ICH GCP reference code |
Standard Operating Procedures (SOPs) |
Current version |
Revision date |
|
|
GLOSSARY (PDF, 345 KB) |
2.4 |
4/22 |
|
4.0 |
Investigator Roles and Responsibilities (PDF, 206 KB) |
2.4 |
4/22 |
|
4.1 |
Conflict of Interest (PDF, 229 KB) |
1.4 |
4/22 |
|
4.2 |
CONFIDENTIALITY (PDF, 234 KB) |
1.6 |
4/22 |
|
4.2.4 |
DELEGATION OF DUTIES (PDF, 202 KB) |
1.2 |
4/22 |
|
4.5 |
Protocol Deviations and Violations (243 kb) |
1.4 |
4/22 |
|
4.5.3 |
FILE NOTES (PDF, 215 KB) |
1.5 |
4/22 |
|
4.7.1 |
RANDOMISATION AND ALLOCATION (PDF, 237 KB) |
2.4 |
4/22 |
|
4.7.2 |
UNBLINDING (PDF, 237 KB) |
2.5 |
4/22 |
|
4.8 |
INFORMED CONSENT (PDF, 232 KB) |
1.5 |
4/22 |
| 4.8.2 |
Participant Information and Consent Form (PICF) (PDF, 311 KB) |
1.0 | 4/22 |
|
4.9.2 |
SOURCE DATA AND DOCUMENTATION (PDF, 239 KB) |
1.3 |
4/22 |
|
5.1.1 |
SOP DEVELOPMENT (PDF, 172 KB) |
2.5 |
4/22 |
|
5.5.1 |
ELECTRONIC DATA HANDLING (PDF, 218 KB) |
2.4 |
4/22 |
|
5.5.2 |
ELECTRONIC DATA TRANSFER (PDF, 246 KB) |
2.5 |
4/22 |
| 5.5.3 |
Electronic Data Capture (EDC) system Access (PDF, 303 KB) |
1.0 | 4/22 |
|
5.5.5 |
ALLOCATION OF PARTICIPANT ID NUMBERS (PDF, 195 KB) |
2.6 |
4/22 |
|
5.5.10 |
DATA OWNERSHIP AND UTILISATION (PDF, 238 KB) |
1.7 |
4/22 |
|
5.6.1 |
SITE SELECTION (PDF, 218 KB) |
1.5 |
4/22 |
|
5.7 |
SITE INITIATION (PDF, 230 KB) |
1.3 |
4/22 |
|
5.14.1 |
INVESTIGATIONAL PRODUCT HANDLING (PDF, 154 KB) |
2.5 |
4/22 |
|
5.17 |
ADVERSE EVENT REPORTING (PDF, 241 KB) |
2.4 |
4/22 |
|
5.17.1 |
MEDICAL MONITORS (PDF, 245 KB) |
1.4 |
4/22 |
| 5.17.2 |
Data and safety monitoring committee (DSMC) (PDF, 363 kb) |
1.0 | 4/22 |
|
5.18 |
MONITORING (PDF, 234 KB) |
2.5 |
4/22 |
|
5.18.1 |
SITE CLOSURE (PDF, 222 KB) |
1.4 |
4/22 |
|
5.18.2 |
STUDY CLOSURE (PDF, 232 KB) |
1.5 |
4/22 |
|
5.23.2 |
DATA COLLECTION WORKSHEET COMPLETION (PDF, 247 KB) |
2.4 |
4/22 |
|
6.0 |
PROTOCOL DEVELOPMENT (PDF, 242 KB) |
2.5 |
4/22 |
|
6.0.1a |
NEW STUDY IDEAS/PROPOSALS (PACCSC STUDIES) (PDF, 237 KB) |
1.5 |
4/22 |
| 6.0.1b |
NEW STUDY IDEAS/PROPOSALS (CST STUDIES) (PDF, 240 KB) |
1.5 | 4/22 |
|
6.0.2 |
PILOT STUDIES (PDF, 240 KB) |
1.3 |
4/22 |
|
6.5.1 |
STUDY RECRUITMENT (PDF, 238 KB) |
2.4 |
4/22 |
|
6.5.2 |
RE-SCREENING (PDF, 238 KB) |
2.3 |
4/22 |
| 6.5.3 |
Collection of demographic information (PDF, 221 kb) |
1.0 | 4/22 |
|
6.10 |
VERSION TRACKING (PDF, 223 KB) |
2.4 |
4/22 |
|
6.12 |
ETHICAL APPROVAL REVIEW AND REPORTING (PDF, 293 KB) |
2.5 |
4/22 |
|
6.15 |
AUTHORSHIP (PDF, 261 KB) |
3.6 |
4/22 |
|
6.15.1 |
DISSEMINATION OF STUDY RESULTS (PDF, 236 KB) |
1.4 |
4/22 |
| 6.15.2 |
JOURNAL PUBLICATIONS FOR IMPACT (PDF, 235 KB) |
1.4 | 4/22 |
|
8.0 |
ESSENTIAL DOCUMENTS (PDF, 217 KB) |
2.4 |
4/22 |
|
8.4.1 |
ARCHIVING OF RESEARCH/PROJECT MATERIALS (PDF, 211 KB) |
2.5 |
4/22 |
|
8.4.2 |
RECORD DESTRUCTION (PDF, 217 KB) |
2.4 |
4/22 |