Biostatistical Consultation provides advanced biostatistical and methodological support in the areas of basic, clinical and translational research to Temple Health faculty, staff and students. Faculty biostatisticians and epidemiologists provide advice related to: study design, randomization procedures, sample size and power calculations, database development and statistical analysis. Assistance in the areas of IRB submission, grant development and manuscript preparation is also available. Collaborative partnerships with clinical investigators are welcomed. While initial consultations are provided at no cost, other financial arrangements, including specific fees for service or grant support, may be necessary. Authorship Policy: Co-authorship of scientific journal articles is expected on studies where substantive input on design and/or analysis is provided.
Electronic Medical Records Data Extraction
Leverage data in the Epic EHR, the TCRI informatics group can run rudimentary aggregate queries for counts of patients needed for study feasibility work, create small de-identified data sets for preparatory-to-research investigations, or can provide PHI on an as-needed basis to members of the covered entity who require a deeper exploration of data, still in the preparatory-to-research phase. Rather than requiring multiple iterations of queries, and movement of data from one source to the next to merge data, the honest broker office will work directly with investigators to refine queries in real-time and crosswalk-matched patient information from different data sources. When research requires outreach for subject recruitment, the office will create patient lists meeting inclusion criteria and stratified by physician so that signed written approval for patient contact can be created where required. Elements to be included in the data extracts will include clinical data of common need across many research studies including demographics, diagnoses, procedures, laboratory and other ancillary tests and results, medications prescribed or dispensed. Electronic Medical Records can only be extracted and used for clinical research after the research protocol has been approved by the IRB.
Regulatory Affairs, Research Integrity and Compliance
Regulatory Affairs provides guidance and support to TUSM investigators and research staff to assure compliance with Federal and State regulations for clinical research. We facilitate submissions to the Food and Drug Administration, more specifically we provide assistance during the submission of IND and IDE applications. We also provide guidance on the registration and reporting requirements on ClinicalTrials.gov. We offer consultative services for investigator-initiated protocols, on-site training for investigators and research staff to optimize regulatory compliance, the development of Data and Safety Monitoring Plans and DSMBs, the development of corrective action plans in response to FDA and sponsor-related audits. We perform clinical research-related quality assurance monitoring. We serve as a liaison between the TUSM investigator and the IRB and/or FDA. We work with TCRI Clinical Research Administration (CRA) and Clinical Research Implementation to help facilitate and coordinate the implementation and monitoring of clinical research studies.