| DOCUMENT ID |
TITLE |
VERSION # |
| Guidance |
| HRP-2600 |
Activities That are Not Human Subjects Research |
1.0 |
| HRP-2602 |
Expanded Access to a Test Article |
1.0 |
| HRP-2603 |
Database and Repository Studies |
1.0 |
| HRP-2604 |
Kuali Research - Protocol Type Selection |
1.1 |
| HRP-2605 |
Protocol Content |
1.0 |
| HRP-2631 |
Types and Examples of Reportable New Information |
2.0 |
| HRP-2633 |
Informed Consent |
1.0 |
| HRP-2680 |
FDA Audit Preparations |
1.0 |
| Decision Trees & Flowcharts |
| HRP-2730 |
Decision Tree for Reporting New Information |
2.0 |
| HRP-2731 |
Decision Tree for Determining the Approrpiate Reliance Arrangement |
5.0 |
| Forms |
| HRP-2200 |
Request for Review of PHI Prepatory to Research |
1.1 |
| HRP-2201 |
Local Context Survey |
2.0 |
| HRP-2220 |
Event Tracking Log |
3.0 |
| HRP-2221 |
Post-Approval Monitoring & Education Self-Assessment Tool |
1.0 |
| Information Sheets |
| HRP-2650 |
Exempt Research Categories |
1.0 |
| HRP-2651 |
Research Categories Eligible for Review by the Expedited Procedure |
1.0 |
| HRP-2652 |
HIPAA Data Guidelines |
3.0 |
| HRP-2653 |
Criteria for IRB Approval of Research |
2.0 |
| HRP-2670 |
LSUHSC Local Context Questionnaire Information |
1.0 |
| Letter Templates |
| HRP-2300 |
Certification of Research on Decedent Information |
1.1 |
| HRP-2301 |
Independent Physician's Certification: Emergency Use of a Test Article Without Informed
Consent |
1.1 |
| HRP-2302 |
Independent Physician's Certification: Emergency or Compassionate Use of an Unapproved
Device |
1.0 |
| HRP-2303 |
Treating Physician's Certification: Emergency Use of an Unapproved Device Withouth
Prior Independent Physician Assessment |
1.0 |
