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IRB submission forms and SOPs

Forms are provided in Word 2003-2007 format for broadest compatibility. To download a file, right click the "Download now" link and choose the option "Save Target as..."  If you are having trouble downloading any of the forms or if a link does not work on a specific document, please call (630.929.6148) or e-mail the AHC IRB office at IRBMail@advocatehealth.com.

Investigator/Study Team Documents and Forms

HRP-103 Investigator Manual (Rev 03/24/14) Download now
HRP-104 BROCHURE Should I Take Part in Research Download now
HRP-211 FORM Initial Review (Rev 07/10/14) Download now
HRP-211a FORM Initial Review - HUD (08/06/14) Download now
HRP-212 FORM Continuing Review (Rev 03/24/14) Download now
HRP-213 FORM Modification (Rev 11/01/13) Download now
HRP-213a FORM Change the Principal Investigator on an open study (03/24/14) Download now
HRP-214 FORM Reportable New Information (Rev 09/13/13) Download now
HRP-226 FORM Department Chair Certification (Rev 01/24/14) Download now
HRP-226a FORM Department Chair & Site Certification - HUD (08/06/14) Download now
HRP-090 SOP Informed Consent Process for Research Download now
HRP-091 SOP Written Documentation of Consent

Download now

AHC-230 FORM Independent Principal Investigator Agreement (08/07/14) Download now


Investigator Templates

HRP-502 TEMPLATE CONSENT DOCUMENT (Rev 11/05/13) Download now
HRP-503 TEMPLATE PROTOCOL (Rev 07/10/14) Download now
HRP-507 TEMPLATE CONSENT DOCUMENT - Short Form Download now
HRP-506 TEMPLATE CONSENT DOCUMENT - Emergency Use Download now

SOP's - General

HRP-001 SOP Definitions (Rev 05/12/14) Download now
HRP-012 SOP Observation of Consent Process Download now
HRP-013 SOP Legally Authorized Representatives, Children, and Guardians Download now

SOP's - Management of incoming information

HRP-020 SOP Incoming Items Download now
HRP-021 SOP Pre-Review Download now
HRP-023 SOP Emergency Use Review Download now
HRP-024 SOP Information Download now
HRP-025 SOP Investigations Download now
HRP-026 SOP Suspension or Termination Download now
HRP-027 SOP Emergency Use Post-Review Download now

SOP's Non-Committee review

HRP-030 SOP Designated Reviewers Download now
HRP-031 SOP Non-Committee Review Preparation (02/18/14) Download now
HRP-032 SOP Non-Committee Review Conduct Download now

SOP's Review process

HRP-040  SOP IRB Meeting Preparation Download now
HRP-041 SOP IRB Meeting Conduct (Rev 11/01/13) Download now
HRP-042 SOP  IRB Meeting Attendance Monitoring Download now
HRP-043  SOP IRB Meeting Minutes Download now
HRP-044 SOP Not Otherwise Approvable Research  Download new
HRP-050 SOP Conflicting Interests of IRB Members Download now
HRP-051 SOP Consultation Download now
HRP-052 SOP Post-Review (Rev 11/01/13) Download now
HRP-055 SOP Financial Conflicts Download now

SOP's Periodic tasks

HRP-060 SOP Annual Evaluations of the HRPP Download now
HRP-061 SOP Monthly Evaluations of the HRPP Download now
HRP-062 SOP Daily Tasks Download now
HRP-063 SOP Expiration of IRB Approval Download now

SOP's Records

HRP-070 SOP IRB Records Download now
HRP-071 SOP Standard Operating Procedures Download now
HRP-072 SOP IRB Records Retention Download now

SOP's Committee Management

HRP-080 SOP IRB Formation Download now
HRP-081 SOP IRB Removal Download now
HRP-082 SOP IRB Membership Addition Download now
HRP-083 SOP IRB Membership Removal Download now
HRP-084 SOP IRB Meeting Scheduling and Notification Download now

Investigator SOPs

HRP-090 SOP Informed Consent Process for Research Download now
HRP-091 SOP Written Documentation of Consent Download now

General Documents

HRP-101 Human research protection program plan (Rev 10/04/13) Download now
HRP-102 Flowchart Download now
HRP-103 Investigator Manual (Rev 03/24/14) Download now
HRP-104 Brochure - Should I Take Part in Research Download now

