Forms & Templates

General IRB Forms & Templates

(e.g., CF, IND/IDE, MRI, PSF, Data use, Short form for Consent)

For more details about PRISM, click here.

To access the new PRISM website, click here.

Affiliate Investigator Instructions

Authorization Agreement (IAA)

Consent Form Template

Form of Notice By IND/IDE Holder

Grant Application/Protocol Concordance Table

IRB Full Board Roster (de-identified)

MRI Director Approval

Note-to-File (NTF) Template

Protocol Summary Form (PSF) (Word version for uploading)

Reliance Request Form (request to have the NYSPI IRB rely on another IRB which serves as the IRB of Record)

Relying Site Information Sheet

Request for Use of De-Identified Data Form

Short Form for Witness of Consent (to be used for non-English speaking participants or participants who cannot read)

For technical questions, click here

HIPAA Forms

HIPAA Authorization  

HIPAA Child Authorization

Notice of Privacy Practices

HIPAA Waiver

HIPAA Authorization (Spanish)

HIPAA Child Authorization (Spanish)

Notice of Privacy Practices (Spanish)

PLEASE NOTE, additional details and related HIPAA materials are also available on on InSite (the NYSPI intranet). To access, login with your NYSPI email account and password.

Patient Chosen Surrogate (PCS) Forms

PCS Checklist

PCS Policy Letter to MHLS

 

English

PCS Form I

PCS Form II

 PCS Form III(a)

 PCS Form III(b) 

 PCS Form III(c)

PCS Form IV

Spanish

PCS Form I
(*Same as English version above)

Spanish PCS Form II

Spanish PCS Form III(a)

Spanish PCS Form III(b)

Spanish PCS Form III(c)

Spanish PCS Form IV

Protocol Specific Plans

(for more than minimal risk studies)

Checklist of Procedures

Training Plan

Internal Monitoring/Quality Assurance Plan

Data Management Plan (REDCap survey)

Monitoring for Good Clinical Practice

(checklists & templates to customize your research)

Consent Process (Informed Consent Process Checklist Template)

Eligibility Criteria (Inclusion/Exclusion Checklist Template)

Regulatory Binder for Clinical Trials with Investigational Drugs (new form with template links)

Regulatory Binder Basics for Non-Clinical Trials (new form with template links)

Note-to-File (NTF) Template

NYSPI IRB Guidance Documents

Alternative Lay Language for Medical Terms (non-scientific terminology)

COVID Guidance for PSF & CF

Gadolinium Guidance

JRSC Radiation Exposure Risk Language for Consent Form

Medication Taper Guidance and
Medication Taper Worksheet

MRI Guidelines

Multi-Site Protocols

NYSPI National Data Archive Guidance

Remote Communication Guidelines

Research Record Retention Policy (RA-102: Retention, Transfer and Destruction of Research Records)

Research Record Scanning Policy (RA-102a: Electronic Storage of All Paper-Based Research Documents)

Revised Common Rule 2019

Suicide Risk Management Guidance and
Suicide Risk Management Checklist

TMS Guidelines and Case Report Form

Women of Childbearing Potential Policy