PROCEDURE Research Management Research Governance Site

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Information contained within Procedure provisions applies to all research projects conducted. at within or by Metro South Health irrespective of whether the Metro South Human Research Ethics. Committee HREC has provided ethical review for the research project. Research governance must be undertaken in parallel with Metro South Health HREC review using. the Australia Online Forms for Research internet site. Research may not commence until HREC review and governance processes are completed and the. research project has received written authorisation from the Metro South Health Chief Executive. Officer or delegate, All research activities will be registered on AU RED Australian Research Ethics Database when. approved by a HREC A recommendation for Metro South Health Chief Executive Officer or delegate. approval to conduct research will not be made unless evidence of consultation with supporting. departments has been provided and financial legal and indemnity issues have been addressed. LEGISLATION OR OTHER AUTHORITY,Legislation, Gene Technology Queensland Act 2016 Privacy Act 1988 Cth. Qld Public Health Act 2005 Qld, Gene Technology Act 2000 Cth Statutory Bodies Financial Management Act. Hospital and Health Boards Act 2011 Qld 1982, Information Privacy Act 2009 Qld Therapeutic Goods Act 1989 Cth. Regulation, Hospital and Health Boards Regulation 2012 Information Privacy Regulation 2009 Qld.
Statements Papers and Guidelines, Australian Radiation Protection and Nuclear Safety Agency ARPANSA Code of Practice. Exposure of Humans to Ionizing Radiation for Research Purposes. National Health and Medical Research Council NHMRC. o Australian Code for the Responsible Conduct of Research 2007. o National Statement on Ethical Conduct in Human Research 2007 Updated May 2015. o Guidance Safety monitoring and reporting in clinical trials involving therapeutic goods. o Values and Ethics Guidelines for Ethical Conduct in Aboriginal and Torres Strait Islander. Health Research 2003, o Research Governance Handbook Guidance for the national approach to single ethical review. Queensland Health, o Fee Schedule and Site Information for Commercially Sponsored Research 2010. o Health Service Directive Research Ethics and Governance HSD 035 2016. o Junior Doctor Research Fellowship Funding Rules Round Two 2016. o Research Fellowship Funding Agreement Rules,o Researcher User Guide RUG 2010. Page 2 of 20, o Standard Operating Procedures for Queensland Health HREC Administrators 2013.
o Standard Operating Procedures for Queensland Health Research Governance Officers 2013. Therapeutic Goods Administration Note for Guidance on Good Clinical Practice CPMP ICH 135 95. 2000 Annotated with TGA Comments, Metro South Health Policies Procedures Manuals Frameworks etc. Contract Management Framework Management of Conflict of Interest Policy. PL 2014 0038,Finance Management Practice Manual,FMPM Research Biorepositories Policy PL2017 53. Integrated Risk Management Framework Risk Assessment Guide V12 6 11 2013. Management of Conflict of Interest All Staff Risk Management Policy PL2013 06. Procedure PR2016 66,RESPONSIBILITIES,Executive Management Team. Ensure collaborative harmonised clear and detailed publicly available Policies and Procedures are in. place for the ethical scientific and governance review of research of all research conducted within Metro. South Health,Metro South Human Research Ethics Committee HREC. Provide oversight of the ethical and scientific review of human research by keeping abreast of. international national and state wide legislation regulations and guidelines Promote Metro South. Health strategic requirements and ethical and responsible decision making which respects the rights of. Metro South Health participants,Centres for Health Research.
Update Metro South Health research governance documents in accordance with Metro South Health. requirements Provision of secretariat administrative support to maintain and uphold principles outlined. in the Metro South Health Research Management Policy and related Procedures Complete due. diligence by ensuring adherence to legislative and institutional policy requirements and recommend. authorisation by the Metro South Health Chief Executive Officer or delegate as appropriate. Metro South Health Chief Executive Officer or Delegate. Provide authorisation on research applications and contracts according to the Metro South Health. Finance Management Practice Manual FMPM and the Contract Management Framework. Principal Investigators Research Team, Conduct research in accordance with national guidelines and the Metro South Health Research. Management Compliance Framework Ensure research practices reflect current professional ethical. and legal standards for research including promptly responding to reporting and monitoring. requirements Ensure compliance with the approval given by a HREC legislative and Policy. requirements for participant contact consent and confidentiality of participant information. Page 3 of 20, Only conduct clinical intervention studies with the essential approved credentialing privileges and clinical. experience Adhere to all relevant Policies Procedures Research Protocols and Standard Operating. Procedures SOPs when conducting research,All Metro South Health Employees. Are required to be aware of and comply with this Procedure when conducting research. SUPPORTING DOCUMENTS,Attachments,Attachment 1 Application. Metro South Research Contracts Approval and Study Execution Form. HREC RGO Annual Report Form,MSF11 Notification of Commencement Form.
MSF19 Metro South HREC Serious Adverse Event SAE Suspected Unexpected Serious Adverse. Reaction SUSAR Report, MSF31 Metro South HREC and Governance Standard Risk Submission Checklist Form. MSF49 Metro South Amendment Form, Multi centre Research Projects only Accepting Site Guidance when Metro South Health HREC is the. reviewing HREC, Multi centre Research Projects only Accepting Site Guidance when Metro South Health HREC is not. the reviewing HREC, Multi centre Research Projects only Lead Site Guidance. DEFINITIONS, See the Metro South Health Research Management Glossary.
