Tool Summary Sheet

Tool:	Quality Management Summary Report Template
Purpose:	Summarizes the results of Site-level Quality Management efforts
Audience/User:	Principal Investigators and other study team members responsible for conducting quality reviews
Details:	This tool provides a framework for reporting the results of site-level quality review activities.
Best Practice Recommendations:	Customize this reporting tool to the specific needs and requirements of the study. Text provided in this template is sample text that should be updated as needed. This report provides only one potential structure. However, variations on this structure may be more effective, depending on the items reviewed and the results. Refer to your Clinical Quality Management Plan (CQMP) for the key quality indicators that will be assessed for your study and the frequency of review. This report can be used in conjunction with the following tools (which should also be customized for the study): Quality Management Subject/Participant Data Review Tool, QM Monthly Review Tool, QM Quarterly Review Tool, QM Annual Review Tool, and QM Essential Documents Review Tool. In each Summary section, indicate whether the review was completed during this reporting period or indicate ‘Not done during this period.’ If a review was performed, provide a general description of the scope of the review. It is likely that some issues will be found during each review described in this report. Perfection is never expected. In each Results section: Use Comments documented in the QM Review Tools to describe the results of the review: issues found; trends revealed; and plans for / completion of corrective actions to resolve issues and/or trends. Any relevant Review Summaries from your completed QM Review Tools can be included as attachments to provide more detailed information / clarification; you may reference those attachments in the section text. You may want to include a summary statement to put the number of issues found in the context of the scope of the review and/or you may choose to include such a summary statement in the Summary and Conclusion Section 6. In the template, the instructions and explanatory text are indicated by {blue italics} (“CROMS_Instruction” style). Instructional text will also be enclosed in braces to signify this text for screen-readers used by the visually impaired. Text enclosed with <> is a placeholder for a specific detail (e.g., <protocol title>); replace as appropriate. Delete template-specific {instructional text} as well as this Tool Summary Sheet during the development process. Leave the template version information in the lower left hand corner of the document. You may choose to add “Based on” in front of “Template Version”. It is easiest and cleanest to use the styles that are embedded in the document, rather than to create your own. (In MS Word 2007: From the Home menu, select the bottom right arrow key to bring up the styles box, select “Options”, under “Select Styles to Show” select “in current document”.) Ensure that all placeholder and example text is replaced with the study-specific information. Distribute the report as specified in the CQMP and file along with other QM materials. Store all QM materials in a Quality Management Binder that is maintained separately from the Essential Documents Binder.

Tool Revision History:

Version Number	Version Date	Summary of Revisions Made:
1.0	20Aug2012	First approved version
2.0	13Apr2015	Added instructional bullets in the Tool Summary Sheet, minimized instructional text in the report body, and added sample text.

Quality Management Summary Report

Protocol: <protocol number and protocol title>

Site: <Name of Clinical Site>

Reporting Period: <specify date range>

{The QM coordinator is the individual responsible for managing QM activities at the clinical site and is named in the Clinical Quality Management Plan. The QM coordinator is also likely to be the author of the QM Summary Report. If this is not the case, include the name and signature of the report author in the set of signatories.}

QM Coordinator Name (Printed)
QM Coordinator (Signature)	Date
Principal Investigator Name (Printed)
Principal Investigator (Signature)	Date

Table of Contents

{This uses the Table of Contents function in Microsoft Word that will automatically update headings and page numbers used in the body of the report. In the body of the report, add, delete, or modify headings as needed. In order to ensure proper updating of the TOC, use the heading styles that are defined in the document: CROMS_Heading 1-CROMS_Heading 9.

To regenerate the Table of Contents and other links and cross-references in the document, Choose “Select all” and then F9.}

1	Staff Participation in QM Reviews	3

2	Subject/Participant Data Review	3

2.1	Summary of Review Process	3

2.2	Results of Review: General Issues, Trend Analysis, Corrective Actions	3

3	Study-wide Review	3

3.1	Essential Documents Review	3

3.1.1	Summary of Review Process	3

3.1.2	Results of Review: General Issues, Trend Analysis, Corrective Action	3

3.2	Other Study-wide Processes and Materials	3

3.2.1	Summary of Review Process	3

3.2.2	Results of Review: General Issues, Trend Analysis, Corrective Action	3

4	Outstanding Items from Prior QM Reports	3

5	Clinical Quality Management Plan Evaluation for Adequacy	3

6	Summary and Conclusion	3

Attachment 1: Results of Subject/Participant Data Review (Sample)	3

Attachment 2: Results of Essential Documents Review (Sample)	3

Attachment 3: Results of Other Study-wide Process and Materials Review (Sample)	3

Staff Participation in QM Reviews

{Include the names of each individual who participated in the quality review being summarized in the report. Include each individual’s title and indicate which item(s) or categories of items that individual reviewed.}

<Name, degree, title, items or categories of items reviewed>

Subject/Participant Data Review

Summary of Review Process

{Note the total number of subjects that were reviewed during this reporting period and provide a general description of the scope of the review; or indicate “Not done during this reporting period.”}

A total of 15 charts were reviewed during this reporting period. Review included consent documentation, eligibility, concomitant medications, source documentation standards, and missed visits.

