Clinical Research and GCP Update

Q & A Document, Version Three, Feb 2021

129

Q & A V3

• Lots of things to look out for • It is not a clarifying set of Q & As as you might expect, but a source of primary information on what the CTR requires. − 1. THE SCOPE OF CLINICAL TRIALS REGULATION IN THE EU − 2. APPLICATIONS LIMITED TO PART I − 3. SUBSTANTIAL MODIFICATIONS − 4. WITHDRAWALS − 5. SPONSOR/LEGAL REPRESENTATIVE; INVESTIGATOR − 6. SUBMISSION OF RESULTS OF CLINICAL TRIALS − 7. SAFETY REPORTING − 8. AUTHORISATION OF MANUFACTURING AND IMPORTATION OF IMPS − 9. “INFORMED CONSENT” & OTHER SUBSTANTIAL REQUIREMENTS FOR CONDUCTING CLINICAL TRIALS − 10. START, END, TEMPORARY HALT, AND EARLY TERMINATION OF CLINICAL TRIAL − 11. ARRANGEMENTS FOR THE TRANSITIONAL PERIOD

130

© Brookwood Global (Canary Ltd) 2021

65