Page 15 - Research Compliance Welcome Package (1.4.19)

Research Compliance Program Routine Audit Cycle
Audit Phase
Study Chosen for Audit
Audit notice is sent to the PI and study team
Remote Audit Activity
Remote review of iRIS records, subject EMR, and documents provided by study the team
On
Comprehensive review of Investigator study files and interviews with staff
Research Compliance Office (RCO) staff compiles and evaluates data collected during the audit
RCO staff communicates preliminary findings and recommendations to the study team
Report Phase
Findings and recommendations are formalized in a draft audit report
RIO Review and Approval
Research Integrity Officer (RIO) reviews and approves the draft audit report
Draft Report Issued
Draft report is released and discussed with the study team at the exit meeting. Response is typically requested within 2 weeks.
RCO staff assists the study team as needed in developing appropriate responses
Study team submits a draft report response to RCO for review and approval
Finalization Phase
RCO staff edits the draft report and proposes a final format
RIO reviews and approves the proposed final audit report
RCO issues the final audit
report to the study team, management, institutional leadership, and applicable oversight committees,
as appropriate
Summary of the final audit results is reported to the BSWH Corporate Compliance Committee
Please note: the above is subject to change depending on the risk level of research deficiencies.
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Site Audit Activity
Responses Insufficient
Responses Sufficient
BSWH Research Compliance | 2401 S. 31st St. | MS-AR-M300 | Temple, TX 76508
254-215-9025 (x21-9025) Office | 254-215-9061 Fax | Research Compliance Office | ResearchCompliance@BSWHealth.org
10/16/18