Onsite Review FAQ

  1. What is an onsite review?
  2. Can I request an onsite review?
  3. I didn’t request an onsite review, how was I selected for one?
  4. How do I prepare for an onsite review?
  5. How long with the onsite review take?
  6. Who needs to be present during an onsite review?
  7. What will happen during the onsite review?
  8. Do I get a report after the onsite review?
  9. Who gets to see my study’s onsite review report?
  10. I only keep electronic files, how do I prepare for my on-site review?

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1. What is an onsite review?

At the request of the Principal Investigator or study staff member, QIP is available to conduct both domestic and international review of study documentation and/or participant files to ensure regulatory compliance including protocol adherence, accurate record keeping, and appropriate informed consent process. During the on-site review, QIP will provide corrective actions and offer quality improvement recommendations.

2.Can I request an onsite review?

Yes! Simply fill out the QIP service request form and a member of the QIP team will contact you shortly to schedule the onsite review. If you would like to learn more email qip@hsph.harvard.edu.

3. I didn’t request an onsite review, how was I selected for one?

A protocol may have been selected for an onsite review for one or more reasons: (a) the PI of the protocol is new; serving in this role for the first time at a Harvard Longwood Medical Area School (Medical, Dental, or Public Health) and/or (b ) the PI of the protocol is not a Harvard Longwood Medical Area School faculty member and the IRB has granted an exception for him/her to serve as PI.

4. How do I prepare for an onsite Review?

Refer to the applicable Regulatory Binder template to familiarize yourself with the documentation QIP will be looking to review. Please arrange for a workspace to be available during the review, including a large table or desk, a couple of chairs, and where applicable, a computer with access to any electronic files. If you would like QIP to look at your participant files, make sure that access is available to these as well. Don’t worry, if you need help, QIP is happy to assist in organizing your files while on-site. If documents are kept electronically, there is no need to print copies for the purposes of the onsite review.

5. How long with the onsite review take

A typical review takes anywhere from 1-2 hours, depending on the nature of the study. The PI or designated member of the study staff provides a brief orientation of the files after which time, the PI and/or staff can go about their day. In rare instances, if there are extensive regulatory or participant files, QIP may need to come back on a subsequent day to finish the review.

6. Who needs to be present during an onsite review?

The PI or designated member of the study staff (generally the person who maintains the regulatory documentation) provides QIP staff with a brief orientation of the files after which time, the PI and/or staff can go about their day. At the conclusion of the review, QIP staff, the PI and/or any applicable study staff present will regroup for a brief exit interview. This exit interview provides an overview of the preliminary findings, including likely corrective actions and/or best practice recommendations.

7. What will happen during the onsite review?
A typical onsite review proceeds as follows: Two members of the QIP staff will come onsite to review the selected protocol’s regulatory documentation and/or participant files. Please arrange for a workspace to be available during the review, including a large table or desk and a couple of chairs, and where applicable a computer with access to any appropriate files. A typical review takes anywhere from 1-2 hours, depending on the nature of the study. The PI or designated member of the study staff provides QIP staff with a brief orientation of the files after which time, the PI and/or staff can go about their day.

At the conclusion of the review, the PI and/or applicable study staff present will regroup with QIP staff for a brief exit interview. This exit interview provides an overview of preliminary findings, including the likely corrective actions and/or best practice recommendations. QIP will provide a written report within 5 business days of the visit. Of note, the onsite review service is voluntary, and is not an IRB requirement; therefore, QIP findings will not be shared with the IRB nor filed in the protocol’s IRB file. The only exception to this rule is if QIP finds potential serious or continuing non-compliance. Under those circumstances, QIP will inform the IRB of the finding and work with the PI to report directly to the IRB.

8. Do I get a report after the onsite review?

The PI will be provided with a written report including corrective actions and/or best practice recommendations within 5 days of the visit. This report does not become a part of the IRB protocol file, but is kept confidential. Feel free to share it with other members of your research team and apply the corrective actions and best practice recommendations to other protocols.

9. Who gets to see my study’s onsite review report?

The onsite review service is completely voluntary, and is not an IRB requirement; therefore, QIP’s report will not be shared with the IRB nor be filed in the protocol’s IRB file. The only exception to this rule is if serious or continuing non-compliance is found. Under those circumstances, QIP will inform the IRB of the finding and work with the PI to report directly to the IRB.

10. I only keep electronic files, how do I prepare for my on-site review?

This is absolutely fine, and becoming the norm. Make sure that there is a computer or two available on-site with access to your files for QIP to use during their review. No need to print any documents for QIP’s visit alone. Alternatively, you can provide a thumb drive containing your electronic regulatory documentation and QIP will review it back at their office.