Monitoring
Bellberry HREC will monitor approved trials in the following ways:
Serious Adverse Events Reports
In line with the new National Statement on Ethical Conduct in Human Research (2007) and the NHMRC Australian Health Ethics Committee (AHEC) Position Statement 2009 we have adopted the following changes in relation to adverse event reporting for clinical trials. These changes are effective from May 2009.
1. Adverse Events are to be recorded in a case report form (CRF). No need to report to the HREC unless it impacts on the research and action is planned.
2. All multi-centre trials must have a Data Safety Monitoring Board (DSMB) or equivalent and all local trials must identify a person or committee with suitable expertise to assist and advise the HREC about reports of serious adverse events (SAEs) occurring at that local site. NHMRC Statement Section 3.3.20 (c).
3. All SAEs, expected or unexpected, should be sent to these bodies for primary review and not to the HREC.
All SAE's occurring at a site under the Bellberry HREC must provide a quarterly report to the HREC with a comment from the Prinicpal Investigator utilising the Bellberry SAE form. Report the event to the Sponsor as per the study protocol and GCP guidelines.
If the study is unsponsored the report should be made to the person or committee responsible for assisting and advising the HREC about reports or serious adverse events.
The quarterly reports should only contain SAEs that have, in the view of the sponsor, DSMB, Pharmacovigilance group, TGA or investigator, an impact on the continued safety or ethical acceptabiility of the trial. These will most likely come as a request for protocol amendment or change to the consent documentation.
4. All Suspected Unexpected Serious Adverse Reactions (SUSARs) occurring at a site under the Bellberry HREC approval are to be reported to the HREC (utilising the Bellberry SAE form), with comment from the investigator including any action planned, in a timely manner. Report to the Data Safety Monitoring Board or equivalent as per the study protocol.
5. All Australian/International SUSARs not occurring under an approved Bellberry site are not required to be reported individually unless it impacts on the research and action is planned. Six monthly summary reports of all SUSARs relating to the drug/device must be reported to the Bellberry HREC. Include sponsor and investigator comment as to whether action is planned for the trial on the basis of the reports.
6. Annually provide an updated Investgators Brochure and an EU Annual Safety Report or current approved product information and any other reports consistent with Section 5.5.5. of the National Statement and GCP as adopted by the TGA.
Please refer to WWW.bellberry.com.au/Forms/AdverseEvents Flowchart. If you require further clarification of SAE reporting requirements please refer to the NHMRC Australian Health Ethics Committee (AHEC) Position Statement, Monitoring and reporting of safety for clinical trials involving therapeutic products May 2009. http://www.nhmrc.gov.au/health_ethics/hrecs/hrecalerts.htm or alternatively contact the Bellberry office at Bellberrry @bellberry.com.au.
Progress Reports
(>> Forms)
Continued approval of a research protocol is dependent on the receipt of an annual progress report from the Principal Investigator. The first report is to be no later than twelve months from commencement of the research (or on completion of the trial if sooner) and annually thereafter. If a request for an annual progress report is not received within sixty (60) days, approval of the project by the Bellberry HREC will automatically lapse.
The report must include the following information:
- Compliance of the trial with the approved protocol, consent procedures and documentation
- Any new information which may have an impact on the continued ethical acceptability of the trial or that may indicate the need for amendments
- Reasons for lack of result in any area or if the trial is discontinued before the expected completion date
- Security of records.
Site Visits
Bellberry may undertake site visits to assess onsite monitoring and compliance with regard to consent procedures, verification of data sources, study protocol and documentation procedures. We may wish to interview willing participants at this time.
Withdrawal of Study Approval
Approval for the continuation of the project may be withdrawn in the event of:
- not receiving a progress report within twelve (12) months from the commencement of research, or as requested;
- the reporting of serious adverse events which may affect the welfare of participants;
- the reporting of any conduct that may affect continued ethical acceptability of the research project.
Study Amendments
The Bellberry HREC must be notified as soon as possible of changes or amendments to the research protocol. Any amendments to documents must be tracked showing new insertions and deletions prior to submitting to the committee.
Study Extensions
>> Forms
All extension requests must be submitted with a progress report.
Pecuniary Interest of Investigators
Principal researchers must disclose any pecuniary interests in the research project. Receiving remuneration does not of itself compromise the research however a researcher must not allow a pecuniary or any other conflict of interest to compromise their position. Accordingly researchers must notify the Bellberry HREC as soon as possible of any material personal interest in the research study or any matter that may give rise to a potential conflict of interest (i.e. shareholding in sponsor company).
