Standard Operating Procedures

GLOSSARY (PDF, 345 KB)

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4.0

Investigator Roles and Responsibilities (PDF, 206 KB)

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4.1

Conflict of Interest (PDF, 229 KB)

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4.2

CONFIDENTIALITY (PDF, 234 KB)

1.6

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4.2.4

DELEGATION OF DUTIES (PDF, 202 KB)

1.2

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4.5

Protocol Deviations and Violations (243 kb)

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4.5.3

FILE NOTES (PDF, 215 KB)

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4.7.1

RANDOMISATION AND ALLOCATION (PDF, 237 KB)

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4.7.2

UNBLINDING (PDF, 237 KB)

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4.8

INFORMED CONSENT (PDF, 232 KB)

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Participant Information and Consent Form (PICF) (PDF, 311 KB)

4.9.2

SOURCE DATA AND DOCUMENTATION (PDF, 239 KB)

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5.1.1

SOP DEVELOPMENT (PDF, 172 KB)

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5.5.1

ELECTRONIC DATA HANDLING (PDF, 218 KB)

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5.5.2

ELECTRONIC DATA TRANSFER (PDF, 246 KB)

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Electronic Data Capture (EDC) system Access (PDF, 303 KB)

5.5.5

ALLOCATION OF PARTICIPANT ID NUMBERS (PDF, 195 KB)

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5.5.10

DATA OWNERSHIP AND UTILISATION (PDF, 238 KB)

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5.6.1

SITE SELECTION (PDF, 218 KB)

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5.7

SITE INITIATION (PDF, 230 KB)

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5.14.1

INVESTIGATIONAL PRODUCT HANDLING (PDF, 154 KB)

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5.17

ADVERSE EVENT REPORTING (PDF, 241 KB)

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5.17.1

MEDICAL MONITORS (PDF, 245 KB)

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Data and safety monitoring committee (DSMC) (PDF, 363 kb)

5.18

MONITORING (PDF, 234 KB)

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5.18.1

SITE CLOSURE (PDF, 222 KB)

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5.18.2

STUDY CLOSURE (PDF, 232 KB)

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5.23.2

DATA COLLECTION WORKSHEET COMPLETION (PDF, 247 KB)

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6.0

PROTOCOL DEVELOPMENT (PDF, 242 KB)

2.5

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6.0.1a

NEW STUDY IDEAS/PROPOSALS (PACCSC STUDIES) (PDF, 237 KB)

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NEW STUDY IDEAS/PROPOSALS (CST STUDIES) (PDF, 240 KB)

6.0.2

PILOT STUDIES (PDF, 240 KB)

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6.5.1

STUDY RECRUITMENT (PDF, 238 KB)

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6.5.2

RE-SCREENING (PDF, 238 KB)

2.3

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Collection of demographic information (PDF, 221 kb)

6.10

VERSION TRACKING (PDF, 223 KB)

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6.12

ETHICAL APPROVAL REVIEW AND REPORTING (PDF, 293 KB)

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6.15

AUTHORSHIP (PDF, 261 KB)

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6.15.1

DISSEMINATION OF STUDY RESULTS (PDF, 236 KB)

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JOURNAL PUBLICATIONS FOR IMPACT (PDF, 235 KB)

8.0

ESSENTIAL DOCUMENTS (PDF, 217 KB)

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8.4.1

ARCHIVING OF RESEARCH/PROJECT MATERIALS (PDF, 211 KB)

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8.4.2

RECORD DESTRUCTION (PDF, 217 KB)

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