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Monitoring & Auditing

Monitoring & Auditing Program

On 1 December 2009, the research governance officer will commence a program of short auditing visits to research teams to monitor the conduct of projects.

The purpose of the auditing program is to review how research is conducted, and to detect, correct and prevent potential and existing problems. 

All ongoing human research projects with ethics approval granted by the RCH HREC are eligible to be audited, including clinical trials, observational studies, clinical audit activities and public health research projects.

Frequently Asked Questions (FAQs)

What is the purpose of the auditing program?
When will auditing begin?
How many projects will be audited?
Which projects will be audited?
How will projects be selected for an audit?
What happens before an audit?
How can researchers prepare for an audit?
What happens during an audit?
How long will an audit take?
What happens after an audit?
What if researchers disagree with the auditor's report?
What are the changes to the Annual & Final Report?

 

What is the purpose of the auditing program?
The purpose of the auditing program is to review how research is conducted, and to detect, correct and prevent potential and existing problems. 

The objectives of the auditing program are:

• to ensure research is conducted ethically, safely, legally and in compliance with the protocol, conditions of Human Research Ethics Committee (HREC) approval and institutional policies and procedures.
• to raise awareness of requirements and promote researchers' accountability.
• to ensure that the conduct of research does not compromise the integrity of the results.

The Royal Children's Hospital (RCH) is required to monitor all approved research in accordance with the National Health and Medical Research Council (NHMRC) National Statement on Ethical Conduct in Human Research (2007).

Together, the auditing program and the review of annual progress reports allow the RCH Research Governance Officer to monitor the conduct of research following HREC approval.

 

When will auditing begin?

October 2009	The following procedures, which provide the framework of requirements against which projects will be audited, will be implemented: Investigators' Responsibilities in Research  Informed Consent in Research Information regarding the Auditing Program will be published on the ERD website
November 2009	Two (2) projects will be audited to pilot the program
December 2009	The auditing of projects will commence

 

How many projects will be audited?
Between 40 and 50 projects per year will be audited. As there are around 150-200 new projects submitted each year and over 500 projects currently being conducted, researchers should be aware that it is not inevitable that they will be audited in the first year of the program.

 

Which projects will be audited?
All ongoing human research projects with ethics approval granted by the RCH HREC are eligible to be audited, including clinical trials, observational studies, clinical audit activities and public health research projects.

Studies from all tiers of risk (negligible risk, low risk and greater-than-low risk) will be audited, however higher risk studies will be the focus of more audits than those considered to be lower risk.

In practice, studies with external monitoring arrangements (e.g. commercially sponsored studies with a monitor) have less chance of being audited.

 

How will projects be selected for an audit?
Projects may be selected for auditing for a variety of reasons:

• Human Research Ethics Committee request
  • following approval of a new protocol;
  • as part of the approval process; or
  • due to the classification of risk.
• Random selection.
• A complaint
• Annual report verification

Studies from all tiers of risk (negligible risk, low risk and greater-than-low risk) will be audited, however higher risk studies will be the focus of more audits than those considered to be lower risk.

Projects will be randomly selected for auditing from within each tier of risk, but in a controlled manner so that repeated audits of the same group within short periods of time are avoided, unless previous audits have revealed problems.

In addition, some projects will be audited on a non-random basis, in response to a perceived need for closer monitoring of those projects for compliance with requirements, as directed by the HREC or ERD.

 

What happens before an audit?
Once a project has been selected for auditing, the following will occur:

1. A letter will be sent to the Principal Investigator (PI) of the project, informing them of the audit, and requesting a suitable time during the following month. The audit report form will be attached to the letter.
2. The date and time for the audit will be arranged.
3. The auditor will review the project's ERD file and database entry to gather information relevant to the audit. This includes a review of the project through the information statement and protocol, as well as approval and version dates of study documents, for cross reference.

 

How can researchers prepare for an audit?
As outlined in the auditor's initial letter to the PI and contact, the researchers must make available the following:

1. Study files and documents (including those in electronic form)
2. Patient data files, including medical records*, for the 3 subjects specified in the initial letter.
3. The signed consent form for every subject enrolled into the study.
4. A member of the research team to answer any questions.
5. A space for the auditor to sit and review the documents
6. The database** containing the study data
7. List of subjects (names and enrolment status)

*If the medical record must be requested from Health Information Services with advanced notice, the researchers must account for this to make sure the correct and complete records are available for the auditor.

**A researcher with authorised access who is familiar with the database is required to assist the auditor with their checks on the database.

Researchers can conduct a review of their own files to ensure they are current, complete and well organised for the audit. The expectations about the study document that should be available are extensive, as specified in the RCH Investigators' Responsibilities in Research Procedure.

If some of these documents are not already filed, it is important to have them filed for the audit.

