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Social and Health Research  \n\n| Protocol Title |  |\n| --- | --- |\n| REB Protocol No. |  |\n| UM Project No. |  |\n| Sponsor(s) |  |\n| Faculty/Department |  |\n| Principal Investigator (PI) |  |\n| Study Location(s) |  |\n| Audit Type |  |\n| Audit No. |  |\n\n1. Audit Objectives  \nThe purpose of the audit is to:  \n• Assess compliance with audit criteria (see below) .  \n• Identify requirements for change and/or improvement based on audit observation(s) . 1  \n2. Audit Scope  \nThe scope of an audit usually varies and is tailored to the complexity of the study. You can, however, expect the audit to cover the following (this list is usually based on information gathered from the approved protocol and protocol- referenced documents, and the correspondence between the PI and the REB):  \n*For a detailed list of documents required for review, see section 5.  \n• Protocol adherence.  \n• Compliance with research agreement stipulations.  \n• Delegation of study responsibilities, that is roles and responsibilities, specifically of:  \no The Principal Investigator (PI) .  \no Co-investigators.  \no Additional study team members.  \n• Training of study personnel.  \n• Research team supervision.  \n• Procedures for participant engagement e.g. , participant recruitment, initial informed consent, ongoing consent, withdrawal, and discontinuation.  \n• Procedures for data collection.  \n• Document storage areas.  \n• Provisions for short and long-term data handling and retention.  \n• Procedures for sharing data.  \n1 An audit observation is a finding observation of a deviation from the approved protocol and protocol referenced documents, or a failure to comply in some way with one or more activities as outlined in the approved protocol and protocol referenced documents, University policies and procedures, other applicable regulatory frameworks, and with contractual obligations.  \n• Confidentiality and privacy procedures.  \n• Participant compensation procedures.  \n• Dissemination plans and activities.  \nPlease note that the Research Compliance Specialist may expand the scope of an auditat any time during the audit process.  \n3. Audit Criteria  \nResearch practices and study conduct will be compared to all applicable requirements such as, but not limited to, the following:  \n• The research protocol and other study-related documents.  \n•  The Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2) .  \n•  The Personal Health Information Act (PHIA) and the Personal Health Information Regulation 245/97 .  \n• The University of Manitoba Ethics of Research Involving Humans Policy and Procedure , and REB associated submission Procedures and Guidelines for the Fort Garry Campus and the Bannatyne Campus.  \n• The University of Manitoba Responsible Conduct of Research Policy, Responsible Conduct of Research-Code of Research Ethics Policy, and Responsible Conduct of Research- Investigation Procedure.  \n• The University of Manitoba Research Agreements Policy and Procedure.  \n4. Audit Methods  \nAudit methods will include some or all of the following:  \n• Review of the REB-approved protocol, all correspondence between the PI and the REB, all other study correspondence, and research files.  \n• Interviews with the PI and some or all study personnel.  \n• Follow-up communications, by email or in-person/virtual meetings, with the PI and some or all study personnel.  \n5. Study Documents Required for Review  \nThe following list is not exhaustive and not all-inclusive, and it is not provided in any order of priority. Additional documents may be requested prior to, during , and/or after the audit. Further some of documents listed may not be applicable in all cases, for example, Case Report Forms (CRFs) may apply to health research and not to s","cbCaigFDGgVwB91P","https://ap.wps.com/l/cbCaigFDGgVwB91P","pdf",228682,"English","# Audit Objectives\n# Audit Scope\n# Audit Criteria\n# Audit Methods\n# Study Documents Required for Review\n## Audit Findings","[{\"question\":\"What are the main audit objectives in this template?\",\"answer\":\"The audit assesses compliance with audit criteria and identifies requirements for change or improvement based on audit observations.\"},{\"question\":\"What topics does the audit scope typically include?\",\"answer\":\"The scope covers protocol adherence, compliance with research agreement stipulations, delegation and study team roles, training, supervision, participant engagement, data collection, storage and retention, and procedures for sharing data, confidentiality, privacy, compensation, and dissemination.\"},{\"question\":\"Which documents are required for review during the audit?\",\"answer\":\"The template lists items such as REB approval letters, other approvals, signed agreements, the study protocol, training records, delegation documentation, informed consent and other participant information materials, recruitment materials, CRFs, REDCap validation certificates, enrollment logs, correspondence files, proof of informed consent, source documents, compensation proof, and dissemination reports.\"}]","Audit Plan Template for Social and Health Research - Research Ethics & Contract Compliance | PDF",1790095527]