Sub-Investigators and Clinical Trials
Sub-investigators (“Sub-I”) are physicians who may also be involved in the research, and will be listed in the information on the Form 1572, but do not sign the form and therefore are not held responsible by the FDA for the trial conduct. Sub-investigator physicians involved in clinical research assist with performing procedures and monitoring the subjects in the study. Sub-investigators may also be specialists who are a critical component to the successful completion of a study due to required procedures or other evaluations particular to their field.
KMRC operates under a unique clinical model, which specifies physician involvement and responsibility at every step. Of importance:
- Clinical and scientific evaluation of each proposed trial, and approval prior to contracting for the trial.
- Pre-study evaluations and protocol-specific training for staff.
- Site initiation.
- Subject recruitment.
- Consenting process.
- Screening.
- Protocol-specified procedures.
- Assessments of every subject at every study visit.
- Study document QA following each subject visit.
- Adverse event assessments.
- Study close out visits
To accomplish this in-depth physician participation, KMRC uses both full-time and part-time, on-site, experienced Physician-Investigators to serve as Principal Investigators for the clinical trials conducted at our site. A KMRC physician will also be involved as a sub-investigator for any of our studies which may require a physician in another specialty to serve as Principal Investigator. If you are interested in participating with us as a sub-investigator in a clinical trial or simply finding out more about our clinical research program, please Contact Us. One of our physicians will be happy to speak with you directly about our trials and how you may become involved.