Needless to say, the projects that are best prepared for an audit are those that have been well managed from the outset, with all staff working in compliance with the protocol, the Investigators' Responsibilities in Research Procedure and other requirements.

Further, all staff delegated responsibilities in any study should be aware of the Investigators' Responsibilities Procedure, and must have training in the protocol, appropriate to their duties in the study.

 

What happens during an audit?
During the audit visit the auditor will take notes on an audit reporting form via a combination of:

1. Inspecting the study documents
2. Asking members of the research team for answers to particular questions

The auditor will ask questions about processes used by the study team, to ascertain how the study is conducted. However not all details will be recorded in the auditing report unless they relate to a particular issue that is identified.

For the study subject data review, the auditor will compare a sample of the collected study data to information in the source documents, to ensure that it is verifiable and to check for discrepancies. This step will often require the assistance of a member of the study team who has access to the study database.

For studies with CRFs, this will involve comparing a sample of data points from the CRFs of three specific subjects to their medical records, as well as cross referencing with the database.

At the end of the visit, time permitting, the auditor may discuss some of their findings with members of the research team, especially if the findings can be rectified immediately and therefore appear in the auditing report as ‘resolved by the research staff during the auditing visit', reducing the volume of audit follow-up items for the researchers to resolve following the visit.

 

How long will an audit take?
The auditor's visit will take approximately 4 hours for a clinical trial and approximately 2 hours for other studies. Studies with well managed research files can expect shorter audits.

A member of the research team must be available to answer the auditor's questions for at least 30 minutes at the start of the audit and 30 minutes at the end of the audit.

 

What happens after an audit?
Following the audit, the auditor will complete the auditing report from their notes taken during the auditing visit.  The comments in the report will focus on any apparent issues.

The following will be considered audit findings and will appear in the auditing report:

• Breaches of the conditions of HREC approval,
• Non-compliance with the protocol
• Non compliance with the Investigators' Responsibilities in Research & Informed Consent in Research Procedures
• Noncompliance with other requirements, as referenced in the Investigators' Responsibilities in Research Procedure
• The auditor will complete an action item summary to outline the items identified during the audit that require resolution following the audit.

The completed report and action item summary will be reviewed in the ERD then sent to the principal investigator and contact within two weeks following the auditing visit. The Principal Investigator's line manager will be copied in on the follow-up letter with the report attached.

The audit follow-up process will be as follows:

1. From the date the report is sent, the researchers are given one month to respond to the audit findings on the action item summary, unless an urgent resolution is indicated.
2. The line manager is asked to oversee the resolution of the issue and the researcher's response.
3. The responses will be review by the auditor and the audit ‘closed' if the response details a resolution or planned resolution,. The PI and contact (copying Line Manager) will be notified that the audit has been ‘closed'.
4. If the items are not resolved, an ‘outstanding issues' reminder will be sent to the PI and their Line Manager.
5. Audit reports and researchers responses will be filed for consideration by HREC.

Findings that are considered to have a potential significant negative impact on any of the following may be escalated to the HREC and may require response within a shorter timeframe (i.e. days or weeks rather than 1 month):

1. The integrity of the results
2. The risks to the research subjects
3. The ethical acceptability of the study
4. The insurance coverage

If the items are not resolved, the HREC may request further steps are taken to address the issues.

 

What if researchers disagree with the auditor's report?
The researchers can respond to the items on the action item summary as they see fit. Responses detailing resolutions that are different to those suggested by the auditor are acceptable if they are sufficiently explained.

If a researcher has a complaint, or would like to discuss an issue with any aspect of auditing, they should contact the Director, Ethics & Research.

 

What are the changes to the Annual & Final Reporting Process?
A revised Annual Report Form and Final Report Form have been implemented. The revised forms contain specific questions to be answered, as opposed to the previous forms which contained little guidance for researchers completing the reports. This will assist when monitoring human research conduct following initial HREC approval.

Like the audit program, the purpose of reviewing annual reports is to keep track of how research is conducted, and to detect, correct and prevent potential and existing problems. 

A completed Annual Report Form must be signed by the Principal Investigator and submitted to the ERD.

The annual report is due within one month of the annual anniversary of the initial approval date for the study.

The Research Governance Officer will review the reports after they are received in the ERD, and contact the researchers to discuss and resolve any issues indicated in the report.

The annual reports will be reviewed periodically by the HREC.

If the annual report is not received within one month following the annual anniversary of the initial approval date for the study, the study approval and legal indemnity will lapse, and the researchers' right to publication and opportunity to seek future funding may be compromised.

A completed Final Report Form  is due at the completion (or abandonment) of the study and should be accompanied by a Thank you Letter to participants, containing a lay summary of the study results, to be approved by the committee (unless previously submitted for approval).

The new forms are now effective and annual & final reports on the old template will not be accepted after January 1, 2010.