Setting up Central Stratified randomization

For the Central Stratified type of randomization, special configuration is necessary if you want the sequence numbers in each drug kit list to start with a number other than 1. In the Central Stratified type of randomization, the study has multiple lists of drug kits. Each new subject is assigned to a drug kit list based on entered subject data. Then, the subject is assigned the next sequential drug kit number on that list.

Under Central Stratified randomization, unless each set of sequence numbers in the Drugkits table in the randomization database starts at 1, randomization fails when you try to randomize a study subject.

If you want your sequence numbers to start with a number other than 1:

1. Set up the Drugkits table so that:
   • Each set of sequence numbers in the SEQUENCENUMBER column starts with 1.
   • The sequence numbers you want to use are in the DESCRIPTION column.
2. In the rule that assigns the sequence number when a subject is randomized, use the GetNextKit method so that the values in the DESCRIPTION column are included in return value provided by the KitInfo variable.