Abbreviations
ICF
What is Informed Consent Form?
This stage of research is conducted in cell and animal models.
What is Pre-clinical Research?
The CRO Regulatory department is responsible for maintaining this collection of essential documents relating to site participation in a trial.
What is the Investigator Site File or Regulatory Binder?
This is the CTMS our CRO uses to enter patient statuses and track participants as they progress through a trial.
What is eVelos?
The Queen of Halloween Floor Wars.
Who is Maria Chavez?
DTL
What is Delegation of Tasks Log?
Also known as post-marketing surveillance trials, these are conducted after a drug has been approved by regulatory agencies like the FDA.
What are Phase IV trials?
This regulatory institution is responsible for ensuring sites in the United States of America conduct research according to Good Clinical Practice.
What is the Food and Drug Administration?
This is the system you use to Register and Randomize patients on NCTN Trials.
What is the Oncology Patient Enrollment Network (OPEN)?
The 4th Floor Fashionista who keeps the CRO running.
Who is Lula Segura?
CTSU
What is Cancer Trials Support Unit?
These trials are first-in-human and seek to establish the highest dose of the new treatment that can be given safely without causing severe side effects.
What are Phase I Trials?
A committee that reviews research proposals involving human subjects to ensure that they are ethically sound and adhere to relevant regulations.
What is an institutional Review Board?
This is the system where you enter QCLs for study biospecimen collections.
What is Mosaiq?
The people in this CRO department ensure patient safety and data integrity.
What is Quality Assurance?
HIPAA
What is Health Insurance Portability and Accountability Act?
These trials compare the safety and effectiveness of the new treatment against the current standard treatment in a large number of people.
What are Phase III Trials?
This strategy focuses on identifying, assessing, and mitigating risks to data quality and patient safety by prioritizing monitoring efforts on the areas with the highest risk potential.
What is Risk-based Monitoring?
This is the system where you order imaging and study labs for patients on trial.
What is CERNER PowerChart?
These two people in the CRO are quick on the draw.
Who are Angelica Alvarado and Fiona Harding?
CLASS
What is Compliance, Learning and SOP solutions?
These trials evaluate the safety and efficacy of a drug for a particular condition in a small number of people.
What are Phase II Trials?
This regulatory body creates recommendations for conduct of clinical research world-wide. Though they are not legally binding in the USA, non-compliance can restrict investigators from marketing drugs in other countries.
What is the International Conference on Harmonisation?
In CTSU on each protocol homepage you can find Master Forms and memorandums under this tab.
What is Protocol Related Documents?
the UNM CRO is part of this state-wide collective of clinical sites working to bring clinical trials to patients across New Mexico.
What is the New Mexico Cancer Research Alliance?