Frequently Asked Questions (FAQs)
How are research studies chosen for QAIP site visits?
Any approved research study can be chosen for a routine review as part of Upstate’s normal post-IRB approval monitoring. This is especially true for:
- Studies not regularly monitored by other entities
- Studies involving vulnerable populations
- High risk studies
A directed (for cause) study site visit may be conducted in response to:
- Problems with compliance policies and regulations
- Repeatedly late or incomplete submissions to the IRB for required activities
- A complaint
- Past problems that require follow-up
In addition, a PI may request a site visit and/or other educational activities.
How are PI’s notified that a research study has been selected for a site visit?
An e-mail will be sent to the principal investigator detailing the study site visit process, and will include a copy of the QAIP schematic diagram. The site visit will be scheduled at a mutually acceptable time.
Can A PI defer or decline a study site visit?
A site visit can be deferred to a later date if necessary; however, a site visit cannot be declined. Every effort will be made to schedule the site visit at the principal investigator’s convenience, and at a time that allows for adequate preparation.
How long does a QAIP site visit take? Does the principal investigator have to be present for the entire visit?
Depending on the complexity and/or size of the study, a site visit can take anywhere from two to six hours. The QAIP coordinator spends the majority of this time reviewing records, but either the PI or coordinator should be reachable if questions arise. The PI’s presence is required only for the initial interview and requested for the close-out meeting.
What documentation will be reviewed?
All of the regulatory documents associated with the study should be available for review (either on paper or on IRBNet). Depending on the study, this may include:
- The current and all previously approved versions of the study protocol
- The current and all previously approved stamped consent forms
- The initial and continuing review approval letters
- The Investigator’s Brochure if applicable
- All protocol amendment request forms and the corresponding approval letters
- All FDA and sponsor required documentation and correspondence
- Adverse event and DSMB reports
Review of subject records will include:
- Informed consent forms
- Appropriate and complete source documentation used to determine eligibility
- Any logs or checklists
- Narrative forms and/or notes-to-file (if applicable)
- Clinic charts/medical records (depending on the study)
Who will receive the study site visit report?
The QAIP coordinator submits the site visit report to the Associate Vice President for Research Integrity. The site visit report will be shared via IRBNet with the IRB. (The IRB makes the final determination regarding recommendations and required actions, if any).
The site visit report will be sent to the PI by the Associate Vice President for Research Integrity. The PI is asked to review, sign and return the report to the QAIP Coordinator, along with any comments or responses. These comments or responses will be forwarded to the IRB.
Findings will also be shared, in regard to HIPAA compliance (i.e., obtaining authorization from subjects for the use and sharing of protected health information), with the University Privacy Officer to fulfill HIPAA auditing requirements. Only coded, aggregate data will be provided to the University Privacy Officer.
What will happen if there are problems noted in the Findings from the site visit?
Depending on the nature of the problem(s), the Associate Vice President for Research Integrity may:
- request that the QAIP Coordinator provide additional education to the PI and study team
- require a remediation plan
- ask the IRB Chairman/IRB to take action.
The IRB will review each report of findings, provided by the Associate Vice President for Research Integrity, and may require additional remediation. In addition, the IRB may be required to report certain findings to OHRP, FDA and study sponsors.