IB and SUSAR rports

[sally123]

Hi,

We have been asked by CRA from 2 different commercial sponsors that if we file IB in pharmacy file (usual practice in pharmacy file), then all SUSAR reports will also need to be filed with it. This is quite new to us as SUSAR reports are usually site file documents where PI keeps hold of. Has anyone come across this? Wondering if we have to follow this for our site and whether this is mandatory.

Thanks.

[MonitorH]

Would the CRA not accept a file note in the Pharmacy File indicating that SUSAR reports are filed in the ISF? If not, ask them to justify why it's necessary to duplicate.

[MHRA Moderator]

Filing a copy of the IB in the pharmacy file would not necessitate storing SUSAR reports in the Pharmacy file; there is no requirement for this. This would potentially lead to duplication if the reports are filed both in the investigator’s site files and pharmacy (and potential for missed filing).

[a123456]

Is it possible to clarify what "there is no requirement for this" means? Is there no requirement only for SUSARs to be filed in the Pharmacy, or is there no requirement for IBs to be filed in the pharmacy? or both? . What is the legal mandate that requires IBs to be filed in the Pharmacy? A quote from the SIs would be helpful. Thanks.

[MHRA Super Moderator]

The SI does not go into specific documentation requirements, other than regulation 31A (7), which covers the trials master file, of which investigator files are a part. The detail is provided in supporting guidance which is not a legal mandate, but justification is required where guidance is not followed. Therefore, Volume 10 and ICH GCP section 8 cover documents to be held in the investigator file, this includes the IB and SAEs/SUSARs information (where applicable). This doesn't break down to the investigator file to separate investigator and pharmacy files (if pharmacy files are required). Therefore the documentation to be held in respective files is defined by the sponsors quality system. However, it would be expected that if a pharmacy is involved, then as pharmacy are responsible for the receipt, dispensing and storage of IMP, they need to be aware of information related to the IMP, which would be available in the IB, but not necessarily the safety reports. As a result, IBs (or the SmPC if there is no IB) are usually expected in the pharmacy files.