|
Date
|
Update Number
|
Overview of content
|
Document changes
|
| Oct-25 |
Update 29 |
- Categorising risk in research
- Waivers of consent in research
- End of year meeting and submission dates
|
|
| 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
|
| Jun-25 |
Update 25 |
- Australia adopting ICH GCP E6(R3)
- Wednesday submission timing encouraged
- PICF guidance on rural travel reimbursements
- Austin Health recognition of Bellberry review.
|
No
|
| May-25 |
Update 24 |
- 2024 CTAR highlights: strong international trial investment, Bellberry reviews ~40% of CTNs registered trials
- Guidance for serious breach/safety reports
- eProtocol issue (character limit in consent field)
- Website feedback survey.
|
- BA G9 Advertising and Social Media
|
| May-25 |
Special Update |
- eProtocol software update: eProtocol version 2 application template from Saturday 10 May 2025
- Further reading on: Provision of personal health information before or without consent
- Further information provided related to Operations Update 23
- Best practice – creating a generic pre-screening PICF
|
No
|
| Apr-25 |
Update 23 |
- eProtocol interface update – Saturday, 10 May 2025
- Screening in clinical trials – fasting before consent
- Relevant GCP and National Statement references:
Real-world example
What you can do instead
Provision of personal health information before or without consent.
|
- BA G5 PICF development including eConsent
|
| Mar-25 |
Update 22 |
Clarified separation of recruitment vs consent in applications; ensure PICF emergency contact details are current. |
No
|
| Feb-25 |
Update 21 |
- Updated MAR G1 timelines for amendments
- PI/organisation change impacts
- Exemption-from-review letters discontinued
- Fee clarifications
- eProtocol system improvements coming; document updates.
|
- MAR G1 Amending approved research
|
| Jan-25 |
Update 20 |
- Site monitoring (audits) – Percentage of studies audited by state, phase and therapeutic area. Common findings across sites, suggestions for improvement on findings
|
No
|
| Dec-24 |
Update 19 |
- eProtocol data standardisation (titles, sponsors, phases)
- Application workaround for logic issue
- CPI-aligned fee increase (Jan 2025), new multi-site trial fee
- User feedback invited, document updates.
|
- BA G6 Application Fees – Effective 1 January 2025
|
| Nov-24 |
Update 18 |
- Annual HREC composition lists published on the Bellberry website replace meeting lists (from Jan 2025)
- Holiday submission deadlines; document updates.
|
- BA G5 PICF development including eConsent
- HRO P5 Bellberry HREC Member Composition
|
| Oct-24 |
Update 17 |
- New eProtocol question on overseas regulator review
- Include eProtocol application ID in queries
- DSMB/SMC reporting via safety form, safety events requiring amendment flagged
- Screening in clinical trials -fasting for screening blood tests before informed consent
|
No
|
| Sep-24 |
Update 16 |
- New consolidated Operations Update format
- REGIS submission requirements, document updates.
|
- BA F1.1.12 Site Specific Clauses Template
- MAR G2 Safety Reporting
- BA G11 Researcher Data Storage and Retention
- BA F1.1.1 Submission Requirements Checklist
- MAR G4 Progress and Final Reports
|
| Aug-24 |
Update 15 |
Document updates and administrative close out of expired applications |
- BA F5.1.1 Photographic & Videographic Release Content
- BA G12 Version Control and Document Naming Conventions
- MAR G4 Progress and Final Reports
|
| Jun-24 |
Update 14 |
- Social media recruitment policy update
- Revised eProtocol fields
- Consolidated approval letters
- CVs now updated biennially, document updates.
|
- BA F1.1.1 Submission requirements checklist
- BA G8 CVs and Investigator qualifications
|
| Dec-28 |
Update 13 |
- Updated documents (site clauses, PICF, payments, data storage), indemnity submission guidance
- Correct eProtocol pathways
- CAR T-cell alert, medicine shortages.
