The TATUM application brings together randomization elements: randomized lists, rules, and questions to designate treatment allocations to patients. It replaces randomization envelopes, tracks progress of the study, and provides documentation of study treatment assignments. The TATUM application allows the Study Admin to set up and maintain study specific questions consisting of two types: 1) mandatory multiple-choice questions used in the randomization process and 2) optional questions allowing free-text input that is not used in the randomization process.
Gaining Access to TATUM
Two levels of TATUM user account access and one non-system user role exist.
Study admin: This role requires TATUM access and is limited to U-M staff only, for UM-sponsored studies. TATUM functions for this role are as follows:
- Has study-specific access.
- Adds and edits studies and study-specific site information
- Assigns study admins to their own studies and staff users to their own sites.
- Creates and assigns contacts for sites.
- Uploads randomized lists for their own studies, creates study questions, downloads rules configuration template, prepares and uploads the rules configuration file.
- May generate reports for their own studies/sites.
Staff user: This role requires TATUM access and is open to internal and external users, in support of UM-sponsored studies. TATUM functions for this role are as follows:
- May be assigned to multiple sites and studies, for which he/she performs randomization tasks (answers study-specific questions for a patient and retrieves a treatment allocation), generates the treatment allocation report.
Site contact: This role does not require TATUM access and is open to any study team member (internal or external to U-M). The role is created and maintained by the study admin. Functions for this role are as follows:
- Receives email notification after a treatment allocation has been assigned.
To obtain a TATUM study admin account:
- Must have either a U-M level one login and password or a U-M Friend/Guest account with login credentials.
- Must be a U-M staff member.
- Must have a U-M-sponsored study and HUM#.
- Successfully complete the TATUM 201 Study Administrator Online training course.
Contact Michr-Support@umich.edu for a TATUM account access request form.
To obtain a TATUM staff user account:
- Must have either a University of Michigan level-one login id/uniqname or a U-M friend/guest account with login credentials.
- Contact MICHR-Support@umich.edu for a TATUM account access request form.
- Access for staff users must be authorized by the TATUM study admin. After obtaining your TATUM account access confirmation, contact the TATUM study admin to be added to the appropriate study site. (NOTE: In order to use TATUM, the study must be set up and loaded by the TATUM study admin in advance.)
TATUM does not generate the randomization strategy. The lists, rules and questions must be produced by a qualified biostatistician and finalized before use in TATUM.
Consult With Your Study Team
The Study Admin role affords study-set-up privileges within the application. Study Admins must work with their biostatistician and study team to define questions and answer options for a study BEFORE configuring them in TATUM. Question and answer options work together with randomization lists in determining the allocation result. Therefore, it is recommended that randomization elements are finalized prior to setting up the study in TATUM.
Post-production changes after the allocation process has begun are not encouraged and need to be handled with extreme care. Adding new questions to an ongoing study will affect the randomization result, and the rules will need to be redefined accordingly. The Study Admin must consult the study team and obtain documented approval before adding or editing study questions/ answers to an ongoing study. The responsibility for making post-production changes after the allocation process has begun reside entirely with the Study Admin and the study team.
Establishing a Sufficient Treatment Allocation Pool
The biostatistician must produce sufficient treatment allocation assignments to allow for patient attrition due to screening failures, withdrawal, adverse events during the study, etc., or even a trial extension. Adding treatment allocations once the process has begun may invalidate the treatment allocation assignments.
Study Set-Up Prerequisites
The randomization list(s) and decision rules must be prepared in advance by a biostatistician and ready to be loaded into TATUM in the required format (.csv file).
The study and site questionnaires must be prepared in advance by the study team and finalized before they are entered into TATUM.
You should create, maintain and implement a business continuity plan in case of TATUM outage (planned or unplanned).
A Note About Protected Health Information (PHI)
Because TATUM's functionality provides reporting functionality and email notification features to study staff, MICHR requires:
- DO NOT USE protected health information (PHI) such as the medical record number (MRN) for patient ID or for the answer to TATUM questions,
- If your study is to be blinded, use other methods of randomization or limit TATUM access only to staff members who are permitted to be unblinded per the study protocol