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| Clinical Research News You Can Use | Winter 2009 |
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CCTS |
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FACES IN THE CROWD |
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MEMORIAL HERMANN HOSPITAL |
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REGULATORY CORNER |
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CLINICAL TRIALS REGISTRATION |
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STEM CELL NETWORK |
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GOOD CLINICAL PRACTICE TIPS |
Training / Education
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| Cardiovascular Cell Therapy Research Network |
Rachel Vojvodic and Shelly Sayre are the project managers for the Cardiovascular Cell Therapy Research Network. Presently, they coordinate all of the activity associated with two approved phase II clinical trial protocols and another phase II protocol which is currently pending FDA approval. The study, which has received funding for five years from the National Heart, Lung, and Blood Institute (NHLBI) is investigating autologous bone marrow derived adult stem cells for treating cardiovascular disease. |
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| Faces In The Crowd |
 Before joining the private practice of two EP physicians at UTHSC-H, Darla Labasse worked at the UTMB Cath lab and EP lab. Her responsibilities included checking the patients' ICDs and pacemakers as well as holding a nurse device clinic. She also became a research coordinator for some device studies. She was hired at UTHSC recently and moved over to MD Anderson to follow Dr. Dougherty's patients where she will assist in research. |
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| Center for the Protection of Human Subjects |
The Office of Research Support Committees, the staff for the Committee for the Protection of Human Subjects and the Animal Welfare Committee, has recently moved. Our new location isin the University of Texas Professional Building, 6410 Fannin, Suite 1100. Inter-institutional mail should be addressed as UPB 1100. |
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| Regulatory Hurdles Made Easier |
If your study involves the use of a new drug, or the new use of an existing drug, the IRB process isn’t the only hurdle you’ll have to jump. In order to conduct a trial using one of these, the FDA requires approval via an Investigational New Drug filing (IND), and the IRB must have the IND number before approving the protocol. Hurdles like this can make the starting point of enrolling your first research subject seem far away, but the good news is that you don’t have to do it alone. |
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| New Manager of Research Finance for the Memorial Hermann Clinical Innovation & Research Institute |
 Tom R. Rice, CPA, the new Manager of ResearchFinance for the Memorial Hermann Clinical Innovation & Research Institute, is responsible for the overall financial management of the Institute. Included in his responsibilities is management of the Grants Accounting process for the research grants awarded to the Memorial Hermann Healthcare System. In this capacity, Tom assures that all sponsored projects comply with the individual sponsor’s policies and procedures, as well as the policies and procedures of the Memorial Hermann Healthcare System. In addition, Tom manages the billing and collection processes for clinical research projects that are conducted within the Memorial Hermann Healthcare System. |
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Good Clinical Practice Tips |
| Source Documentation and Record Keeping |
Each year, records related issues, inadequate and inaccurate records represent the second most commonly cited deficiency in CDER’s (Center for Drug Evaluation and Research’s) GCP (Good Clinical Practice) compliance inspections of clinical trial investigators and sites. The first one is failure to adhere to clinical protocol. |
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| CCTS Offers Assistance to PIs and Research Staff |
Do you need regulatory help at your research site? The CCTS Regulatory Component provides an array of guidance and support for UTHSC PIs and clinical staff who are conducting research- and are here to help you! |
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Clinical Trials Registration |
It is time to update your clinical trials registrations in order to meet the International Committee of Medical Journal Editors (ICMJE) 6 month update requirements for publication. In addition to accessing the registration and recording the new record verification date, this is the opportunity to add any new information about the study and note any changes in the study that may have occurred. |
| Find out more... |
