Support for Your Clinical Trial
The HPCRL team maintains a well-developed infrastructure based on industry standards and FDA compliance for human subject clinical research.
Good Clinical Practice Standards
Good Clinical Practice Standards are recognized by the FDA, NIH, and the global academic and scientific industry as the gold standard for scientific research.
GCP standards are designed to ensure:
- Human participant protection
- Ethical study conduct
- Data integrity
By following the GCP format you will ensure you are ethically collecting high-quality data. We are able to offer GCP training and oversight for your study. Our priority is to keep your clinical study in adherence to these standards by building them into your study protocols from the IRB to the last collected data point.
In 2011, we identified a need to build and develop a program to follow the GCP guidelines and ensure FDA compliance for our research faculty.
Since 2011, our research operations team has grown. We now have two full-time assistant managers, a manager of research operations, and a medical director, that support GCP Investigator-Initiated Sponsored studies. We have the experience supporting and monitoring FDA New Investigational Drug, Investigational Device Exemption, NIH, and IND exempt GCP pharmaceutical/ nutraceutical contracted studies. We are excited to now extend these types of service to investigators across the University. We are here to help you navigate compliance with the regulatory process and provide the necessary medical oversight to conduct your study.
Even if your study is not a pharmaceutical, device or biologic FDA regulated study, there are still a number of requirements for all human clinical intervention NIH funded and industry contracted funded trials. For example, every study must have a Data and Safety Monitoring Plan, be registered on clinicaltrials.gov, and adhere to GCP guidelines throughout the entirety of the trial. You can lean on our team to get your study underway and be sure all requirements are met.
In September 2016, NIH announced that all NIH-funded investigators and staff involved in the conduct, oversight, or management of clinical trials must be trained in GCP. This new training requirement is effective Jan. 1, 2017, and applies to all new and existing NIH clinical trials.
Compliance and Peace of Mind
We help you dot your i’s and cross your t’s so you can focus on conducting the highest quality clinical trial. Based on the specific goals of your study, we are able to offer two support packages assuring you are in compliance.
AgingPlus Study Collaborative and Professional
“The collaboration of the ADAPT research team with the research staff at the Human Performance and Clinical Research Lab has been and continues to be, a very positive experience. In particular, we are conducting a randomized controlled trial for which the staff at the HPCRL implements the physical performance assessment protocol.”
“The feedback that we have received from study participants has been unanimously positive. All in all, our team and the team at the HPCRL work together smoothly and we could not ask for a better research partner.”
Manfred Diehl, Ph.D., Principal Investigator
Katherine Thompson, B.S., Project Coordinator