OTHER DOCUMENTS


DOCUMENT ID DOCUMENT TYPE TITLE VERSION #
HRP-2600 GUIDANCE Activities That are Not Human Subjects Research 1.0
HRP-2602 GUIDANCE Expanded Access to a Test Article 1.0
HRP-2603 GUIDANCE Database and Repository Studies 1.0
HRP-2604 GUIDANCE Kuali Research - Protocol Type Selection 1.1
HRP-2631 GUIDANCE Types and Examples of Reportable New Information 2.0
HRP-2680 GUIDANCE FDA Audit Preparations 1.0
       
HRP-2730 FLOWCHART Decision Tree for Reporting New Information 2.0
HRP-2731 FLOWCHART Decision Tree for Determining Use of Individual Investigator Agreement vs IRB Authorization Agreement 3.0
       
HRP-2200 FORM
Request for Review of PHI Preparatory to Research
1.1
HRP-2201 FORM Local Context Survey 1.0
HRP-2220 FORM
Event Tracking Log
1.0
HRP-2221 FORM Post-Approval Monitoring & Education Self-Assessment Tool 1.0
       
HRP-2650 INFORMATION Exempt Research Categories 1.0
HRP-2651 INFORMATION Research Categories Eligible for Review by the Expedited Procedure 1.0
HRP-2652 INFORMATION HIPAA Data Guidelines 2.0
HRP-2653 INFORMATION Criteria for IRB Approval of Research 1.0
HRP-2654 INFORMATION Registering a Study at ClinicalTrials.gov 1.1
HRP-2670 INFORMATION LSUHSC Local Context Questionnaire Information 1.0
HRP-2672 INFORMATION Non-HSC Research Personnel Training and Documentation Requirements 1.0
       
HRP-2655 INSTRUCTIONS Supplemental Instructions for Consent Form 1.0
HRP-2656 INSTRUCTIONS Instructions for Short Consent Forms 1.2
       
HRP-2300 LETTER Cetification of Research on Decedent Information 1.1
HRP-2301 LETTER
Independent Physician's Certification: Emergency Use of a Test Article Without Informed Consent 
1.1
HRP-2302 LETTER
Independent Physician's Certification: Emergency or Compassionate Use of an Unapproved Device
1.0
HRP-2303 LETTER
Treating Physician's Certification: Emergency Use of an Unapproved Device without Prior Independent Physician Assessment
1.0
       
  MEMORANDUM IRB Roster 1.0