27 - Using a RedCap form as an RNI submission tool

Background:  Despite training, outreach, and guidance, study teams submit RNIs that lack sufficient information for the IRB to evaluate the RNI reportability, root cause, effect on risks and/or benefits, CAPA, and subject notification requirements. To address this problem, our IRB created an RNI appendix form.

Program

Description:  We piloted an RNI appendix form as a supplement to the base RNI application in our electronic submission system. The RedCap-hosted appendix collects information required for the review of RNIs including the number of affected subjects, study and subject impact, root causes, and the scope, timeline, and documentation of corrective and preventive actions. The appendix was created with input from HRP Leadership, IRB chairs, board members, and RNI reviewers.

During the 12-month pilot period, the RNI pre-reviewers asked teams to complete the appendix whenever an RNI was missing a CAPA or RNI review requirement. The appendix was used to report a range of protocol violations, researcher errors, and noncompliance events. In total, the appendix was used for 51 RNI submissions from 38 studies. We sent a survey with quantitative and open-ended questions to the 38 teams who used the RNI appendix during the pilot period.

Program

Assessment:  29 researchers (76%) completed the post-pilot feedback survey. Most respondents (n=22) submitted 1-3 RNIs during the pilot. Using the appendix resulted in an equal or less time-intensive review process for 18 respondents (62%). 17 respondents (59%) said the appendix improved their ability to provide all the RNI submission requirements while six (21%) did not see a difference. Response to the form was overwhelmingly positive with 20 respondents (69%) endorsing a favorable experience with the form while seven respondents (24%) were neutral.
The RNI appendix improved and streamlined the RNI review process for teams, RNI reviewers, and board members. We obtained qualitative feedback from IRB members and RNI reviewers. Board members found RNIs that used the appendix easier to evaluate. Using the appendix decreased the number of administrative pre-reviews required to confirm the event met reporting criteria and prepare the submission for IRB review. There were also fewer rounds of pre-review spent flushing out CAPA elements since the appendix includes a mix of open-answer and multiple-choice options for corrective and preventive actions.

Limitations: - In response to requests to shorten the form, we incorporated branching logic into the final version of the appendix to hide questions that don’t apply to a particular RNI submission.
- Since the appendix is based in Redcap, teams must remember their return code to make any edits requested during pre-review. To address this, we include reminders in the appendix and during pre-review for teams to save the return code.

Discussion:  The use of an RNI appendix improved and streamlined RNI submissions and will be useful for any institution that adopts it. However, we are still receiving many RNIs that don’t meet reporting criteria. Our IRB has started working on simple solutions to educate and guide study teams. Institutions considering adopting the RNI appendix should also consider the creation of simplified RNI guidance or decision aids.