under Metadata Management.
   

Access the Study PDAP

Study PDAPs are configured in Data Central Configuration.

1. Access Data Central Configuration for a study.
2. Click Protocol Deviations in the left navigation. A list of all existing Study Assessment Plans (PDAPs) is displayed. 
   

Toolbar Actions

Toolbar actions are similar in Global and study-level PDAP configuration. 

Icon	Icon Label	Action
	Add	Manually create new PDAP entries.
	Edit	Manually edit existing PDAP entries.
	Delete	Remove any PDAP entries that are not in use on any study-level PDAPs.
	Import	Create new PDAP entries from an Excel file.
	Export	Export all existing PDAP entries to an Excel file.
	Get Template	Download an empty template version of the global / study PDAP.
	Add from Global List	Add new entries to the Study PDAP from the configured Global PDAP.
	Help	Access the Help Center, Community (Conversations), Learning Portal, Support Information, Privacy Policy, Legal Notices, and the current version of elluminate.

Manually Add PDAP Entries

Adding PDAP entries for a Global or Study PDAP works the same.

1. Click the Add icon. The Add Protocol Deviation Assessment Plan Entry window opens.
2. Enter the PDAP Standard Values, fields with red asterisks are required.
3. Click Save.

Global PDAP Entry Window	Study PDAP Entry Window

Edit PDAP Entries

1. From the Global or Study PDAP list, highlight the PD to edit.
2. Click the Edit icon, or double-click a record. The Edit Protocol Deviation Assessment Plan Entry window opens. It is similar in layout to the Global or Study PDAP Entry window and displays all the information previously entered in that window.
3. Make the updates.
4. Click Save.

Important: Global PDAP Entries cannot be edited from a Study PDAP. In 24.1, edits to a Global PDAP do not cascade down to those applied to a Study PDAP. 

Assign Global PDAPs to a Study PDAP

1. From Data Central Configuration PDAP, click the Add from global list (globe) icon. The Select Global Assessment Plans to Assign to Study window opens.
   
2. Select the checkbox in the header next to Level to select all, or select checkboxes individually.
   
3. Click Save.

Note: If selected Global PDAPs were already assigned, a message displays.

Import PDAP Entries

PDAP entries can be imported to both the Global and Study PDAPs using an Excel file. While downloading and using the available template is not required, it may be the most efficient way to import entries. Alternatively, an existing Global or study PDAP can be exported, updated, and then re-imported. 

1. Click Get Template. The template is downloaded to the computer. Enter the appropriate data into the spreadsheet, ensuring all entries are in the required format, otherwise the file cannot be imported. 
2. Click the Import icon. An Import Protocol Deviation Assessment Plan Entries window opens.

3. Drop or browse to add the Excel file. If entries are in the correct format, a message displays, 'Entries are ready for import, please click import to finalize!' When importing a new version, existing entries and PDAPs currently in use are skipped during import; a message displays in the import window based on the import content.

   Note: When importing study PDAPs, the study name displays in the Excel sheet name and must match the name of the target study. This prevents PDAPs from being imported into an incorrect study.

4. Click Import.

Tip: The elluminate platform supports import validation for both Global and Study PDAPs to allow matching PDAP entries from the ingested file and the configured PDAP. Existing entries that are restricted, such as Global PDAPs for Study PDAPs actively applied to a PD, are skipped. New entries from the file are created as new records.

Delete PDAP Entries

1. From the Global or Study PDAP list, highlight the PD to delete.
2. Click the Delete icon.
3. A confirmation question displays, click OK to confirm, or Cancel to dismiss.

Important: Global PDAP entries applied to a Study PDAP cannot be deleted. Study PDAP entries used in a PD cannot be deleted.

Export PDAP Entries

Global and Study PDAPs can be exported. This functionality is helpful when there are updates to existing entries or when new entries need to be added. The PDAP can be exported, updated, and re-imported.

1. From the Global or Study PDAP list, click the Export icon.

The Excel file downloads to the computer.

Best Practices for Protocol Deviation Assessment Plans (PDAPs)

• Establish a Global PDAP as the enterprise standard. Use the Global list as the authoritative source for PD categories and definitions, and avoid modifying existing entries. Record study-specific needs as new entries in the Study PDAP to keep definitions stable and ensure comparable metrics across studies.
• Structure entries with stable identifiers. Define Level, Standard Category, Standard Description, and assign a PD Code for each entry. Use Category + Description + PD Code as the unique key. 

• Define PDAP Level deliberately. For Global PDAPs, use the Organizational level for global standards reused across all or most studies. Use the Intermediate level for Therapeutic Area, Compound, Program, or study-specific rules used across multiple studies. When configuring the Study PDAPs, assign relevant Global entries, then add Intermediate PDAPs when variation is required. Add a Study level PDAP entry if more granularity is needed.

  A Global Intermediate entry is created in the Global PDAP with a Level of Intermediate and assigned to multiple studies, where it is read-only. In contrast, a study-level entry is made in the Study PDAP for a single study, can include a Protocol Version, and remains editable.

• Manage PDAP imports with traceability. Use Get Template when creating a new PDAP or performing an initial bulk load. Use Export → Edit → Import when updating an existing PDAP to maintain exact field formats and identifiers. Ensure the Study PDAP sheet/tab name matches the study title, and rely on automatic eDrive storage to keep a verifiable history across environments.