Monitoring/Audit If your study is audited by a member of the Ethics Office or an external monitor, letters and reports documenting the auditor’s visit and findings should be filed here. All general monitoring correspondence unless specifically belonging in another file section, pre-trial monitoring report, feasibility assessments, monitoring visit reports and follow-up letters, correspondence, close-out visit reports should be included here. Adverse Events A condition of ethics committee approval for each study is that certain Serious Adverse Events (SAEs) are reported to the ethics committee, for ongoing review of the ethical acceptability of the study. A copy of the submitted documentation for every SAE reported to the ethics office can be filed in this section, or in the specific patient’s study file. External SAEs and SUSARs Any SAEs that occur at other sites that require submission to the ethics committee should be filed here. Internal SAEs and SUSARs The participant should be referred to in the report by their study ID, not their name, so that this documentation does not compromise patient confidentiality. Any supporting documentation submitted to the ethics committee (such as death certificates) should be de-identified. Other Include here any documents that do not fall into any of the above sections. ***** Drug trials only ***** Regulatory documents This section must include Australian CTX or CTN form (fully executed), other regulatory agency forms and all correspondence to the regulatory agencies (e.g. TGA). Investigator brochures (IB) The IB documents that relevant and current scientific information about the investigational product has been provided to the investigator. Include the current HREC approved IB here. Superseded IB This can be the front page of the document only (to conserve space) APPENDIX – templates
Monitoring/Audit If your study is audited by a member of the Ethics Office or an external monitor, letters and reports documenting the auditor’s visit and findings should be filed here. All general monitoring correspondence unless specifically belonging in another file section, pre-trial monitoring report, feasibility assessments, monitoring visit reports and follow-up letters, correspondence, close-out visit reports should be included here. Adverse Events A condition of ethics committee approval for each study is that certain Serious Adverse Events (SAEs) are reported to the ethics committee, for ongoing review of the ethical acceptability of the study. A copy of the submitted documentation for every SAE reported to the ethics office can be filed in this section, or in the specific patient’s study file. External SAEs and SUSARs Any SAEs that occur at other sites that require submission to the ethics committee should be filed here. Internal SAEs and SUSARs The participant should be referred to in the report by their study ID, not their name, so that this documentation does not compromise patient confidentiality. Any supporting documentation submitted to the ethics committee (such as death certificates) should be de-identified. Other Include here any documents that do not fall into any of the above sections. ***** Drug trials only ***** Regulatory documents This section must include Australian CTX or CTN form (fully executed), other regulatory agency forms and all correspondence to the regulatory agencies (e.g. TGA). Investigator brochures (IB) The IB documents that relevant and current scientific information about the investigational product has been provided to the investigator. Include the current HREC approved IB here. Superseded IB This can be the front page of the document only (to conserve space) APPENDIX – templates
study_binder_toolkit_2013.docx