Results of Review: General Issues, Trend Analysis, Corrective Actions

{Describe the results of the review: issues found, trends revealed, and plans for (or completion date of) corrective actions to resolve issues or trends. See Attachment 1 for sample summary table report attachment.}

Consent process documentation was insufficient for 8 out of 15 subjects. Staff members responsible for consenting subjects were retrained on 16Jul2014.

A total of 3 missed visits were identified as part of the quality management review. All of these visits were appropriately documented in the source and study data, including protocol deviations.

See the attached Subject/Participant Review Summary for detailed results information.

Study-wide Review

Essential Documents Review

Summary of Review Process

{Indicate the scope of the review, or indicate “Not done during this reporting period.”}

Results of Review: General Issues, Trend Analysis, Corrective Action

{Describe the results of the review. See Attachment 2 for sample summary table report attachment.}

Training documentation was found to be incomplete for staff who joined the study subsequent to site initiation. The site study coordinator created and implemented a checklist for new staff, which includes an item for ensuring proper training and documentation.

Other Study-wide Processes and Materials

Summary of Review Process

{Indicate the scope of the review, or indicate “Not done during this reporting period.”}

Results of Review: General Issues, Trend Analysis, Corrective Action

{Describe the results of the review. See Attachment 3 for sample summary table report attachment.}

The SOP for Study Product Storage was not being followed. The Pharmacy staff determined that the SOP was unnecessarily restrictive. This was discussed with the PI and the pharmacy will update the SOP by September 5, 2014.

Outstanding Items from Prior QM Reports

{Review the status of items that were outstanding as of the last QM Summary Report, such as corrective actions that were slated to occur after the report was finalized.}

Clinical Quality Management Plan Evaluation for Adequacy

{Indicate whether the CQMP was reviewed for adequacy during this reporting period and describe the review activities, recommendations, and schedule for making changes to the CQMP, if applicable. If this review did not occur, indicate “Review not done.”}

Summary and Conclusion

{Provide an executive summary of the results of the QM review.}

Attachment 1: Results of Subject/Participant Data Review (Sample)

Category	Clarification
Consent documentation	Issues identified	8 of 15 subjects reviewed had incomplete consent process documentation, including lack of date/time in the consent note and no indication of whether or not the subject had his/her questions answered.
Corrective actions	Introduced consent note template to consenting process (used tool from NIDCR-CROMS website entitled “Documenting the Consent Process”) on 16JUL2014.
Updated the Manual of Procedures (MOP) amendment tracker on 18JUL2014 to clarify the updated consenting process. This change will be made to the MOP during the next regularly scheduled MOP amendment cycle (slated for Q4 2014).
Completed re-training on 16JUL2014 for all staff responsible for consenting, per the protocol. Re-training documented in the Training Log.
Data correction formatting errors	Issues identified	There were 5 separate instances in which data on paper CRFs were modified without proper dating of the changes.
Corrective action	Because initials were available for the incorrectly modified data, it was possible to identify the individual who had been making the error. The study coordinator met with the individual on 11JUL2014 and discussed the technique for properly correcting data. The study coordinator will monitor the work of this individual over the next month to ensure that he is now following correct process.

Attachment 2: Results of Essential Documents Review (Sample)

Category	Clarification
Missing documents	Issue	Internal correspondence was not stored in the file.
Corrective action	A page was added to the Essential Document file indicating that internal correspondence is archived monthly by the study coordinator. This archived email is stored in a particular electronic location (location noted on the inserted page) that is accessible by the study team and clinical monitors (during site visits).
Delegation of Responsibilities Log	Issue	Not all individuals engaging in study activities have been noted in the DoR. End dates for individuals who have left the study have been inconsistently included.
Corrective action	DoR reconciled against current staff on 11JUL2014. Re-reviewed and confirmed as correct.
Subject Code List	Issue	Subject code list incomplete. 3 most recently enrolled subjects not included.
Corrective action	Subjects added to list on 14JUL2014. Study coordinator reminded to update the list the same day as consent.

Attachment 3: Results of Other Study-wide Process and Materials Review (Sample)

Category	Clarification
MOP	Not reviewed this quarter	MOP is reviewed annually. Next review slated for Q4.
Calibration	Issue	According to the calibration plan, clinicians are to be recalibrated annually. It has been 14 months since the original calibration, but no new training has occurred.
Corrective action	Team recalibration scheduled for 14NOV2014. Also, based on Team discussions and agreement, the calibration plan will be updated to indicate that recalibration is only required every 2 years.