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The primary mission of the Research Quality Assurance Office is to support the planning and conduct of both clinical research and basic laboratory research being conducted at the Penn State College of Medicine.
Key components of this work include research laboratory safety, biosafety, human research trials compliance and IACUC compliance.
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Working with Research Quality Assurance
The Research Quality Assurance mission is fulfilled by working with investigators to help them identify gaps that might negatively impact their research and assist them by making recommendations to eliminate these gaps. This support is provided to aid investigators in conducting research as required by regulatory authorities, to ensure that laboratory research follows acknowledged best practices, that research fulfills promises to study volunteers and with due respect for laboratory animals.
To complete this mission, this office works directly with investigators to promote research integrity and best practices through education and mentoring of investigators and their staff.
The Research Quality Assurance team works collaboratively to develop, establish and provide training material, programs and tools (checklists) for research investigators, coordinators and research administrative and laboratory staff related to applicable federal, state, local and institutional research regulations and guidelines.
In collaboration with others at Penn State Health Milton S. Hershey Medical Center, Penn State College of Medicine and Penn State University Park, the team reviews and revises current institutional and University research policies, and drafts new policies, to maintain adherence to current regulatory guidelines and best practices.
The Manager of Research Laboratory Safety develops systems to perform laboratory site visits to assist investigators in meeting their regulatory obligations and to continually improve laboratory safety.
In addition, the team has redefined a Research Compliance Monitor position to provide assistance to investigators and support staff in the preparation, submission and maintenance of investigational new drug and investigational devices.
RQA also works to improve human subject research through
- personal communication and consultation;
- departmental and institutional seminars and on-site reviews; and
- evaluations of current research practices.
In cooperation with investigators, the Human Subjects Protection Office, the Office of Research Affairs and the Office of Research Protection at University Park, the Research Quality Assurance office works to establish and maintain a contemporaneous database of clinicaltrials.gov registrations and establish mechanisms to assist investigators in compliance with statutory requirements and publication guidelines for publicly accessible clinical trial registration.
Furthermore, this office is an independent unit that oversees and directs the monitoring, auditing and evaluation of research activities.
RQA’s intent is to be a proactive unit that helps investigators successfully contribute to the advancement of medical science.
Location: The main RQA office is on the second floor of the Support Services Building.
Research Quality Assurance
Penn State College of Medicine
500 University Dr., Mail Code SB36
P.O. Box 850
Hershey, PA 17033
Penn State College of Medicine is committed to preventing exposure to bloodborne pathogens through its policies, procedures and training.
A number of resources are available as guidelines for maintaining biological safety.
Internal Review and Monitoring
The Data Management team in the Department of Public Health Sciences at Penn State College of Medicine offers clinical trial monitoring.
Clinical trial monitoring services provided by Data Management help the investigator ensure that:
- All clinical trial activities follow the research protocol
- Participants’ rights, welfare and safety are protected
- Quality, reliability and integrity of data collected are maintained throughout the study
- Liability risk to the institution is minimized
Resources and Training
Association of Clinical Research Professionals (ACRP) eLearning Modules are available at no cost to Penn State faculty and staff who have been provided a user account through the institutional site license.
ACPR recommends the successful completion of the two foundational training modules:
- Good Clinical Practice: An Introduction to ICH GCP Guidelines
- Ethics and Human Subject Protection
Research coordinators using services of the Clinical Research Center and coordinators participating in multi-site clinical trials must complete these two modules within six months of being identified as part of a research study team.
All faculty, staff and students are encouraged to request a user account to utilize these training opportunities in an effort to enhance their knowledge of clinical research.
Contact a representative from RQA to obtain a user account.
Note: ACRP members must use the username and intuitional access link to access the modules included in the institution’s license at no cost, not their individual ACRP membership user account and the general ACRP webpage accessible to the public.
A list of past and upcoming RQA Lunchtime Lectures and Quarterly Workshops appears here.