The Role of the Secure Data Office in Creating Randomisation Lists for Clinical Trials
Randomisation lists are an essential part of clinical trials, as they ensure that the allocation of subjects to different treatment groups is unbiased and fair. The creation and management of randomisation lists are critical to maintaining the integrity of clinical trial data. In the case of double-blinded studies, the secure data office (SD Office) can create randomisation lists to maintain blinding throughout the entire study.
For simple studies, the randomisation list can be created in SAS and distributed on paper. In this case, the SD Office can provide code breaking envelopes in case emergency unblinding is needed. However, for more complex studies, such as those with multiple sites or stratification factors, an Interactive Web Response System (IWRS) module can be set up. The SD Office can provide support and handle the unblinding data in the IWRS system, such as uploading the final medication kit list and randomisation list in the IWRS module or staged release of randomisation numbers in the system.
In some studies, sentinel subjects are used, and sponsors might want to wait with dosing the next subject a fixed number of hours to make sure no serious adverse events are occurring in this period. In that case, the SD Office can manually release the next randomisation number at the expected moment. The SD Office can also create the Study Data Tabulation Model (SDTM) datasets containing the randomisation information for double-blind studies.
There are two possible scenarios for the creation of randomisation lists in double-blinded studies. In the first scenario, an external IWRS vendor is involved in the study, and the random assignment of subjects to a certain treatment group happens automatically in the system according to predefined rules. In this case, an unblinded transfer of the randomisation data from the IWRS vendor to SD Office is needed. The IWRS vendor has both the treatment information and the real subject IDs in the database, and both need to be transferred to the SD Office.
In the second scenario, the SD Office creates the randomisation list themselves. In this case, the link between randomisation number and treatment information is already available. The data management department should provide the link between the real subject ID and the randomisation number to the SD Office. The SD Office will then convert all this information into one SDTM dataset. If there is other information related to the randomisation, such as stratification factors, this is also included in the same SDTM domain.
The advantage of having the SD Office create the randomisation datasets is that these can already be prepared before the lock. Possible issues can be detected sooner, and the SD Office can release this information to other unblinded parties, such as statistical support groups, independent data monitoring committees, independent review committees, and others. The randomisation information is also necessary for internal use in preparing the input files for pharmacokinetic or pharmacodynamic analysis before database lock.
Conclusion
The creation and management of randomisation lists are critical to maintaining the integrity of clinical trial data. The secure data office plays a crucial role in this process by creating randomisation lists, managing IWRS modules, and creating SDTM datasets containing randomisation information for double-blinded studies. By having the SD Office create randomisation datasets, issues can be detected sooner, and the information can be released to other unblinded parties, making the process more efficient. Ultimately, the SD Office’s role in creating and managing randomisation lists ensures that clinical trial data remains unbiased, accurate, and reliable.
