The following records ( if applicable) will be required for the self-assessment and/or the in-person assessment meeting: 

1. Currently approved protocol and Notice of Approval
2. Amendments
3. Subsequent continuing reviews
4. Copy of the IRB approved and stamped consent form, children’s assent form, or oral consent script
5. Adverse Event Notices
6. Copies of grants which reference the protocol number

The following (if applicable) may be required and should be housed in the research files or binder as they may be necessary in order to complete the assessment:

1. Signed consent forms; roster of the human participants, and recruiting practices
2. IRB correspondences relating to the protocol
3. Approval notices by non-Rutgers affiliated institutions (e.g. collaborating institutions, governmental departments, etc.)
4. Letters of Authorization for access to the research data
5. Storage of research records and confidentiality measures for research records and data
6. Authorization letters to conduct the study from research sites (e.g. schools)
7. Documentation of study instruments used
8. Internal standard operating procedures (i.e. if other than what is outlined in the methods section of the research protocol; this may be specific to the research environment or lab)
9. Description and activities of the Data Safety Monitoring Board
10. Human Subjects Certifications for principal investigator and all key personnel
11. Investigator’s CV