As most of our users have now formalised local governance processes for internal safety reporting, we have updated MAR G2 Safety reporting, to no longer require the submission of SUSARs for individual events at Bellberry sites.
To assist sites in understanding the updated requirements, if Bellberry’s administrative team receives documentation not outlined in MAR G2, a reference will be made to MAR G2, and the submission returned.
General advice to sites regarding submissions:
If your study is multi-centre, please ensure your submission considers the participants at all centres.
For example:
• There is a halt in recruitment due to drug supply issues in Australia. The Sponsor has confirmed there will be no supply for three weeks.
Example wording for the site submission:
Our site is awaiting governance sign off and has not recruited any participants. We will not recruit until the halt is lifted.
Dr Peters (site AA) has recruited one participant, and they have enough study drug to last their participant for 6 weeks. If there is any update to the supply issue that puts this participant at risk, we will notify the HREC.
• If the urgent safety measure includes a request to inform participants of a safety issue:
Example wording for the site submission:
Our site has four active participants. Prof Barnes (site AA) has two participants. All were phoned and told of the safety event and documented in their notes. No participant had any further queries on the matter.
If your study includes a caveat and you are attaching documentation in relation to the caveat, please ensure your submission details the purpose of your attachments.
For example:
• The caveat on the initial approval letter requests the following “Please submit correspondence from the DSMB during Part A of the trial. Part B cannot proceed until the HREC has reviewed the DSMB letters and an updated PICF and protocol is approved”.
Example wording for the site submission:
The attached DSMB letters refer to the caveat from the HREC on the initial approval letters that all correspondence must be submitted during Part A of the trial. Once the safety letters are acknowledged, the site will submit an amendment for Part B with an updated PICF and Protocol for HREC consideration.
The ‘AER’ safety reporting pathway questions will be updated in eProtocol in due course. Until then sites are welcome to select option 2, ‘Summary report’ for all submissions, as the relevant information regarding dates of events should exist in the attachments.
Please take the time to reflect on the updated reporting requirements and how this will impact your local procedures.
If you have any queries regarding these changes please contact Bellberry at bellberry@bellberry.com.au