CHAPTER 6
RANDOMIZATION
6.1. Overview
The goal of recruitment, eligibility determination, baseline assessment, and randomization activities, is to enroll eligible participants as quickly and efficiently as possible for inclusion into the study. The overall goal of MOTOR is to randomize 1800 participants (900 per arm) over a 42 month recruitment period.
In order to satisfy assumptions necessary for the validity of the statistical analysis that will be used to evaluate the MOTOR trial, eligible participants must be randomly assigned to treatments. Once informed consent, screening, and baseline data collection procedures are complete, participants are randomized into one of two study groups using the computer generated randomization program through the Web based study data management system.
6.2. Final Patient Eligibility for MOTOR Randomization
Participant eligibility with regards to protocol inclusion/exclusion criteria was determined during the screening phase of the study, resulting in participants being enrolled. This is documented on the Obstetric Eligibility Form (OEF) question # 12, and the Dental Eligibility Form (DEF) question #16. In addition, all baseline data collection and baseline specimen collection must also be completed prior to a participant being eligible for randomization.
The Project Coordinator (or other staff member appropriately trained by the Project Coordinator) is responsible for assuring that all procedures required for randomization have been completed and documented appropriately.
Participants who have been deemed eligible and enrolled into MOTOR and who are no longer interested in participating, or, participants who are not randomized (for whatever reason) once enrolled, must have a Participant Change of Status Form (PCS) completed, see Chapter 11 of the MOP. This will close an enrolled participant ID within the study database.
6.3. Randomization
The randomization procedure is done through the Data Management System (MOTOR DMS) on the Web triggered by the entry of the Participant Randomization Form (PRF). To guard against randomizing participants who do not meet the eligibility criteria, it is necessary that the data used in defining eligibility criteria be collected, preferably entered into the DMS, and reviewed, before randomization takes place. Only then should the PRF form be completed, and entered.
The following forms and procedures will need to have been completed to randomize a patient:
· Informed consent for study participation must be completed and signed.
o Specimen Consent Tracking Form (SCT) completed and data entered
· Screening data collected and preferably data entered, including:
o Participant Screening Log (PSL)
o Obstetric Eligibility Form (OEF)
o Dental Eligibility Form (DEF)
· All baseline OB data collection and specimen collection completed, and preferably data entered, including:
o Baseline Demographic Form (BDF)
o Baseline Obstetric Data Form (BOF)
o Maternal Blood Collection Form (MBF)
§ Maternal serum sample collected
o Baseline Obstetric Sample Collection Form (BSF)
§ FFN sample collected
§ Gram stain sample collected
§ PH result obtained
§ Paper point sample collected
· All baseline Periodontal data collection and specimen collection completed, and preferably data entered, including:
o Dental Baseline History Form (DBH)
o Periodontal Baseline Examination Form (DBE)
o Examination data entered in DDES or on Emergency Form (DEX)
o Plaque samples collected
· Completion and entry of the Participant Randomization Form (PRF) see below.
6.3.1. Participant Randomization Form (PRF)
The Participant Randomization Form must be completed and entered into the DMS in order to randomize a participant. This form provides an additional checklist on the eligibility of each participant to be randomized. Information needed to complete this form must come from a review of the participants study chart and/or files. Randomization is documented as a visit=02 procedure on the PRF form.
The process of data entry of this form into the MOTOR DMS automatically triggers the randomization process. Randomization, and thus, data entry of this form should be performed at the time the participant is present in the clinic, to avoid randomizing any participant who become a no-show or ineligible.
6.3.2. Normal Randomization Procedure Using the Data Management System
The randomization program is automatically run when you enter a ‘Y’ response to the last question, #7, on the PRF, ‘Do you want to randomize this patient?’ At this time you will be prompted with the participant’s treatment assignment, Prenatal Treatment, or Post-Partum Treatment. The data entry screen providing the randomization information should be immediately printed onto paper for the participant’s clinic chart. A successful randomization will also automatically send an email to the SCC notifying them of the randomization.
In the event that the randomization program aborts and does not run, you will be prompted with an error message explaining the reason for the randomization failure. Update the PRF with corrections and and begin the randomization procedure again.
6.3.3. Randomization Procedure when System is Not Functional
Since the randomization procedure requires entry through an internet connection, a backup procedure is necessary for cases in which the clinic’s computer system is not functional, or the WEB is inaccessible or not operating appropriately. The following procedure will be used in such cases:
· All necessary forms must be completed per usual procedure.
· Final assessment of randomization eligibility must be completed.
· The Study Coordinator (or other appropriately trained staff member) can call the DSCC, normally staffed from 8AM – 5PM EST, Monday through Friday. Randomizations at other times must be arranged in advance.
First the DSCC will attempt to solve the computer problem, if it relates to the MOTOR DMS. If this fails, the Study Coordinator and DSCC research assistant will review the participant’s eligibility forms to assess eligibility and to determine the randomization stratum. The randomization assignment tables at the DSCC and clinic will be compared to assure that the correct treatment assignment will be given. The DSCC will then give the treatment assignment code to the Study Coordinator. (Note: Since chances for error are increased by transmitting eligibility data by phone, this system should only be used when absolutely necessary).
As soon as the system at the center becomes operational, the randomization must be entered on that system BEFORE ANY FURTHER RANDOMIZATIONS CAN OCCUR, and the contact person providing the telephone randomization must be notified that this has happened. It is essential to enter any remote randomizations into the MOTOR DMS in the order in which they were randomized by phone, before using it for any further randomizations.
6.3.4. Randomization Assignments
The randomization procedure will provide information that identifies the treatment assignment to one of two assignments:
1. Prenatal Treatment, Scaling and Planing to be completed by 236 weeks gestation
2. Post-Partum Treatment, Scaling and Planing scheduled approximately 4 weeks after delivery.
Chapter 7 of the MOTOR MOP describes the study intervention more fully.
CHAPTER 6: Randomization 9/13/06 Page 6 - 1