Research > Resources and Services

Resources and Services

Stephens Family Clinical Research Institute provides Carle investigators with staffing support and research services to promote and facilitate clinical trials as well as investigator initiated research.

Biostatistics Services (BS) provides expert statistical consulting for complex studies and grant proposals to Carle investigators on study design, sample size calculations and selection challenges. BS also contributes to protocol development, writing statistical analysis plans, performing quality assurance of data and providing biostatistical expertise on grant proposals.
 
Budget Development Services (BDS) assists Carle investigators and collaborating researchers with the development and management of budgets for both internally and externally funded research projects. BDS helps identify funding opportunities according to clinicians’ areas of expertise and Carle’s research strategy. In addition, BDS assists in the preparation and submission of research proposals to external sponsors. For more information, or assistance with any further questions, please email kathy.dams@carle.com.
 
Carle Research Editorial Support Team (CREST) assists Carle authors in preparing manuscripts for submission to high impact medical journals. CREST provides a variety of services including manuscript editing, creation of original art work, conducting literature searches and reference checks, and obtaining any needed copyright clearance. CREST members are available to assist seven days a week as well as evenings.
 
Clinical Trials Support Services (CTSS) assists Carle investigators throughout the life of clinical trial studies or investigator initiated projects. Some services include offering Good Clinical Practice trained project coordinators and managers, developing recruitment strategies, offering clinical protocol development expertise, managing regulatory documents, offering financial oversight, and providing study quality assurance reviews and recruitment tracking.
 
Data Services (DS) assists with collection, mining and management of EMR data for Carle research projects. DS also provides data delivery, surveys, information about REDCap and assistance with questions about patient populations for new studies.
 
Financial and Regulatory Oversight (FRO) ensures all financial, regulatory and contractual aspects of a Carle research study are in place prior to its activation and throughout its life. FRO manages clinical research billing – including Medicare billing analysis – to determine routine costs in a clinical trial. In addition, FRO assists with Institutional Review Board (IRB) submission, notification of approval and facilitating modifications to existing research, and provides information about FDA Expanded Access and research training such as CITI, Human Subject Protection Training and Good Clinical Practice.
 
Grants Administration (GA) monitors project related budgets as well as account balances and expenditures, and prepares financial reports and analyses to assist Carle investigators with the administration and development of sponsored research projects.  GA assists investigators in meeting various internal and external reporting requirements by deadlines, and completes sponsored project close out reviews. GA also represents SFCRI during internal and external sponsored research audits, in collaboration with Carle’s accounting and compliance units. For more information, or assistance with questions, please email kathy.dams@carle.com.
 
Human Subject Protection/Carle Institutional Review Board (HSP/Carle IRB) office works in daily support of the Carle IRB. The department collaborates with investigators, research coordinators, subjects and regulatory agencies to ensure that research at Carle takes place in an ethically rigorous and compliant manner. HSP/Carle IRB also handles IRB related documentation and provides regular educational opportunities for those interested in conducting research at Carle.

Intellectual Property (IP) encompasses all forms of creativity such as inventions, software, discoveries, creative or artistic works, know-how processes and unique material. IP is protected through patent, copyright, trademark and trade secrets laws. Employees of Carle are encouraged to disclose to Stephens Family Clinical Research Institute new discoveries and findings. To learn more, or request a disclosure form, please email emily.wee@carle.com.

Investigator Initiated Research Services (IIRS) provides consultation support to Carle investigators developing investigator initiated research projects. Consultation support includes assistance on planning and designing a study, development of hypotheses, power analyses and sample size calculations, data analyses and interpretation, manuscript and presentation writing, and other logistical considerations. IIRDS also assists with the development of study proposals for grants. If you have a research idea and would like to discuss it, please complete a Carle Research Services Request Form. To learn more, please email emily.wee@carle.com.

Nursing Evidence Based Practice and Research is supported by SFCRI, assisting students and professionals who want to participate in nursing evidence-based practice and research. Professionals and students interested should email lori.vanwingerden@carle.com or research@carle.com.


Carle IRB

The Carle Institutional Review Board oversees and provides support for all research at Carle. Requests must be submitted and approved in advance of any research project to ensure complete consideration of human subject protection requirements, regulatory guidelines, and necessary education and training.

View Carle IRB Information