RCA Frequently Asked Questions
What is the difference between a routine and directed review?
A certain number of routine reviews are selected each quarter based on a risk metrics developed by RCA. A directed review is a review that has been requested by a department, the IRB, SOM administration or is the result of a subject or anonymous complaint. Both types of reviews are conducted according to the SOPs for research compliance assurance review.
How are routine protocol selections made?
The Administrative Development Group (ADG) has developed a query which allows RCA to mine the IRB database for routine review protocols with the following risk factors:
- Does the study involve an IND or IDE?
- Who holds the IND/IDE?
- What phase of a study is involved?
- Is the protocol federally funded?
- Does the protocol recruit vulnerable populations?
- How many subjects are enrolled?
- How many safety events and protocol deviations have been filed with the IRB?
How am I notified?
If your IRB protocol is selected for a review you will receive a Letter of Intent to Review via e-mail from our office. This correspondence will provide you with a selection of dates from which to choose and requests that you complete and return the attached questionnaire with your enrollment log within 7 days.
What does RCA review?
RCA will require full access to all source documentation (e.g., medical records, appointment logs, laboratory results, shadow charts), internal SOPs, all subject information (such as Case Report Forms, electronic or paper and screening logs), personnel certification records (such as IRB certification, clinical certification, and Occupational and Environmental Safety Office certification), regulatory documentation and site activity areas (such as file storage, drug/device storage, subject examination areas). The reviewer will determine whether the requested subject information is available and will then assess the following protocol elements:
- Protocol specific regulatory binder and IRB documentation
- Review of the contract or grant for consistency with practice
- Case Report Forms
- Signed Informed Consents
- Research article accountability and storage
- Record retention and storage
- Overall data quality
Will I need to provide RCA with access to my electronic systems/databases?
Yes. RCA will need to validate the accuracy of electronic databases as part of the review. As such, we will need access to the electronic database or the study team will need to provide copies of the eCRFs via paper or CD.
What should be in my enrollment log?
An Enrollment Log Tip Sheet can be found on the Duke Office of Clinical Research (DOCR) website at the following link.
The minimum information that should be included is as follows: subject’s first and last name, medical record number (if applicable) Subject ID #, screen failure status, consent date and end study date. If the enrollment log is maintained in Maestro Care then RCA staff can retrieve a copy from there.
Who needs to attend the opening meeting and what happens there?
The RCA reviewers prepared for the on-site portion by reviewing all documentation in IRB and becoming extremely familiar with the requirements of the protocol. This extensive review can generate questions and the opening meeting is an opportunity for those questions to be answered prior to beginning the on-site portion of the review. The opening meeting is also an opportunity for the study team to meet with the assigned reviewer and answer any questions that the study team may have about the review. A typical opening meeting should take no more than 30 minutes. The meeting should be attended by the PI and study coordinator and these individuals may invite anyone else they feel would benefit from meeting the reviewer. The CRU medical director and research practice manager are notified of the date and time, but they are not required to attend.
I already get monitored by my sponsor, why is RCA coming to review me too?
The review will serve as a quality assurance measure, internal to the institution. Additional goals of such reviews are to detect both random and systemic errors occurring during the conduct of clinical research and to emphasize “best practices” in the research/clinical trials environment. Generally, a RCA review is much more in depth than a study monitor visit.
How many informed consents will RCA review?
The number of consents reviewed will depend on the study, but generally RCA will review a minimum of 20% of the consents. An exact number is left to the discretion of the reviewer.
How many reviewers will there be?
The on-site portion of the human subjects audit will generally involve only one reviewer unless there are a large number of subject and/ or consents to be reviewed or there is a new individual training in RCA human subjects reviews. Occasionally, RCA will also be accompanied by someone wanting to learn about our process by way of shadowing a review.
Who needs to attend the closing meeting and what happens there?
The PI and study coordinator must attend the closing meeting. The CRU medical director and research practice manager are notified of the meeting but are not required to attend. Any additional attendees are at the discretion of the study team. At the closing meeting the reviewer(s) will present a draft summary of the noted observations. This is a working meeting and is a time to clarify issues and discuss the observations prior to the final compliance review summary being issued. After the closing meeting, the study team has 5 business days to clarify any human subject issues with the reviewer prior to the final summary being issued.
What kind of summaries do I get and what do I need to do?
As a part of the review, you will receive a Final Compliance Review Summary for the human subject portion of your study. The summaries will contain observations and action plans that will need to be completed within the required time frame, usually 25-30 business days. You may also get a client Services Memo which may contain items the review feels would benefit the study team going forward as best practices.
What types of observations are contained in the summary?
Observations include but are not limited to the following types of issues:
- Violation of federal or state law or regulation that could lead to a government enforcement action, penalty, exclusion action or debarment
- Violation of good clinical practices (which have been cross referenced and adopted as the standard for Duke research in institutional policies
- Violations of the Common Rule
- Violation of institutional policies or procedures
- Any observation warranting a deviation report to IRB. These deviations are evaluated by the IRB for an independent determination of whether it constitutes serious or continuing noncompliance Unintended problem for subject or others that should be reported to IRB to determine if it should be reported as potential Unintended Problem Involving Research Subjects or Others
- Unreported SAEs
- IND IDE issues - not having one when needed, lack of annual reports, failure to fulfill sponsor obligations such as monitoring if Duke holds IND IDE
- Drug accountability issues
- Temperature control issues (could affect patient safety)
- Subject eligibility issues (inclusion/ exclusion / waiver from sponsor/ IRB)
- Substantive consent issues (wrong version of ICF if difference is material, unauthorized consenters)
- Any indicia of subject coercion
- Any indicia of falsification/ fabrication or plagiarism (referred over to Research Integrity Office for investigation)
- HIPAA breaches or lack of HIPAA Authorization, lack of appropriate waivers, transmission of PHI unencrypted. Violations of HIPAA Privacy or Security rule
- Broken blinds
- Research prior to consent
- Material discrepancies in research records (dates not matching in various documents, subject and consenter not signing on same day, etc.
- Failure to fulfill corrective actions from monitors
- Minor observations that are significant in number
What are the most common findings?
- Protocol deviations that need to be filed
- Informed consent /consent process issues
- HIPAA violations
- Signature and Delegation of Authority log issues
- Missing data/CRF errors
- Protocol not being followed as written/IRB approved
- Subject eligibility (inclusion/ exclusion criteria)
- Missing original consent forms
If I am reviewed what is the length of time before I might be reviewed again?
If a study is selected for a routine review it will be a minimum of two years before that same PI would be selected for another routine review. However, a directed review can occur at any time and may cover multiple protocols belonging to the same PI.
Who gets a copy of the Final Compliance Review Summary?
The Final Compliance Review Summary is distributed to the PI, study coordinator and the following institutional officials: Associate University Counsel; Vice Dean for Research; Chief Compliance Officer, Duke University; DUHS Chief Medical Officer; Vice Dean for Research Informatics; Executive Director, Duke Institutional Review Board; Director, Human Subject Research Compliance; Director, Duke Office of Clinical Research; Assistant Dean for Clinical Research; Associate Dean, Resource Planning; CRU Medical Director and CRU Research Practice Manager.
How long do I have to complete my corrective actions?
The Closing Meeting Summary will contain the dates by which corrective actions must be completed, generally 25 business days from the date of the closing meeting, unless an extension is requested in writing.