ࡱ> VYSTUc bjbjZWZW 8=`\8=`\J! `````ttt8<,tT$L$$$'><(P( $r(ɨE`\('"'\(\(ɨ``$$***\(R`$`$*\(**Q k$@Cdx(R#^$0T)kk`\(\(*\(\(\(\(\(ɨɨ*\(\(\(T\(\(\(\(\(\(\(\(\(\(\(\(\( > &:  ANNUAL REPORTING FORM (& RENEWAL APPLICATION)  Date of this report:RCH HREC Reference: Project title: RENEWAL Is HREC Approval Renewal required? FORMCHECKBOX  YES  FORMCHECKBOX  NO, not expired Brief synopsis of project and progress to date:  Section 1: Study Team1.1Principal Investigator name:1.2Study Contact name:1.3Has the study commenced? FORMCHECKBOX  YES Commencement date:  FORMCHECKBOX  NO Estimated commencement date: 1.4What is the current status of the study? FORMCHECKBOX  Ongoing  FORMCHECKBOX  Completed ! Do not proceed with this form, please submit a completed  HYPERLINK "http://www.rch.org.au/uploadedFiles/Main/Content/ethics/Final_Report_Form.doc" Final Report Form FORMCHECKBOX  Abandoned ! Do not proceed with this form, please submit a completed  HYPERLINK "http://www.rch.org.au/uploadedFiles/Main/Content/ethics/Final_Report_Form.doc" Final Report Form Section 2: Recruitment2.1Total number of participants APPROVED for recruitment under RCH HREC approval:2.2Total number of participants RECRUITED under RCH HREC approval:  2.3 If recruitment has been less or more than expected, please provide explanation: (Please note, excessive (or slow) recruitment may require an amendment to the protocol)  Section 3: Protocol3.1What is the current version number and date of the study protocol: (e.g. version 2 dated 1 Jan 09)3.2Have all amendments been submitted to HREC for approval? (If no, please notify the REG as soon as possible) FORMCHECKBOX  YES  FORMCHECKBOX  NO  FORMCHECKBOX  Not Applicable 3.3Has the project been conducted in accordance with the approved protocol over the last 12 months? FORMCHECKBOX  YES  FORMCHECKBOX  NO 3.4Have all significant departures from the protocol been reported to REG? (If no, please notify the REG as soon as possible) FORMCHECKBOX  YES  FORMCHECKBOX  NO  FORMCHECKBOX  Not Applicable 3.5 Are all study personnel who have been delegated roles and/or responsibilities appropriately qualified, trained and familiar with the protocol? (If no, please explain):  FORMCHECKBOX  YES  FORMCHECKBOX  NO 3.6Is the latest approved protocol still current for this study? (If no, and the protocol has not been amended within the past 5 years, please provide an updated version along with a new peer review as evidence of continued scientific merit.) FORMCHECKBOX  YES  FORMCHECKBOX  NO  Section 4: Informed Consent 4.1Is this study obtaining informed consent from participants? FORMCHECKBOX  YES  FORMCHECKBOX  NO - go to Section 54.2Please list all approved Information Statement and Consent forms currently in use, including the version number and date: (e.g. P/GIS & Consent v2 dated 1 Jan 09)4.3Is the information within the statement(s) still current? (If no, the documents need to be updated in line with the templates available on the  HYPERLINK "http://www.rch.org.au/ethics/researcher-resources/Informed_consent/" REG website, and should be submitted with this application.) FORMCHECKBOX  YES  FORMCHECKBOX  NO 4.4Have the Information Statement(s) been amended within the past three (3) years? (If no, the documents need to be updated in line with the templates available on the  HYPERLINK "http://www.rch.org.au/ethics/researcher-resources/Informed_consent/" REG website, and should be submitted with this application.) FORMCHECKBOX  YES  FORMCHECKBOX  NO 4.5 Has informed consent been conducted in accordance with all the relevant stipulations of the  HYPERLINK "http://www.rch.org.au/policy/policies/Informed_Consent_in_Research/" RCH Procedure: Informed Consent in Research? FORMCHECKBOX  YES  FORMCHECKBOX  NO  4.6 Are original signed consent forms available for all participants? (If