Our documents and templates are provided below. If you would like to see our standard operating procedures please click here.
| Title | Description |
|---|---|
| FRM101 Protocol Acceptance Form | FRM101 |
| Statistical Analysis Plan GD003.docx | GD003 |
| GD005 Freezer List | GD005 |
| Clinical Data Management Study Set up GD007.docx | GD007 |
| GD008 User Acceptance Testing (UAT) | GD008 |
| User Access GD009.docx | GD009 |
| User Training GD010.docx | GD010 |
| OpenClinica User Guide GD011.pdf | GD011 |
| Data Cleaning GD012.docx | GD012 |
| GD013 Database Locking | GD013 |
| GD015 Monitoring and Audit Random Sample Selection | GD015 |
| GD016 Data Management Plan | GD016 |
| 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 v2.0.pdf | GD022 |
| GD027 User guide to signing off SOPs on OpenClinca v5.0.pdf | GD027 Guidance for Signing of SOPs on OpenClinica |
| GD028 EDGE Guidance Document | GD028 |
| GD043 Management of freezer alerts and emergency sample transfer | GD043 |
| GD044 R&D Lab Users Manual | GD044 |