SOP 19
SOP 19 Annual Progress Report [PDF 309KB]
- Associated Document 1: AD1 APR and DSUR Template Emails [DOC 28KB]
- Associated Document 2: AD2 Sponsor Oversight Annual questionnaire [DOC 64KB]
- Associated Document 3: AD3 Progress reports guidance for JRMO reviewers [PDF 35KB]
- Associated Document 4: AD4 DSUR template [DOC 67KB]
- Associated Document 5: AD5 DSUR MHRA cover letter template [DOC 28KB]
Correction:
Section 12 of the SOP should read:
The DSUR should be submitted to the MHRA no later than 60 calendar days from the clinical trial authorisation anniversary date.