Page 4 of 20, PROCEDURE RESEARCH GOVERNANCE SITE SPECIFIC ASSESSMENT. SITE SPECIFIC ASSESSMENT PRE AUTHORISATION, Step 1 Commencing the Site Specific Assessment Human Research Ethics Committee Review. It is strongly recommended to commence completion and collation of Site Specific Assessment SSA. documentation at the same time as the Human Research Ethics Committee HREC review process. Please see Ethical and Scientific Review of Human Research Procedure PR2017 113 for more. information, Step 2 Commencing the Site Specific Assessment Conflicts of Interest. If any person believes they may have a Conflict of Interest in relation to a Site Specific Assessment the. conflict must be declared and detailed prior to submission of Site Specific Assessment SSA. documentation The Principal Investigator must escalate approval of the Site Specific Assessment. SSA documents and signing of the Metro South Research Contracts Approval and Study Execution. Form to a relevant line manager or delegate, Step 3 Preparing the Site Specific Assessment Specific Components. In order to fulfil Site Specific Assessment SSA requirements the following specific components must be. 3 a Cover Letter and or HREC Governance Standard Risk Submission Checklist Form. A cover letter outlining the reason for submission and itemising all supporting documentation and or. complete the MSF31 Metro South HREC and Governance Standard Risk Submission Checklist Form. Ensure the cover letter and or MSF31 Metro South HREC and Governance Standard Risk Submission. Checklist Form is signed approved by the Principal Investigator. 3 b Metro South Research Contracts Approval and Study Execution Form. Researchers must only complete Part A of the Metro South Research Contracts Approval and Study. Execution Form As the Metro South Research Contracts Approval and Study Execution Form must be. completed for all research projects occurring within Metro South Health the authorising signatories must. be employees of Metro South Health, For research projects that involve more than one 1 Metro South Health facility a signature from the.
authorised representative of the facility is required. The Metro South Health Principal Investigator is only required to sign when assuming full. responsibility for the conduct of the research project at the site and ownership of the research. contract agreement if applicable, The head of department at the initiating site in which the research project is to be conducted. normally the director of the department This delegate must not be a member of the research team. If necessary researchers must seek approval from the Executive Director of the department Their. signature indicates that they support the conduct of the research project within the department. The Business Manager Financial Officer of the department in which the research project is to be. conducted Their signature indicates that there are sufficient resources available to conduct the. research project,Page 5 of 20, Part B is to be completed by the Metro South Health Research Governance Office r. 3 c Site Specific Assessment SSA Form, The online Site Specific Assessment SSA form available on the Australia Online Forms for Research. internet site must be completed as it relates to information about research activities that are occurring. within a Metro South Health facility Note Only 1 one Site Specific Assessment SSA form is required. for research projects that involve multiple Metro South Health facilities. It is important to note that the online Site Specific Assessment SSA form can be saved and updated. throughout the preparation process, All supporting documents must be uploaded electronically against the online Site Specific Assessment. SSA form See Step 4 Preparing the Site Specific Assessment Supporting Documents below for. more information on required supporting documentation. Step 4 Preparing the Site Specific Assessment Supporting Documents. In addition to the above specific components the following associated supporting documents may also. be required based on research project requirements All supporting documents must be prepared and. uploaded against the research project s online Site Specific Assessment SSA form available on the. Australia Online Forms for Research internet site, For document control purposes all supporting documents must have version control number and date in.
the footer For example the site specific Participant Information and Consent Form PICF must include. the following,Master Version x dated XX,Site Specific Version x dated XX. 4 a Metro South Health HREC Clearance Approval Letter. The Metro South Health HREC Clearance Approval Letter is a mandatory requirement and must be. provided prior to authorisation,4 b Research Contract Agreement as applicable. Researchers are encouraged consult with the Metro South Health Research Governance Office r via. email PAH Research health qld gov au to ascertain if there is a requirement for a research. contract agreement, Research contract agreements are typically required when a third 3rd party entity is involved in the. collaboration or when a student is undertaking a research higher degree as part of the research team. Please see Research Contracts and Study Execution Procedure PR2017 122 for more information. 4 c Medicines Australia Standard Indemnity, Researchers must complete the Medicines Australia Standard Indemnity in addition to the Medicines. Australia Agreement for commercially sponsored research projects. Page 6 of 20, 4 d Australian Radiation Protection and Nuclear Safety Agency ARPANSA Radiation Risk.
Assessment, A copy of the Australian Radiation Protection and Nuclear Safety Agency ARPANSA Radiation Risk. Assessment is required for research projects involving ionising radiation as a specific component of the. Research Protocol,4 e Risk Versus Benefit Letter, The Risk Versus Benefit Letter is required for clinical trials or clinical interventional trials where Metro. South Health is acting as the research project sponsor The letter must be signed by an appropriate. 4 f Quotes and Approvals, Quotes and approvals from departments providing a service to support the research project i e. Pharmacy Radiology and Pathology etc must be included. 4 g Clinical Trial Notification CTN Form, As supplied by the commercial sponsor a copy of Clinical Trial Notification CTN Form in pdf which. has been submitted to the Therapeutic Goods Administration TGA Additionally if available a copy of. the TGA acknowledgement letter in respect of the CTN notification. 4 h Invoicing Details, Invoicing details are required for research projects that attract a fee as per Research Fees Procedure.
PR2017 123,4 i External HREC Approval, Research projects that are approved by an external HREC i e non Metro South Health HREC require. the following additional supporting documents,Research Protocol. printed Human Research Ethics Application HREA Low and Negligible Risk Application Form LNA. Form available on the Australia Online Forms for Research internet site. o master PICF for multi centre research projects only or. o site specific PICF which contains site contact details and site logo. current Curriculum Vitaes CV of research personnel if not already supplied within the previous two. All research activities will be registered on AU RED Australian Research Ethics Database when approved by a HREC A recommendation for Metro South Health Chief Executive Officer or delegate approval to conduct research will not be made unless evidence of consultation with supporting departments has been provided and financial legal and indemnity issues have been addressed LEGISLATION OR

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