Protocol Title : A Randomised, open labelled study in anti ... - EME
Protocol Title : A Randomised, open labelled study in anti ... - EME
Protocol Title : A Randomised, open labelled study in anti ... - EME
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5.11. Laboratory Assessments! 26<br />
5.12. Radiology Assessments! 27<br />
5.13. Synovial biopsies and tissue analysis! 27<br />
5.14. End of Study Def<strong>in</strong>ition! 28<br />
5.15. Subject Withdrawal! 28<br />
5.16. Data Collection and Follow up for Withdrawn Subjects! 28<br />
6. PHARMACOVIGILANCE 28<br />
6.1. Adverse Event (AE)! 28<br />
6.2. Adverse Reaction (AR)! 28<br />
6.3. Investigators Assessment! 29<br />
6.4. Notification and report<strong>in</strong>g Adverse Events or Reactions! 29<br />
6.5. Notification and Report<strong>in</strong>g of Serious Adverse Events/SUSAR! 29<br />
6.6. Urgent Safety Measures! 30<br />
6.7. Development Safety Update Report<strong>in</strong>g (DSUR)! 30<br />
6.8. Overview of the Safety Report<strong>in</strong>g and Pharmacoviligance responsibilities! 30<br />
6.9. Pregnancy ! 30<br />
7. STATISTICAL CONSIDERATIONS 30<br />
7.1. Primary Endpo<strong>in</strong>t Efficacy Analysis! 30<br />
7.2. Secondary Endpo<strong>in</strong>t Efficacy Analysis! 31<br />
7.3. Exploratory end po<strong>in</strong>t! 31<br />
7.4. Safety Endpo<strong>in</strong>ts! 31<br />
7.5. Sample Size! 31<br />
7.6. Statistical Analysis! 32<br />
8. DATA HANDLING & RECORD KEEPING 32<br />
8.1. Case Report Form! 33<br />
8.2. Record Retention and Archiv<strong>in</strong>g! 33<br />
8.3. Compliance! 33<br />
8.4. Cl<strong>in</strong>ical Governance Issues! 33<br />
8.5. Quality Control and Quality Assurance! 33<br />
8.6. Serious Breaches <strong>in</strong> GCP or the Trial <strong>Protocol</strong>! 34<br />
9. TRIAL COMMITTEES 35<br />
9.1. Trial Management Group (TMG)! 35<br />
9.2. Trial Steer<strong>in</strong>g Committee (TSC)! 35<br />
9.3. Data Monitor<strong>in</strong>g and Ethics Committee (DMC)! 35<br />
10.PUBLICATION POLICY 35<br />
11.REFERENCES 35<br />
Study: R4RA EudraCT: 2012-002535-28 10 / 34