IRB Study Tools
It is the responsibility of the Principal Investigator to ensure that human research is conducted with a focus on both ethics and compliance. It is the PI's responsibility to monitor the on-going conduct of active research. The UNM OIRB has created Study Tools that may be used by researchers to meet these responsibilities.
| File Name | Document Description | Category | Version Date |
|---|---|---|---|
| Self-Assessment Tool | Tool for researchers to assess their project to ensure they are being conducted in compliance with approved procedures, regulations and IRB policies. | Study Tools | 01/19/2018 |
| CITI - COI Tracking Log | Use this log to track project team training (CITI) and Conflict of Interest (COI). | Study Tools | 09/01/2020 |
| Research Staff Group Training Log | To document that project staff have completed all required training. This log is specific for group training at the initiation of the study or as new project team members are added. | Study Tools | 08/05/2019 |
| Regulatory Files Checklist | To establish organizational compliance for research documentation at the beginning of the project. | Study Tools | 09/20/2017 |
| Participant Contact Information (Word) | To organize and store participant contact information. | Study Tools | 09/20/2017 |
| Participant Contact Information (Excel) | To organize and store participant contact information. | Study Tools | 09/20/2017 |
| Linking and Screening Log | To keep track of participant names and participant codes.For projects that involve screening, it can be used to track the screening process. | Study Tools | 09/20/2017 |
| Informed Consent Process Checklist | To document that the consent process includes all of the required components and that it is following the approved process in the protocol. | Study Tools | 09/20/2017 |
| Event Reporting Log | To keep track of events that have occurred, even if they did not require reporting to the UNM IRB. | Study Tools | 09/20/2017 |
| Complaint Report | Complaints can come from participants or others and this form helps to record the details of the issue, investigation, and resolution | Study Tools | 09/20/2017 |
| Compensation Log | To track compensation given to participants. It may be useful for projects that compensate participants with money or gift cards. | Study Tools | 09/20/2017 |
| Note to file | To document the ongoing conduct of a research project. Examples of appropriate use of a note to file includes failure of research team to sign and/or date a signed consent form, documenting a missed time point to complete a survey, etc. | Study Tools | 09/20/2017 |
| Research Staff Individual Training Log | To document that individual project staff have completed all required training. This log is used to document individual team member training at the initiation of the study or as new team members are added. | Study Tools | 08/05/2019 |