Forms

HRP-202 FORM Member Information Download now
HRP-211 FORM Initial Review (Rev 03/224/14) Download now
HRP-211a FORM Initial Review - HUD (08/06/14) Download now
HRP-212 FORM Continuing Review (Rev 03/24/14) Download now
HRP-213 FORM Modification (Rev 11/01/13) Download now
HRP-213a FORM Change the Principal Investigator on an open study (03/24/14) Download now
HRP-214 FORM Reportable New Information (Rev 09/13/13) Download now
HRP-226 FORM Department Chair Certification (Rev 01/24/14) Download now
HRP-226a FORM Department Chair & Site Certification - HUD (08/06/14) Download now
AHC-230 FORM Independent Principal Investigator Agreement (08/07/14) Download now

Worksheets

HRP-301 WORKSHEET Review Materials Download now
HRP-302 WORKSHEET Approval Intervals Download now
HRP-303 WORKSHEET Communication of Review Results Download now
HRP-304 WORKSHEET IRB Composition Download now
HRP-305 WORKSHEET Quorum and Expertise (Rev 06/02/14) Download now
HRP-306 WORKSHEET Drugs Download now
HRP-307 WORKSHEET Devices Download now
HRP-310 WORKSHEET Human Research Determination Download now
HRP-311 WORKSHEET Engagement Determination Download now
HRP-312 WORKSHEET Exemption Determination Download now
HRP-313 WORKSHEET Expedited Review Download now
HRP-314 WORKSHEET Criteria for Approval Download now
HRP-315 WORKSHEET Advertisements Download now
HRP-316 WORKSHEET Payments Download now
HRP-317 WORKSHEET Short Form of Consent Documentation Download now
HRP-320  WORKSHEET Scientific or Scholarly Review Download now
HRP-321  WORKSHEET Review of Information Items Download now
HRP-322  WORKSHEET Emergency Use Download now
HRP-323  WORKSHEET Criteria for Approval HUD Download now
HRP-324  WORKSHEET Contracts Download now
HRP-330  WORKSHEET HIPAA Authorization Download now
HRP-331  WORKSHEET FERPA Compliance Download now

Checklists

HRP-401 CHECKLIST Pre-Review Download now
HRP-402 CHECKLIST Non-Committee Review (02/18/14) Download now
HRP-410 CHECKLIST Waiver or Alteration of Consent Process (07/10/14) Download now
HRP-411 CHECKLIST Waiver of Written Documentation of Consent (07/10/14) Download now
HRP-412 CHECKLIST Pregnant Women (07/10/14) Download now
HRP-413 CHECKLIST Non-Viable Neonates (07/10/14) Download now
HRP-414 CHECKLIST Neonates of Uncertain Viability (07/10/14) Download now
HRP-415 CHECKLIST Prisoners (07/10/14) Download now
HRP-416 CHECKLIST Children (07/10/14) Download now
HRP-417 CHECKLIST Cognitively Impaired Adults (07/10/14) Download now
HRP-418 CHECKLIST Non-Significant Risk Device Download now
HRP-419 CHECKLIST Waiver of Consent Process for Emergency Research (07/10/14) Download now
HRP-430 CHECKLIST Investigator Quality Improvement Assessment Download now
HRP-431 CHECKLIST Minutes Quality Improvement Assessment Download now
HRP-441 CHECKLIST HIPAA Waiver of Authorization Download now

Short Form Consent and Foreign Language Versions

The cover sheet is to be used with all short forms.  Insert the AHC IRB study number and complete protocol title and retain it with the signed short form.
To download forms, right click the appropriate link and choose "Save target as..." 
AHC-300  Cover sheet to be used and retained with all short form uses   Download now
HRP-507   Short form consent in English Download now
AHC-306  ... Arabic Download now
AHC-309  ... Assyrian Download now
AHC-312  ... Bosnian Download now
AHC-315  ... Chinese Download now
AHC-318  ... French Download now
AHC-321

 ... Greek

Download now
AHC-324  ... Gujarati Download now
AHC-327  ... Hindi Download now
AHC-330  ... Italian Download now
AHC-333  ... Japanese Download now
AHC-336  ... Korean Download now
AHC-339  ... Laotian Download now
AHC-342  ... Malayalam Download now
AHC-345  ... Polish Download now
AHC-348  ... Russian Download now
AHC-351  ... Serbian Download now
AHC-354  ... Spanish Download now
AHC-357  ... Urdu Download now

 


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