Based on feedback from sites and sponsors, and in our aim for continuous improvement, Bellberry has made further attempts to streamline progress reporting.
The change in reporting will make it easier for sites and sponsors to control and manage the due dates for progress reports and consolidates the two processes of progress reports and extension (PRE) requests to occur at the same time.
Bellberry has moved to one-year terms of approval for all studies approved from 29 April 2020. The DD-MM cycle of the lead site will determine the due date for PRE submissions, with an exception to sites approved within 60 days of the due date.
60-day exception rule explained below:
- The lead site is approved 22 May 2020
- Additional site one approved 18 August 2020
- Additional site two approved 05 May 2021.
The following will occur:
- The lead site and additional site one have their first progress report due 22 May 2021.
- As approval for site two is within 60 days of the progress report being due, they are an exception, and their first progress report is due 22 May, 2022.
The guidance sent to sites in early 2020 stated the changes would not impact older studies. This advice has changed. Please continue reading.
Many studies have two, three, and five-year terms of approval. When extension requests are submitted for studies approved before April 29, 2020, they will move to the one-year term of approval.
Often, sites have a different term of approval expiry to their progress report due date. These dates will be realigned, and all sites will move to the reporting cycle of the lead site. For some sites, this will mean a complete change of month and shorter than a one-year term of approval for the next reporting cycle.
Date realignment explained below:
- The lead site is approved 15 April 2016, their term of approval ends 30 August 2020.
- Additional site one approved 25 September 2018; term of approval ends 16 December 2022
- Additional site two approved 02 December 2019; term of approval ends 16 December 2023
The following will occur:
- Lead site progress report due 15 April annually, they also submit an extension request in August 2020. The site will be granted an extension until 15 April 2021. In April 2021, the site provides a progress report/extension request.
- Additional site one submits a progress report in September 2020, site two in December 2020. At the time of processing, the Bellberry administration team will realign their reporting with the lead site, revising their terms of approval. The progress report/extension request will now be due 15 April 2021.
While the last two sites now have less than six months before their next report is due, it will bring all sites under the one reporting cycle. It also reduces the need to submit a progress report and an extension request as they become the same item.
In the event the lead site has closed, the advice does not change. The PRE will align with the initial approval date cycle (DD-MM). Once your site is updated and realigned, all sites will receive a reminder email at 30, 14 and 7 days before the due date.
Sites will notice the change to their reporting from June 01, 2020.
Related documents
For comprehensive guidance on Bellberry’s reporting requirements, please see MAR G4 Progress and final reports, available at the Bellberry website: monitoring approved research