Research Education and Quality Management

There are many regulatory requirements, policies, standard operating procedures (SOPs) and ICH Good Clinical Practices that investigators are responsible for complying with when conducting a research study.

REQM offers new study start-up services to help investigators and coordinators ensure they understand all of the requirements of conducting a study and maintaining complete and accurate research files prior to initiating a new study. This is a voluntary service, so you are not required to participate. However, you are encouraged to take advantage of any of the services that you think would be useful to you.

New study start up assistance may include:

• A short (30 minute) meeting at your site.
• Discussion of the purpose of a Regulatory Binder and the contents. If you have not started a Regulatory Binder, one can be provided to you with the documents you will need for your study.
• Providing and reviewing tools for study management (IRB documentation, subject file documentation, tools for tracking enrollment, delegation logs, protocol deviation logs, monitoring logs, etc.).
• Discussion of the documentation requirements when obtaining informed consent. If you do not have an Informed Consent Discussion Checklist, one can be provided to you with a template.
• An opportunity for you to ask any questions you may have.
• Attendance at research staff training meetings scheduled by the PI to assist in answering questions on topics such as best documentation practices or the informed consent processes.
• Any discussions and recommendations from the study start up program do not become part of the study record and are not shared with the IRB. These services are provided as support and education for researchers as a way to assist in the successful conduct of research.

This is an opportunity for study staff to ask questions and obtain guidance specific to their protocol. The study staff may request a consultation meeting or be invited by the REQM to participate. Consultation topic examples include record keeping, adverse event reporting, and the informed consent process. REQM can also provide assistance with study-specific tools for ensuring compliance and successful study management.

Routine Reviews are not-for-cause assessments of research practices initiated by Research Education & Quality Management or study staff. Routine

Reviews are performed as a service to investigators, with feedback provided regarding the conduct of the study. Activities may include a brief meeting at the beginning of the visit, review of study files, and an exit interview. A written report of observations and corrective actions is provided following the review. Written reports are distributed to the PI and Research Coordinator for quality improvement and educational purposes. The final report does not become part of the study record and is not shared with the IRB. If any serious findings are identified, the report will include directions to promptly report those specific findings to the IRB.

Regulatory Binder

• Regulatory Binder Guidance & Template
• Participant ID Log
• Enrollment Log
• Subject Screening Log
• Concomitant Medications Log
• Study Visit Log
• Deviation & Minor Non-Compliance Tracking Log
• Adverse Log
• Study Site Signature & Delegation of Responsibility Log
• Study Team Tracking Log
• IRB Communication Log
• Gift Card Tracking Log

Investigational Product Accountability

• Device Accountability Log
• Device Inventory Log

Checklists

• Documentation of Consent Checklist & Note
• Subject Study File Checklist
• Consent Process Feedback Tool

Other

• Note to File Template
• Corrective Action Preventive Action Plan (CAPA) Guidance and Template

Investigators may choose to evaluate effectiveness and improve quality of their research through a self-assessment. The self-assessment evaluation checklist can be used to verify compliance, identify areas needing improvement, and familiarize the study team with regulations and proper research conduct. Research Education & Quality Management is available to any questions the investigator may have during or at the conclusion of a self-assessment evaluation.

• Investigator Self-Assessment Evaluation Checklist
• Informed Consent Form Self-Review

Regulatory Templates

• Regulatory Binder Guidance & Template
• Note to File Template
• HUD Patient Log
• HUD Team Tracking Log
• HUD Communication Log

For-Cause audits are initiated to obtain or verify information necessary to ensure compliance with the regulations and institutional requirements and to inform decisions about the conduct of human subjects research and/or human subject protection.

The IRB may request a For-Cause audit as part of ensuring protocol compliance. Other reasons for initiating an audit include, but are not limited to, subject or sponsor complaints, Ascension Wisconsin Official request, and in response to concerns raised by government agencies. Results are reported to the Research Integrity and Protection Program Director and the requesting individual/IRB.

In addition to monitoring the conduct of research, REQM staff also routinely monitors IRB activity. Routine evaluations of IRB operations are conducted to review and assess the IRB files, database records, actions of the convened IRB, membership roster and IRB meeting minutes.