Forms and Documents

The following provides a checklist, tips, forms and template documents for PPHS:

E-Submission Checklist

  • HRP-430 Checklist—Investigator QI Assessment
    The HRP-430 Checklist covers what must be stored in the regulatory (study) binder, study records, PI responsibilities when holding an IND or IDE, and other requirements that must be met for each study.

Effective September 23rd 2020, forms can be found in the RUTH Portal Library.

HRP-212B Continuing Review Specimen Banking Progress Report

HRP-234—CHECKLIST—for All Sema4 Related Studies


For Forms and Templates related to relying on an external IRB, please visit the Request to Rely (R2R) page.

Effective September 23rd 2020, consent templates can be found in the RUTH Portal Library. If a specific version is needed, please send an email to

ADULT EMERGENCY USE/TREATMENT CONSENT - this consent should not be used without prior authorization from the FDA and IDS.

For SOPS, Worksheets & Checklists IRB Uses to Make Determinations