Operations Updates

Bellberry is committed to continuous improvement across our ethics review operations. This page provides regular updates on process changes, policy refinements, and system enhancements that support researchers, committee members, and partners using eProtocol.

Please see below for posts regarding operational matters at Bellberry:

Date	Update number	Overview of content	Document changes
Apr-26	Update 36	Upholding Participants’ Rights: Complaints to the HREC Consent Updates & Re-Consent Investigator’s Brochure & Annual Safety Report	LER G2 AI Research Guidance BA G18 Participant ID Card Guidance BA F1.1.7 PICF Submission Pathways BA G12 Version Control & Document Naming Conventions
Mar-26	Update 35	What documents does the HREC need? HREC composition listings FDA draft guidance on NAMs NHMRC guidance on PICFs Protocol number changes	BA G1 Submission requirements & responsibilities BA G5 participant information & consent form BA F5.1.2 Sample consent form BA G15 Insurance & Indemnities
Feb-26	Update 34 (33 void)	Principal Investigator CVs Study related submissions via eProtocol	BA G14 Pregnancy & sexual health BA F14.1.2 Pregnancy & pregnant partner data release template BA G8 CVs and Investigator Qualifications
Jan-26	Update 32	Completing the Sponsor page of your HREC application Inclusion of side effects in study documentation GCP R3 Update	BA F1.1.12 Site specific clauses template
Dec-25	Update 31	Guidance updates – PICF development & optional objectives Indemnity address reminder Race-based recruitment strategies Participant notification of incidental findings	BA G5 PICF Development BA F1.1.1 Submission requirements checklist
Nov-25	Update 30	HREC response timeframes Clinical trial site disaster recovery Common HREC Queries End of year meeting and submission dates	No
Oct-25	Update 29	Categorising risk in research Waivers of consent in research End of year meeting and submission dates	BA G5 PICF Development
Sep-25	Update 28	New Bellberry office address New eProtocol registrations contact email Bellberry user satisfaction survey End of year meeting and submission dates Digital scribes National Statement 2025 Update When the study is full – what about the next screened participant?	No
Aug-25	Update 27	A Smarter, Simpler PICF for Participants: CT:IQ InFORMed PICF Timely Submissions and Amendment Review Updates Submission deadline Post approval amendments Complex amendments End of Year Meetings and Submission Deadlines HREC Audits: Supporting Researchers, Protecting Participants Top three trends and tips from audits in recent years We’re Moving (Bellberry Adelaide Office)	No
Jul-25	Update 26	eProtocol registration tips (organisation, email, address) OVOP form to avoid delays PICF admin vs formal changes, versioning rules, amendment submission guidance, confirm with HREC if unsure.	No