Post Approval Monitoring

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Routine Audit Common Results

 

Below are examples of common results from Post-Approval Monitoring visits:

 

Consent 

• The informed consent document on file is not complete (i.e., only the page containing the signature is on file).
• The IRB-approved version of the informed consent or assent document is not used.

 

Dates

• Informed consents are not dated by participants or those obtaining consent (in real time).
• Dates are added in by persons other than those giving or obtaining consent.
• Dates of consent occur after study procedures have begun.
• Dates of consent occur prior to receiving IRB approval of study.

 

Changes without IRB Approval

• Questions have been added prior to IRB review or approval.
• Questions have been removed prior to IRB review or approval.
• Recruitment methods have been changed prior to IRB review or approval.
• Survey methods have changed (e.g., from paper versions to online versions).

 

Signatures

• No real time signatures by individuals obtaining consent (missing, or postdated).
• Signatures are illegible; this is particularly important when determining if individual giving consent for minors is authorized to do so.

 

Compensation

• Logs are not kept of human subject compensation.
• Compensation amount differs from that stated in the IRB.
• Subjects who signed compensation logs are not the same as those consented.

 

Study records

• Study records are not STORED as indicated (i.e., storing other than removal for working on them, stored unsecured).
• Persons reviewing study records who are not approved or trained to do so.

 

Personnel are not CITI trained nor do they have accurate knowledge of approve protocol.

If you have identified discrepancies between your current research practice and those outlined in your IRB approved protocol, please make the appropriate corrections. This may require submitting a Modification Request Form or by implementing better documentation practices. If you are unsure that your protocol requires a Modification Request, please contact the IRB Office.