Consultation, Protocol Development, Regulatory/Compliance Support:
For investigators wishing to initiate a project involving clinical/translational research, this core provides the following assistance:
Consultation: Clinical staff and the leadership of the associated cores are available to provide consultation and facilitate the process of effective project development. This includes clinical staff to discuss the relevance of the questions to clinical practice, the identification of existing resources (data or samples in existing repository collections), other experimental data that may already exist on samples or collections that could aid in preliminary data for new projects/proposals. The staff can also facilitate understanding of the necessary steps that a new investigator should follow to develop a new clinical research project.
Protocol Development: Staff versed in new clinical protocol development are available to assist with the design and drafting of new IRB protocols, informed consent documents and other tools for collection of clinical data. This includes interfacing with staff in the Clinical/Translational Informatics group for the appropriate development of electronic data collection forms and database development. See Clinical/Translational Informatics page for more information.
Regulatory Compliance: Staff is available to help monitor compliance with IRB protocols, drafting amendments as required, reporting for IRB and NIH grant progress reports. Staff is also available to assist with ensuring that any MTAs comply with the clinical research regulatory concerns for consent, protections of personal health information, etc.
Contacts:
Clinical Research Questions:
Joan Merrill, MD
Email: joan-merrill@omrf.org
Cristina Arriens, MD
Email: cristina-arriens@omrf.org
Gabriel Pardo, MD
Email: gabriel-pardo@omrf.org
Judith A. James, MD, PhD
Email: Judith-James@omrf.org
Existing Collections (Data and Sample Repositories)
Joel M. Guthridge, PhD
Email: Joel-Guthridge@omrf.org
Judith A. James, MD, PhD
Email: Judith-James@omrf.org
Bridget Adney, MS (Program Manager)
Email: Bridget-Adney@omrf.org
Regulatory Issues (IRB, MTA, Protocol Development)
Nancy Redinger (Associate Director of Clinical Affairs)
Email: Nancy-Redinger@omrf.org
Liz Brouchard, (Clinical Regulatory Specialist)
Email: Liz-Brouchard@omrf.org
Bridget Adney, MS (Program Manager)
Email: Bridget-Adney@omrf.org
