Our documents and templates are provided below. If you would like to see our standard operating procedures please click here.
| Title | Description |
|---|---|
| FRM103 Principal Investigator Declaration | FRM103 |
| FRM104 IQM new user request form | |
| FRM109 Confidential HTA Audit Report | |
| GD002 Site Initiation Report Form v 3.0.docx | |
| GD005 Freezer List | GD005 |
| GD008 User Acceptance Testing (UAT) | GD008 |
| GD010 User Training | GD010 |
| GD013 Database Locking | GD013 |
| GD014 Clinical Data Management Validation | |
| GD015 Monitoring and Audit Random Sample Selection | GD015 |
| GD016 Data Management Plan | GD016 |
| GD017 - Randomisation Procedure and Unlocking v2.0.pdf | |
| GD019_TMF and eTMF Process | GD019 |
| GD020_Research and Development Lorenzo Guidance | GD020 |
| GD021 OpenClinica User Guide for Monitors | GD021 OpenClinica User Guide for Monitors |
| GD022 CAPA Guidance Document | GD022 |
| GD023 eForms system for study documents | GD023 |
| GD025 - Data Sharing.docx | Data Sharing |
| GD026 - Data Management Software Managment.docx | Data Management Software Management |
| GD028 EDGE Guidance Document | GD028 |