|
Document codes have been renamed in line with corporate strategy:
- CG P7 → HRO P1 Research Policy
- CG P8 → HRO P2 Terms of Reference
- CG P9 → HRO P3 Complaints
|
| Dec-23 |
Update 12 |
eProtocol application question changes (effective Q1 2024) |
- BA F1.1.12 Site specific clauses template
- BA G2 Registrations
- BA G16 eProtocol navigation guide for researchers
- BA G6 Application Fees
- BA G10 Participant payment and reimbursement
- BA G5 PICF development including eConsent
- BA G11 Researcher data storage and retention
- MAR G1 Amending approved research
|
| Nov-23 |
Update 11 |
Process change: Caveats now rare (not default for complex trials); removal of existing caveats by end of 2023. |
No
|
| Jul-23 |
Update 10 |
TGA CTN and HREC Indemnities updates:
- Clinical Trial Notification (CTN) – Bellberry contact
- Emailing electronic HREC Indemnities
- General advice to sites regarding HREC Indemnities
- Accreditation, Certification and Registration
- AAHRPP – Bellberry awarded full reaccreditation
- NHMRC – Certification and Registration
- Safety Reporting and Serious Breaches:
- Understanding the reporting requirements of ‘MAR G2
- Safety Reporting’ and ‘MAR G3 Serious Breaches’
- What does not require submission
- Examples of serious breaches
|
No
|
| Jul-22 |
Update 9 |
Quality update: progress and final reporting refresher:
- Progress reporting realignment initiative
- Progress and final reporting – guidance materials
- Progress and final reporting – email correspondence
- Progress reporting key information
- Final reporting key information
|
No
|
| Mar-22 |
Update 8 |
eProtocol error – some users are missing ‘Start Progress Report’ button, workaround via email. Reminder to submit within 30 days. |
No
|
| Nov-21 |
Update 7 |
Updated MAR G2 Safety Reporting – SUSARs no longer required, guidance for multi-centre/urgent safety submissions. |
|
| Sep-21 |
Update 6 |
Progress reporting and Final reporting refresher
New guidance/forms for progress and final reports. |
No
|
| Jul-21 |
Update 5 |
New radiation guidance documents; document updates. |
- BA F1.1.12 Site specific clauses template
|
| May-21 |
Update 4 |
Document updates. |
- BA F1.1.12 Site specific clauses template – Pre-submission checklist and examples included.
|
| Mar-21 |
Update 3 |
- Table comparator of additional site start up times 2020-2021
- FAQ’s around radiation reports, site specific clause documents, does the master PICF version and date have to be referenced in the site specific clauses document, naming conventions, clauses in the master PICF etc.
- Changes to various documents (see Affected Documents/Document Changes).
|
- BA G1 Submission requirements and responsibilities
- BA F1.1.1 Submission requirements checklist (external)
- BA G5 PICF development guide including eConsent
- BA G6 Application Fees
- BA F6.1.2 NSW EPCT fee form
- BA G8 CV’s
- BA F13.1.3 Standard of care declaration – template
- BA F14.1.2 Pregnancy/pregnant partner data release
|
| Jan-21 |
Update 2 |
Summary of Nov 2020 submission process changes (same topics as Update 1). |
- BA F1.1.17 PICF submission pathways – Introduction of PICF pathways.
|
| Oct-20 |
Update 1 |
Major submission process changes: Master and site specific PICF and other participant facing documents.
• Initial applications and reviews.
• Additional sites approved post initial approval.
• Amendments and safety reporting.
• Serious breaches.
• Progress reports.
• Version control and document naming conventions.
• HREC Indemnities.
• Site monitoring and desktop audits.
• Submission requirements.
• Sponsor submissions.
• Changes to various documents (see Affected Documents/Document Changes). |
- BA F1.1.17 PICF submission pathways – Introduction of PICF pathways.
|
