PowerTrials is the research module that resides within the Electronic Health Record at Augusta University Medical Center and the Children's Hospital of Georgia. PowerChart is the name of the electronic health record.
Research Development Services (RDS) is responsible for administering PowerTrials. Each study that utilizes a billable hospital service is entered in PowerTrials by RDS staff. The research site is responsible for entering each patient that becomes enrolled in the study. The RDS PowerTrials Administrator provides training to support investigators, coordinators, monitors, and other research staff. Only persons given appropriate roles on an IRB approved study have access to the study information in PowerTrials. Features of PowerTrials include:
PowerTrials has a component called Screener. Researchers can utilize PowerTrials Screener to obtain study feasibility information. Screener can provide the number of patients that have been seen at AUMC or the Children's Hospital of Georgia in the past 5 years that meet the major study criteria. This type of information does not require IRB approval. PowerTrials Screener can guide protocol development and enable the discovery and prioritization of research opportunities.
PowerTrials Screener also enables research staff to obtain a list of potential study subjects from the hospital electronic health record. Screener scans study inclusion and exclusion criteria from PowerChart to better define patients who may meet study eligibility requirements. In order to obtain specific patient information, PowerTrials Screener needs to be indicated as a method of study subject recruitment in the initial submission to the Institutional Review Board (IRB) or by an amendment if the study is already IRB approved. The method(s) as to how potential subjects will be contacted needs to be described (i.e. phone call, email, or letter). On the RDS website there is an IRB approved phone call template that can be used to contact potential subjects.
PowerTrials Screener uses a HIPAA compliant process. Security is supported in PowerChart, PowerTrials, and Screener through Citrix using application logins, passwords and research access based on role.
Physicians, Residents, and Fellows obtain clinical access to Citrix and PowerChart from their departmental Systems Administrator. If a physician, resident, or fellow needs access to PowerChart and/or PowerTrials for research purposes email or call the OCIS.
All users must be listed on an IRB approved study. If the user is not currently listed on the study, a study amendment should be submitted to the IRB prior to access to the EMR.
The following Information is needed when emailing or calling OCIS:
Name, job title, department, and last five of social security number of person requesting access
Phone number and email address
IRB Protocol Number
Name of Principal Investigator for the study
Copy of the IRB approval letter for the study
Contact phone number(s)
All other employees obtain access to PowerTrials by sending an email to the OCIS with the above information.
All non-employees requesting access to PowerTrials for research purposes need to contact the OCIS.
Contact OCIS for access to the hospital clinical data warehouse (i2b2); OTTR (Transplant database); and other hospital online programs for research purposes.
NOTE: Screener PowerTrials needs to be indicated as a method of study subject recruitment in the initial submission to the Institutional Review Board (IRB) in order to utilize Screener. The method of how potential subjects will be contacted also needs to be described (i.e. phone call, email, or letter). If the study is already IRB approved, an amendment is submitted to the IRB to add this information.
The RDS PowerTrials Administrator will schedule an appointment with study staff member.
The appointment for Screener will include:
When the Service Request is complete, the designated investigator or study coordinator can run the Screener tool for the study.
The list of potential subjects and subject status is maintained in PowerTrials application within the specific study folder. (Only approved study staff has access to the folder.) Any results that are copied must be stored on the R Drive.
Outcome of subject contact and status is entered in PowerTrials by the person designated to contact potential subjects for the study.
