果冻影院

IRB Forms

Agreement of Investigator Responsibilities (DOC)
This must be submitted whenever there is a change in Principal Investigator

Attestation for Ceded Reviews & Projects (DOCX)
This attestation should be completed by the investigator in the process of requesting a ceded review or in the establishment of a reliance agreement of IRB review.

De-identified Data Agreement (DOC)
Model letter to include in IRB submissions when receiving or providing de-identified samples to/from other institutions

Electronic Copy Certification for paper Informed Consents (DOCX)
For projects which seek to archive paper informed consents electronically in accordance IRB SOP: Research Consent Storage: Electronic Copies of Paper Informed Consent Forms.  

• How to bookmark and password protect scanned documents (PDF)
  Additional guidance on how to bookmark and password protect electronic copies of paper ICF file has been developed

IRB Reliance Request Form (DOCX)
Use this form to request 果冻影院 to serve as the IRB of record or defer IRB oversight when a project may involve 2 or more institutions.

• Please use Request for Single or Central IRB Services from 果冻影院 IRB (DOCX) if you would like 果冻影院 to serve as the central IRB including for NIH-funded projects 

ICH-GCP E.6 Checklist for Investigators (DOCX)
An attestation to confirm Investigators will follow ICH-GCP E.6 requirements for project.

Letter of Support Template (DOCX)
This Letter of Support Template can be used for projects where research activities are occurring outside of 果冻影院/FH at locations/organizations which may not have a formal ethics review board or IRB.

 

IND Exemption Forms

• IND Exemption Form for Marketed Products (DOCX)
  This exemption form should be used for drugs or biologics which already have FDA approval
• IND Exemption Form for Products with Isotopes (DOCX)
  This exemption form should be used for drugs or biologics which contain either a radioactive or cold isotope component
• IND Exemption Form for GRAS Products or being used in a Challenge (DOCX) - This exemption form should be used for products which have been deemed generally regarded as safe (GRAS) or if the FDA approved product is being used to induce a physiological challenge

In-vitro Diagnostic (IVD) Device Research Attestation (DOCX)
An attestation to confirm that the proposed research involving an IVD device meets the criteria as outlined in 2006 FDA guidance for Approval without the Requirements of Informed Consent.

Protocol Deviation Summary Report Template (DOC)
A template for study teams to use when reporting protocol deviations at the time of continuing progress report

Public Data Set Nomination Checklist (DOCX)
An application to nominate new data sets to be determined as publicly available by the 果冻影院 HRPP office

Translation & Interpreter Certification Form (DOCX)
Required documents when Investigators submit translated documents to the IRB for review