7 Ways to Help Prevent Common Non-Compliance Issues
The May issue of the HRPP/IRB Bulletin introduced our series, "7 Ways to Help Prevent Common Non-Compliance Issues" and listed seven common compliance pitfalls:
1. Assess Your Research Plan Feasibility
2. Data Collection Forms and Checklists
3. Standard Operating Procedures (SOPs)
4. Resource Availability
5. Training
6. Documentation
7. Reporting
If you missed the June issue, catch up on "Topic #1 Assess your research plan feasibility" here.
The July issue continues this series by taking a deep dive into Data Collection Collection Forms and Checklists.
#2: Data Collection Forms and Checklists:
Creating data collection forms and checklists can increase compliance with the protocol by helping you and your study team members keep track of what is required at each step of the study.
By customizing your own data collection forms and/or checklists, your team can both ensure the safety of participants and ensure the integrity of the data collected.
For example, here are some of the tools you can use to keep your study on track:
- Participant screening and enrollment logs
- Consent and consent process logs
- Telephone/Communication log
- Procedural logs: study visits, interview(s), or survey tools
- Regulatory logs/folders/binders including:
- IRB Approvals Memos
- Protocol Modification Log
- Protocol Deviation and Adverse Event Logs
- Drug or Device Accountability logs
- Delegation of Authority Logs
- Staff Training Logs
Using these tools can assist you and your study team in the conduct and management of your research and should be used as guidance for setting up research studies and conducting periodic self-guided quality assurance reviews.
You can either create your own forms and checklists to suit your specific needs or you can use previously created templates provided by the Quality Assurance and Evaluation (QAE) team.
Please find the QAE checklists here.
These checklists are provided to the study team prior to any Post-Approval Monitoring (PAM) Review, but are available on our website at any time. We encourage researchers to familiarize themselves with our self-assessment checklists as a way to ensure you are conducting your research in compliance with IRB regulations and policies, as well as the protocol’s approved procedures.
We hope these checklists assist you and your staff with federal, state, and university expectations and assessing your own programs.
For assistance please contact:
Andrea Dragan, Quality Assurance and Evaluation Director
andrea.dragan@rutgers.edu
Barbara LoDico, Quality Improvement Senior Analyst
Barbara.lodico@research.rutgers.edu
Kathleen Villipiano, Compliance Administrator
Smithk6@research.rutgers.edu
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