no, please explain):   FORMCHECKBOX  YES  FORMCHECKBOX  NO  FORMCHECKBOX  Not Applicable  Section 5: Governance5.1Have you notified REG of all significant events (including complaints)? (If no, please attach reports to this submission.) FORMCHECKBOX  YES  FORMCHECKBOX  NO  FORMCHECKBOX  Not Applicable 5.2Is the study being conducted in accordance with the  HYPERLINK "http://www.rch.org.au/policy/policies/Investigators_Responsibilities_in_Research/" RCH Procedure Investigators Responsibilities in Research? FORMCHECKBOX  YES  FORMCHECKBOX  NO  5.3 Are all study documents (including electronic records) that contain participant data accessible only by authorised study team members? (If no, please explain):   FORMCHECKBOX  YES  FORMCHECKBOX  NO 5.4 Are all study data and documents stored safely and regularly backed-up to prevent loss? (If no, please explain):  FORMCHECKBOX  YES  FORMCHECKBOX  NO 5.5 Does the documentation maintained for the study form a complete record of the study and permit evaluation of the conduct of the study and the quality of the data produced? (If no, please explain):   FORMCHECKBOX  YES  FORMCHECKBOX  NO 5.6. Are study documents up to date, accessible, clearly ordered and comprehensible? (If no, please explain):   FORMCHECKBOX  YES  FORMCHECKBOX  NO Section 6: Funding / Budget 6.1 Is the expenditure proceeding according to budget? (If no, please explain):   FORMCHECKBOX  YES  FORMCHECKBOX  NO  6.2 Is the project funding (income) being received in a timely manner? (If no, please explain):   FORMCHECKBOX  YES  FORMCHECKBOX  NO  FORMCHECKBOX  Not Applicable  6.3 Have any changes to the budget been required? (If yes, please explain including the name and position of the person who authorised any changes):   FORMCHECKBOX  YES  FORMCHECKBOX  NO  Section 7: CLINICAL TRIALS ONLY If the study is NOT a Clinical Trial (please tick the checkbox and leave this section blank):  FORMCHECKBOX   7.1 Have all relevant Significant Safety Issues been reported to the HREC within 72 hours as per the  HYPERLINK "https://www.nhmrc.gov.au/_files_nhmrc/file/publications/16469_nhmrc_-_ahec_position_statement-web.pdf" NHMRC Safety Monitoring and Reporting in Clinical Trials Involving Therapeutic Goods (November 2016)? (If no, please explain):   FORMCHECKBOX  YES  FORMCHECKBOX  NO  7.2 Have all SUSARs occurring in RCH participants been reported to the Therapeutic Goods Administration (TGA)? (If no, please explain):   FORMCHECKBOX  YES  FORMCHECKBOX  NO  7.3 Has an Independent Data Safety Monitoring Board (DSMB) or equivalent considered interim results of the study in the last 12 months?   FORMCHECKBOX  YES  FORMCHECKBOX  NO  FORMCHECKBOX  No DSMB for this study  7.4 If this is a commercially sponsored trial, is the Insurance Certificate current (i.e. in date)? (If no, please submit an updated certificate with this report.)  FORMCHECKBOX  YES  FORMCHECKBOX  NO  FORMCHECKBOX  Not Commercially Sponsored  7.5 Is a copy of the TGA acknowledgement letter saved in the study file? (Note: this documents that the TGA has received the appropriate CTN (clinical trial notification) of the sites involvement in the study.)  FORMCHECKBOX  YES  FORMCHECKBOX  NO  FORMCHECKBOX  Not a CTN study 7.6 Has the clinical trial been registered on an appropriate public register?   FORMCHECKBOX  YES  FORMCHECKBOX  NO 7.7 Has the PI successfully completed Good Clinical Practice (GCP) training within the last three years, using a  HYPERLINK "http://www.transceleratebiopharmainc.com/gcp-training-attestation/list-of-training-providers/" TransCelerate accredited course?  FORMCHECKBOX  YES  FORMCHECKBOX  NO Declarations  Principal Investigator (PI): I agree that the above information is true and correct at the time of submitting this report. 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