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 | |
| Subject ClinCard Receipt | 06.12.2023 | |
| 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 | |
| Delegation of Authority | 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 |