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Randomization sequences
A study that uses randomization requires the following sequence definitions:
- One SequenceType definition for the Randomization sequence. This definition is included in the base study and is in the following format:
<SEQUENCETYPE SEQUENCETYPENAME="Randomization"/>
- A Sequence definition for each randomization sequence needed for the study. You need to define one randomization Sequence element for each randomization source. For example:
- If your study uses the Simple Central randomization method, you need one Sequence definition for the single list of randomization kits.
- If your study has ten sites and it randomizes by using the Simple Site randomization method, you need ten Sequence definitions, one for each site.
- If your ten-site study uses the Stratified by Site randomization method, and you categorize subjects into one of three stratifications, you need 30 Sequence definitions.
Each Sequence definition requires the following attributes:
- SEQUENCENAME—Name used when referring to the Sequence in the randomization rule and in the randomization source database.
- SEQUENCETYPENAME—Randomization, indicating that the sequence is of the Randomization SequenceType.
- UUID—Universally Unique Identifier: a string that identifies the element uniquely across all studies, study databases, and machines.
Note: The format of the UUID must follow the format used in the sample UUIDs provided in the Base study. A suggested method for generating UUIDs for Sequence definitions is to copy the UUID of the randomization Sequence definition provided in the core_DefinitionSequences.xml file and change one character for each Sequence definition you create. This ensures that the format is correct and each string is unique. Alphabetic characters in UUIDs should be uppercase.
