Clinical Trials Resource Center

Conducting Clinical Trials

conducting clinical trials

Get started here finding helpful forms and guidelines for all your research needs.

Protocol Development -  What should be in your protocol? Go here to find templates, outlines and guidelines.

Consent Development - What elements have to be covered? What is the latest required UT-IRB language?

Budgeting & Billing - For what expenses should you plan? What will be required from the Office of Sponsored Projects?

Research Participant Payment (1099) Guidelines- When should you collect W-9 information from participants who are being paid for participation in research? 

Recruitment Strategies - Now that you've developed your protocol and consent, how do you plan to get subjects?

Data and Safety Monitoring -When do you need a Data Safety Monitoring Plan? A Data Safety Monitoring Board?  Who forms the board?

Safety Reporting - What should be reported? To whom? How quickly?

Quality Management - What are GCP Guidelines for conducting a quality clinical trial?

Study Management - The day-to-day study coordinator experience from pre-study initiation to subject management and drug accountability -get your tips and template forms here.

Lab Certificates - If you will be working with a local lab during the course of your clinical trial, then you will need to keep current CAP and CLIA certificates in your regulatory binder.  For your convenience, we are providing them here.  If you notice that a posted certificate has expired, please contact us at clinicaltrials@uth.tmc.edu.  

Memorial Hermann Hospital Laboratory - CAP and CLIA (Director CV & licenses are available in iRIS)

ADDITIONAL RESOURCES

CLINICAL RESEARCH UNITS (CRU) | BERD | REDCap
COMMITTEE FOR THE PROTECTION OF HUMAN SUBJECTS |ANIMAL RESEARCH | ENVIRONMENTAL HEALTH & SAFETY | CORE LABORATORIES | SPONSORED PROJECTS TECHNOLOGY MANAGEMENT
OFFICE OF RESEARCH 

Center for Clinical and Translational Sciences

Clinical Trials Resource Center (CTRC)
7000 Fannin Street, Suite 795

Houston, Texas 77030
phone 713-500-3622
fax 713-500-0334
clinicaltrials@uth.tmc.edu

last modified October, 2013
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