One-Year Improvement Plans

When reviewing reports of non-compliance, the IRB ensures that appropriate actions are taken to (a) correct the existing problem and (b) prevent the problem from happening again in the future. The IRB may require a one-year improvement plan as part of the preventive action for non-compliance determinations. The one-year improvement plan is intended to provide enhanced monitoring of compliance such that the IRB can determine if problems are appropriately addressed and prevented.  

Elements of a One-Year Improvement Plan

The IRB may choose to include one or more of the following elements in a one-year improvement plan, depending on the type of non-compliance reported. In some cases, the IRB may include elements not listed below based on the specific study/non-compliance. Investigators must consult the non-compliance determination letter for the specific elements required and complete each element according to the timeline specified by the IRB.  

• Additional training requirements for study team members
• An enhanced data monitoring plan
• An enhanced safety monitoring plan
• Increased reporting to the IRB

Each of these elements is described in detail below.

Additional Training Requirements

The IRB may require that study team members receive additional training to supplement their knowledge of regulation and IRB policy, such that compliance with regulation and IRB policy may be improved. To fulfill the training requirement, documentation of completion must be provided to the IRB showing that each study team member completed the necessary training within one year from the date the IRB placed the requirement.  Generally, the IRB requires that additional training be completed in the very early stages of the one-year improvement plan and a deadline for training completion is likely to be within one month from the date the PI receives the determination letter.  

The following training options may include, but are not limited to, the following:

Good Clinical Practices Training 

The IRB will either (a) give you a choice of one of the following options or (b) require a particular training. Refer to your determination letter to determine which training option you should complete.

• • Good Clinical Practices module via the online CITI Program (www.citiprogram.org).  See instructions on the Investigator & Research Staff Training page for instructions on accessing this module.  CITI Program will issue a completion certification.
  • Online modules through OnlineGCP.com.  An individual license for this course is $120.  Group licenses can also be purchased.  OnlineGCP.com will issue a completion certificate.  

Informed Consent Training

The IRB will either (a) give you a choice of completing a recommended training or (b) require a particular training. Refer to your determination letter to determine which training option you should complete.

IRB Policy and Guidance Training

The IRB may require the study team to read various IRB policies and guidance documents that are available online. Refer to your determination letter to determine which documents you should read. To document completion of this requirement, the PI must submit a signed memo indicating the documents that were read and the names of the study team members who completed the requirement. The PI should maintain written confirmation from each study team member that the requirement was completed (e.g., an email or memo from the individual, an initialed and dated copy of the policy/guidance document, etc.).

IRB SOPs and primary guidance documents are available using the following hyperlinks; however, the IRB may choose to have the study team read documents not listed on these webpages.

• • IRB SOPs
  • Investigator Guidance Series

Enhanced Data Monitoring Plan

The IRB may require that the study implement a more frequent or targeted data monitoring plan, such that compliance with the protocol, regulation, and IRB policy may be improved over time. The IRB will stipulate in the determination letter if this monitoring may be completed by a member of the study team, an independent auditor, or a combination of both. The IRB generally expects that this enhanced plan will be followed for the duration of the study not just during the one-year improvement period; however, the IRB will specify which components of the enhanced plan are for the lifetime of the study and which are for the one-year improvement period only.   

If an enhanced data monitoring plan is requested, the study team must submit an amendment to their application to update the Data Monitoring Plan page of their application to reflect the requirements that the IRB expects for the study. The amendment must be submitted within one month from the date the PI receives the determination letter. If an independent audit is required, the independence of the auditor must be confirmed by the IRB via the amendment. The study team is responsible for any and all costs associated with use of an independent auditor.  

Data monitoring must be completed according to the timelines and specifications of the IRB. The study team must complete and document each data monitoring event according to the requirements for Data and Safety Monitoring, which is usually done via an audit report written by the person who conducted the audit. Study teams or an independent auditor may use the Investigator Self-Assessment Checklists to conduct the audit to ensure the appropriate components of the study are monitored.  

Enhanced Safety Monitoring Plan

The IRB may require that the study implement a more frequent or targeted safety monitoring plan, such that compliance with the protocol, regulation, and IRB policy may be improved over time to ensure the safety of participants. The IRB will stipulate in the determination letter if this monitoring may be completed by a member of the study team, an independent monitor, a data and safety monitoring board (DSMB), or a combination of all three. The IRB generally expects that this enhanced plan will be followed for the duration of the study not just during the one-year improvement period; however, the IRB will specify which components of the enhanced plan are for the lifetime of the study and which are for the one-year improvement period only.   

If an enhanced safety monitoring plan is requested, the study team must submit an amendment to their application to update the Safety Monitoring Plan page of their application to reflect the requirements that the IRB expects for the study. The amendment must be submitted within one month from the date the PI receives the determination letter. If an independent monitor or DSMB is required, the independence of the monitor/DSMB must be confirmed by the IRB via the amendment. The study team is responsible for any and all costs associated with the identification of an independent monitor or creation of an independent DSMB. 

Safety monitoring must be completed according to the timelines and specifications of the IRB. The study team must complete and document each safety monitoring event according to the requirements for Data and Safety Monitoring, which is usually done via a safety/DSMB report written by the person(s) who performed the review. 

Increased Reporting to the IRB

The IRB generally requires that the study team report their progress during the one-year improvement period. This increased reporting is in addition to the standard reporting requirements of the IRB. Progress reports must be prepared by the study team and will discuss the efforts made to meet the requirements in the determination letter, generally discussing the results of data and safety monitoring events. Progress reports are required either quarterly or bi-annually, which will be stated in the determination letter, and due dates for progress report submissions will be given. Progress reports must be submitted as a report of information in ERICA.  

When preparing a progress report, the study team must address the following points:

1. Findings from data and safety monitoring events
2. Corrective actions taken to address findings from data and safety monitoring events
3. Preventive actions put in place to prevent newly identified non-compliance or unanticipated problems from occurring in the future

If individual findings from data and safety monitoring events would be reportable as non-compliance or unanticipated problems, these must also be reported separately from the progress report. In these cases, normal reporting deadlines for prompt reporting apply. For example:

• If the data monitoring identifies several consent deviations that meet deviation reporting criteria, a report form for the deviation must be promptly submitted in addition to the progress report that will be submitted as a report of information.  
• If the safety monitoring identifies an unexpected, related adverse event, a report form for the unanticipated problem must be promptly submitted in addition to the progress report that will be submitted as a report of information.

Finishing a One-Year Improvement Plan

After one year, the IRB will review the progress that has been made and determine if additional actions are needed. The IRB will issue a final letter to either (a) confirm that the requirements of the one-year improvement plan have been met, or (b) request additional actions.  After the one-year period has ended, increased reporting is no longer required and study teams are required to follow the standard reporting requirements.