1. Safety Reporting
Carrie Bayliss

2. What is reportable? Expedited Reporting: SARs SUSARs
Pregnancy in female participants
Scheduled Review:
SAEs routinely captured within the following systems HES, IDS, PEDW, HSNI and ONS and reviewed at least 6 monthly for SAE line listing

3. SARs
Any serious adverse event that has a reasonable causal relationship to the IMP.
Reasonable defined as Definitely, Probably or Possibly related.
Reportable to the Simplified Trial Office within 24 hours of first notification/awareness to anyone within the trial team
Simplified SAR Reporting Form to be completed as fully as possible
SAR Reporting Form must be countersigned by the PI but doesn’t need to be completed prior to submission of the initial report if this will impact on the 24 hour notification timeline

4. SUSARs
Expectedness assessment to be conducted against the Reference Safety Information: Section 4.8 of the Fultium –D3 (colecalciferol 20,000IU capsules) from Internis Pharma Limited. If not specifically listed in the RSU, the event is Unexpected
Reportable immediately (within 24 hours)
Complete SAR Reporting Form and submit to the Simplified Trial Office
Timeline for follow-up information will be confirmed by the Simplified Trial Office
Any queries regarding (potential) SUSARs should be raised with the Simplified Trial Office immediately

5. SAR Reporting Form

6. SAR Reporting Form cont.

7. Pregnancy Reporting Only for female participants (not partners)
Reportable to the Simplified Trial Office within 7 days of first notification/awareness to the trial team
Pregnancy only reportable if the patient conceived whilst receiving active treatment with colecalciferol – ie if the patient ceased treatment prior to conceiving this is not reportable.
Where there is ambiguity between treatment cessation and conception date, report as a trial pregnancy

8. Pregnancy Reporting Form

9. Pregnancy Reporting Form cont.

10. Reporting Form Submission
Completed Reporting Forms submitted to the Simplified Trial Office:
SARs & SUSARs – within 24 hours
Pregnancy – within 7 days
Submission by fax: or
Submission by
Each or fax coversheet should state in the subject line ( ) or main body (fax) whether the reporting form is for a SAR, SUSAR or pregnancy
All reports will be acknowledged within 48 hours.
For SUSARs the acknowledgement will also state the 7 or 15 day regulatory deadline

11. SAE Line Listings
SAE Line Listings will be generated by the Simplified Trial Office from review of routinely collected data for the trial
Generated at least every 6 months
Reviewed by the CI and any queries raised with the PI
Will contribute to the safety data reported to the MHRA and REC via the DSUR
DSUR will be provided to PIs for inclusion in the ISF