|
|
| No |
Title |
Version and Date |
Date Implemented |
|
| STH SOPs, for current versions - www.sth-research.group.shef.ac.uk/documents/sops.html |
| STH A104 |
Protocol Amendments |
v3.3, 05.03.08 |
14.07.08 |
| STH A105 |
Protocol Violation and Deviation |
v2.4, 25.02.08 |
14.07.08 |
| STH A106 |
Informed Consent |
v2.2, 15.11.06 |
14.07.08 |
| STH A116 |
Investigator Site File |
v2.2, 15.11.06 |
14.07.08 |
| STH A117 |
Delegation of Study Duties |
v2.2, 15.11.06 |
14.07.08 |
| STH A118 |
Preparation of study related info for clinical personnel |
v2.0, 22.08.05 |
14.07.08 |
| STH A123 |
Adverse Event Reporting |
v2.4, 05.03.08 |
14.07.08 |
| STH A125 |
Responding to Data Queries |
v1.4, 15.11.06 |
14.07.08 |
| STH C103 |
Data Protection Act and Research |
v1.2, 15.11.06 |
14.07.08 |
| STH C106 |
Research Misconduct and Fraud |
v2.4, 25.02.08 |
14.07.08 |
| STH C107 |
Regulatory Inspection |
v1.1, 15.11.06 |
14.07.08 |
|
| CTRU SOPs, for current versions - www.shef.ac.uk/ctru/sops.html |
| GOV001 |
Trial Management Group |
v1, 28.05.07 |
14.07.08 |
| GOV002 |
Trial Steering Committee |
v1, 05.07.07 |
14.07.08 |
| GOV003 |
Data Monitoring and Ethics Committee |
v1, 25.05.07 |
14.07.08 |
| DM002 |
Archiving |
v1. 15.05.07 |
14.07.08 |
| DM003 |
Case Report Form |
v1, 25.05.07 |
14.07.08 |
|
| 3Mg SOPs, for current versions - www.shef.ac.uk/scharr/sections/hsr/emergency/3mg/ |
| |
Unblinding |
v2 29.07.08 |
29.07.08 |
| |
Protocol Violation and Deviation |
v2, 01.12.08 |
01.12.08 |
| |
Randomisation |
v1 14.07.08 |
14.07.08 |
| |
SAE Reporting |
v1, 14.07.08 |
14.07.08 |
|
|
|
