The following provides a checklist, tips, forms and template documents for PPHS:
Forms and Documents
- 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.
- Investigator Information Sheet: Comparative Review
Information sheet explaining when to use the Comparative Review Form
Effective September 23rd 2020, forms can be found in the RUTH Portal Library.
For Forms and Templates related to relying on an external IRB, please visit the Request to Rely (R2R) page.
ADULT EMERGENCY USE/TREATMENT CONSENT - this consent should not be used without prior authorization from the FDA and IDS.