National Jewish Health Institutional Review Board Research Review Program: Routine Site Monitoring Visits
Guidance for Investigative Sites
As part of the National Jewish Health Institutional Review Board's commitment to Human Research Protections, the IRB staff's functions have expanded to include routine site monitoring visits of research protocols approved by the NJ IRB. These visits are intended to ensure that the research conducted at National Jewish Health is conducted according to the approved protocol and within federal regulations governing human subjects research.
Purpose
The purpose of a routine site monitoring visit is to assure that the requirements for the conduct of the study in regards to the protection of human subjects are adequately being met. This is accomplished by assessing adherence to federal regulations and NJ IRB guidelines, ensuring that adequate protections for the rights and safety of human subjects exist, and educating the investigative staff.
Areas and Information to be Reviewed
- Subject Selection
- Informed Consent Process/Documentation
- Study Documentation
- Recordkeeping
- Subject Safety
Review Process
Study Selection
Studies are selected for routine site monitoring visits through a query of the NJ IRB database.
All active protocols are eligible for audit, including those protocols sponsored by NIH, pharmaceutical industry or other sponsors. A protocol is considered eligible for an audit once it has undergone its first Continuing Review. Each research area will be audited at least once to ensure protocol compliance. An investigator who is audited once during the year may be audited a second time that year on a different study. Studies will not be audited more than once in its lifetime unless a re-audit is indicated. All Investigator-initiated HIGH risk studies will be audited at least once.
Notification of Investigators
All reviews will be scheduled at least two weeks in advance with the Investigator and research staff. Written confirmation will be sent to all sites detailing the date, time, place and duration of the audit.
Documentation to be reviewed
- Informed consent documents
- Subject research records
- Regulatory binder
Depending on the nature of the study, any or all of the above documentation will be reviewed.
In general, reviews involving subject records will be sampled as follows:
- For studies with < 5 subjects enrolled, a review of all subject files will be performed.
- For studies with = 5 subjects enrolled, research subject files will be reviewed for up to 100% of total enrollment.
Prior to the visit, the PI may be asked to provide a list of study participants (initials or ID numbers only) and the date(s) of informed consent.
Problems Identified During Audit Preparation
If minor errors or omissions are identified while preparing for the research review, the occurrence should be documented and a signed and dated memo should be placed in the research file. If major deviations are identified, a Protocol Deviation/Violation Report must be submitted to the IRB per the National Jewish Health IRB Unanticipated Problems Policy.
Findings/Reports
A report summarizing the review findings will be generated and forwarded to the PI, IRB Co-Chairs and the Institutional Audit Committee. In reporting the results, the study will be graded as follows:
Exceptional: Evidence of excellent source documentation, data quality, protocol and regulatory compliance.
Satisfactory: Few minor deviations/violations noted. No response required.
Acceptable, Requires Follow-up: Major deviations/violations and/or many minor deviations/violations noted. Requires a written corrective plan.
Unacceptable: Requires (as a minimum) a written corrective plan and interim re-audit interval clearly specified in the audit report.
The acting IRB Co-Chair determines whether the findings should be reviewed by the full IRB. The IRB Co-Chair's/IRB's comments will also be forwarded to the PI. If corrective action is necessary, PI will be notified.
