Load Randomization Data

You can load randomization data for the Oracle Argus Unblinding profile from the Patient Randomization Data tab.

The following table describes Patient Randomization Data tab Fields and Controls:

Field/Control	Description
Data File	Enables you to select the data file to load.
Load Data	Clicking this button loads data into the Randomization Data Tables.
Validate Data	Clicking this button validates the data and generates a report that you can access through the Report Viewer.
Save	Enables you to save the data on the tab.
Close	Enables you to close the tab without saving the data.

To load randomization data for the profile:

1. In the Configure Argus Unblinding Profile dialog box, click the Patient Randomization Data tab.
   
2. When the Patient Randomization Data tab opens:
   1. Click Browse, select the appropriate Excel data file to load, and click Save.

Patient Randomization Data file is an MS Excel file (version 5.0 onwards) that contains multiple attributes.

Data present in each record is validated against the data present in Case Form / Codelist tables, as per the rules below.

The records can be presented in any order.

Attribute	Data Type and length	Validation rules
Study number	VARCHAR2 (20)	Validated against LM_STUDIES. STUDY_NUM
Country of patient enrollment	VARCHAR2 (50)	Validated against LM_COUNTRIES. COUNTRY
Centre number	VARCHAR2 (20)	Validated against LM_CENTERS. CENTER_NO
Patient randomization number	VARCHAR2 (15)	Validated against CASE_PAT_INFO. RAND_NUM
Treatment code	VARCHAR2 (10)	Validates that data is not null
Patient ID	VARCHAR2 (10)	Validates that data is not null

Note:

Leading zeros and spaces within the Patient Randomization Data don't need to be removed prior to loading. EOSU will treat each of the above fields and their associated fields within Argus as equal, if the values being compared are equal, once any leading zeros and spaces are removed.