Title |
Number |
Version |
Implementation Date |
Related Documents |
Application to the Trust for Sponsorship of a CTIMP |
R&D/S02 |
9.0 |
13th February 2023 |
F03 |
Application to the Trust for Sponsorship of a Research Study |
R&D/S82 |
3.0 |
13th February 2023 |
S02, S14, S74, S83, G05, G06 |
Application for Sponsorship of a Non-CE Marked Medical Device Study |
R&D/S83 |
2.0 |
15th July 2019 |
None |
Case Report Form (CRF) Design and Completion |
R&D/S81 |
4.0 |
14th December 2022 |
None |
Data Management |
R&D/S29 |
4.0 |
2nd October 2019 |
None |
Data Monitoring Committees for Clinical Trials |
R&D/S72 |
5.0 |
7th December 2022 |
T27 |
Delegation of Tasks for Trust Sponsored Research Studies |
R&D/S03 |
9.0 |
6th December 2022 |
F16, T62 |
End of Study Reports and Publications |
R&D/S27 |
4.0 |
15th July 2019 |
T24 |
Making Amendments to Trust Sponsored Research Studies |
R&D/S74 |
6.0 |
27th February 2023 |
F18, F101 |
Monitoring of Trust Sponsored Research Studies |
R&D/S08 |
13.0 |
17th April 2023 |
F10, F14, F17, F64, F65, F66, F69, F70, F78, T03 |
Preparing a Statistical Analysis Plan |
R&D/S85 |
5.0 |
7th December 2022 |
None |
Production of a Randomisation Schedule for Randomised Controlled Trials (RCTs) |
R&D/S62 |
5.0 |
24th April 2023 |
F45 |
Risk Assessment |
R&D/S18 |
5.0 |
13th February 2023 |
F15 |
Reporting Requirements During Research Studies |
R&D/S06 |
6.0 |
21st November 2022 |
F21, F22 |
Study Close-Out |
R&D/S21 |
5.0 |
21st November 2022 |
F19 |
REDCap Database Access |
R&D/S65 |
1.0 |
15th May 2024 |
None |