Research Toolkit

Requirements for Human Subjects Researchers/Personnel

There are three requirements to be approved as an investigator or research personnel on a study that uses identifiable data or specimens from humans. These include:

  1. Submit a Conflict of Interest (COI) disclosure.
  2. Upload your CV into the InfoEd system.
    • Go to InfoEd eRA
    • Select your campus to log in (Denver).
    • Login using your CU Anschutz username and password.
    • In the top menu bar, select “My Profile”.
    • Under "Biography" on the left had menu, select "Biosketch".
    • Select add, and follow the directions.
  3. Complete applicable human subjects protections courses through CITI. Visit the Colorado Multiple Institutional Review Board (COMIRB) Training Page for information on accessing the following courses:
    • Everyone must complete:
      • Group 1 Biomedical Investigators
      • CITI Health Information Privacy and Security (HIPS) for Clinical Investigators
    • If your study is funded by the NIH:
      • Group 4: ICH/GCP – meets NIH Requirements
    • If your study is funded by Industry, you may need to complete:
      • GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus)
        (depending on Sponsor requirements)
    • If you are the PI of a study with a drug or device, you will need to complete:
      • GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus)

 

Contact Info

Pamela Alvarez Moran
Administrative Research Core Manager
12700 East 19th Avenue
Room 3009, MS 8613
Aurora, CO 80045

Phone: (303) 724-6501
Fax: (303) 724-3512

 

 

Contact Info

Pamela Alvarez Moran
Administrative Research Core Manager
12700 East 19th Avenue
Room 3009, MS 8613
Aurora, CO 80045

Phone: (303) 724-6501
Fax: (303) 724-3512