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Quality Control Activities ? Quality Control is the real time, day-to-day, observation and documentation of the sites work processes to ensure that accepted

    DMID SAMPLE QUALITY MANAGEMENT SUMMARY REPORT TOOL INSTRUCTIONS

This sample Quality Management Summary Report Tool has been developed in Microsoft Word as a

    sample that may be adapted, as needed, to adequately capture how findings are summarized, analyzed,

    and communicated to site staff. This report includes the aggregated information from completed chart

    review tools, regulatory file review tools, and any other site-developed internal quality management tools.

    This report and any other internal quality management report tools should be filed in a separate quality

    management binder, separate from the site regulatory documents.

    1. Begin using this tool by completing the header information (name of site, reporting period, and

    audit participants).

    2. Complete Section 2. Identification of Problem Areas per protocol. This form may be modified as

    necessary.

    3. To ensure the content of reporting adequately addresses site performance, please include

    applicable key quality indicators, as listed in your Clinical Quality Management Plan (i.e. informed

    consent, eligibility, specimen collection, etc.), as well as broader processes (i.e. quality control,

    quality assurance, etc).

Note: When preparing a summary report consider data collection/reporting sources (i.e.

    local/regional/centralized databases) supporting protocol activity and ongoing reporting requirements.

References:

    OHRP Code of Federal Regulations Title 45 Part 46:

    www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm ICH Guideline for Good Clinical Practice E6 (Section 8):

    www.ich.org/LOB/media/MEDIA482.pdf

    U.S. Food and Drug Administration, Title 21 Part 312, Investigational New Drug:

    www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=312

    U.S. Food and Drug Administration, Title 21 Part 812, Investigational Device Exemptions:

    www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=812

    DMID Clinical Research Resources - Regulatory File Document Guidelines:

    www3.niaid.nih.gov/research/resources/DMIDClinRsrch/PDF/regulatoryfiledocumentguidelines.pdf

    DMID Clinical Quality Management Plan Policy:

    www.dmidctm.com/partners/SectionQualityManagement/PageSOPs/SOPs.htm

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    DMID SAMPLE QUALITY MANAGEMENT SUMMARY REPORT TOOL

    <Replace DMID SAMPLE with Institution/Site Name>

Date of Report: <enter date report was written>

    Reporting Period: From Through

    1. Staff Participation in Audits: <List the name, title, and role of each staff member involved in the internal review processes>

    ? <Name, Title, and Role>

    ? <Name, Title, and Role>

    2. Identification of Problem Areas

    2.1. Quality Control Activities Quality Control is the real time, day-to-day, observation and documentation of the sites

    work processes to ensure that accepted procedures are being followed. For example, review of demographic

    information for accuracy on each Case Report Form (CRF) prior to entry into a database.

    Quality Control Reviews: <insert the protocol number, CRF number/name and a summary of the findings>

    Protocol CRF Summary of Finding(s) Number Number/Name

    <Insert or delete rows as needed>

    Trend Analysis: <describe any trends found during the review of findings>

    Corrective and Preventive Actions: <describe any corrective and preventive actions, including training>

    Evaluation/Re-Evaluation: <describe the any follow-up actions verifying resolution>

    Resolution Date: <provide the date the findings are confirmed to be resolved >

2.2. Quality Assurance Activities - Quality Assurance is the periodic, systematic, objective, and comprehensive

    examination of the total work effort to determine the level of compliance with accepted Good Clinical Practice

    Standards. For example, a monthly review of source documents compared to Case Report Form pages to determine

    adherence to protocol requirements.

    Subject Record Review: <insert the Protocol Number and a summary of the findings found during subject record review>

    Protocol Summary of Finding(s) Number

    <Insert or delete rows as needed>

    Trend Analysis: <describe any trends found during the review of findings>

    Corrective and Preventive Actions: <describe any corrective and preventive actions, including training>

    Evaluation/Re-Evaluation: <describe the any follow-up actions verifying resolution>

    Resolution Date: <provide the date the findings are confirmed to be resolved >

DMID Sample QM Summary Report Tool March 2009 2 of 4

Regulatory Files Reviewed: <Insert the protocol number and a summary of the findings found during regulatory file review>

    Protocol Summary of Finding(s) Number

    <Insert or delete rows as needed>

Trend Analysis: <describe any trends found during the review of findings>

    Corrective and Preventive Actions: <describe any corrective and preventive actions, including training>

    Evaluation/Re-Evaluation: <describe the any follow-up actions verifying resolution>

Resolution Date: <provide the date the findings are confirmed to be resolved >

    Study Product Review: nsert the protocol number and a summary of the findings found during study product review>

    Protocol Summary of Finding(s) Number

    <Insert or delete rows as needed>

Trend Analysis: <describe any trends found during the review of findings>

    Corrective and Preventive Actions: <describe any corrective and preventive actions, including training>

    Evaluation/Re-Evaluation: <describe the any follow-up actions verifying resolution>

Resolution Date: <provide the date the findings are confirmed to be resolved >

    Other Areas of Review: <insert the protocol number and a summary of the finding from other areas reviewed>

    Protocol Summary of Finding(s) Number

    <Insert or delete rows as needed>

Trend Analysis: <describe any trends found during the review of findings>

    Corrective and Preventive Actions: <describe any corrective and preventive actions, including training>

    Evaluation/Re-Evaluation: <describe the any follow-up actions verifying resolution>

Resolution Date: <provide the date the findings are confirmed to be resolved >

    DMID Sample QM Summary Report Tool March 2009 3 of 4

3. Summary Report Conclusion:

    summary information. If findings are not resolved, re-evaluate at the next meeting/reporting period. Include any plans for the next

    reporting period such as training, staffing, updates to tools, etc. If the issues found within this report constitute a re-evaluation of the

    Clinical Quality Management Plan (CQMP), describe the details and timelines for review, submission, and approval.>

    Quality Assurance Coordinator Signature: ____________________________________________Date: ______________

DMID Sample QM Summary Report Tool March 2009 4 of 4

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