Data and Safety Monitoring Boards (DSMBs) and Data and Safety Monitoring Committees (DSMCs) carry out important aspects of clinical trial monitoring. A clinical trial Data Monitoring Committee is a group of individuals with pertinent expertise that reviews on a regular basis accumulating data from one or more ongoing clinical trials. The DSMB advises the investigator regarding the continuing safety of trial subjects and those yet to be recruited to the trial, as well as the continuing validity and scientific merit of the trial.

Monitoring is the act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCPs), and the applicable regulatory requirement(s). Typically, academic sites are familiar with monitors assigned by a sponsor or a contract research organization (CRO). However, GCP requires that investigator-initiated trials enrolling human subjects also provide a monitoring plan to assure that the data collected throughout the study are accurate.

The CTSI BERD (Biostatistics, Epidemiology and Research Design) Core consultations pool Penn State resources across campuses to offer training in biostatistical and epidemiological methodologies and assistance to investigators in study design, data management and analysis. BERD provides for free up to four hours of consultation per project for the development of clinical and translational science external grant proposals and consultations for institute-funded pilot projects.

College or unit administrators assist investigators submit applications and develop their non-technical sections, including the budget.

The CTSI provides provides proposal development services. Learn more and access the consultation form on the CTSI website.

This activity is required for industry-sponsored clinical studies and investigator-initiated clinical studies with funding from industry and may be needed for other research activities. In many instances a sponsor sends a Confidential Disclosure Agreement (CDA) prior to sharing a protocol or confidential documents. PIs should contact the Office of Sponsored Programs for more information and assistance.

Because it may be necessary for a researcher to obtain access to and review PHI in order to prepare a research study, HIPAA rules allow such a review upon compliance with specified criteria. An application for review of PHI preparatory to research must be submitted to the IRB for review and approval.

ACT Network

The Accrual to Clinical Trials (ACT) Network is a real-time platform for researchers to explore and validate the feasibility for clinical studies across the NCATS Clinical and Translational Science Award consortium. ACT helps researchers design and complete clinical studies and is secure, HIPAA-compliant and IRB-approved.

With the ACT Network, researchers can:

The Trial Innovation Network is a new collaborative initiative within the CTSA Program and is composed of three key organizational partners – the CTSA Program Hub network, the Trial Innovation Centers (TICs), and the Recruitment Innovation Center (RIC). All are key partners of the Trial Innovation Network and make unique and essential contributions. Other important partners include NIH Institutes, other federal and non-federal stakeholders, researchers, patients, providers, and the public.

REDCap (Research Electronic Data Capture) is a secure web application for building and managing online surveys and research databases. It is a novel workflow methodology and software solution designed by Vanderbilt University for rapid development and deployment of electronic data capture tools to support clinical and translational research. Using REDCap’s streamlined process for rapidly developing projects, you may create and design projects using

The Clinical Research Center (CRC) provides clinical research expertise, facilities and resources to Penn State investigators. Resources include unique facilities and equipment, as well as highly experienced staff who are trained in human subjects’ protection, good clinical practices, protocol implementation and compliance. The facilities at University Park CRC are approximately 6,800 square feet and include five patient exam rooms, an interview/consult room, a DXA room, two procedure rooms, three infusion sleep rooms and an exercise room.