FORMS & TEMPLATES
Financial |
Version Date | |
LSU Health Clinical Trial Fees for Industry-Sponsored Research | 10.20.2022 | |
LSUHSC/OLOL Clinical Trial Fees for Industry-Sponsored Research | 12.06.2022 | |
LSUHSC In-House Budget Worksheet | 10.13.2022 |
Legal |
Version Date | |
Clinical Trial Agreement | 01.27.2022 | |
Amendment to a Clinical Trial Agreement | 01.27.2022 | |
Data Use and Transfer Agreement (HIPAA) | 01.26.2022 | |
Data Use and Transfer Agreement (Common Rule) | 01.26.2022 |
Study Conduct |
Version Date | |
Protocol Implementation Checklist | 07.07.2022 | |
Inclusion/Exclusion Criteria Checklist | 08.02.2022 | |
Screening Log | 08.08.2022 | |
Consent Process Checklist | 08.02.2022 | |
Enrollment Log | 08.08.2022 | |
Subject Payment/Stipend Log | 09.09.2022 | |
Specimen Tracking Log | 08.02.2022 | |
Specimen Destruction Log | 08.02.2022 | |
Regulatory Binder Guidance | 08.05.2022 | |
Emergency Preparedness Guidance | 08.05.2022 | |
Study Subject Contact Information Log | 08.08.2022 | |
Research Training Log | 09.28.2022 |
Notes to File |
Version Date | |
Note to File - PI Privileges | 07.07.2022 | |
Note to File - Event Documentation | 07.07.2022 | |
Note to File - Miscellanous | 07.07.2022 |
Audit/Inspection |
Version Date | |
FDA Inspection Intake Form | 08.02.2022 | |
FDA Inspection Checklist | 08.02.2022 | |
Subject Record Review Worksheet | 08.05.2022 | |
Informed Consent Form Review Worksheet | 08.02.2022 |
University Medical Center |
Version Date | |
UMC-LSUHSC Clinical Trial Approval Process (Flowchart) | 07.21.2021 | |
UMC-LSUHSC Clinical Trial Approval Process (Detailed) | 06.17.2021 | |
Tripartite Subcontract Template | 10.20.2021 |